Quinacrine Sterilizations Banned

Author(s): Dr. Mohan Rao
Date Published: July 17, 2006
Source: (Political Environments #6, Fall 1998)

On March 16 of this year, at the final hearing of the writ petition filed by the All India Democratic Women's Association (AIDWA) and the faculty of the Center of Social Medicine and Community Health of Jawaharlal Nehru University (JNU), New Delhi, the Drug Controller of India gave a written commitment to the Supreme Court that the use of the drug quinacrine for female sterilization would be banned in India. Additionally, the Government by notification in the official Gazette would prohibit "the manufacture, sale or distribution" of quinacrine in pellet form. The commitment prescribed penalties for violation including "imprisonment for a term which shall be not less than five years but which may extend to a term of life with fine which shall not be less than ten thousand rupees."

The three-member bench of the Supreme Court, headed by Justice A.S. Anand, had earlier issued notices to the Drug Controller of India; the distributor of the drug in India, Dr. J.K. Jain, former Rajya Sabha member of the Bhartiya Janata Party (now heading the national government); and one of the promoters of the method, CHIP Trust of Bangalore, which had set itself the objective of performing 25,000 sterilizations over a two-year period. Significantly, the Court did not accept the appeal made by Dr. Jain and the CHIP Trust for a review of the decision on the ban.

The positive intervention of the Supreme Court in the matter of the illegal sterilization of women with quinacrine has been hailed as a significant victory for the women's movement. Indeed the ban in India will provide a fillip to the international movement against the misuse of the drug, which is distributed by two US-based non-governmental organizations, in nineteen Third World countries. These so-called "trials" have been carried out in spite of the World Health Organization's categorical statement calling for cessation of human trials pending further toxicology tests in laboratories since the initial tests revealed possibilities of carcinogenicity.

The quinacrine "trials", among primarily poor women in Third World countries, have raised major controversies concerning the safety and efficacy of the method and, above all, the trials' ethical and scientific dubiousness. In 1992 the Indian Council of Medical Research prematurely terminated its trial of quinacrine due to the extremely high failure rate and unacceptably high rates of complications. Recently, the Government of India stated in Parliament, in response to a question by Professor Ashok Mitra, that "approval for clinical trials of quinacrine pellets had not been granted to any investigator" and further that "no drug manufacturer has been granted license to manufacture quinacrine and the drug is not imported."

Media reports, which depicted private medical practitioners and NGOs in a number of cities using this method to sterilize thousands of women, evoked strong protests from women's groups and health activists. That no action was being initiated against the distributor of the drug and the doctors unlawfully utilizing this method, and the Government's statement in Parliament that it was unaware of quinacrine sterilizations being performed in the country, compelled AIDWA and the public health faculty of JNU to file their public interest litigation in the Supreme Court.

It should be noted, however, that the Court did not answer the petitioners' prayer for follow-up and compensation for the victims of this method of sterilization in India nor for the punishment of the doctors involved. The Court's intervention is, therefore, only the first step, although a significant one, in the struggle of health activists and women's groups to strengthen public institutions for the conduct, monitoring and regulation of public health research even as they are held accountable to the people. This need is particularly acute, in the context of the undermining of public health systems, with the reckless incorporation of the Indian economy in the global market. Justice Anand's observation that "Indian women cannot be guinea pigs" could not have been more poignant or pointed.

Despite the commitment made to the Supreme Court, the Government of India took until August 17, 1998, an unconscionably long time, to issue the gazette notification of the ban. Reports indicate that this delay was due not, as the new Health Minister claimed in Parliament, to the routine delay in translating the ban order into Hindi, but the intense lobbying undertaken by Dr J.K. Jain who has emerged more powerful after his party assumed leadership of the national government. Dr. Jain attempted to have the decision on the ban 'reconsidered' while continuing to supply the pellets to those doctors willing to carry on with what was still referred to as trials. That this effort was unsuccessful is as much a consequence of the functional autonomy and strength of the judiciary in the country as of the weakness of the current political regime.

The success in obtaining the ban on quinacrine sterilizations was made possible by the broad-based nature of the movement, with a wide range of women's groups and health activists coming together in the demonstrations organized in various cities in the country starting off in Calcutta in front of Dr. Biral Mullik's clinic. Led by Professor Malini Bhattacharya, former Member of Parliament and a respected academic, the demonstration forced the Government of West Bengal to initiate an inquiry into his practice. Demonstrations were also held outside the clinic run by J.K. Jain in New Delhi, the prime mover of these sterilizations in the country and subsequently in Bangalore at the offices of the CHIP Trust.

