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.
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