1. Adequate Inspectorate Staff in States and Centre:
In India, we have one Drug Inspector overlooking one and sometimes more than one districts at a time. Reportedly there are more than 3.5 lakh sales outlets and only 800-900 drug inspectors for about 600 districts in the country. As per established guidelines, there ought to be at least one Drug Inspector designated for every 100 drug sales establishments or for every 25 manufacturing units. They are the only personnel legally empowered to enforce various provisions of the Drugs and Cosmetics Act. We should have them in adequate numbers so that they share a manageable jurisdiction and workload. This has not only been necessitated by the Mashelkar Committe (2003) but also endorsed vide orders of the Supreme Court of India and the recommendations of several committees like Hathi Committee report (1975), National Human Rights Commission Report (1999) and the report of Parliamentary Standing Committee on Petroleum and Chemicals (2001).
In most of the states across India there is paucity of Drug Inspectors and their jurisdiction/workload is not fairly manageable. Recently governments of Karnataka and Gujrat have undertaken drives to recruit good number of Drug Inspectors for their FDAs. In J&K too, a proposal towards creation of 72 posts of Drug Inspectors for their placement at Medical Block level in the state, framed by me on behalf of the J&K Pharmacy Graduates Association was endorsed by the Drugs Controller of the state and subsequently accepted by the ministry of H&FW, J&K govt. The posts already stand advertised and the recruitment process is on at present. There is lack of adequate transportation, accommodation, communication and judicial assistance facilities to the available inspectorate. In J&K, Drugs inspectors are not even conferred Gazetted status making them incompetent to launch proceedings for over-charging of drugs under the provisions of Drug Prices Control Order, 1995.
2. Appropriate Legal Assistance and Intelligence Cells:
The inspectorate have to spend most of their time in courts pleading for various prosecutions launched by them and they are left with no time to conduct any secret probe against possible spurious drug rackets functioning in their jurisdiction areas. There is urgent need to create separate intelligence and legal cells in state as well as central offices with adequate provisions of secret funds and incentives for informers. Further special courts need to be designated to exclusively try the cases of spurious drugs. There should be appropriate incentives for informers who provide vital clues leading to seizure of spurious medicines or busting of such rackets.
3. Adequate Drug Testing Facilities in States and Centre:
Adequate and up-to-date drug testing facilities are essential for an exact estimation of frequency and prevalence of spurious drugs in the market. As such, there is a need for an urgent augmentation of the drug testing facilities in every state in respect of equipment, technical staff and infrastructure. Modernization and up-gradation of the laboratories should be taken up at war footing basis. Latest testing equipments like HPLC, HPTLC, GC/MS, FTIR, NMR and UV-Spectrophotometry need to be introduced without further delay. Continuing education programmes, training workshops etc will have to be conducted for training the existing technical staff in handling such instruments. Moreover an ever-increasing need for more extensive testing and analysis of drugs and pharmaceuticals demand more number of posts of Govt. Analysts and other skilled technical personnel for such analysis. Annual testing load and average testing time of each laboratory should be streamlined and fixed in line with the available facilities. All testing laboratories should be sophisticated to the extent of making them able to test all kinds of drugs including parenterals. At present, most of the parenteral products are sent by the state laboratories to CIPL, Ghaziabad as the necessary facilities are not available here thus causing inordinate delay in initiating legal proceedings against the defaulters. Quality control cells will have to be constituted in every major hospital as part of in-house Quality Assurance system.
4. Creation of awareness among masses:
There is lack of awareness and paucity of informational inputs by common consumers in regard to sub-standard, spurious, adulterated and misbranded drugs, resulting into failure of administration in busting the rackets of spurious drugs. There should be introduction of fundamental medical and health education at the basic high school level. There should be greater recognition of the distinction between qualified and non-qualified pharmacists and the role that can be played by the qualified pharmacists in strategic and scientific administration, preparation, sale, storage and distribution of drugs and pharmaceuticals. Further there should be more resistance on part of druggists, chemists and patients against unethical and irrational prescriptions. There should be larger establishment of private, govt.-approved drug testing laboratories by qualified pharmacists and related NGOs.
5. More Stringent Drug Legislations:
The existing provisions i.e., Section 274, 275 and 276 of IPC/CrPc related to drug offences need to be made non-bailable and cognizable and in consonance with the provisions of the Drugs and Cosmetics Act, 1940. There has been no major amendment in the Drugs and Cosmetics Act, 1940 since 1982. Unlike Labour laws, Act does not allow on-the-spot imposition of fines by inspectorate. As a result, matters get dragged in lengthy judicial procedures yielding very few convictions. Section 27 of the Drugs and Cosmetics Act, 1940 lists out penalties for various contraventions of the Act and Rules thereunder but at the same time authorizes courts to impose a lesser sentence of imprisonment or fine in view of some adequate or special reasons which unfortunately are not amply clear and well-defined in the Act, resulting into reduction of punishments by courts on clumsy and inadequate grounds to only a few hours of imprisonment and a fine up to a few hundred rupees only. At present the offenders usually get bails and the prosecutions normally take about 10-15 years for any judgements. In many cases, the offender may get away with minor punishment whereas in all likelihood, he continues to indulge in spurious drug trade during the period of his trial.
Procedure prescribed under Section 25 of D & C Act, 1940 for retesting of drugs is faulty and provides an ample opportunity for the offenders to escape from the jaws of law. The procedure is so cumbersome, tedious and lengthy that the drug samples in question get expired even before it is retested or any prosecution is launched against the offenders. Narcotic Drugs and Psychotropic Substances Act, 1985 though a strong, stringent and powerful piece of legislation, is not being properly implemented in most of the states due to lack of adequate enforcement staff and non-delegation of relevant powers under the Act to the available manpower.
6. Constitution of Central Drug Authority:
Decision on setting up of National Drug Authority had been taken in 1994 but the same has not been implemented till date, reportedly due to lack of infrastructure. NDA was to be set up for monitoring the prescribing practices and evaluation of their appropriateness for the purpose of guiding the medical professionals and for achieving the aim of rational prescribing. Further it was envisaged that NDA shall be levied with the task of monitoring the standard practices in drug promotion and use, clearly identify those that are acceptable and prohibit those which are unethical and against the consumers’ interests. Failure of the government to establish NDA/CDA has been the biggest hurdle in the way of ethical prescribing and rational use of drugs.
Sunday, September 12, 2010
Saturday, September 11, 2010
Major impediments in the quality control and rational use of medicines in J&K state
The Quality of a product has been defined as its “fitness for a purpose”. “Quality Control” could be defined as any process, or a series of processes, which guarantee the fitness of a product for a given purpose. The concept of “Total Quality Control” refers to the process of striving to produce a perfect product by a series of measures requiring an organized effort by the entire company to prevent or eliminate errors at every stage in production. To be effective, Quality Control process must be supported by team effort.
Because of the increasing complexity of modern pharmaceutical manufacture arising from a variety of unique drugs and dosage forms, complex ethical, legal and economic responsibilities have been placed on those concerned with the manufacture of modern pharmaceuticals. An awareness of these factors is the responsibility of all those involved in the development, manufacture, control, sale and marketing of quality products.
Over the past few years, there has been increasing concern among the masses in regard to the progressively deteriorating quality control of drugs and their irrational use. A host of social, political, economic, legal and administrative factors have been attributed to this grim scenario. Some of these factors are discussed as under.
1.0 SOCIAL FACT0RS:
1.1 Lack of awareness among masses in regard to Quality Control of drugs and about the difference between misbranded, adulterated, spurious and sub-standard drugs.
1.2 Lack of awareness among masses regarding legal aspects concerning quality control. For instance, common people do not realize the significance of cash memos and do not demand the same upon every purchase of drugs.
1.2.1 Consequences of non-issuance of Cash-memos:
i) sale of spurious drugs
ii) overcharging of taxes
iii) sale of drugs without prescriptions resulting into self-medication, drug-addiction, abuse etc.
iv) Failure of enforcement agencies in getting such dealers convicted by the court of law.
1.3. Lack of informational inputs by common consumers in regard to sub-standard, spurious, adulterated and misbranded drugs, resulting into failure of administration in busting the rackets of spurious drugs.
1.4. Lack of complaints made by consumers to concerned authorities in the event of ineffectiveness of a genuine formulation.
1.5. People resorting to self-medication and consultation by Medical Assistants, Compounders, fake medical practitioners etc resulting into severe and even serious adverse drug reactions, ineffectiveness of medication, improper diagnosis and inappropriate therapy
1.6. Lack of fundamental medical and health education at the basic high school level.
1.7. Lack of recognition of the distinction between qualified and non-qualified pharmacists and the role that can be played by the qualified pharmacists in strategic and scientific administration, preparation, sale, storage and distribution of drugs and pharmaceuticals.
1.8. Lack of resistance on part of druggists, chemists and patients against unethical and irrational prescriptions.
1.9. Lack of establishment of private, govt.-approved drug testing laboratories by qualified pharmacists and related NGOs.
2.0 LEGAL FACTORS:
Drug services to common masses and related issues are regulated through following laws:
» Drugs and Cosmetics Act, 1940
» Drugs and Cosmetics Rules, 1945
» Pharmacy Act, 1948
» Drug Prices Control Order, 1995
» Narcotic Drugs and Psychotropic Substances Act, 1985
The existing provisions i.e., Section 274, 275 and 276 of IPC/CrPc related to drug offences are bailable and cognizable and are not in consonance with the provisions of the Drugs and Cosmetics Act, 1940.
2.1 There has been no major amendment in the Drugs and Cosmetics Act, 1940 since 1982, which was passed with an objective to regulate the sale, storage, manufacture and distribution of Drugs and Cosmetics.
2.2 There are several loopholes in this Act that pave way for the safe passage of offenders.
2.3 Unlike Labour laws, Act does not allow on-the-spot imposition of fines by inspectorate for violating various norms like sale of drugs without prescription, not displaying the license within premises, stocking of expired drugs within the premises, absence of “qualified person” from the sales premises, stocking of physicians samples etc. Inspectorate has to launch formal prosecutions for such petty offences also. As a result, matters get dragged in lengthy judicial procedures yielding very few convictions.
2.4 Section 27 of the Drugs and Cosmetics Act, 1940 lists out penalties for various contraventions of the Act and Rules thereunder but at the same time authorizes courts to impose a lesser sentence of imprisonment or fine in view of some adequate or special reasons which unfortunately are not amply clear and well-defined in the Act, resulting into reduction of punishments by courts on clumsy and inadequate grounds to only a few hours of imprisonment and a fine up to a few hundred rupees only. At present the offenders usually get bails and the prosecutions normally take about 10-15 years for any judgements. In many cases, the offender may get away with minor punishment whereas in all likelihood, he continues to indulge in spurious drug trade during the period of his trial.
2.4 Procedure prescribed under Section 25 of D & C Act, 1940 for retesting of drugs is faulty and provides an ample opportunity for the offenders to escape from the jaws of law. The procedure is so cumbersome, tedious and lengthy that the drug samples in question get expired even before it is retested or any prosecution is launched against the offenders.
2.5 Pharmacy Act, 1948 has become obsolete and redundant due to lack of adequate and proper amendments from time to time. Even after 55 years of its enforcement, the Act does not extend to the state of Jammu and Kashmir.
2.6 Narcotic Drugs and Psychotropic Substances Act, 1985 though a strong, stringent and powerful piece of legislation, is not being properly implemented in most of the states due to lack of adequate enforcement staff and non-delegation of relevant powers under the Act to the available manpower.
3.0 ADMINISTRATIVE FACTORS:
3.1 Insufficient workforce and excessive workload.
3.1.1 Guidelines put forth by several committees prescribe one inspector for every 100 drug sale outlets or every 25 manufacturing establishments, whereas at state levels there are only 14 inspectors in 14 districts of J&K State. Reportedly there are more than 3.5 lakh sales outlets and only 800-900 drug inspectors for about 600 districts in the country.
3.1.2 There are only 32 inspectors with CDSCO whose capacity is 72 inspections per year whereas the need is 2800 inspections annually @ a minimum of two inspections per establishment per year.
3.1.3 The kind of budget the Drug Control Department receives is somewhere in the region of Rs. 25 crore under non-plan and Rs. 10 crore under planned expenditure. With this kind of budget it is impossible to do anything.
3.1.4 There are about 4000 manufacturing units of whom hardly 20% are in the organized sector and account for about 145 in number, the rest are in the small scale sector which are hard to be monitored by such a meager inspectorate staff.
3.1.5 Number of prosecutions being launched is declining day by day. The number of cases of sub-standard drugs etc coming to notice is only about 11 % and even that is on a plateau. Based on the samples tested by the state drug controlling authorities during the period 1995 – 2003, the extent of sub-standard drugs varied from 8.19 to 10.64 % and of spurious drugs varied between 0.24 % to 0.47 % whereas Confederation of Indian Industries (CII) has recently revealed that spurious drugs comprise 18 % of total pharmaceutical production in India causing revenue loss to the tune of whopping Rs. 4112 crores annually. This raises serious doubts about the quality and quantity of testing by our government laboratories.
3.2 Lack of adequate transportation, accommodation, communication and judicial assistance facilities to the available inspectorate. In J&K, Drugs inspectors are not even conferred Gazetted status making them incompetent to launch proceedings for over-charging of drugs under the provisions of Drug Prices Control Order, 1995.
3.3 Standards of Good Manufacturing Practices not being enforced properly by the state governments. At present there are over 16000 licensed drug companies in India producing about 500 bulk drugs and over 60,000 formulations. Indian Pharmaceutical Industry has a domestic turnover which is worth more than Rs. 20,000 crores, and exports worth over Rs. 10,000 crores, making quality control and enforcement of GMP standards by the limited workforce even more difficult.