The demonstrations, widely reported in the press and evoking strong editorial comment in the major national dailies, were followed by a series of memoranda to the Ministry of Health and the Drug Controller. There was also sustained writing about the issue in a range of newspapers and journals across the country. "The Yellow Haze," a documentary on the quinacrine sterilizations in New Delhi made by students at the Mass Communication Department of Jamia Milia Islamia , was widely shown among health groups and women's groups. Importantly, New Delhi-based Saheli published an excellent report, "The Sordid Story of Quinacrine Sterilizations," which was widely distributed and helped inform public opinion. In many of these efforts, there was documentation assistance from the Committee on Women, Population and the Environment (CWPE) as well as other individuals.

The ban obtained on quinacrine sterilizations is only a beginning. There is much more to be done in the case of the women subjected to quinacrine sterilizations. There is also a need for a sustained campaign to question the whole range of reproductive technologies being unleashed on the Third World as part of the West's continuing obsession with population growth in these countries. These efforts to reduce population growth are an integral part of the neo-colonial agenda of structural adjustment programs that further impoverish the vast masses of these nations. Nevertheless, that the quinacrine victory was possible in these bleak times is a morale booster for those involved in the much larger struggle for responsible health research and a radically different health agenda.

Dr. Mohan Rao is Assistant Professor at the Centre of Social Medicine and Community Health at Jawaharlal Nehru University in New Delhi.

STATEMENT TO THE PRESS, OCTOBER 20, 1997

A bench of the Supreme Court headed by Justice A.S. Anand today issued notice on a petition filed by the All India Democratic Women's Association and certain members of the faculty of Social Medicine, Jawaharlal Nehru University to the Drug Controller of India. The petition seeks a ban on the use of quinacrine as a method of sterilization of women. The court also impleaded Dr. Jain's Medical Centre which is distributing the drug illegally in India and the Chip Trust in Karnataka, which is currently engaged in large scale sterilization of women by this harmful method.

The present petition is directed against the distribution and use of Quinacrine as a method of non-surgical sterilization on women. In this method of sterilization, pellets of quinacrine are inserted into the fundus of the uterus. This leads to inflammation of the uterus which is followed by the formation of scar tissue which is expected to occlude or close the Fallopian tubes and hence result in sterilization. The mode apart from being barbaric is completely illegal as no licence has been obtained for use of quinacrine as a method of sterilization under the Drugs & Cosmetics Act, 1945. In fact, the use of quinacrine has not been approved by any drug authority in the world as a method of sterilization. The short term effect of this method of sterilization is that it is highly painful and has been known to cause extreme body ache, dizziness, painful periods, irregular bleedings, etc. The failure rate of this method of sterilization is also extremely high and the said method has been known to cause ectopic pregnancy in the fallopian tube with potential fatal consequences for the child as well as the mother. In fact the Indian Council for Medical Research had stopped trials of quinacrine because of its high failure rate. There is hardly any information about the long term effects of the said method although laboratory tests indicate that the drug is mutagenic and may possibly be carcinogenic. In India illegal trials have been carried out in New Delhi, West Bengal and Karnataka. The drug is being distributed in the country by Jain Medical Center, South Extension, New Delhi, and is being imported by the said center and others without any license from two doctors in the United States of America, Elton Kessel and Stephen D.Mumford, who feel that this method of population control should be used in Third World countries.

Presently, certain doctors in Bangalore are involved in a two-year project of sterilization of 25,000 women by the quinacrine method and have started a Trust called CHIP for this purpose. The two doctors have recruited 300 to 400 doctors from parts of Karnataka as part of this current project. The petitioner brought all these facts to the notice of the respondents but no action has been taken by the respondents to ban the use of this drug or to take appropriate action against the offenders under the law. This is despite the fact that between July 1994 and July 1996, 600 women in Bangalore alone are said to have been subjected to this method of sterilization. Illegal trials with quinacrine are being carried on and the petitioners are seeking a ban on the use of the said drug apart from directions to the government to prosecute those who have been involved in the said trials.