An Open Letter to the Minister of Health & family Welfare

On World Population Day

Newsletter September 1998


Mr Dalit Ezhimalai,

On the occasion of the World Population Day, 11th July I998, we, the members of Saheli, an autonomous women’s group that has been working for 17- years on issues related to women’s health, would like to draw your attention to various instances of gross medical malpractices that thousands of women in India, especially the poor, are being subjected to.

Ever since the horrors of forced sterilisation of men during the Emergency, successive governments have made women of the country bear the brunt of aggressive population control programmes. Consequently, women have become the target of coercion, hazardous contraceptive methods and unethical contraceptive research.

On this day last year, Saheli had released a booklet titled ‘Quinacrine: A sordid story of chemical sterilisation of women’ extensively documenting its history and abuse on women. The use of Quinacrine pellets for sterilisation of women has been banned by the World Health Organisation, and the Indian Council of Medical Research (ICMR), abandoned its trials because of unsatisfactory safety and efficacy, and some life threatening hazards. No permission was granted by the Drugs Controller General of India (DGCI) for any other trials of Quinacrine or import/manufacture of its pellets for sterilisation yet, over the last two decades, the promoters of Quinacrine sterilisation have brazenly propagated the method and conducted trials with illegally imported pellets.

In the process, they have subjected thousands of women to the procedure and its risks. Additionally, these trials have also been marked by utter disregard for informed consent and follow-up. And the guilty are private practitioners, non-governmental organisations (NGOs), and even doctors in government hospitals! DGCI has adequate information and documentary evidence of the involvement of Dr. JK Jain (Jain Medical Centre, Delhi) as the main distributor of the Quinacrine pellets in India, and Drs. B. Mullick [Calcutta], S. Bhateja and P. Kini (Bangalore), A. Sareen (Patiala) and M. Sood (Delhi).

The last year has seen a widespread campaign against Quinacrine sterilisation by women’s and health groups all over the country. Consequently the DGCI, on the recommendation of the Drug Technical Advisory Board, has announced a ban on the import, manufacture, distribution and sale of Quinacrine for chemical sterilisation under the provisions 10A and 26A of the Drugs and Cosmetics Act. Further, the Supreme Court has, on l6th March I998, upheld the ban. However, it has failed to do so with retrospective effect. Also, the DGCI claims his helplessness to take punitive action. So those involved in illegal Quinacrine sterilisations are going scot-free. Meanwhile, women continue to suffer the pain, menstrual abnormalities and complications caused by the procedure, and unwanted pregnancies due to its failure, without the follow up that is expected with ‘clinical trials’.

Hon‘ble Minister, a year ago Saheli had apprised your predecessor, Ms.Renuka Choudhary of the legal and ethical violations of Quinacrine sterilisations in India. But, no action has been initiated against the crusaders of this hazardous method. Instead, they continue to assert their brazenness. Dr. Elton Kessel (USA), one of the major proponents, working in association with Dr Jain, responded to the ban in India by saying, ‘The future of Quinacrine will be with village midwives. They are so scattered it will be very hard for the government to stop.’(The Wall Street Journal, June I9, I998).

However, the story of Quinacrine sterilisations is not an isolated one. The last two- decades have seen many other, equally horrible instances of unethical clinical trials and gross medical malpractices: The ICMR has itself been guilty of blatantly disregarding accepted ethics of informed consent in trials of hazardous contraceptives like Norplant, Net-En etc., and more recently, in a study carried out by the Institute of Cytology and Preventive Oncology, Delhi (an ICMR funded institute) on women with cervical dysplasia, a precancerous condition. Similar disregard for informed consent and follow up has been seen in the trials of the Anti-hCG vaccine by the government funded institute, National Institute of Immunology.

So today, ethical guidelines of clinical trials and medical practice are being blatantly flouted across the board. If the government continues to turn a blind eye to such malpractices, the guilty will continue to gain strength, while women continue to pay the price of the government’s apathy. You have been in office for 100 days. We would like to know what you have done to stop such blatant violations. In farming out the health sector, the government has already shirked a large part of its responsibilities; it cannot abdicate them further.

It is imperative that the government develop mechanisms to permit and monitor clinical trials, control sale and use of hazardous drugs and contraceptive methods. We demand that you take punitive action against those guilty of playing with women’s lives and well-being. We insist that you exhibit your commitment to women’s health by ensuring implementation of the laws of the land. On World Population Day, we call for an immediate stop to aggressive population control policies and practices, so as not to add to the misery of women who constitute half the population of the country.