3.4 No substantial headway in the direction of upgradation and modernization of state as well as centrally-run drug testing laboratories. Out of information provided by 26 states to the recently framed Mashelkar Committee, only 15 drug-testing laboratories have been found to be functional and out of 15 state having their own testing laboratories, only 7 are reasonably equipped or staffed for being able to test all categories of drugs, while the other states are poorly staffed and equipped and do not even have the bare minimum equipment. The total testing capacity for the state and central laboratories is only 3500 samples per year against a need for around 10,000 samples per year. Drug testing facilities in the states badly need to be augmented and drug testing time needs to be brought down to one month which in many states extends to six months.
3.5 The inspectorate have to spend most of their time in courts pleading for various prosecutions launched by them and they are left with no time to conduct any secret probe against possible spurious drug rackets functioning in their jurisdiction areas. There is urgent need to create separate intelligence and legal cells in state as well as central offices with adequate provisions of secret funds and incentives for informers. Further special courts need to be designated to exclusively try the cases of spurious drugs.
4.0 IRRATIONAL USE OF DRUGS:
4.1 Several combinations and formulations available in the markets have been identified as irrational by several expert groups.
4.2 Pharmaceutical companies offer their brands at cheaper rates with huge margins for retailers and exorbitant complimentary gifts and commissions for physicians. No definite mechanism or regulations to curb unethical prescribing by doctors or to control unjustified distribution of costly gifts by Pharmaceutical companies are in place.
4.3 Decision on setting up of National Drug Authority had been taken in 1994 but the same has not been implemented till date, reportedly due to lack of infrastructure. NDA was to be set up for monitoring the prescribing practices and evaluation of their appropriateness for the purpose of guiding the medical professionals and for achieving the aim of rational prescribing. Further it was envisaged that NDA shall be levied with the task of monitoring the standard practices in drug promotion and use, clearly identify those that are acceptable and prohibit those which are unethical and against the consumers’ interests. Failure of the government to establish NDA has been the biggest hurdle in the way of ethical prescribing and rational use of drugs.
Because of the increasing complexity of modern pharmaceutical manufacture arising from a variety of unique drugs and dosage forms, complex ethical, legal and economic responsibilities have been placed on those concerned with the manufacture of modern pharmaceuticals. An awareness of these factors is the responsibility of all those involved in the development, manufacture, control, sale and marketing of quality products.
Over the past few years, there has been increasing concern among the masses in regard to the progressively deteriorating quality control of drugs and their irrational use. A host of social, political, economic, legal and administrative factors have been attributed to this grim scenario. Some of these factors are discussed as under.
1.0 SOCIAL FACT0RS:
1.1 Lack of awareness among masses in regard to Quality Control of drugs and about the difference between misbranded, adulterated, spurious and sub-standard drugs.
1.2 Lack of awareness among masses regarding legal aspects concerning quality control. For instance, common people do not realize the significance of cash memos and do not demand the same upon every purchase of drugs.
1.2.1 Consequences of non-issuance of Cash-memos:
i) sale of spurious drugs
ii) overcharging of taxes
iii) sale of drugs without prescriptions resulting into self-medication, drug-addiction, abuse etc.
iv) Failure of enforcement agencies in getting such dealers convicted by the court of law.
1.3. Lack of informational inputs by common consumers in regard to sub-standard, spurious, adulterated and misbranded drugs, resulting into failure of administration in busting the rackets of spurious drugs.
1.4. Lack of complaints made by consumers to concerned authorities in the event of ineffectiveness of a genuine formulation.
1.5. People resorting to self-medication and consultation by Medical Assistants, Compounders, fake medical practitioners etc resulting into severe and even serious adverse drug reactions, ineffectiveness of medication, improper diagnosis and inappropriate therapy
1.6. Lack of fundamental medical and health education at the basic high school level.
1.7. Lack of recognition of the distinction between qualified and non-qualified pharmacists and the role that can be played by the qualified pharmacists in strategic and scientific administration, preparation, sale, storage and distribution of drugs and pharmaceuticals.
1.8. Lack of resistance on part of druggists, chemists and patients against unethical and irrational prescriptions.
1.9. Lack of establishment of private, govt.-approved drug testing laboratories by qualified pharmacists and related NGOs.
2.0 LEGAL FACTORS:
Drug services to common masses and related issues are regulated through following laws:
» Drugs and Cosmetics Act, 1940
» Drugs and Cosmetics Rules, 1945
» Pharmacy Act, 1948
» Drug Prices Control Order, 1995
» Narcotic Drugs and Psychotropic Substances Act, 1985
The existing provisions i.e., Section 274, 275 and 276 of IPC/CrPc related to drug offences are bailable and cognizable and are not in consonance with the provisions of the Drugs and Cosmetics Act, 1940.
2.1 There has been no major amendment in the Drugs and Cosmetics Act, 1940 since 1982, which was passed with an objective to regulate the sale, storage, manufacture and distribution of Drugs and Cosmetics.
2.2 There are several loopholes in this Act that pave way for the safe passage of offenders.
2.3 Unlike Labour laws, Act does not allow on-the-spot imposition of fines by inspectorate for violating various norms like sale of drugs without prescription, not displaying the license within premises, stocking of expired drugs within the premises, absence of “qualified person” from the sales premises, stocking of physicians samples etc. Inspectorate has to launch formal prosecutions for such petty offences also. As a result, matters get dragged in lengthy judicial procedures yielding very few convictions.
2.4 Section 27 of the Drugs and Cosmetics Act, 1940 lists out penalties for various contraventions of the Act and Rules thereunder but at the same time authorizes courts to impose a lesser sentence of imprisonment or fine in view of some adequate or special reasons which unfortunately are not amply clear and well-defined in the Act, resulting into reduction of punishments by courts on clumsy and inadequate grounds to only a few hours of imprisonment and a fine up to a few hundred rupees only. At present the offenders usually get bails and the prosecutions normally take about 10-15 years for any judgements. In many cases, the offender may get away with minor punishment whereas in all likelihood, he continues to indulge in spurious drug trade during the period of his trial.
2.4 Procedure prescribed under Section 25 of D & C Act, 1940 for retesting of drugs is faulty and provides an ample opportunity for the offenders to escape from the jaws of law. The procedure is so cumbersome, tedious and lengthy that the drug samples in question get expired even before it is retested or any prosecution is launched against the offenders.
2.5 Pharmacy Act, 1948 has become obsolete and redundant due to lack of adequate and proper amendments from time to time. Even after 55 years of its enforcement, the Act does not extend to the state of Jammu and Kashmir.
2.6 Narcotic Drugs and Psychotropic Substances Act, 1985 though a strong, stringent and powerful piece of legislation, is not being properly implemented in most of the states due to lack of adequate enforcement staff and non-delegation of relevant powers under the Act to the available manpower.
3.0 ADMINISTRATIVE FACTORS:
3.1 Insufficient workforce and excessive workload.
3.1.1 Guidelines put forth by several committees prescribe one inspector for every 100 drug sale outlets or every 25 manufacturing establishments, whereas at state levels there are only 14 inspectors in 14 districts of J&K State. Reportedly there are more than 3.5 lakh sales outlets and only 800-900 drug inspectors for about 600 districts in the country.
3.1.2 There are only 32 inspectors with CDSCO whose capacity is 72 inspections per year whereas the need is 2800 inspections annually @ a minimum of two inspections per establishment per year.
3.1.3 The kind of budget the Drug Control Department receives is somewhere in the region of Rs. 25 crore under non-plan and Rs. 10 crore under planned expenditure. With this kind of budget it is impossible to do anything.
3.1.4 There are about 4000 manufacturing units of whom hardly 20% are in the organized sector and account for about 145 in number, the rest are in the small scale sector which are hard to be monitored by such a meager inspectorate staff.
3.1.5 Number of prosecutions being launched is declining day by day. The number of cases of sub-standard drugs etc coming to notice is only about 11 % and even that is on a plateau. Based on the samples tested by the state drug controlling authorities during the period 1995 – 2003, the extent of sub-standard drugs varied from 8.19 to 10.64 % and of spurious drugs varied between 0.24 % to 0.47 % whereas Confederation of Indian Industries (CII) has recently revealed that spurious drugs comprise 18 % of total pharmaceutical production in India causing revenue loss to the tune of whopping Rs. 4112 crores annually. This raises serious doubts about the quality and quantity of testing by our government laboratories.
3.2 Lack of adequate transportation, accommodation, communication and judicial assistance facilities to the available inspectorate. In J&K, Drugs inspectors are not even conferred Gazetted status making them incompetent to launch proceedings for over-charging of drugs under the provisions of Drug Prices Control Order, 1995.
3.3 Standards of Good Manufacturing Practices not being enforced properly by the state governments. At present there are over 16000 licensed drug companies in India producing about 500 bulk drugs and over 60,000 formulations. Indian Pharmaceutical Industry has a domestic turnover which is worth more than Rs. 20,000 crores, and exports worth over Rs. 10,000 crores, making quality control and enforcement of GMP standards by the limited workforce even more difficult.
3.4 No substantial headway in the direction of upgradation and modernization of state as well as centrally-run drug testing laboratories. Out of information provided by 26 states to the recently framed Mashelkar Committee, only 15 drug-testing laboratories have been found to be functional and out of 15 state having their own testing laboratories, only 7 are reasonably equipped or staffed for being able to test all categories of drugs, while the other states are poorly staffed and equipped and do not even have the bare minimum equipment. The total testing capacity for the state and central laboratories is only 3500 samples per year against a need for around 10,000 samples per year. Drug testing facilities in the states badly need to be augmented and drug testing time needs to be brought down to one month which in many states extends to six months.
3.5 The inspectorate have to spend most of their time in courts pleading for various prosecutions launched by them and they are left with no time to conduct any secret probe against possible spurious drug rackets functioning in their jurisdiction areas. There is urgent need to create separate intelligence and legal cells in state as well as central offices with adequate provisions of secret funds and incentives for informers. Further special courts need to be designated to exclusively try the cases of spurious drugs.
4.0 IRRATIONAL USE OF DRUGS:
4.1 Several combinations and formulations available in the markets have been identified as irrational by several expert groups.
4.2 Pharmaceutical companies offer their brands at cheaper rates with huge margins for retailers and exorbitant complimentary gifts and commissions for physicians. No definite mechanism or regulations to curb unethical prescribing by doctors or to control unjustified distribution of costly gifts by Pharmaceutical companies are in place.
4.3 Decision on setting up of National Drug Authority had been taken in 1994 but the same has not been implemented till date, reportedly due to lack of infrastructure. NDA was to be set up for monitoring the prescribing practices and evaluation of their appropriateness for the purpose of guiding the medical professionals and for achieving the aim of rational prescribing. Further it was envisaged that NDA shall be levied with the task of monitoring the standard practices in drug promotion and use, clearly identify those that are acceptable and prohibit those which are unethical and against the consumers’ interests. Failure of the government to establish NDA has been the biggest hurdle in the way of ethical prescribing and rational use of drugs.
Poor quality of drugs and drug services - Mass resentment and factors responsible
Over the past few years, there has been widespread dissatisfaction among the masses with regard to quality of drugs available in the market. People have been expressing their resentment over the available drug services through newspapers, television and radio programs. In spite of several remedial measures taken by the concerned authorities in this context, public outcry continues to occupy the prime slots in print as well as mass communication media. This emphasizes the need to enhance general awareness among masses in regard to the modalities of drug services and various aspects related to their quality control. At the same time, various factors responsible for the prevailing scenario and necessary measures required for restoration of quality medicare services to the people need to be assessed.
Poor quality of drugs and drug services can be attributed to a host of factors that can be broadly categorized into following three groups:
1) Social factors
2) Legal factors
3) Administrative factors
1) Social factors
Due to lack of general awareness, people do not realize the significance of cash memos and do not bother to demand the same on purchasing drugs. On the contrary, at times customers have been seen refusing to take cash memos when offered by the chemists, as it happens generally when drugs are purchased in quantities larger than usual. Thus the importance of cash memos continues to be under-estimated which could otherwise have served like a “triple antigen” and provided immunity against three dreadful diseases that plague the society we live in, namely, overcharging of taxes, sale of spurious drugs and sale of drugs without a doctor’s prescription.
It is a well-known fact that spurious and substandard drugs are generally purchased without proper purchase invoices/bills and sold without issuing any cash memos. Moreover, it has been observed that chemists charge taxes as per the norms whenever they issue cash memos, in order to save their skin from any legal complications and due to the threat of decoy customers sent by the drug control officials. When a cash memo is issued, it becomes imperative for the chemists to mention the name and address of the doctor who has prescribed the medicine. Thus when an atmosphere of issuing cash memos is generated, sale of drugs only against the prescription of a Registered Medical Practitioner shall automatically precede, thereby putting brakes on the sale of drugs to addicts who do not possess any prescription. Since things have to be proved beyond any reasonable doubt through concrete evidence in the court of law in order to prove anybody guilty and get him convicted, there is a need to understand that it will be difficult to prepare firm legal grounds against a person or firm found indulging in overcharging of taxes or sale of spurious and substandard drugs, in the absence of a cash memo containing all necessary details and duly signed by the qualified person in-charge of the firm. Sale of drugs by unlicensed dealers could also be effectively checked through this fabulous tool since unlicensed dealers generally do not issue any cash memos
It is almost impossible for a drug control official to distinguish between a spurious and a genuine drug merely by its visual appearance. More often spurious drugs look more original than the genuine drug. Such drugs are pumped into the market through intelligently mastered and well-knit rackets which are hard to bust by ordinary means and moreso in absence of any specific informational inputs about the same. It has been found during recent raids outside the state that two of the ten strips of tablets in a box were fake. Under such circumstances mere verification of purchase records of drugs at random and lifting of drug samples for test/analysis cannot suffice in curbing the menace that is eating the very vitals of our society. It is extremely important that whosoever has any information regarding spurious drugs passes it on to the regulatory official for immediate action. Without such tip offs, situation is most unlikely to change for good and it will not be rational to expect much improvement in the overall scenario. However, the general belief that most of the drugs currently available in the market are spurious is not based on facts. Only a few unscrupulous agents are thought to be indulging in this unfair trade and they need to be brought to the book through a united effort.
