ISSUES : WHY DRUGS ARE MISUSED?

There are many reasons why drugs are misused. We discuss some of the important ones below.

DRUGS ARE PROFITABLE
Much as the drug industry likes to deny it, the marketing and manufacture of drugs is one of the most profitable businesses in the world.
In 1973, according to the Hathi Committee report, 49 multinational drug firms were holding foreign equity of more than 40% and 17 firms less than that. By 1986, according to Indian Government sources, 44 multinational companies (MNCs) in India have ‘dominant control by their principal international companies’ (See Table 1).

Table 2 shows that formulations were the major preoccupation of the MNCs and they did very little basic drugs or bulk drug manufacture.

Accoding to FERA a company is considered ‘foreign’ if more than 40% of its ‘Equity in india is held by its foreign parent company or equivalent foreign agency’. Section 29 of the FERA lays down that all non banking foreign branch companies and those incorporated in India with foreign equity of more than 40 percent require the permission of the Reserve Bank of India to carry on, establish, purchase shares of, and acquire wholly or partly any undertaking engaged in activities whether of trading, commercial or indutrial nature. The FERA also laid down guidelines for foreign branch companies to reduce their equity to 40 percent or less. In practice, even though the foreign subsidiary reduces its equity even less than 40 percent, it still continues to be controlled as has been observed, by the foreign parent company. This defeats the purpose of Section 29 of FERA.
The profitability and share prices of some major drug companies in India is shown in Tables 3A and 3B. In addition to drugs being profitable, a significant percentage of medicines marketed are of doubtful efficacy and many have no value, and/or are harmful. However, drug companies are able to push these drugs successfully because of the millions spent on advertising and persuading doctors to use them.

Table 3B
WHO SAYS THE DRUG COMPANIES ARE INCURRING LOSSES
Book Values and Price Share of Pharmaceuticals

Table 4 & 5A give statistics of a survey of sales of 1984 and shows how irrational and useless some of the top selling drugs in India are. The responsibility for this trend lies not only with drug companies, but also with prescribers and educated consumers.

The ICSSR/ICMR report’s calculations on the availability of INH and dapsone showed that only 7 percent and 16.5 percent of their rspective total requirements was being produced. (Health for All - An Alternative Strategy. Indian Institute of Education, Pune 1981. p.178).
Table 5B below shows how Pfizer, a monopoly producer of anti T.B. drugs in India was producing far below its licensing capacity and was producing an irrelevant item like protinex far above its licensed capacity.

TOO MANY DRUGS
A study carried out in Spain, using criteria suggested in Table 6 revealed that only 54.2% of all drugs consumed in 1980 had an acceptable potential therapeutic value; 22% of the consumed drugs had no value at all, and more than 22% of the consumed drugs had no value at all, and more than 20% had an ‘unacceptable’ value. The digures in India are likely to be more.

Table 6
A Possible Qualitative Classification of Medicines
According To Their Potential Therapeutic Value

High Value
Products with no backing from controlled clinical trials, which are justified by their immidiate and obvious effect (e.g. insulin for acute juvenile diabetes, vitamin B 12 for perniscious anaemia, penicillin for certain infections, and products for which controlled clinical trials exist, supporting their clinical efficacy; the estimation term ‘high’ does not depend on the therapeutic and toxic doses, or on the incidence of side effects, and is based only upon publichsed data on controlled clinical efficacy. Examples: ampicillin, 500 mg capsules; chloramphenicol, 250 mg capsules; ASA 500 mg tablets.

Relative Value
Pharmaceutical specialities that are irrational from a pharmacological and therapeutic point of view, because, together with a highly valid active principle, they contain one or more chemical entities with a rather doubtful therapeutic efficacy (vitamins, co-enzymes, and so on), the addition of which is not supported by any published clinical data obtained by an adequately controlled clinical trial. Examples: liazepam + vitamin B6; ampicillin + ‘mucolytic’; antacil + pancreativ enzymes.

Doubtful Value
Drugs which are currently considered controversial and about whose long-term efficacy there is open discussion in international literature. This group includes chiefly drugs used in the treatment of chronic conditions, such as oral antidiabetics and antiplatelet drugs.

No value
Those products for which no adequate controlled clinical trials exist, supporting their clinical efficacy. This group also includes some products with ‘high value’ active ingredients formulated in an insufficient dose, even for paediatric use. Examples: co-enzymed (ATP, acetyl-CoA, etc.): ‘cerebral vasodilators’.

