FRESH INITIATIVES AND NOVEL APPROACHES REQUIRED IN THE FORMULATION OF STATE MEDICINES POLICIES WITHIN INDIA

INITIATIVES FOR CURBING THE MENACE OF SPURIOUS/COUNTERFEIT/SUB-STANDARD/MISBRANDED/ ADULTERATED DRUGS:

a.       Special courts should be designated to try the cases of spurious drugs.

b.      Creation of intelligence cum legal cell to facilitate busting of spurious drug rackets and their prompt prosecution respectively should receive thrust.

c.       Provision of secret funds and incentives to informers giving information about spurious drugs should be endeavoured.

d.      Effective networking system between neighbouring states should be developed.

e.       Necessary changes in law should be made to award severe and deterrent punishments as afforded under law to those dealing with spurious drugs, making the offences cognizable and non-bailable in the light of similar provisions in Narcotic Drugs and Psychotropic Substances Act.

f.       Proliferation of drug distribution outlets should not be encouraged. A distance of at least 500 meters should be maintained between two successive shops.

g.      Drug sale licences should be issued only to persons holding diploma or degree in pharmacy from a recognized/duly approved university/institution. Necessary amendments should be made in the relevant Acts to enforce this provision.

h.      Preparation of dossiers of suspected dealers and manufactures should be a perpetual exercise. Such dealers should be black-listed and their licences cancelled.

i.        Manufacturers should be encouraged to have their own anti-counterfeit drug strategies like RFID, QRC etc, better surveillance and efficient complaint handling system.

j.        A statewide survey should be conducted to measure the magnitude of spurious drug trade in the state, lifting samples from every nook and corner of the state in a statistically designed scientific manner.

k.      Effective interaction between the stakeholders i.e. industry and regulators, industry and consumers, trade and regulators and medical professional and regulators, should be developed

INITIATIVES IN RESPECT OF DRUGS BELONGING TO AYUSH SYSTEMS OF MEDICINE:

a.      A committee comprising of traditional health practitioners and healers, and experts in pharmacognosy, toxicology and related fields should be constituted to study and guide the various activities with respect to AYUSH drugs.

b.      The health conditions that can be treated with these traditional systems of medicine should be identified.

c.       An appropriate methodology and technology for the identification, development and production of medicinal items used by the traditional systems of medicine should be developed.

d.      Scientific studies to evaluate the quality, safety and efficacy of traditional and herbal medicines should be fostered and promoted.

e.      All practitioners of traditional medicine systems as well as the public should be encouraged to remain alert to adverse reactions to traditional and herbal medicines and to notify them to the Drug Information Centres and the nodal centre for drug information in the State.

f.        Cultivation and research of medicinal plants, should also be encouraged and promoted.

INITIATIVES FOR RATIONAL DRUG PROMOTIONAL PRACTICES:

a.      All drug promotional practices of pharmaceutical companies and prescribing practices of doctors should be in accordance with Dec.,2010 amendments of the MCI code of Medical Ethics (professional conduct, etiquette and ethics Regulations), 2002 and the prescribers should be made to adhere to these guidelines in letter and spirit.

b.      Authorities of government hospitals, particularly teaching hospitals, should ensure that medical and pharmaceutical sales representatives’ activities and conduct are in conformity with standard ethical norms and do not, in any way, hamper routine patient care. All sales representatives should be allotted a specified time and venue inside the hospital for detailing their products.

c.       Drug Policy should ensure rational prescribing practices by doctors, rational dispensing practices by pharmacists and rational use of medicines by the consumers in an integrated and seamless manner.

d.      Promotion-making claims of pharmaceutical suppliers should be reliable, accurate, truthful, informative, balanced, up-to-date, capable of substantiation and in good taste.

e.      Product information of all kinds, should be scientifically valid and evidence-based.

f.        Offering, soliciting or accepting inducements of any kind, monetary or material (except free samples of product in modest quantity) for promotional purpose should not be indulged in.

g.      Prescribing doctors or dispensing pharmacists should not accept support or assistance of any kind conditional upon obligation to promote a medicinal product.

h.     Professional societies, educational organizations may accept partial sponsorship from the pharmaceutical companies for holding scientific meetings and symposia, but this should be clearly stated at the meetings and in proceedings. Care should be taken to ensure that the sponsorship in no way affects the quality of scientific deliberations in the meeting.

INITIATIVES TO COUNTER THE MENACE OF DRUG ADDICTION AND SUBSTANCE ABUSE:

a.      Sale, storage and use of drugs specified under Schedule X of the Drugs and Cosmetics Act, 1940 should be regulated with a greater vigil by the inspectorate working under Drug and Food Control Organization, J&K. Proliferation of drug stores should be discouraged and easy availability of substances of abuse should be reversed.

b.   Record-keeping of such drugs should be made indispensable and the same should be checked regularly by the inspectorate. Special checking squads should be framed and authorized to undertake periodic necessary inspections in this regard along the length and breadth of the state.

c.   License to sell, stock and distribute drugs pertaining to Schedule X should be restricted to dealers with absolutely spotless track record and should not be issued to those indulging in any sort of unlawful activities.

d.   Workforce of the Narcotics Control Bureau should be augmented and its nodal centre established at Srinagar. 

e.   A multi-disciplinary Coordination Committee under the Chairmanship of Chief Secretary or a senior Secretary should be established for regular interaction with various Central and State agencies; to receive support and grant-in-aid assistance from Narcotics Control Bureau of India.

f.        The state should set up an Anti Narcotics Task Force under an IG level officer with duties and responsibilities duly demarcated.