People at large avoid making complaints to the concerned authorities whenever any drug is found not to bring about desired relief from an ailment. Instead, people choose to gossip around amongst themselves regarding such drugs and fail to realize that any action can be initiated or investigations made only when a complaint is lodged at the proper forum. Complaints received by the Drugs Control Department mostly pertain to so-called Welfare Associations who often do so to fulfil their selfish motives and such complaints are mostly hazy and non-specific in nature. Very few instances are such where any specific charges are attributed to any particular individual or firm. People need to have faith in the system and regulatory machinery and lodge specific complaints with concerned authorities. This is essential because there is no parallel/alternative set-up that could investigate and take necessary action in such cases. Further, whenever any person lodges a complaint, he should ensure its necessary follow-up for the cause of humanity and social welfare. He should not give up until remedial measures, as warranted under rules, are taken by the concerned officials towards redressal of the grievance. Even a few such sincere efforts can have far-reaching consequences and yield remarkable results.
It is no secret that people living in rural as well as urban areas prefer to consult compounders, medical assistants and even nursing orderlies with an intention to save few bucks of consultation fee, who in turn prescribe drugs without proper diagnosis and technical know-how, resulting into ineffectiveness of the medication and even adverse reactions in several cases. Under such circumstances too, patients put the entire blame squarely on the quality of drugs and do not bother to ponder whether they have received the most desired drug therapy. This is the case even in large cities where there is a doctor’s clinic available only next-door. Self-medication by patients is yet another cause of concern which also leads to similar consequences.
2) Legal factors
Drug services to common masses and other related issues are regulated through the Drugs and Cosmetics Act, 1940, Drugs and Cosmetics Rules, 1945 and Drugs Price Control Order, 1995. Drugs and Cosmetics Act, 1940, which was passed with an objective of regulating the manufacture, distribution and import of drugs and cosmetics has undergone its latest and major amendment way back in 1982 and no major amendment has been made thereafter. Though the Act has conferred satisfactory powers upon the inspectorate staff, yet there are loopholes that occasionally pave way for the safe passage of offenders.
Unlike labour laws, the Act does not provide for imposition of on-the-spot fines as and when any violations like supply of drugs in the absence of approved qualified person, non-display of license, stocking of physicians samples or expired drugs within the premises etc are detected by the field staff. Inspectorate has to approach the court of law for each and every contravention, be it minor or major, and the matters get dragged in lengthy judicial procedures yielding very few results, often acquitting the offender on one or the other grounds.
Whereas section 27 lists out the penalties for various contraventions of the Act and Rules thereunder clause (a), (b), (c) and (d), at the same time it authorises the courts to impose a sentence of imprisonment or fine less than that prescribed under clause (b), (c) and (d) for any adequate and special reasons. Unfortunately such special reasons have not been elaborately defined or specified in the Act. Consequently punishments are often reduced by courts on clumsy and inadequate grounds. Rather only rarely such special provisions are left unutilized by the judiciary, thus letting the offenders go scot free and commit further contraventions with greater conviction. There are very few instances where any deterrent penalties have been imposed upon the accused for violating the provisions of Act and Rules thereunder. Hence there is urgent need to amend section 27 of the Drugs and Cosmetics Act, 1940 and reconsider the special provisions of reduction of penalties prescribed under clause (b), (c) and (d) or otherwise make the circumstances under which punishments are reduced, more specific and well defined so that any kind of misuse of these provisions could be prevented.
Procedure prescribed under section 25 of the Drugs and Cosmetics Act, 1940 for retesting of drugs that have been tested once and declared to be not of standard quality by the Govt. Analyst require a prosecution to be launched against the manufacturer and suppliers of such a drug before it could be sent for retesting by the court. This leads to considerable delay in early disposal of such cases since prosecution can be launched only when other statutory requirements have been compiled with and necessary documentary evidence collected, that often takes time owing to slow pace of work in various departments. Many a times, the drug in question gets date expired even before it is retested or any prosecution is launched against the concerned, resulting into their acquittal. Therefore, section 23 and 25 too need a suitable amendment in such a way that one sample portion of the drug is preserved until its manufacturer’s name is disclosed by the suppliers and the same is utilized for retesting, if required, without prior permission from the court.
2) Adminsistrative factors
Keeping in view the vast number of drug sale outlets along the
length and breadth of the state, the workforce currently available with Drugs Control Department is not sufficient enough to fully cater to the actual field requirements. At present one post of Drug Inspector exists in each district, whereas there ought to be at least one post available for each tehsil in order to ensure strict vigil in every nook and corner. Moreover, those presently in service are also devoid of adequate transportation and communication facilities. They have to rely on local road transport for conducting tours across far-flung and remote areas thus occasionally resulting into lack of instant action and free flow of information.
Licensing to drug manufacturing units by various state governments needs to be made more stringent. Standards of granting such licences need to be upgraded and proper compliance with current Good Manufacturing Practices (GMPs) and other quality standards as prescribed under WHO guidelines need to be thoroughly probed before issuing such licenses. Severe punitive action, be it legal or disciplinary, needs to be taken against the manufacturers whose drugs are declared to be not of standard quality by the Govt. Analyst. It should be made mandatory for every new manufacturer who has been granted license by another state to seek prior approval before launching their products in our state and the approval should be granted only after thoroughly testing the quality of their products. Such an initiative is essential in the wake of steep rise in the number of pharmaceutical brands flowing into the market. At an estimate, every year approximately 600 new drug formulations hit the market. There are about 1800 antibiotic preparations having different brand names made from only a dozen drugs and there is absolutely no control over the inflow of fresh new brands.
Mediocre pharmaceutical companies are offering their brands at cheaper rates with huge margins for retailers and exhorbitant complimentary gifts and commissions for physicians. Consequently, some physicians prescribe their brands most often irrationally in a bid to gain more, without any consideration for patients’ actual needs and quality standards of reputed pharmaceutical companies. The practice needs to be curbed through more frequent lifting of drug samples for testing, modernization and sophistication of drug testing laboratories, more rigid regulations for launching of new brands in the state and evolution of some mechanism by means of which irrational prescribing of drugs by some doctors could be checked and brought under control. At present drug control officials are not suitably empowered to lay their hands on those erring practitioners, who prescribe some drugs ruthlessly and irrationally, notwithstanding the actual requirements of the patients. In the absence of any strategic mechanism to counter such malpractice, Chemists and Druggists Associations need to play their role by taking necessary steps and show resistance towards dispensing of drugs prescribed in such a manner. Moreover such steps on their part could also go a long way in stopping the supply of counterfeit drugs.
In nutshell, the general notion that most of the drugs available in the market are spurious and that Drugs Control Department is solely responsible for the poor quality of drugs is not based on facts. All sections of our society including those who consume; those who sell and those who prescribe drugs equally share the responsibility of making qualitative better medical services available to the masses and all of them need to join hands together towards achieving this goal. These initiatives clubbed with the steps recently taken by Union Ministry of Chemicals and Fertilizers in formulating the new drug policy to be called the Pharmaceutical Policy 2001, wherein focus is likely to shift from sales, import and turnover of drugs to their quality, research and selective price control and the recent nod given by the Drugs Controller General of India for upgradation of drug manufacturing norms in harmony with WHO-GMP standards, are expected to drastically improve the overall situation and restore the faith of common masses.
Poor quality of drugs and drug services can be attributed to a host of factors that can be broadly categorized into following three groups:
1) Social factors
2) Legal factors
3) Administrative factors
1) Social factors
Due to lack of general awareness, people do not realize the significance of cash memos and do not bother to demand the same on purchasing drugs. On the contrary, at times customers have been seen refusing to take cash memos when offered by the chemists, as it happens generally when drugs are purchased in quantities larger than usual. Thus the importance of cash memos continues to be under-estimated which could otherwise have served like a “triple antigen” and provided immunity against three dreadful diseases that plague the society we live in, namely, overcharging of taxes, sale of spurious drugs and sale of drugs without a doctor’s prescription.
It is a well-known fact that spurious and substandard drugs are generally purchased without proper purchase invoices/bills and sold without issuing any cash memos. Moreover, it has been observed that chemists charge taxes as per the norms whenever they issue cash memos, in order to save their skin from any legal complications and due to the threat of decoy customers sent by the drug control officials. When a cash memo is issued, it becomes imperative for the chemists to mention the name and address of the doctor who has prescribed the medicine. Thus when an atmosphere of issuing cash memos is generated, sale of drugs only against the prescription of a Registered Medical Practitioner shall automatically precede, thereby putting brakes on the sale of drugs to addicts who do not possess any prescription. Since things have to be proved beyond any reasonable doubt through concrete evidence in the court of law in order to prove anybody guilty and get him convicted, there is a need to understand that it will be difficult to prepare firm legal grounds against a person or firm found indulging in overcharging of taxes or sale of spurious and substandard drugs, in the absence of a cash memo containing all necessary details and duly signed by the qualified person in-charge of the firm. Sale of drugs by unlicensed dealers could also be effectively checked through this fabulous tool since unlicensed dealers generally do not issue any cash memos
It is almost impossible for a drug control official to distinguish between a spurious and a genuine drug merely by its visual appearance. More often spurious drugs look more original than the genuine drug. Such drugs are pumped into the market through intelligently mastered and well-knit rackets which are hard to bust by ordinary means and moreso in absence of any specific informational inputs about the same. It has been found during recent raids outside the state that two of the ten strips of tablets in a box were fake. Under such circumstances mere verification of purchase records of drugs at random and lifting of drug samples for test/analysis cannot suffice in curbing the menace that is eating the very vitals of our society. It is extremely important that whosoever has any information regarding spurious drugs passes it on to the regulatory official for immediate action. Without such tip offs, situation is most unlikely to change for good and it will not be rational to expect much improvement in the overall scenario. However, the general belief that most of the drugs currently available in the market are spurious is not based on facts. Only a few unscrupulous agents are thought to be indulging in this unfair trade and they need to be brought to the book through a united effort.
People at large avoid making complaints to the concerned authorities whenever any drug is found not to bring about desired relief from an ailment. Instead, people choose to gossip around amongst themselves regarding such drugs and fail to realize that any action can be initiated or investigations made only when a complaint is lodged at the proper forum. Complaints received by the Drugs Control Department mostly pertain to so-called Welfare Associations who often do so to fulfil their selfish motives and such complaints are mostly hazy and non-specific in nature. Very few instances are such where any specific charges are attributed to any particular individual or firm. People need to have faith in the system and regulatory machinery and lodge specific complaints with concerned authorities. This is essential because there is no parallel/alternative set-up that could investigate and take necessary action in such cases. Further, whenever any person lodges a complaint, he should ensure its necessary follow-up for the cause of humanity and social welfare. He should not give up until remedial measures, as warranted under rules, are taken by the concerned officials towards redressal of the grievance. Even a few such sincere efforts can have far-reaching consequences and yield remarkable results.
It is no secret that people living in rural as well as urban areas prefer to consult compounders, medical assistants and even nursing orderlies with an intention to save few bucks of consultation fee, who in turn prescribe drugs without proper diagnosis and technical know-how, resulting into ineffectiveness of the medication and even adverse reactions in several cases. Under such circumstances too, patients put the entire blame squarely on the quality of drugs and do not bother to ponder whether they have received the most desired drug therapy. This is the case even in large cities where there is a doctor’s clinic available only next-door. Self-medication by patients is yet another cause of concern which also leads to similar consequences.
2) Legal factors
Drug services to common masses and other related issues are regulated through the Drugs and Cosmetics Act, 1940, Drugs and Cosmetics Rules, 1945 and Drugs Price Control Order, 1995. Drugs and Cosmetics Act, 1940, which was passed with an objective of regulating the manufacture, distribution and import of drugs and cosmetics has undergone its latest and major amendment way back in 1982 and no major amendment has been made thereafter. Though the Act has conferred satisfactory powers upon the inspectorate staff, yet there are loopholes that occasionally pave way for the safe passage of offenders.
Unlike labour laws, the Act does not provide for imposition of on-the-spot fines as and when any violations like supply of drugs in the absence of approved qualified person, non-display of license, stocking of physicians samples or expired drugs within the premises etc are detected by the field staff. Inspectorate has to approach the court of law for each and every contravention, be it minor or major, and the matters get dragged in lengthy judicial procedures yielding very few results, often acquitting the offender on one or the other grounds.
Whereas section 27 lists out the penalties for various contraventions of the Act and Rules thereunder clause (a), (b), (c) and (d), at the same time it authorises the courts to impose a sentence of imprisonment or fine less than that prescribed under clause (b), (c) and (d) for any adequate and special reasons. Unfortunately such special reasons have not been elaborately defined or specified in the Act. Consequently punishments are often reduced by courts on clumsy and inadequate grounds. Rather only rarely such special provisions are left unutilized by the judiciary, thus letting the offenders go scot free and commit further contraventions with greater conviction. There are very few instances where any deterrent penalties have been imposed upon the accused for violating the provisions of Act and Rules thereunder. Hence there is urgent need to amend section 27 of the Drugs and Cosmetics Act, 1940 and reconsider the special provisions of reduction of penalties prescribed under clause (b), (c) and (d) or otherwise make the circumstances under which punishments are reduced, more specific and well defined so that any kind of misuse of these provisions could be prevented.
Procedure prescribed under section 25 of the Drugs and Cosmetics Act, 1940 for retesting of drugs that have been tested once and declared to be not of standard quality by the Govt. Analyst require a prosecution to be launched against the manufacturer and suppliers of such a drug before it could be sent for retesting by the court. This leads to considerable delay in early disposal of such cases since prosecution can be launched only when other statutory requirements have been compiled with and necessary documentary evidence collected, that often takes time owing to slow pace of work in various departments. Many a times, the drug in question gets date expired even before it is retested or any prosecution is launched against the concerned, resulting into their acquittal. Therefore, section 23 and 25 too need a suitable amendment in such a way that one sample portion of the drug is preserved until its manufacturer’s name is disclosed by the suppliers and the same is utilized for retesting, if required, without prior permission from the court.