Unacceptable value
Pharamceutical specialities which, because of their composition, have a clearly unfavourable benefit/risk ratio under all circumstances. Examples: chlorampheicol + phenothiazine + corticosteroid + sulphonamide; cyproheptadione + isoniazid + corticosteroid.

Source : Laporte et al: British Journal of Clinical Pharmacology, 1983, No. 16 pp.301-304.

In India the estimated amount of formulations vary anything from 15,000 to 60,000. Expert committees like the Hathi Commission have recommended only 116 drugs. Who’s Action Programme on Essential Drugs recommends 250 drugs for 90% of the health care needs of any third world country. In 1977, Afghanistan decided to decrease the number of drugs from over 2000 to 400 in private as well as public sector. All drugs were sold under generic names. Mozambique (343 drugs in 1980), Sri Lanka (600 in 1972), Iran (600 in 1980), Kenya (maximum of 200 drugs), Norway and other Nordic countries are examples of countries which tried to implement an essential drugs or minimum drugs programme.
Even as there are too many drugs in the market, there are many which are irrational and harmful drugs. Most fixed dose (F.D.) combinations are harmful or are not rational. Only under certain conditions drug combinations are rational. Appendix 1 discusses in detail when rational drug combinations can be allowed. The WHO essential drug list mentioned only about 10 fixed dose combinations.
Among irrational/harmful drugs some of the drugs which have been in the news are: Analgin (brand: Novalgin); Amidopyrine: Butazones; Clioquinols (Mexaform); Anabolic Steroids; tonics containing expensive organic phosphates, and minerals like manganese, zinc or even copper; Cyproheptadines (Periactin), Pizotifen (Mosegor); Kaolinpectin, guicolates, creosates and other expectorants, glafenine (Flifanan), Chymotrypsin, Net-en, high dose Estrogen Progesterone Combination Drugs like EP Forte, Menstrogen, Disecron Forte etc. (brand since June 1988) by Drug Controller of India).
A study by LOCOST (1986) revealed that most cough syrups marketed in India are therapeutically useless or of doubtful value. Appendix 2 summarises this study. Studies by MFC (Medico Friends Circle, 1985) on analgesics and antipyretics revealed a similar situation. Only 14% of the 59 analgesic/antipyretics revealed a similar situation. Only 14% of the 59 analgesic/antipyretics were justified; 18 needed to be banned immediately on account of harmful ingredients. Another study in 1984 found that only 7 out of the 47 top selling antidiarrhoeal preparations were justified. In addition protein powders (Proteinules, proteinex), Glucose powder (Glucon-D), Vitamin B-Complexes, Vitamin E preparations, Placentrex (an aqueous extract of healthy human placenta containing alkaline phosphotase and claimed to be useful in tissue regeneration), memory miracles or brain tonics (Encephaleol, Hydergine), Styptics (claimed useful for stopping haemorrhages), etc. are drugs whose use is not supported by any standard textbook of Pharmacology like Goodman Gillman’s or Martindale’s Extrapharmacopoeia. There are irrationalities marketed in almost every therapeutic category. Table 7 gives the fixed dose combinations banned by the Government of India.

In June 1982, Bangladesh Drug Ordinance eliminated quite a few unnecessary drugs. The graded essential drug list of Bangladesh consists of 150 drugs :

1. 12 essential drugs for village health workers.

2. Additional 33 essential drugs for PFC to Thana Health Complex level.

3. Additional 105 essential drugs for use at tertiary level. (An additional supplementary list of 76 drugs to be increased upto 100 was darwn up for resitricted use by specialists.)

The criteria used by Bangladesh to withdraw drugs is given in Appendix 3. Every country needs to draw similar criteria for withdrawl of harmful, useless and/or unessential drugs and implement the same.

In addition, essential drugs should -

- meet real medical need

- have significant therapeutic value

- be acceptably safe

- offer satisfactory value for money.