INITIATIVES FOR RATIONAL BLOOD BANKING AND TRANSFUSION POLICY

a.      Procedures of blood banks e.g. blood collection, processing, compatibility testing, storage, component separation, transfusion of blood and blood products and all other related activities should be practised as per the rules and regulations under the Drugs and Cosmetics Act 1940 and the Drugs and Cosmetics Rules 1945 and in accordance with relevant statutory guidelines.

b.      In keeping with the constant needs and constraints, special provisions should be made to facilitate availability of blood and blood products through a substitute storage system, in peripheral areas where good blood banking system is still in the process of development.

c.       An expert Committee shall devise Standard Operating Procedures and oversee the functioning of all blood banks and peripheral storage facilities to ensure and facilitate the above goals.

INITIATIVES FOR PHARMACY EDUCATION REGULATION POLICY

a.      For this purpose central Pharmacy Act of 1948 should be enforced in the state to replace J&K Pharmacy Act 2011 (samvat) and the J&K Pharmacy Council should endeavour to constitute its executive committee and frame Pharmacy Education Regulations and implement them as soon as possible so that minimum standards can be prescribed for colleges and institutes offering diploma or degree courses in Pharmacy.

b.      This will make sure that nobody enters the profession of pharmacy without earning a legal qualification. Further the constitution and scope of J&K Pharmacy Council should be broadened, making it all-inclusive by enrolling professionals from academia, hospitals, industry and trade as its members.

INITIATIVES FOR DRUG SAFETY MONITORING POLICY

a.      Although medicines are useful to alleviate human illness, all medicines are not completely safe. Therefore, pharmacovigilance is necessary to safeguard the public from the possible adverse drug reactions and prevent the cause of false public alarm and misinterpretation. Pharmacovigilance activities should be funded through the State drug budget.

b.      Pharmacovigilance centres should be established to monitor and document adverse drug reactions and events.  These centres should collect data on adverse reactions and events and other drug related problems like substandard drugs, counterfeit drugs, inappropriate use, medication errors etc. from various health professionals/workers.

c.       Pharmacovigilance centres should also be established under the national Pharmacovigilance Programme of India in all hospitals of the state.

d.      Measures should be taken to enhance spontaneous reporting of adverse drug reactions in all hospitals of the state.

e.      All adverse drug reaction reports and other drug related problems should be properly documented and follow up action including preventive measures shall be taken.

f.        Besides Pharmacovigilance, other clinical pharmacy services including Pharmaceutical Care Services, Drug Utilization Studies, Therapeutic Drug Monitoring, Patient Counseling, Evaluation of Prescribing Practices, Pharmaco-economics & Cost analysis and Pharmacy Practice divisions should be established in all hospitals.

INITIATIVES FOR DRUG LICENSING POLICY

In order to control mushrooming of retail shops in urban areas at least 500 meters distance to be kept between two shops. Stringent norms should be followed with regard to service of Pharmacists, storage & issuing of cash memos.

INITIATIVES FOR DRUG INFORMATION POLICY

a.      All potential and actual users of medicines must have ready and meaningful access to scientific, truthful, unbiased, evidence based and independent drug information.

b.      Drug Information Dissemination Centres (DIDC) must be established in all major hospitals of the state.

c.       The Nodal Centre should collate all current information on drug use and disseminate them appropriately to all potential users in general and the prescribers in particular, towards the promotion of RUD.

d.      The feasibility and prospect of collaborating with NGOs in the State, working in this area should be explored.

e.      A Committee with the representatives from Drugs Control Authority, Health Administration, Drug Seller's Association, Consumers and Academia, must oversee and monitor the functioning of the DIDC and suggest changes, if and as necessary.

INITIATIVES FOR LOCAL (STATE LEVEL) DRUG INDUSTRIAL POLICY

a.      Development of Pharmaceutical manufacturing Industry/Pharma Zone within the state by providing capacity building, soft loans, subsidies and special exemptions

b.      To attract pharmaceutical formulation and bulk drug manufacturers to set up plants at an area which is easily accessible will be provided for developing an upgraded Pharma zone / city.

c.       The govt. of J&K must consider providing the following facilities:

Ø    Sufficient and uninterrupted supply of electricity

Ø    Common effluent treatment plant

Ø    Single window system

Ø    A liaison officer to co-ordinate between industry and govt.

Ø    Provision for low cost land and relaxation of tax and duties

Ø    Special packages for encouraging NRK investors

Ø    Soft loan to encourage R & D

Ø    Subsidy for modernisation of existing facilities.

BARRIERS IN THE RATIONAL USE OF QUALITY MEDICINES

        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 FACTORS:

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.