2) Adminsistrative factors
Keeping in view the vast number of drug sale outlets along the
length and breadth of the state, the workforce currently available with Drugs Control Department is not sufficient enough to fully cater to the actual field requirements. At present one post of Drug Inspector exists in each district, whereas there ought to be at least one post available for each tehsil in order to ensure strict vigil in every nook and corner. Moreover, those presently in service are also devoid of adequate transportation and communication facilities. They have to rely on local road transport for conducting tours across far-flung and remote areas thus occasionally resulting into lack of instant action and free flow of information.
Licensing to drug manufacturing units by various state governments needs to be made more stringent. Standards of granting such licences need to be upgraded and proper compliance with current Good Manufacturing Practices (GMPs) and other quality standards as prescribed under WHO guidelines need to be thoroughly probed before issuing such licenses. Severe punitive action, be it legal or disciplinary, needs to be taken against the manufacturers whose drugs are declared to be not of standard quality by the Govt. Analyst. It should be made mandatory for every new manufacturer who has been granted license by another state to seek prior approval before launching their products in our state and the approval should be granted only after thoroughly testing the quality of their products. Such an initiative is essential in the wake of steep rise in the number of pharmaceutical brands flowing into the market. At an estimate, every year approximately 600 new drug formulations hit the market. There are about 1800 antibiotic preparations having different brand names made from only a dozen drugs and there is absolutely no control over the inflow of fresh new brands.
Mediocre pharmaceutical companies are offering their brands at cheaper rates with huge margins for retailers and exhorbitant complimentary gifts and commissions for physicians. Consequently, some physicians prescribe their brands most often irrationally in a bid to gain more, without any consideration for patients’ actual needs and quality standards of reputed pharmaceutical companies. The practice needs to be curbed through more frequent lifting of drug samples for testing, modernization and sophistication of drug testing laboratories, more rigid regulations for launching of new brands in the state and evolution of some mechanism by means of which irrational prescribing of drugs by some doctors could be checked and brought under control. At present drug control officials are not suitably empowered to lay their hands on those erring practitioners, who prescribe some drugs ruthlessly and irrationally, notwithstanding the actual requirements of the patients. In the absence of any strategic mechanism to counter such malpractice, Chemists and Druggists Associations need to play their role by taking necessary steps and show resistance towards dispensing of drugs prescribed in such a manner. Moreover such steps on their part could also go a long way in stopping the supply of counterfeit drugs.
In nutshell, the general notion that most of the drugs available in the market are spurious and that Drugs Control Department is solely responsible for the poor quality of drugs is not based on facts. All sections of our society including those who consume; those who sell and those who prescribe drugs equally share the responsibility of making qualitative better medical services available to the masses and all of them need to join hands together towards achieving this goal. These initiatives clubbed with the steps recently taken by Union Ministry of Chemicals and Fertilizers in formulating the new drug policy to be called the Pharmaceutical Policy 2001, wherein focus is likely to shift from sales, import and turnover of drugs to their quality, research and selective price control and the recent nod given by the Drugs Controller General of India for upgradation of drug manufacturing norms in harmony with WHO-GMP standards, are expected to drastically improve the overall situation and restore the faith of common masses.
Pros and cons of the proposed new National Pharmaceutical Policy
As part of an exercise to repeal the drug policy of 1994 that is in force at present, government of India released a new policy draft in 2002 after a gap of eleven years, followed by another draft in 2006. However neither of them could take off due to protracted litigations in various courts. Now after long drawn legal battle, a new National Pharmaceutical Policy is in its final stages of review before a fourteen member union ministerial panel and is likely to be promulgated soon. Formulation of a new policy has been necessitated due to several developments like the introduction of product patent regime in pharmaceuticals with effect from January 2005 in place of the erstwhile process patent regime as a result of India becoming a signatory to the WTO and TRIPS agreements. Some of the main concerns to be addressed by the new Pharmaceutical Policy pertain to accessibility and affordability of medicines by the common man particularly the vast segment of poor population, instituting standards of quality, strengthening the fragmented regulatory system, sustaining growth of generic drugs (drugs sold under their chemical names rather than brand names) and meeting the challenge of product patent regime besides price regulation of the essential medicines. The main part of the new draft policy seeks to bring a revamped drug regulatory system both at the Centre and the States. An independent and autonomous body by the name of National Drug Authority (NDA) would be constituted in place of the present Central Drugs Standard Control Organisation (CDSCO). Several of the existing provisions of the Drugs and Cosmetics Act, 1940 would be amended to make the penalties more deterrent for various offences and in particular for spurious and sub-standard drugs. In the long run the proposal of merger of National Pharmaceutical Pricing Authority (NPPA) and NDA would be considered in the form of National Authority on Drugs and Therapeutics (NADT) that will lead to an integrated regulatory system in the country.
Drug pricing and drug safety are other two areas where frequent violations are taking place as there is no integrated machinery to suitably monitor these activities. Amidst reports suggesting that the pharma companies are fixing astronomical prices for essential medicines making them out of reach of the predominantly poor people, Supreme Court of India ruled in March, 2003 that the prices of life-saving and essential drugs be kept under government control. Accordingly govt. prepared a National List of Essential Medicines (NLEM) comprising of 354 drugs that were initially proposed to be brought under government price control. However due to stiff opposition from industrial sector, the price control has ultimately boiled down to only 200 drugs. Still price control to this extent is likely to bring down the sky rocketing prices of some crucial life-saving drugs. There are several cases pending in various courts against all the top pharmaceutical companies for overcharging the consumer. The government has not been successful in recovering these overcharged amounts estimated to be several hundreds of crores of rupees because of the inadequacy of the current enforcement machinery and due to the fact that at present only 74 drugs fall under govt. price control mechanism. For remaining drugs, prices are fixed by the pharmaceutical companies in accordance with well-established norms and formulae.
For making available anti-cancer and anti-HIV/AIDS drugs at reasonable prices to a much larger section of the population, government would evolve a public–private partnership programme with the concerned manufacturers and cancer hospitals. At any given point of time there are about 20 to 25 lac people suffering from cancer in India and as many as 5.1 million people are affected by HIV/AIDS, about 85% of the South Asian total. Most of these patients are unable to afford the cost of expensive anti-cancer and antiretroviral (AIDS) drugs. Government would completely exempt anti-cancer and antiretroviral drugs from all types of central taxes - excise duty, import duty etc and the states would also be asked to exempt these medicines from all types of state and local levies. Industry and trade would be asked to reduce their margins – both profit and trade margins to the barest minimum level and all these benefits would be passed on to the consumers. Drugs for other life threatening diseases requiring life long treatment would also be identified and brought under the public-private partnership model. Further it has been decided to reduce the excise duty on all pharmaceutical products from 16% to 8%. This step is likely to reduce prices of medicines. Since last year, all medicines are required to have a label declaration of retail sale price in the form of MRP “inclusive of all taxes”. From the consumer’s point of view this step was most desirable. A new Drug Price Control Order (DPCO) replacing the existing DPCO 1995 would be issued under the Essential Commodities Act, 1955. In order to exercise more effective monitoring and control of the prices of drugs, a new Act to replace the existing system of Drug Price Control Orders would be enacted by the name of Drugs and Therapeutics Regulation Act (DATA) that will allow levying of penalties that would be graded – fines, temporary withdrawal of marketing approval, withholding of marketing approval, sealing of production facilities, compounding of offences etc. So far there was no provision for imposing fines for violation of any DPCO statutes. Further greater role and accountability of State Drug Controllers would be specifically provided under the Act.
It is seen that generally generic drugs are priced much lower than the branded ones. Presently the branded drugs dominate the market in India and there is a very small presence of the generic drugs. One of the ways to make available cheaper drugs to people at large and to the public health system could be to promote the production of generic drugs in the country. This would be done by giving preference to generic drugs during procurement and distribution of drugs through the public health system. No govt. control on price fixing of generic drugs would be specified. Further it has been agreed that the retail margins for these drugs would be kept at 35 per cent while the wholesale margins would be 15 per cent. Indian Pharmaceutical Alliance has predicted that to double the pharmaceutical exports by 2010, there is need for highly trained manpower of one thousand per annum for the next five years. As such, five more National Institutes of Pharmaceutical Education and Research would be set up on the analogy of NIPER, Mohali, Chandigarh which has been declared an institute of national importance by the Act of Parliament and is engaged in training the human resources in the field of Pharmaceutical Sciences. It is imperative for the Indian pharmaceutical industry to accelerate its efforts in Research and Development (R&D) sector. The present level of expenditure on R&D (about 5% of turnover) is much lower as compared to most of the developed countries (15 to 20%). With a view to encourage R&D in pharma sector, suitable incentives would be provided to R&D intensive pharmaceutical companies fulfilling certain conditions like Gold Standards besides giving them price benefits for the drugs under DPCO.
An annual grant of Rs. 150 crores would be allocated towards the Pharmaceutical Research and Development Support Fund (PRDSF) for utilization in funding R&D projects of research institutions and industry. Priority would be given for R&D in case of diseases that are endemic to India like malaria, tuberculosis, hepatitis-B, leishmania (kala-azar), HIV/AIDS etc. A special scheme for setting up pharmaceutical parks on the lines of Integrated Textile Parks in the next five years is also proposed. Each park would be set up in a minimum area of 250 acres for bulk and 100 acres for formulations. Besides these initiatives, new Pharmaceutical Policy seeks to make drugs available free of cost to over 26% population of the country living below poverty line through National Health Insurance Scheme, National/State/District Illness Assistance Funds and District Drug Banks. A 2% health cess is proposed to be levied on the lines of education cess to fund these schemes. At present enforcement of quality and standards in medicines is being done through the provisions contained in the Drugs and Cosmetics Act, 1940 that is administered by the Ministry of Health and Family Welfare. However the aspects relating to industrial licensing and pricing of drugs are instituted by the Ministry of Chemicals and Fertilizers. The new policy seeks to change the name of Department of Chemicals and Fertilizers so as to reflect Pharmaceuticals also. Accordingly the proposed new name is Department of Chemicals, Petrochemicals and Pharmaceuticals. An overall goal of the new policy will be to make quality medicines available at affordable prices to all sections of the society.
Drug pricing and drug safety are other two areas where frequent violations are taking place as there is no integrated machinery to suitably monitor these activities. Amidst reports suggesting that the pharma companies are fixing astronomical prices for essential medicines making them out of reach of the predominantly poor people, Supreme Court of India ruled in March, 2003 that the prices of life-saving and essential drugs be kept under government control. Accordingly govt. prepared a National List of Essential Medicines (NLEM) comprising of 354 drugs that were initially proposed to be brought under government price control. However due to stiff opposition from industrial sector, the price control has ultimately boiled down to only 200 drugs. Still price control to this extent is likely to bring down the sky rocketing prices of some crucial life-saving drugs. There are several cases pending in various courts against all the top pharmaceutical companies for overcharging the consumer. The government has not been successful in recovering these overcharged amounts estimated to be several hundreds of crores of rupees because of the inadequacy of the current enforcement machinery and due to the fact that at present only 74 drugs fall under govt. price control mechanism. For remaining drugs, prices are fixed by the pharmaceutical companies in accordance with well-established norms and formulae.
For making available anti-cancer and anti-HIV/AIDS drugs at reasonable prices to a much larger section of the population, government would evolve a public–private partnership programme with the concerned manufacturers and cancer hospitals. At any given point of time there are about 20 to 25 lac people suffering from cancer in India and as many as 5.1 million people are affected by HIV/AIDS, about 85% of the South Asian total. Most of these patients are unable to afford the cost of expensive anti-cancer and antiretroviral (AIDS) drugs. Government would completely exempt anti-cancer and antiretroviral drugs from all types of central taxes - excise duty, import duty etc and the states would also be asked to exempt these medicines from all types of state and local levies. Industry and trade would be asked to reduce their margins – both profit and trade margins to the barest minimum level and all these benefits would be passed on to the consumers. Drugs for other life threatening diseases requiring life long treatment would also be identified and brought under the public-private partnership model. Further it has been decided to reduce the excise duty on all pharmaceutical products from 16% to 8%. This step is likely to reduce prices of medicines. Since last year, all medicines are required to have a label declaration of retail sale price in the form of MRP “inclusive of all taxes”. From the consumer’s point of view this step was most desirable. A new Drug Price Control Order (DPCO) replacing the existing DPCO 1995 would be issued under the Essential Commodities Act, 1955. In order to exercise more effective monitoring and control of the prices of drugs, a new Act to replace the existing system of Drug Price Control Orders would be enacted by the name of Drugs and Therapeutics Regulation Act (DATA) that will allow levying of penalties that would be graded – fines, temporary withdrawal of marketing approval, withholding of marketing approval, sealing of production facilities, compounding of offences etc. So far there was no provision for imposing fines for violation of any DPCO statutes. Further greater role and accountability of State Drug Controllers would be specifically provided under the Act.
It is seen that generally generic drugs are priced much lower than the branded ones. Presently the branded drugs dominate the market in India and there is a very small presence of the generic drugs. One of the ways to make available cheaper drugs to people at large and to the public health system could be to promote the production of generic drugs in the country. This would be done by giving preference to generic drugs during procurement and distribution of drugs through the public health system. No govt. control on price fixing of generic drugs would be specified. Further it has been agreed that the retail margins for these drugs would be kept at 35 per cent while the wholesale margins would be 15 per cent. Indian Pharmaceutical Alliance has predicted that to double the pharmaceutical exports by 2010, there is need for highly trained manpower of one thousand per annum for the next five years. As such, five more National Institutes of Pharmaceutical Education and Research would be set up on the analogy of NIPER, Mohali, Chandigarh which has been declared an institute of national importance by the Act of Parliament and is engaged in training the human resources in the field of Pharmaceutical Sciences. It is imperative for the Indian pharmaceutical industry to accelerate its efforts in Research and Development (R&D) sector. The present level of expenditure on R&D (about 5% of turnover) is much lower as compared to most of the developed countries (15 to 20%). With a view to encourage R&D in pharma sector, suitable incentives would be provided to R&D intensive pharmaceutical companies fulfilling certain conditions like Gold Standards besides giving them price benefits for the drugs under DPCO.
