For Quality, Essential, Generic Medicines
Chapter 4: Drug Marketing    
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Glaxo Scandal

The Maharashtra State Food and Drug Administration (FDA) ordered the closure of Glaxo (India), a British multinational company's production in its Worli factory in Bombay for 10 ten days in March 1994 for violating the provisions of the Drugs and Cosmetics Act and the rules of FDA. In June 1993, the FDA found that Glaxo, instead of destroying rejected drugs had authorised a scrap dealer to collect the substandard drugs from its premises. These drugs were then recycled and sold in black market, putting unwary consumers to grave risk.

The FDA seized large stocks of unlabeled drugs like Betnesol, Viteneuron and Prepalin Forte injections manufactured by Glaxo, rubber stamps and also large stocks of coded and plain Glaxo labels from the scrap dealer's godown in Dharavi slum area. Following the discovery of labelled and unlabeled drugs, coded and blank labels, and printed cartons in the factory's unit in the presence of the company's quality assurance manager and the general manager, the company was issued a show-cause notice. On June 14, 1993, FDA suspended Glaxo's licence to manufacture various drugs for ten days from July 15 to 24, 1993. However, Glaxo appealed to the State Health Minister against this order.

The British multinational company challenged the charges saying that it was the largest pharmaceutical company in India with a good reputation and well qualified persons, maintaining strict quality-control measures. It claimed the penalty imposed on it was too harsh and unjustified and would result in the shortage of life-saving drugs in the market. In addition, it would be render 2000 employees idle and reduce the government's revenue by way of sales tax and excise. Glaxo felt it was not responsible for the contractor's failure to destroy the rejected drugs or printed packaging materials.

However, the company was well aware that the drugs were being removed undestroyed by the contractor. The FDA also found that proper records were not kept with regard to the drugs rejected and the actual destruction. Moreover, it took a serious view because a big MNC violated the rules and also because consumers preferred well-known branded brand names and paid more for them believing them to be of good quality. The FDA also pointed to the company's track record which showed that drug controllers in several states had taken action for various violations; among them, warnings, reduction of shelf-life of products, suspension of licences for manufacture of specific products from one month to four months because active ingredient was weak, contents were less than indicated on the label, and in one case the presence of an insect in an ampoule.

Finally, almost a year later, Glaxo decided not to appeal against the order issued by the Maharashtra FDA and suspended the manufacture at its Worli factory in Bombay for 10 days from March 18, 1994. (25).

     
 

Depo Provera and Injectable Contraceptives : Disturbing Side-effects

Dr. C. Sathyamala's book. An Epidemiological Review of the Injectable Contraceptive, Depo Provera (Pune/Mumbai: Medico Friend's Circle and Forum for Women's Health, 2000) is required reading for anybody intrested in injectable contraceptives, whichever side of the debate one tends to be. At the end of her carefully argued monograph, she concludes :

".......The weight of evidence relating to the hazardous nature of Depo Provera is sufficient to compel its proponents to admit to the injectable's potential for adverse outcomes including death. However, the issue is side-stepped and the relatively high maternal mortality in developing countries is cited as reasons for differing risk-benefit assessment for use in developed and not so-developed countries (WHO, 1982; Chilvers, 1994).

While it is debatable whether high contraceptive prevalence alone as a single measure will reduce mortality and morbidity posed by pregnancy related causes, in the context of the third world countries, three points need to be remembered Firstly, the population at risk of pregnancy may be different from the population at risk of contraception; secondly, the contraceptive risks may be an added on risk to pregnancy risks; and thirdly, the very factors that are responsible for the high obstetric deaths in a developing country would increase deaths due to Depo Provera use.

The review of literature presented in this monograph is to enable the reader to weigh the risks and benefits of the use of Depo Provera as a temporary method of contraception in women from the disadvantaged sections of society.

Depo Provera appears to be hazardous to the health of the women and her progeny. The contraceptive appears to be not suitable for nulliparous women, adolescents, breast feeding women, women who have not completed their family, and women who are in the reproductive age group. In short, there does not seem to be a single group of women for whom Depo Provera can be safely recommended as a contraceptive method of choice......"

On the other side, Dr. R. P. Soonawalla, eminent gynacologist of Mumbai and Principal Investigator, Post Marketing Surveillance Study of Depo Provera, has this to say (interview, The Hindustan Times, May 22, 1994, quoted in Satyamala, op. cit.)

"...I am saying, let it (Depo Provera) be available. Nobody is forcing anybody to take it. Let the doctor decide what is right for the patient. Obviously, the doctor will monitor its use and if there are problems, no doctor or patient is foolish enough to continue its use.

Why should it be banned, and why should we have to smuggle it for our patients? Who are these women who are protesting against it? Ill-informed, so-called feminists, who are just a bunch of college girls with nothing better to do. Without going into the issue they are making a noise about it. Barging into meetings, carrying placards, shouting slogans. There are so many important issues that need attention. Why don't they do something about slum children dying or about the blind?

They say that the first world is trying to foist it on the third world women. This is rubbish. A lot of life-saving drugs came to us after being formulated and tested in the West, they didn't object to those, but here they have a platform to make a lot of noise and hullabaloo about nothing. What kind of ethics are these? For atleast the next decade there won't be a perfect contraceptive. Every drug has some side-effects. It is up to the doctor and the patient to decide what is the best method. My only concern is for my patients....

.... Calling for a ban on Depo Provera is like the anti-abortion protests, which want to take away the choice from women. I have come across so many cases of women who publicly opposed abortions, but quietly went and had abortions done. I am sure a lot of women who are opposing Depo Provera will take the injections themselves. It is alright to be clever when it comes to other people. They have no right to dictate to responsible doctors what they should or should not prescribe to their patients. If there are a few black sheep, pick on them, don't deprive everybody else of the use of a particular drug, especially when all research has proved these contraceptives to be safe."

A third opinion runs something like this: in view of Depo's disturbing side-effects, it may not be introduced in the Government's Family Welfare Programme, as it is target-oriented and therefore it may be imposed on innocent women without checking for contraindications or otherwise properly explaining to the user. The Indian Public Health system is not geared to meet the need of close followup and monitoring that the use of Depo requires. Thus Depo Provera may be used for 'private marketing'. As of today Depo is available against prescription and is not included in the Government of India's Family Welfare programme.

However, Net-en, another contraceptive with equally disturbing side-effects, is being introduced in the official family welfare programme in "such places where adequate facilities for followup and counselling are available" (affidavit filed by Ministry of Health and Family Welfare on August 18, 2000 in the Supreme Court of India in the matter of Stree Shakti Sanghatana and Others versus the Union of India and Others). What is the real danger of either injectable contraceptive being misused or used in the wrong situation is anybody's guess.

 
     

       
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