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Chapter 3: Rationality of Drugs    
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Drugs Weeded Out

A series of drug combinations have been weeded out since 1980 by the Drug Controllereither as a result of the recommendations of the Drug Technical Advisory Board, or public pressure mounted through the Supreme Court and resulting court orders. (See Appendix 1)

However, the resulting gazette notifications often tend to have a lot of loopholes, thus rendering the executive actions weak and ineffective. (See box `Banned Drugs: When is a Banned Drug not Banned'). For an excellent study of these notifications see Mira Shiva and Wishvas Rane, Banned and Bannable Drugs (Fourth Revised Edition). New Delhi: VHAI, 1996.
Banned Drugs : When is a Banned Drug not Banned?
1. When the Government decides (in effect) to lift the ban, as the case of clioquinol (di-iohydroxyquinoline).
 
 
2. When the drug companies who stand to lose from the ban, obtain a stay order on it and Government itself fails to vacate the stay order.
 
 
3. When the ban is diluted, so as the leave out some hazardous drugs.
   

The banning of steroid combinations excluded steroids. Intended for asthma. The result was that steroid combinations previously indicated for other illnesses were suddenly recommended for asthma, while usage for earlier indications continued.

    Fixed does combination of chloramphenicol was recommended for banning by DCC in 1980. it was diluted by the DTAB to chloramphenicol combination, excluded choloramphenicol and streptomycin combination.

4.

When a ban order is ambiguously worded. Leaving room for loopholes. The Gazette Notifications of July 1983 failed to specify weather a drug would be banned only if all ingredients or if any of the combination of ingredients were present, e.g. yohibmine strychnicnine in testerone in tonic as in Category 5 Gazette Notification.

 
    Failure to specify meaning of steroid combination as to whether it would include anabolic steroids and listing of the specific drags.
    Wording the Gazette Notifications in such a way that injectable preparation is left out when the preamble clearly states that the formulations are harmful and have no therapeutic value. But only oral dosage forms are mentioned in the sections having legal status. Thus giving an impression that all formulations are banned (injectable and tablets) yet banning only the latter, e.g. high dose oral formulation.
5.

When the ban order is not enforced. When the legislation is inadequate, e.g. the 22 categories of banned drugs could not be banned till the Drugs and Cosmetics Act was amended following which alone was the Gazette Notification issued in July 1983.

 
    When the ban order is issued in a Gazette Notification and no effort is made in use the government media, e.g. AIR, Doordarshan as well as major national dailies to publicise the drugs and the brands involved.
    When name of and the manufactures of the banned drugs is not made public to prevent doctors from prescribing and consumers from consuming them.
    When authorities concerned to fail to seriously monitor the continued sale of banned drugs.
6. When authorities concerned consistently fail to punish those who violate the ban orders.
    An urgent screening and listing of all the drugs in the market is required.
Identification of hazardous and also irrational and non-essential drugs is required.

Withdrawal of these drugs should take place immediately.

Deterrent punishment of those who continue to sell banned drugs and challenge the decision of the Drug Controller and the Drugs
Consultative Committee
    Source: Mira Shiva and Wishvas Rane, op.cit.
Ethics of Drug Use for Doctors
1).
Prescribe strictly rationally and promote rational therapy on all occasions, personal and professional.
2).
Prescribe only essential, generic drugs, that are single ingredient formulations with accepted exceptions of combination drugs like co-trimoxazole, ORS, etc.
3).
When two or more equivalent drugs are available for the same condition, prescribe the less costlier and safer alternative. Thus minimise use of liquids, injections and IVs.
4).
When not sure of the dosage, mechanism or side-effects consult standard textbooks and/or journals.
5).
Update your knowledge by reading relevant scientific journals, and by promoting discussion of clinical experiences of rational therapy in appropriate professional forums. (Points 4 & 5 mean conscious investment of time and money).
6).
Explain to the patient clearly how he/she has to take the drug. Encourage your patient to ask questions about the therapy and the mode of treatment. Respect the autonomy of the patient. And encourage his/her self-reliance.
 
7).
Do not take, and if possible actively oppose, taking of, bribes, gifts, etc. from drug companies or going for seminars and trips sponsored by drug companies. It all adds to the cost of the drug to the end user apart from biasing your prescription in favour of the drug company's products.
8.
Look out for adverse drug reactions; record and report the same to ADR (Adverse Drug Reaction Centres) centres in India and in relevant professional journals.
9.
Avoid cut practice and poly therapy. Keep X-rays, lab tests and other such investigations to the minimum. If possible oppose publicly cut practice and poly therapy.
10.
Above all innovate by using your clinical judgment. Most patients, especially from rural areas, will not be able easily to come back to you (if you are an urban practitioner for instance). See how you can make your client well in one trip and if possible with one or two drugs. Remember getting ill and getting well are socio-medical processes.
Sir William Osler: A doctor at the beginning of his/her career starts with 20 drugs for one disease, and the one at the end of his/her career has one drug for 20 diseases.

References

1.
Silverman, Milton et al. Prescription for Death: the Drugging of the Third World. Berkeley: University of California Press, 1982. pp. 13
2.
Use of Essential Drugs: Model List (Eleventh List). Geneva: World Health Organization, 1999
3.
Beardshaw, V. Prescription for Change. Penang: IOCU/HAI, 1983. pp.19
4.

ibid. pp.18.

5.
Consultation for Rational Selection of Drugs. New Delhi: VHAI, 1986. pp. RSOD-85.
6.
Bangladesh Drug Policy - Criteria for recommended withdrawal of products from the Bangladesh market in Zafrullah Chowdury's The Politics of Essential Drugs (1995).
7.
Bangladesh Drug Policy, op cit.
8.
Chetley, A. Problem Drugs, Amsterdam: HAI, 1993.
9.
Duggan, Lynn. "From Birth Control to Population Control: Depo-Provera in Southeast Asia" in McDonnell, Kathleen, ed. Adverse Effects: Women and the Pharmaceutical Industry. Penang: IOCU, 1986. pp.159-165. Also see : Sathyamala C., An Epidemiological Review of the Injectable Contraceptive, Depo-Provera. MFC and Forum for Wome''s Health. Pune/Mumbai, 2000.
Other References
1.
"Ten reasons for misuse of drugs". Health Action. February 1993. pp 9-13.
2.
Towards a Rational Drug Policy: Problems, Perspectives, Recommendations. New Delhi: AIDAN, 1986.
3.
Banned and Bannable Drugs. New Delhi: VHAI, 1995, op.cit.
       
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