An annual grant of Rs. 150 crores would be allocated towards the Pharmaceutical Research and Development Support Fund (PRDSF) for utilization in funding R&D projects of research institutions and industry. Priority would be given for R&D in case of diseases that are endemic to India like malaria, tuberculosis, hepatitis-B, leishmania (kala-azar), HIV/AIDS etc. A special scheme for setting up pharmaceutical parks on the lines of Integrated Textile Parks in the next five years is also proposed. Each park would be set up in a minimum area of 250 acres for bulk and 100 acres for formulations. Besides these initiatives, new Pharmaceutical Policy seeks to make drugs available free of cost to over 26% population of the country living below poverty line through National Health Insurance Scheme, National/State/District Illness Assistance Funds and District Drug Banks. A 2% health cess is proposed to be levied on the lines of education cess to fund these schemes. At present enforcement of quality and standards in medicines is being done through the provisions contained in the Drugs and Cosmetics Act, 1940 that is administered by the Ministry of Health and Family Welfare. However the aspects relating to industrial licensing and pricing of drugs are instituted by the Ministry of Chemicals and Fertilizers. The new policy seeks to change the name of Department of Chemicals and Fertilizers so as to reflect Pharmaceuticals also. Accordingly the proposed new name is Department of Chemicals, Petrochemicals and Pharmaceuticals. An overall goal of the new policy will be to make quality medicines available at affordable prices to all sections of the society.
Changing dynamics of higher education in J&K state
Department of Higher Education, Ministry of Human Resource Development, Government of India has decided to observe 11th November, birthday of Maulana Abul Kalam Azad, the first Union Minister of Education as the “National Education Day” every year. A resolution to this effect has been adopted by the Government of India on September 11th, 2008. At this occasion, it will be pertinent to present a brief overview of the proceedings and recommendations of an expert level panel discussion organized by the Academic Staff College of the University of Kashmir in association with Indian Institute of Public Administration, Kashmir Chapter at SKICC, Srinagar on November 1st, 2008. Veteran educationists of the state including principals of several degree colleges and noted academicians of the Universities of Kashmir and Jammu participated in the panel discussion that was divided into two sessions in addition to the inaugural session. Theme of the first session was, “Higher Education in India – Changing Dynamics”, whereas the theme for second session was, “Higher Education – Professional Development and Quality Control”.
Dignitaries and academicians who spoke during the inaugural session include Dr. Ashok Bhan, Hon. General Secretary, IIPA, Kashmir Chapter, Prof. Mehraj-ud-din, Director, Academic Staff College, University of Kashmir, Prof. Riyaz Punjabi, Vice-Chancellor, University of Kashmir, Shri N. N. Vohra, Governor of Jammu and Kashmir and Dr. G. N. Qasba, Hony. Jt. Secretary, IIPA, Kashmir Chapter. During his keynote address, Prof. Mehraj-ud-din comprehensively dwelled upon various government reports and recommendations vis-a-vis higher education in India and besides presenting statistical information about the past and prevailing scenario, he focussed upon the progressively falling standards in higher education and the remedial measures required to address the same. He also substantiated his observations with the remarks made by renowned educationists, political leaders, former prime ministers, vice-chancellors etc from time to time. He made a number of recommendations towards improving the entire system.
Prof. Riyaz Punjabi, Vice-Chancellor, University of Kashmir, in his special address also made a set of recommendations for introspection and subsequent rectification of our higher education system that include addressing the problems at micro level with special reference to the J&K state, bridging the gap between academia and policy-makers, making greater infrastructure available to colleges and universities, restoring dignity of teachers and honouring their feedback, need for non-intervention by political forces, greater collaboration and better coordination between three units of education at school, college and University level. Shri N. N. Vohra, Governor of the J&K state presented a comparative overview of the situation existing at the time of independence of India and the one existing today. He expressed his grave concern over deteriorating standards of education alongside a proportional increase in the number of educational institutions. He emphasized upon the eminent academicians of the state to determine the extent, in the context of present democratic functioning, to which we can proceed further and set the system right. He informed the gathering about the government decision to set up a committee to establish state knowledge commission.
During the first session that was chaired by Prof. A.G. Madhosh, former Dean, Faculty of Education, University of Kashmir and co-chaired by Prof. T. A. Kawoos, Principal, Amar Singh College, Sringar, several noted educationists of the state presented their views and recommendations. Those who spoke besides Chairman and Co-Chairman during the first session include Prof. G. R. Malik, former Head, Dept. of English/Director, EMMRC, University of Kashmir, Prof. Mushtaq Ah. Peer, Director, Institute of Computer Sciences, University of Kashmir, Prof. (Dr.) Zeenat Ara, Principal, Govt. Women’s College, Srinagar, Prof. Z. A. Chatt, Senior Faculty, Govt. Degree College, Anantnag and Prof. C. L. Vishen, Chairman, CASET. During post-session interaction, Mr. Nasir Mirza, Senior Faculty, MERC, University of Kashmir, Prof. M. I. Nazki, ex-Controller of Examinations, University of Kashmir, Prof. A. R. Khan, Professor of Zoology, Prof. Yasmin, Prof. Sharf-e-Alam, former Vice-Chancellor of Patna University and others participated in the deliberations.
During the second session that was chaired by Prof. Nisar Ali, Coordinator, PG Centres, University of Kashmir and co-chaired by Prof. G. M. Dar, Principal, Sadiq Memorial College of Education, Srinagar, experts who presented their views and suggestions besides chairman and the co-chairman include, Prof. G. M. Sangmi, Dean, Faculty of Commerce and Management Studies, University of Kashmir, Prof. N. A. Nadeem, Dean, Faculty of Education, University of Kashmir, Prof. M. I. Nazki, ex-Controller of Examination, University of Kashmir, Prof. A. R. Rather, former Dean, Faculty of Education, University of Kashmir, Prof. Ashok Aima, Senior Faculty, The Business School, University of Jammu, Prof. V.K. Kapoor, Director, Law School, University of Jammu, Prof. Abdul Hamid, Principal, Govt. College of Education, Sringar, Prof. Syed Rabia Firdous, Principal, Gandhi Memorial College, Srinagar and Prof. Nazir Ahmed Gilkar, Senior Faculty, Degree College, Bemina. Several principals of various degree colleges and university teachers participated in the post-session interactions and posed many questions to the panellists.
A brief overview of the recommendations made by the above-mentioned experts towards improving the existing scenario in our higher education system during the day-long panel discussion is given as under.
Almost all panellists including Prof. Riyaz Punjabi were of the view that there is need for greater integration and better coordination between primary, secondary, higher secondary and university level education in the state. While nobody was averse to establishing any educational institute with an aim of making education accessible to all, at the same time it was felt that prior to opening up of new colleges, adequate infrastructure, faculty and other facilities need to be made available. New colleges should not be opened at the cost of the faculty strength of existing ones. As such the practice of diverting faculty to the newly established colleges from the already existing ones should be done away with and adequate infrastructure, faculty and other facilities should also be made available to the existing higher educational institutions in addition to the newly established ones. They should not be ignored in the race of taking credit for opening up a number of new colleges in the state. Participants of the panel discussion opined that unplanned expansion of educational institutions as has recently been in vogue in the state is not in the larger interests of our higher education set up and therefore should be stopped unless we address the issue of capacity building first in its right earnest.
There is also need for diversification of education at middle or high school level owing to the fact that orientation of students towards professional subjects needs to be done from 8th or 10th standard onwards so as to provide greater avenues and foster their inherent capabilities in one particular stream rather than making them study all kinds of subjects irrespective of their personal interests and inclinations. Education should be made compulsory only upto a particular stage and then it should be made more choice-based. Admission policy in colleges and universities should be streamlined and made fool-proof. Admissions should be strictly made on the basis of total intake capacity of the respective institutions and the aptitude/merit of aspiring candidates rather than on the basis of other stray considerations. There are instances where colleges having a total intake capacity of 4000 have ended up giving admissions to over 12000 students in a single session. Need of the hour is to implement UGC guidelines in letter and spirit and stop violating norms.
Many academicians in the discussion vehemently asserted that the privatization of higher education is essential and needs to be fostered to the utmost extent possible in order to realize the dream of imparting quality education to our youth. Therefore initiatives of private players in higher education may be encouraged subject to a strict regulatory vigil under the aegis of a regulatory authority or higher education council. However some experts aired their views by saying that partnership should be the key to development rather than gross privatization of the education sector. A robust and comprehensive education policy should be framed in the state and there should be equitable participation and involvement of academicians in framing policies related to higher education. Reports and recommendations submitted by various committees and academicians should find due place in the ultimate policy framework of the government. Faculty strength of our educational institutions should be augmented in order to face the challenges of globalization and open up vistas for national as well as trans-national higher education. The role of a teacher in higher education should change from knowledge disseminator to knowledge creator with greater emphasis to be laid on making higher education more professional/vocational so as to enhance the job opportunities of our products and make our pass-outs more acceptable in job markets of the world.
Creative skills and competitive spirits of the students of higher education should be fostered and encouraged. In order to make our students better citizens, human and moral values need to be inculcated in them by way of value-based education. That is very important in order to lessen the burden of evils and turmoil in our society. Industry-academia interaction should be enhanced. At least one residential college at each district headquarters should be upgraded/established with extended library access to students as well as the faculty beyond normal working hours of the college. There should be greater autonomy to institutions of higher learning and the concept of autonomous colleges as envisaged under the objectives of proposed state knowledge commission should be seriously considered. There is dire need to carry out regular review and updation of syllabi as well as reforms in evaluation/examination patterns by all educational institutes. Adhocism and contractualism that breeds mediocrity in higher education should be abolished and only clear vacancies should be created and subsequently got filled up by meritorious candidates through proper selection procedure.
Objectives of higher education should be properly defined and total quality management procedures adopted in teaching, research and extension at the institutions of higher learning. Undue intervention by politicians in educational institutions should be stopped and the academicians should be allowed to work freely without submitting to any extraneous considerations. Ways and means should be explored to reduce the stress levels among students as a result of emerging cut throat competition and decreasing job opportunities. We should keep pace with brisk technological advancements in teaching learning process and should not lag behind in adopting the latest technology in every sphere of our education, be it in teaching, devising syllabi, evaluation methods, certification and automation procedures etc. Distance mode of education should be expanded to enhance accessibility to education. Alongside providing better perks and remuneration to teachers, they should be made more accountable. Transparency in educational institutions should be increased and teachers should have a greater realization of their responsibilities towards the society. Recruitment and transfer procedures and policies in educational institutions should be made more transparent so that they are not used by the vested interests as a tool for punishment or reward. Integrated efforts should be made by all stake holders in converting our educational institutes into the centres of knowledge and excellence. All players should contribute their bit towards building a knowledge based society.
Dignitaries and academicians who spoke during the inaugural session include Dr. Ashok Bhan, Hon. General Secretary, IIPA, Kashmir Chapter, Prof. Mehraj-ud-din, Director, Academic Staff College, University of Kashmir, Prof. Riyaz Punjabi, Vice-Chancellor, University of Kashmir, Shri N. N. Vohra, Governor of Jammu and Kashmir and Dr. G. N. Qasba, Hony. Jt. Secretary, IIPA, Kashmir Chapter. During his keynote address, Prof. Mehraj-ud-din comprehensively dwelled upon various government reports and recommendations vis-a-vis higher education in India and besides presenting statistical information about the past and prevailing scenario, he focussed upon the progressively falling standards in higher education and the remedial measures required to address the same. He also substantiated his observations with the remarks made by renowned educationists, political leaders, former prime ministers, vice-chancellors etc from time to time. He made a number of recommendations towards improving the entire system.
Prof. Riyaz Punjabi, Vice-Chancellor, University of Kashmir, in his special address also made a set of recommendations for introspection and subsequent rectification of our higher education system that include addressing the problems at micro level with special reference to the J&K state, bridging the gap between academia and policy-makers, making greater infrastructure available to colleges and universities, restoring dignity of teachers and honouring their feedback, need for non-intervention by political forces, greater collaboration and better coordination between three units of education at school, college and University level. Shri N. N. Vohra, Governor of the J&K state presented a comparative overview of the situation existing at the time of independence of India and the one existing today. He expressed his grave concern over deteriorating standards of education alongside a proportional increase in the number of educational institutions. He emphasized upon the eminent academicians of the state to determine the extent, in the context of present democratic functioning, to which we can proceed further and set the system right. He informed the gathering about the government decision to set up a committee to establish state knowledge commission.
During the first session that was chaired by Prof. A.G. Madhosh, former Dean, Faculty of Education, University of Kashmir and co-chaired by Prof. T. A. Kawoos, Principal, Amar Singh College, Sringar, several noted educationists of the state presented their views and recommendations. Those who spoke besides Chairman and Co-Chairman during the first session include Prof. G. R. Malik, former Head, Dept. of English/Director, EMMRC, University of Kashmir, Prof. Mushtaq Ah. Peer, Director, Institute of Computer Sciences, University of Kashmir, Prof. (Dr.) Zeenat Ara, Principal, Govt. Women’s College, Srinagar, Prof. Z. A. Chatt, Senior Faculty, Govt. Degree College, Anantnag and Prof. C. L. Vishen, Chairman, CASET. During post-session interaction, Mr. Nasir Mirza, Senior Faculty, MERC, University of Kashmir, Prof. M. I. Nazki, ex-Controller of Examinations, University of Kashmir, Prof. A. R. Khan, Professor of Zoology, Prof. Yasmin, Prof. Sharf-e-Alam, former Vice-Chancellor of Patna University and others participated in the deliberations.