Table 7
NOTIFICATION OF BANNED DRUGS
List of banned Drugs
Ministry of Health & Family Welfare
New Delhi, the 23rd July 1983

G.S.R. 578 (ET) - Whereas the Central Government is satisfied that the use of the Drugs specified in the table below is likely to involve risk to human beings or the said drugs do not have the Therapeutic value claimed or purported to be claimed for them or contain ingredients and in such quantity for which there is no thereapeutic justification and it is necessary and expedient in the public interest so to do:
Now, therefore, in exercise of powers conferred by Section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture and sale of the said drugs namely:

Table

1. Amidopyrine
2. Fixed dose combination of Vitamins with anti-inflammatory drugs and Tranquilisers.
3. Fixed dose combination of Atropine in Analgesics and Anti-pyretics.
4. Fixed dose combination of Strychnine and Caffeine in tonics.
5. Fixed dose combinations of Yohimbine and Strychnine with Testosterone and Vitamins
6. Fixed dose combination of Iron with Strychnine, Arsenic and Yohimbine
7. Fixed dose combination of Sodium Bromide Chloral Hydrate with other drugs.
8. Phenacetin
9. Fixed dose combinations of Anti-histaminic with anti-diarrhoeals
10. Fixed dose combinations of Penicillin with Sulphonamides.
11. Fixed dose combinations of Vitamins with analgesics.
12. Fixed dose combinations of Tetracycline with Vitamin C.
13. Fixed dose combinations of Hydroxyquinoline group of drygs except preparations which are used for the treatment of diarrhoea and dysentery and for external use only.
14. Fixed dose combinations of Cortico Steroids with any other drug for internal use.
15. Fixed dose combinations of Chloramphenical with any other drug for internal use.
16. Fixed dose combination of Ergot.
17. Fixed dose combination of Vitamins with anti-T.B. drugs except combination of Isoniaside with Pyridoxine Hydro-chloride (Vitamin B6)
18. Penicillin skin [Eye Ointment
19. Totracycline Liquid oral preparations
20. Nialamide
21. Practolol
22. Methapyrilene, its salts

(No. X.11014/1/83-DMS & PFA

S.V. Subramniyam
Jt. Secretary

ADDENDUM

23. Methaqualone
24. Oxytotracycline lquid oral preparations
25. Demeclocylcline liquid oral preparations

Also, it should be acceptable by other related social and medical criteria like using national resources, ease of administration, long shelf life, etc. (See also Table 8).
Appendix 4 gives WHO’s criteria for the selection of essential drugs. Somerelated reasons that are traceable to the drug industry and which lead to widespread availability of irritational drugs, and their overpricing are:

DRUM DUMPING
This refers to the phenomena by which drugs which are banned in Western/developed countries are marketed in poor countries like India, Examples, Analgin (novalgin of Hoecht banned in West Germany), Baralgan, Please see also Table 9 for some other instances of dumping.

Table 8
ADVANTAGES OF THE CONCEPT OF
ESSENTIAL DRUGS

Preparing a rational list of essential/restricted drugs has several advantages: medical, economic, social and Administrative.

Medical advantages

• It is medically, therapeutically and scientifically sound, and it ensures rational use of drugs.
• It limits the use of irrational and hazardous drugs and decreases the risks of iatrogenesis. (Doctor induced illness)

Economic Advantages

• It is economically beneficial to the nation because it prevents wastage of scarce resources on non-essentials.
• The economics of scale achieved in the larger production of priority drugs brings down their prices.
• It curtails the aggressive marketing of non-essential formulations.
• It is economically beneficial to the patient because it prevents wastage on irrational and non-essentials.

Social Advantages

• It responds to the real health needs of the people.
• It facilitates the dissemination of correct information about the drugs to health personnel, medical practitioners and consumers in general.
• it makes it imperative to draw up priorities to meet the most urgent needs of the people for essential health care.

Administrative Advantages

• It is organizationally sound because it makes quality control easier because of the limited number of drugs to be monitored.
• It facilitates the streamlining of production, storage and distribution of drugs, because of the smaller number of drugs involved.
• It helps in the clear identification of the drugs.
• It facilitates the fixing of prices as well as the revision/withdrawal of excise duties, sales tax, etc.

Source: Towards a Rational Drug Policy. AIDAN, New Delhi, 1986.

Table 9 : DOUBLE STANDARDS

According to the voluntary code of IFPMA (International Federation of Pharmaceutical Manufacturers’ Associtaion) "Information on pharmaceutical products should be accurate, fair and objective and presented in such a way as to conform not only to legal requirements, but also to ethical standards and to standards of good taste."
The constituents to IFPMA in India and under-developed countries consider that ‘ethical standard’ or ‘standard of good taste’ in these countries differ drastically from those of developed countries. Therefore, they maintain double standards. We mention a few such examples of double standards by multinationals in India.
The following drugs are not promoted by the multinationals in their own countries or in any developed country. Yet they are marketed in India and have sizeable market.