During the second session that was chaired by Prof. Nisar Ali, Coordinator, PG Centres, University of Kashmir and co-chaired by Prof. G. M. Dar, Principal, Sadiq Memorial College of Education, Srinagar, experts who presented their views and suggestions besides chairman and the co-chairman include, Prof. G. M. Sangmi, Dean, Faculty of Commerce and Management Studies, University of Kashmir, Prof. N. A. Nadeem, Dean, Faculty of Education, University of Kashmir, Prof. M. I. Nazki, ex-Controller of Examination, University of Kashmir, Prof. A. R. Rather, former Dean, Faculty of Education, University of Kashmir, Prof. Ashok Aima, Senior Faculty, The Business School, University of Jammu, Prof. V.K. Kapoor, Director, Law School, University of Jammu, Prof. Abdul Hamid, Principal, Govt. College of Education, Sringar, Prof. Syed Rabia Firdous, Principal, Gandhi Memorial College, Srinagar and Prof. Nazir Ahmed Gilkar, Senior Faculty, Degree College, Bemina. Several principals of various degree colleges and university teachers participated in the post-session interactions and posed many questions to the panellists.
A brief overview of the recommendations made by the above-mentioned experts towards improving the existing scenario in our higher education system during the day-long panel discussion is given as under.
Almost all panellists including Prof. Riyaz Punjabi were of the view that there is need for greater integration and better coordination between primary, secondary, higher secondary and university level education in the state. While nobody was averse to establishing any educational institute with an aim of making education accessible to all, at the same time it was felt that prior to opening up of new colleges, adequate infrastructure, faculty and other facilities need to be made available. New colleges should not be opened at the cost of the faculty strength of existing ones. As such the practice of diverting faculty to the newly established colleges from the already existing ones should be done away with and adequate infrastructure, faculty and other facilities should also be made available to the existing higher educational institutions in addition to the newly established ones. They should not be ignored in the race of taking credit for opening up a number of new colleges in the state. Participants of the panel discussion opined that unplanned expansion of educational institutions as has recently been in vogue in the state is not in the larger interests of our higher education set up and therefore should be stopped unless we address the issue of capacity building first in its right earnest.
There is also need for diversification of education at middle or high school level owing to the fact that orientation of students towards professional subjects needs to be done from 8th or 10th standard onwards so as to provide greater avenues and foster their inherent capabilities in one particular stream rather than making them study all kinds of subjects irrespective of their personal interests and inclinations. Education should be made compulsory only upto a particular stage and then it should be made more choice-based. Admission policy in colleges and universities should be streamlined and made fool-proof. Admissions should be strictly made on the basis of total intake capacity of the respective institutions and the aptitude/merit of aspiring candidates rather than on the basis of other stray considerations. There are instances where colleges having a total intake capacity of 4000 have ended up giving admissions to over 12000 students in a single session. Need of the hour is to implement UGC guidelines in letter and spirit and stop violating norms.
Many academicians in the discussion vehemently asserted that the privatization of higher education is essential and needs to be fostered to the utmost extent possible in order to realize the dream of imparting quality education to our youth. Therefore initiatives of private players in higher education may be encouraged subject to a strict regulatory vigil under the aegis of a regulatory authority or higher education council. However some experts aired their views by saying that partnership should be the key to development rather than gross privatization of the education sector. A robust and comprehensive education policy should be framed in the state and there should be equitable participation and involvement of academicians in framing policies related to higher education. Reports and recommendations submitted by various committees and academicians should find due place in the ultimate policy framework of the government. Faculty strength of our educational institutions should be augmented in order to face the challenges of globalization and open up vistas for national as well as trans-national higher education. The role of a teacher in higher education should change from knowledge disseminator to knowledge creator with greater emphasis to be laid on making higher education more professional/vocational so as to enhance the job opportunities of our products and make our pass-outs more acceptable in job markets of the world.
Creative skills and competitive spirits of the students of higher education should be fostered and encouraged. In order to make our students better citizens, human and moral values need to be inculcated in them by way of value-based education. That is very important in order to lessen the burden of evils and turmoil in our society. Industry-academia interaction should be enhanced. At least one residential college at each district headquarters should be upgraded/established with extended library access to students as well as the faculty beyond normal working hours of the college. There should be greater autonomy to institutions of higher learning and the concept of autonomous colleges as envisaged under the objectives of proposed state knowledge commission should be seriously considered. There is dire need to carry out regular review and updation of syllabi as well as reforms in evaluation/examination patterns by all educational institutes. Adhocism and contractualism that breeds mediocrity in higher education should be abolished and only clear vacancies should be created and subsequently got filled up by meritorious candidates through proper selection procedure.
Objectives of higher education should be properly defined and total quality management procedures adopted in teaching, research and extension at the institutions of higher learning. Undue intervention by politicians in educational institutions should be stopped and the academicians should be allowed to work freely without submitting to any extraneous considerations. Ways and means should be explored to reduce the stress levels among students as a result of emerging cut throat competition and decreasing job opportunities. We should keep pace with brisk technological advancements in teaching learning process and should not lag behind in adopting the latest technology in every sphere of our education, be it in teaching, devising syllabi, evaluation methods, certification and automation procedures etc. Distance mode of education should be expanded to enhance accessibility to education. Alongside providing better perks and remuneration to teachers, they should be made more accountable. Transparency in educational institutions should be increased and teachers should have a greater realization of their responsibilities towards the society. Recruitment and transfer procedures and policies in educational institutions should be made more transparent so that they are not used by the vested interests as a tool for punishment or reward. Integrated efforts should be made by all stake holders in converting our educational institutes into the centres of knowledge and excellence. All players should contribute their bit towards building a knowledge based society.
Pharmacovigilance at SKIMS, Srinagar - Prospects and perspectives
It was not until the disaster caused by thalidomide in 1961 that the first systematic international efforts were initiated to address drug safety issues. The Erice Declaration of 19971 called for all the players in healthcare including public health administration, health professionals, the pharmaceutical industry, government, drug regulators, the media and the consumers to strive towards the highest ethical, professional and scientific standards in protecting and promoting safe use of medicines and in establishing a new culture of transparency, equity and accountability in communicating drug safety information. Of late, sustained efforts in this area have led to the advent of a new discipline named Pharmacovigilance which means the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems. Recently its concerns have been widened to include herbals, traditional and complementary medicines, blood products, biologicals, medical devices, diagnostic products and vaccines.2,3,4 Pharmacovigilance is needed for the prevention of drug-induced human sufferings and to avoid financial risks associated with unexpected adverse effects.
Its major objectives are:5,6
• Early detection of hitherto unknown adverse reactions and interactions.
• Detection of increases in frequency of known adverse reactions.
• Identification of risk factors and possible mechanisms underlying adverse reactions.
• Estimation of quantitative aspects of benefit/risk analysis and dissemination of information on the need to improve drug prescribing and regulation.
Pharmacovigilance activities are specifically aimed to improve patient care and safety in relation to the use of medicines and all medical and paramedical interventions, contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use, and promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public.1
Sher-i-Kashmir Institute of Medical Sciences (SKIMS), Srinagar is a 500-bedded teaching-cum-service referral centre, offering primary, secondary and tertiary care facilities. During the year, 2002, a total of 3,11,182 patients attended different speciality poly- and referral clinics at SKIMS;6,129 patients were admitted by super speciality disciplines for various surgical procedures;529 patients were admitted in surgical intensive care unit for life support and intensive monitoring.7 Calculating between the period 1996 to 2002, at an average, over twenty four thousand patients get admitted, 1.7 lack patients attend referral clinic, over seventy thousand patients attend polyclinic and over thirty thousand patients attend emergency department at SKIMS every year. Considering the fact that SKIMS has been established towards the end of 1982, it is estimated that during its life span of 20 years up to ending 2002, it might have admitted about 5 lac patients, treated over 30 lack patients at its referral clinic, over 14 lac patients at its polyclinic and over 6 lac patients at its emergency department.
However this huge inflow of patients does not run commensurate to the information and data collected/available on the pattern of adverse drug reactions (ADRs) and interactions in Kashmiri population or on drug utilization patterns at SKIMS. This becomes evident from the fact that upon literature search for published ADR reports and drug utilization patterns using various database resources like Medline, Toxline, Chemical, Biological and Pharmaceutical Abstracts between 1966 to 2004, reports not exceeding a two-digit figure in number from entire Kashmir could be retrieved depicting a very grim scenario of ADR monitoring and reporting from the valley. It is astonishing to know that even such a large population of patients catered by SKIMS over the past twenty years could not be utilized for collection of some valuable information on how drugs behave in this part of the globe or on what drug utilization patterns at SKIMS are like, due to the lack of any systematic pharmacovigilance activities.
The need for pharmacovigilance activities within Kashmir valley is emphasized by the fact that there are differences between countries and even regions within countries in the occurrence of ADRs and other drug related problems. This may be due to differences in drug production, distribution and use, genetics, diet, traditions of the people, pharmaceutical quality and composition of locally produced pharmaceutical products, use of non-orthodox drugs like herbal remedies which may pose special toxicological problems when used alone or in combination with other drugs, prescribing and dispensing practices etc.8,6 As such it is most likely that drugs having been used successfully elsewhere may prove detrimental and dangerous to the population here. Moreover as a result of complete dearth of any sustained efforts in the valley, several drugs that have been either banned abroad or several ADR reports on their use continue to pour in from across the globe, are being used unabated without any monitoring. Some of these drugs include Phenylbutazone, Phenacetin, Cefloridine, Analgin etc. Drugs belonging to Quinolone group that are not recommended for use below 18 years of age, are routinely being prescribed without any proper monitoring of their adverse drug reactions. Similarly a number of drugs to be used with greater caution in pregnancy (Class C, D or X) are being used either advertantly or inadvertantly. Further the data derived from within the valley may have greater relevance and educational value. Information obtained from other parts of the country or the world may not be relevant to this part where above-mentioned factors differ.
Drug and Pharmacy department of SKIMS dispenses around 1000 prescriptions daily for in- and out-patients and around 200-250 prescriptions for employees per day making an annual sale of drugs/surgicals to the tune of approx. Rs. 1.5 crore7 and thereby taking the total number of prescriptions dispensed per year to over four lacks. Given this rate, it is estimated that over 80 lack prescriptions might have been handled by the Drug and Pharmacy department over the past 20 years but sadly so, not even 80 reports of adverse events at the rate of a mere ten reports per year are available in the literature from entire SKIMS though this figure of dispensed prescriptions represents only a small fraction of total number of prescriptions actually written by the physicians at SKIMS due to the fact that majority of prescriptions get filled from outside in open drug markets. Does it mean that drugs do not show any usual or unusual adverse drug reactions here? Surely the answer is in negative, for, the harm caused by medicines has been shown to be significant. Morbidity and mortality from drug-induced diseases have been recognized as an important item on the public health agenda in developed and developing countries. Recent studies have shown that ADRs are responsible for 11.5% of hospital admissions in Norway, 13% in France and 16% in UK9,10,11;6.5% of hospital patients suffer serious ADRs12 and 0.1-0.3% of hospital patients suffer fatal ADRs.13 Situation becomes even more grievous in view of the fact that even medicines that do not need a prescription (over-the-counter medicines) can cause problems. Vaccines, health foods and herbal products may also cause adverse reactions.14 The reasons for non-reporting from Kashmir valley are non-existence of systematic and organized pharmacovigilance and drug information services/activities within SKIMS or any other hospital. Since there is no dearth of well-qualified pharmacy professionals working under the immediate supervision of an experienced hand at SKIMS, the respective section too needs to be encouraged and promoted to actively participate and contribute through their expertise in this field.
The huge inflow of patients makes SKIMS an ideal case for immediate initiation of pharmacovigilance activities in order to ensure safe, rational and effective drug therapy to its patients. Recently Central Drug Standards Control Organization (CDSCO), Government of India has taken up a project in association with and under the financial assistance of W.H.O, wherein national, zonal and regional pharmacovigilance centres are to be established throughout India. SKIMS could well provide a centre under this scheme. In this direction, Dept. of Clinical Pharmacology can serve as the epicenter of all drug safety monitoring studies/programs and can provide all necessary inputs for launching of a Pharmacovigilance center in collaboration with the Dept. of General Medicine and some other institute/department outside SKIMS like Department of Pharmaceutical Sciences, University of Kashmir. Such a centre could play an important role through training, teaching, research, policy development, clinical research, ethics committees, and other related clinical services. It is advisable to appoint an ADR advisory committee comprising amongst others of independent experts in general medicine, epidemiology, pediatrics, pathology and clinical pharmacology.
Some other issues of relevance to pharmacovigilance include substandard medicines, irrational drug use, overdoses, medication errors, lack of efficacy reports, increasing self-medication practices, increasing use of traditional and herbal medicines with other medicines, illegal sale of medicines, use of medicines for indications that are not approved and for which there is inadequate scientific basis, case reports of acute and chronic poisoning, assessment of drug-related mortality, abuse and misuse of medicines, polypharmacy and adverse interactions of medicines with chemicals, other medicines, and food. There are other aspects of drug safety that should be included in monitoring latent and long-term effects of medicines. These include detection of drug interactions, measuring the environmental burden of medicines used in large populations, assessing the contribution of ‘inactive’ ingredients (excipients) to the safety profile etc.5
The entire cost of a pharmacovigilance system, compared with the national expenditure on medicines or the cost of ADRs to the nation is very small.15 Moreover, keeping in view the fact that about 30-80% of ADRs may be preventable,16 comprehensive ADR monitoring, evaluating and reporting programs need to be undertaken that should focus on the assessment of incidence, prevalence, category, severity, preventability, costs and burdens of ADRs. This would help ensure that patients receive safe medicines and mortality/morbidity due to ADRs is considerably reduced.17 By way of pharmacovigilance, healthcare practitioners could make good use of their patients’ positive and negative experiences of treatment and thereby contribute to the medical sciences and towards an improved understanding of disease and of the medicines.
REFERENCES
1. Effective communications in pharmacovigilance. The Erice Report. International conference on developing effective communications in Pharmacovigilance, Erice, Silcily, 24-27 September, 1997.
2. Meyboom RHB, Egberts ACG, Gribnau FWJ, Hekster YA. Pharmacovigilance in perspective. Drug Safety. 1999;21(6):429-47
3. Mehta U, Milstein JB, Duclos P, Folb PI. Developing a national system for dealing with adverse events following immunization. Bulletin of the World Health Organization,2000;78(2):170-77
4. Craven BM, Stewart GT, Khan M, Chan TYK. Monitoring the safety of herbal medicines. Drug Safety. 1997;17(4):209-15
5. The importance of Pharmacovigilance - Safety monitoring of medicinal products. WHO, 2002.
6. Safety monitoring of medicinal products - Guidelines for setting up and running a pharmacovigilance centre. The Uppsala Monitoring Centre, Sweeden.WHO,2000.
7. Sher-i-Kashmir Institute of Medical Sciences, Soura, Srinagar - Annual Report, 2002.
8. Imbs JI, Pouyanne P, Harambaru F. Iatrogenic medication:estimation of its prevalence in French public hospitals. Therapie.1999;54(1):21-27
9. Moore N, Lecointre D, Noblet C, Mabille M. Frequency and cost of serious adverse drug reactions in a department of general medicine. Br J Clin Pharmaco.1998;45(3):301-08
10. Griffin GP. The evaluation of human medicines control from a national to an international perspective. Adv Drug React Toxicol Rev. 1998;17(1);19-50
11. Lepaklin VK (ed.). Safety of Medicine - A guide to detecting and reporting ADRs. Why health professionals need to take action. WHO, Geneva, 2002.
12. Jick H. Drugs - Remarkably non-toxic. N Engl J Med. 1974;291:824-28
13. Bates DW, Spell N, Cullen DJ. The costs of adverse drug events in hospitalized patients. J Am Med Soc.1997;277:307-11
14. Ramesh M, Parathasarathi G, Pandit J. Adverse drug reactions - What we need to know. Ind J Hosp Pharm, May-June, 2003;99-105
15. Folb PI, Ham M. Drug monitoring in developing countries; a drug regulator's perspective. Drug Inf Journal. 1995;29:303-05
16. Pearson TF. Factors associated with preventable ADRs. Am J Hosp Pharm. 1994;51:2268-72
17. Geer MI, Shah MY, Koul PA, Tanki SA. Adverse drug reaction monitoring with a Kashmiri perspective-need for an urgent initiative. JK-Practitioner.2004;11(2):85-87
Its major objectives are:5,6
• Early detection of hitherto unknown adverse reactions and interactions.
• Detection of increases in frequency of known adverse reactions.
• Identification of risk factors and possible mechanisms underlying adverse reactions.
• Estimation of quantitative aspects of benefit/risk analysis and dissemination of information on the need to improve drug prescribing and regulation.
Pharmacovigilance activities are specifically aimed to improve patient care and safety in relation to the use of medicines and all medical and paramedical interventions, contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use, and promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public.1
Sher-i-Kashmir Institute of Medical Sciences (SKIMS), Srinagar is a 500-bedded teaching-cum-service referral centre, offering primary, secondary and tertiary care facilities. During the year, 2002, a total of 3,11,182 patients attended different speciality poly- and referral clinics at SKIMS;6,129 patients were admitted by super speciality disciplines for various surgical procedures;529 patients were admitted in surgical intensive care unit for life support and intensive monitoring.7 Calculating between the period 1996 to 2002, at an average, over twenty four thousand patients get admitted, 1.7 lack patients attend referral clinic, over seventy thousand patients attend polyclinic and over thirty thousand patients attend emergency department at SKIMS every year. Considering the fact that SKIMS has been established towards the end of 1982, it is estimated that during its life span of 20 years up to ending 2002, it might have admitted about 5 lac patients, treated over 30 lack patients at its referral clinic, over 14 lac patients at its polyclinic and over 6 lac patients at its emergency department.
However this huge inflow of patients does not run commensurate to the information and data collected/available on the pattern of adverse drug reactions (ADRs) and interactions in Kashmiri population or on drug utilization patterns at SKIMS. This becomes evident from the fact that upon literature search for published ADR reports and drug utilization patterns using various database resources like Medline, Toxline, Chemical, Biological and Pharmaceutical Abstracts between 1966 to 2004, reports not exceeding a two-digit figure in number from entire Kashmir could be retrieved depicting a very grim scenario of ADR monitoring and reporting from the valley. It is astonishing to know that even such a large population of patients catered by SKIMS over the past twenty years could not be utilized for collection of some valuable information on how drugs behave in this part of the globe or on what drug utilization patterns at SKIMS are like, due to the lack of any systematic pharmacovigilance activities.
The need for pharmacovigilance activities within Kashmir valley is emphasized by the fact that there are differences between countries and even regions within countries in the occurrence of ADRs and other drug related problems. This may be due to differences in drug production, distribution and use, genetics, diet, traditions of the people, pharmaceutical quality and composition of locally produced pharmaceutical products, use of non-orthodox drugs like herbal remedies which may pose special toxicological problems when used alone or in combination with other drugs, prescribing and dispensing practices etc.8,6 As such it is most likely that drugs having been used successfully elsewhere may prove detrimental and dangerous to the population here. Moreover as a result of complete dearth of any sustained efforts in the valley, several drugs that have been either banned abroad or several ADR reports on their use continue to pour in from across the globe, are being used unabated without any monitoring. Some of these drugs include Phenylbutazone, Phenacetin, Cefloridine, Analgin etc. Drugs belonging to Quinolone group that are not recommended for use below 18 years of age, are routinely being prescribed without any proper monitoring of their adverse drug reactions. Similarly a number of drugs to be used with greater caution in pregnancy (Class C, D or X) are being used either advertantly or inadvertantly. Further the data derived from within the valley may have greater relevance and educational value. Information obtained from other parts of the country or the world may not be relevant to this part where above-mentioned factors differ.
Drug and Pharmacy department of SKIMS dispenses around 1000 prescriptions daily for in- and out-patients and around 200-250 prescriptions for employees per day making an annual sale of drugs/surgicals to the tune of approx. Rs. 1.5 crore7 and thereby taking the total number of prescriptions dispensed per year to over four lacks. Given this rate, it is estimated that over 80 lack prescriptions might have been handled by the Drug and Pharmacy department over the past 20 years but sadly so, not even 80 reports of adverse events at the rate of a mere ten reports per year are available in the literature from entire SKIMS though this figure of dispensed prescriptions represents only a small fraction of total number of prescriptions actually written by the physicians at SKIMS due to the fact that majority of prescriptions get filled from outside in open drug markets. Does it mean that drugs do not show any usual or unusual adverse drug reactions here? Surely the answer is in negative, for, the harm caused by medicines has been shown to be significant. Morbidity and mortality from drug-induced diseases have been recognized as an important item on the public health agenda in developed and developing countries. Recent studies have shown that ADRs are responsible for 11.5% of hospital admissions in Norway, 13% in France and 16% in UK9,10,11;6.5% of hospital patients suffer serious ADRs12 and 0.1-0.3% of hospital patients suffer fatal ADRs.13 Situation becomes even more grievous in view of the fact that even medicines that do not need a prescription (over-the-counter medicines) can cause problems. Vaccines, health foods and herbal products may also cause adverse reactions.14 The reasons for non-reporting from Kashmir valley are non-existence of systematic and organized pharmacovigilance and drug information services/activities within SKIMS or any other hospital. Since there is no dearth of well-qualified pharmacy professionals working under the immediate supervision of an experienced hand at SKIMS, the respective section too needs to be encouraged and promoted to actively participate and contribute through their expertise in this field.
The huge inflow of patients makes SKIMS an ideal case for immediate initiation of pharmacovigilance activities in order to ensure safe, rational and effective drug therapy to its patients. Recently Central Drug Standards Control Organization (CDSCO), Government of India has taken up a project in association with and under the financial assistance of W.H.O, wherein national, zonal and regional pharmacovigilance centres are to be established throughout India. SKIMS could well provide a centre under this scheme. In this direction, Dept. of Clinical Pharmacology can serve as the epicenter of all drug safety monitoring studies/programs and can provide all necessary inputs for launching of a Pharmacovigilance center in collaboration with the Dept. of General Medicine and some other institute/department outside SKIMS like Department of Pharmaceutical Sciences, University of Kashmir. Such a centre could play an important role through training, teaching, research, policy development, clinical research, ethics committees, and other related clinical services. It is advisable to appoint an ADR advisory committee comprising amongst others of independent experts in general medicine, epidemiology, pediatrics, pathology and clinical pharmacology.
Some other issues of relevance to pharmacovigilance include substandard medicines, irrational drug use, overdoses, medication errors, lack of efficacy reports, increasing self-medication practices, increasing use of traditional and herbal medicines with other medicines, illegal sale of medicines, use of medicines for indications that are not approved and for which there is inadequate scientific basis, case reports of acute and chronic poisoning, assessment of drug-related mortality, abuse and misuse of medicines, polypharmacy and adverse interactions of medicines with chemicals, other medicines, and food. There are other aspects of drug safety that should be included in monitoring latent and long-term effects of medicines. These include detection of drug interactions, measuring the environmental burden of medicines used in large populations, assessing the contribution of ‘inactive’ ingredients (excipients) to the safety profile etc.5
The entire cost of a pharmacovigilance system, compared with the national expenditure on medicines or the cost of ADRs to the nation is very small.15 Moreover, keeping in view the fact that about 30-80% of ADRs may be preventable,16 comprehensive ADR monitoring, evaluating and reporting programs need to be undertaken that should focus on the assessment of incidence, prevalence, category, severity, preventability, costs and burdens of ADRs. This would help ensure that patients receive safe medicines and mortality/morbidity due to ADRs is considerably reduced.17 By way of pharmacovigilance, healthcare practitioners could make good use of their patients’ positive and negative experiences of treatment and thereby contribute to the medical sciences and towards an improved understanding of disease and of the medicines.
REFERENCES
1. Effective communications in pharmacovigilance. The Erice Report. International conference on developing effective communications in Pharmacovigilance, Erice, Silcily, 24-27 September, 1997.
2. Meyboom RHB, Egberts ACG, Gribnau FWJ, Hekster YA. Pharmacovigilance in perspective. Drug Safety. 1999;21(6):429-47
3. Mehta U, Milstein JB, Duclos P, Folb PI. Developing a national system for dealing with adverse events following immunization. Bulletin of the World Health Organization,2000;78(2):170-77
4. Craven BM, Stewart GT, Khan M, Chan TYK. Monitoring the safety of herbal medicines. Drug Safety. 1997;17(4):209-15
5. The importance of Pharmacovigilance - Safety monitoring of medicinal products. WHO, 2002.
6. Safety monitoring of medicinal products - Guidelines for setting up and running a pharmacovigilance centre. The Uppsala Monitoring Centre, Sweeden.WHO,2000.
7. Sher-i-Kashmir Institute of Medical Sciences, Soura, Srinagar - Annual Report, 2002.
8. Imbs JI, Pouyanne P, Harambaru F. Iatrogenic medication:estimation of its prevalence in French public hospitals. Therapie.1999;54(1):21-27
9. Moore N, Lecointre D, Noblet C, Mabille M. Frequency and cost of serious adverse drug reactions in a department of general medicine. Br J Clin Pharmaco.1998;45(3):301-08
10. Griffin GP. The evaluation of human medicines control from a national to an international perspective. Adv Drug React Toxicol Rev. 1998;17(1);19-50
11. Lepaklin VK (ed.). Safety of Medicine - A guide to detecting and reporting ADRs. Why health professionals need to take action. WHO, Geneva, 2002.
12. Jick H. Drugs - Remarkably non-toxic. N Engl J Med. 1974;291:824-28
13. Bates DW, Spell N, Cullen DJ. The costs of adverse drug events in hospitalized patients. J Am Med Soc.1997;277:307-11
14. Ramesh M, Parathasarathi G, Pandit J. Adverse drug reactions - What we need to know. Ind J Hosp Pharm, May-June, 2003;99-105
15. Folb PI, Ham M. Drug monitoring in developing countries; a drug regulator's perspective. Drug Inf Journal. 1995;29:303-05
16. Pearson TF. Factors associated with preventable ADRs. Am J Hosp Pharm. 1994;51:2268-72
17. Geer MI, Shah MY, Koul PA, Tanki SA. Adverse drug reaction monitoring with a Kashmiri perspective-need for an urgent initiative. JK-Practitioner.2004;11(2):85-87
Some bitter pills for unqualified "Pharmacists" of J&K state
This bears reference to a very well anticipated write-up entitled, “Their demand, your verdict” (GK dt. 16th Feb., 2005) published in response to my earlier article dt. Mar., 3rd, 2005. At the outset I wish to clarify that there was absolutely nothing wrong in my verdict on the demands of the agitating govt. pharmacists as can be ascertained from the series of press statements issued by JKGPA (GK dt. Jan 12, Jan 16, Feb 26 & Mar 22). In all these statements they have unequivocally been demanding their rank promotions on the posts of senior and chief pharmacists. Though in a welcome move, author of the above-mentioned write-up had sullenly and astoundingly renounced this demand and expressed his willingness to stay contended with the designations of medical assistants Grade I, II, III & IV, which was by no means objectionable, his counterparts at Jammu are still pressing for this demand at the corridors of power (GK dt. Mar. 22nd).
In my previous article, I had substantiated my comments and remarks in light of the reports and recommendations of Hathi Committee (1975), Standing Parliamentary Committee (2001), National Human Rights Commission (1999) and the guidelines put forth by Medical/Pharmacy Council of India from time to time. There is little scope for contesting these recommendations/guidelines since they are framed and finalized after marathon debate and discussions with a host of experts in the field. Either the author has not comprehended these guidelines well or has deliberately chosen to ignore the same. Contrary to the claims made in the said write-up, I doubt whether even a single practical instance can be cited by the author where any class fourth orderly has risen to the level of a Chief Secretary or a Divisional Commissioner, any police constable has been able to carve himself out as a Director General of Police or any draftsman has been able to occupy the chair of a Chief Engineer merely on the basis of his service length. Even if there is any stray case, whose chances are very remote albeit, that cannot be used as a justification by them for their indiscriminate promotions on the posts of chief pharmacists without even possessing a diploma in pharmacy. Ironically first the author has ascribed the proximity of aspirants with the men in power as one of the reasons for such hitherto unknown promotions and then in a self-contradictory and non-sequitur fashion called such elevations “sheer fruits of their mettle and dedication”.
In order to maintain some quality standards in technical and professional fields, I feel it is essential to keep some qualification barriers for higher-rung posts. In this respect, govt. pharmacists are not the only pebbles on the beach. I mean it does not apply to them alone but to other professionals too in an equitable manner. What is sauce for the goose is sauce for the gander. An MBBS graduate is not promoted on an Asstt. Professor’s post in absence of a masters degree, a university lecturer is denied Readership unless he possesses a doctorate, a pharmacy or nursing graduate cannot dream of becoming a lecturer without post-graduation and so on. Nevertheless, there could be some exceptional cases with some extra-ordinary grounds. Barring such unusual cases, mere experience can’t work any wonders in mass promotions. In my article I had duly advocated a progressive hike in the pay scales of govt. pharmacists in accordance with their length of service. However their upgradation on the posts of senior or chief pharmacists without mandatory qualification shall always remain unacceptable to the pharmacy graduates. So far as their demand of being accorded “Registered Medical Practitioner” certification is concerned, it is for the physicians to express their willingness or dismay, whatever they deem appropriate, over the issue. However, at a time when a virtual war is being waged against quackery, fake, under- and unqualified medical practitioners, I wonder how pragmatic and advisable would this kind of a move be that is fraught with many other service-related connotations too. RMP certification means conferring a legal authority upon them to consult patients prescribe drugs and practice medicine in a full-fledged manner, be it during duty hours only. I wish to throw an open question. How many of our readers would like to be treated for their ailments by practitioners possessing one year para-medical training course certificates? Whether they flash stethoscopes or aprons over their shoulders or not is immaterial. So-called harassment at the hands of police or other agencies does not lend sufficient ground towards their en-masse declaration as registered medical practitioners.
Author has tried to use the scenario involving improper storage and handling of tetanus toxoid injections, polio vaccines or life-saving antibiotics as a tool to justify his assertion of maintaining status-quo in our prevailing, miserably pathetic drug and healthcare delivery system. If injections or vaccines are not transported or handled in compliance with standard conditions, does that mean we should never even think of scientific storage and modern dispensing techniques. If anyone dares to talk about implementing good pharmacy practices of W.H.O., reports and recommendations of various technical committees and guidelines put forth by MCI or PCI in our hospital and clinical pharmacy settings, why should he be considered unrealistic and unreasonable? What makes people think it is unattainable and “fairytale” stuff. The problem perhaps lies in our thinking, vision and congenital reluctance to progress and change. As a result, people can be seen putting up stiff resistance to any sincere efforts aimed at bringing out modernization, advancement, sophistication and development in such an important walk of life concerning the well-being of community at large. Describing scientific storage and modern dispensing techniques of commodities none other than drugs and pharmaceuticals that have got the potential to decide on the life and death of a consumer as “fairytale” fantasies aptly reflects the degree of mediocrity in our professional conduct, our unprogressive approach and our unenterprising and poignant attitudes.
The author has resorted to an uncalled for exuberance, acrimony and impudence in his language and has tried to draw parallels between an ordinary person who is free to express his views and ideas in a democratic set-up, and the likes of Mohammad Tughlaq. This only depicts the nature of professionalism, mannerism and decency prevailing in the community. Instead of rising to the bait, I would rather prefer to abstain from indulging in this kind of a retaliatory lingo. We are living in an era that is blessed with full freedom of thought and expression, occasional attempts made by certain power centers to subvert or thwart this freedom notwithstanding. Any reservations or differences of opinion can be expressed vide a healthy and meaningful debate without abhorring the dissenters. No degree of excoriation can however deter me from raising genuine issues related to the basic healthcare of common masses and legitimate interests of my fellow professionals, since I myself am one amongst them. So far as the question whether govt. needs advisors or not, I would rather leave it to the readers to draw their opinion. Yet one fact beyond any doubt is that every govt. does require “eye-openers”, a role that is very commendably being played by our fourth estate and to which people like me contribute occasionally in a very small and humble way and the same shall continue in future too, no matter what others feel or say about it. The very fact that there is no Drug Policy in our state, no legal provisions to regulate the sale, storage or distribution of ayurvedic, unani or homeopathic drugs, no education regulations to govern our basic health and pharmacy education, no Pharmacy Act (central) in place in spite of over fifty years of its enforcement in other states, explains the constant need for such fact-reminders and conscience-shakers.
I had made it amply clear in my previous article that I am not averse to the genuine demands of govt. pharmacists, but I am and shall always be concerned about my fellow professionals who spend three or four years of their precious youth in undergoing hard professional training only to find a square peg in a round hole at their aspired and well-deserved positions. Further in my opinion, it does not behoove the president of an association to describe the job responsibilities assigned to him that include the most vital and emerging concepts of drug storage and dispensing as “ a very petty task” and thereby undermine the dignity of his own job profile and designation. To my perception, no job done with full zeal, zest and dedication can ever be termed as “petty”. Moreover, had he been aware of the recent advancements made in these areas in rest of the world, I am sure he would have desisted from using such misnomers. Nevertheless, author is right in saying that the concerned agencies in the govt. have not shown adequate interest in conducting regular quality improvement and continuing education programmes for in-service pharmacists and other health workers in order to apprise and educate them of the latest happenings and recent trends in these areas. Therefore govt. pharmacists could very well include this as one of their demands.
My intention was never to show the govt. pharmacists down by way of my article or to assail them in any manner. I have absolutely no intention to enter into an indecorous and insalubrious squabbling spree with them. Pharmacy graduates have nothing to do with their agitation or demands as long as any attempt is not made to usurp their rights or transgress their jurisdiction. They have their own distinctly discernible role to play and we have ours. No grudges, no hostility. With these remarks, I hope entire controversy will be put to an end and they will give up their demand for their rank promotions on the posts of senior or chief pharmacists. I once again reiterate that I have no objection to the rest of their demands excluding RMP certification.
In my previous article, I had substantiated my comments and remarks in light of the reports and recommendations of Hathi Committee (1975), Standing Parliamentary Committee (2001), National Human Rights Commission (1999) and the guidelines put forth by Medical/Pharmacy Council of India from time to time. There is little scope for contesting these recommendations/guidelines since they are framed and finalized after marathon debate and discussions with a host of experts in the field. Either the author has not comprehended these guidelines well or has deliberately chosen to ignore the same. Contrary to the claims made in the said write-up, I doubt whether even a single practical instance can be cited by the author where any class fourth orderly has risen to the level of a Chief Secretary or a Divisional Commissioner, any police constable has been able to carve himself out as a Director General of Police or any draftsman has been able to occupy the chair of a Chief Engineer merely on the basis of his service length. Even if there is any stray case, whose chances are very remote albeit, that cannot be used as a justification by them for their indiscriminate promotions on the posts of chief pharmacists without even possessing a diploma in pharmacy. Ironically first the author has ascribed the proximity of aspirants with the men in power as one of the reasons for such hitherto unknown promotions and then in a self-contradictory and non-sequitur fashion called such elevations “sheer fruits of their mettle and dedication”.
In order to maintain some quality standards in technical and professional fields, I feel it is essential to keep some qualification barriers for higher-rung posts. In this respect, govt. pharmacists are not the only pebbles on the beach. I mean it does not apply to them alone but to other professionals too in an equitable manner. What is sauce for the goose is sauce for the gander. An MBBS graduate is not promoted on an Asstt. Professor’s post in absence of a masters degree, a university lecturer is denied Readership unless he possesses a doctorate, a pharmacy or nursing graduate cannot dream of becoming a lecturer without post-graduation and so on. Nevertheless, there could be some exceptional cases with some extra-ordinary grounds. Barring such unusual cases, mere experience can’t work any wonders in mass promotions. In my article I had duly advocated a progressive hike in the pay scales of govt. pharmacists in accordance with their length of service. However their upgradation on the posts of senior or chief pharmacists without mandatory qualification shall always remain unacceptable to the pharmacy graduates. So far as their demand of being accorded “Registered Medical Practitioner” certification is concerned, it is for the physicians to express their willingness or dismay, whatever they deem appropriate, over the issue. However, at a time when a virtual war is being waged against quackery, fake, under- and unqualified medical practitioners, I wonder how pragmatic and advisable would this kind of a move be that is fraught with many other service-related connotations too. RMP certification means conferring a legal authority upon them to consult patients prescribe drugs and practice medicine in a full-fledged manner, be it during duty hours only. I wish to throw an open question. How many of our readers would like to be treated for their ailments by practitioners possessing one year para-medical training course certificates? Whether they flash stethoscopes or aprons over their shoulders or not is immaterial. So-called harassment at the hands of police or other agencies does not lend sufficient ground towards their en-masse declaration as registered medical practitioners.
Author has tried to use the scenario involving improper storage and handling of tetanus toxoid injections, polio vaccines or life-saving antibiotics as a tool to justify his assertion of maintaining status-quo in our prevailing, miserably pathetic drug and healthcare delivery system. If injections or vaccines are not transported or handled in compliance with standard conditions, does that mean we should never even think of scientific storage and modern dispensing techniques. If anyone dares to talk about implementing good pharmacy practices of W.H.O., reports and recommendations of various technical committees and guidelines put forth by MCI or PCI in our hospital and clinical pharmacy settings, why should he be considered unrealistic and unreasonable? What makes people think it is unattainable and “fairytale” stuff. The problem perhaps lies in our thinking, vision and congenital reluctance to progress and change. As a result, people can be seen putting up stiff resistance to any sincere efforts aimed at bringing out modernization, advancement, sophistication and development in such an important walk of life concerning the well-being of community at large. Describing scientific storage and modern dispensing techniques of commodities none other than drugs and pharmaceuticals that have got the potential to decide on the life and death of a consumer as “fairytale” fantasies aptly reflects the degree of mediocrity in our professional conduct, our unprogressive approach and our unenterprising and poignant attitudes.
The author has resorted to an uncalled for exuberance, acrimony and impudence in his language and has tried to draw parallels between an ordinary person who is free to express his views and ideas in a democratic set-up, and the likes of Mohammad Tughlaq. This only depicts the nature of professionalism, mannerism and decency prevailing in the community. Instead of rising to the bait, I would rather prefer to abstain from indulging in this kind of a retaliatory lingo. We are living in an era that is blessed with full freedom of thought and expression, occasional attempts made by certain power centers to subvert or thwart this freedom notwithstanding. Any reservations or differences of opinion can be expressed vide a healthy and meaningful debate without abhorring the dissenters. No degree of excoriation can however deter me from raising genuine issues related to the basic healthcare of common masses and legitimate interests of my fellow professionals, since I myself am one amongst them. So far as the question whether govt. needs advisors or not, I would rather leave it to the readers to draw their opinion. Yet one fact beyond any doubt is that every govt. does require “eye-openers”, a role that is very commendably being played by our fourth estate and to which people like me contribute occasionally in a very small and humble way and the same shall continue in future too, no matter what others feel or say about it. The very fact that there is no Drug Policy in our state, no legal provisions to regulate the sale, storage or distribution of ayurvedic, unani or homeopathic drugs, no education regulations to govern our basic health and pharmacy education, no Pharmacy Act (central) in place in spite of over fifty years of its enforcement in other states, explains the constant need for such fact-reminders and conscience-shakers.
I had made it amply clear in my previous article that I am not averse to the genuine demands of govt. pharmacists, but I am and shall always be concerned about my fellow professionals who spend three or four years of their precious youth in undergoing hard professional training only to find a square peg in a round hole at their aspired and well-deserved positions. Further in my opinion, it does not behoove the president of an association to describe the job responsibilities assigned to him that include the most vital and emerging concepts of drug storage and dispensing as “ a very petty task” and thereby undermine the dignity of his own job profile and designation. To my perception, no job done with full zeal, zest and dedication can ever be termed as “petty”. Moreover, had he been aware of the recent advancements made in these areas in rest of the world, I am sure he would have desisted from using such misnomers. Nevertheless, author is right in saying that the concerned agencies in the govt. have not shown adequate interest in conducting regular quality improvement and continuing education programmes for in-service pharmacists and other health workers in order to apprise and educate them of the latest happenings and recent trends in these areas. Therefore govt. pharmacists could very well include this as one of their demands.
My intention was never to show the govt. pharmacists down by way of my article or to assail them in any manner. I have absolutely no intention to enter into an indecorous and insalubrious squabbling spree with them. Pharmacy graduates have nothing to do with their agitation or demands as long as any attempt is not made to usurp their rights or transgress their jurisdiction. They have their own distinctly discernible role to play and we have ours. No grudges, no hostility. With these remarks, I hope entire controversy will be put to an end and they will give up their demand for their rank promotions on the posts of senior or chief pharmacists. I once again reiterate that I have no objection to the rest of their demands excluding RMP certification.
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