Joint Memorandum to the Health Minister Against NORPLANT
We the undermentioned Women's Organizations and Concerned Groups register our protest at the completely arbitrary decision of the Government of India to introduce NORPLANT® in the National Family Planning Programme.
Introducing a sub-dermal hormonal Implant such as NORPLANT® is a totally untenable decision even if it were fully tested. The screening procedures, surgical implantation and removal and the known adverse reactions of NORPLANT® are such that its use in the Family Planning Programme would create a new public health hazard in the absence of a sophisticated and well-equipped health-care system. Our country's health-care system has proved itself to be incapable of detecting and treating even tuberculosis and malaria. Such a system is totally inadequate to meet the requirements of NORPLANT® administration.
We are alarmed to note that with aid from the United States of America the government has launched a programme of population control in Uttar Pradesh with special emphasis on low parity couples and hence on spacing methods. We are given to understand that this programme will be run with the co-operation of NGOs, will entail social marketing of contraceptives and NORPLANT® will be one of them.
At the same time we understand that a pre-programme introduction (Phase IV) study using NORPLANT® will be carried out in urban centres on 20,000 women recruited through Medical College Hospitals, by the Indian Council of Medical Research (ICMR).
You must be aware that NORPLANT® is as yet an inadequately tested contraceptive in India. To date, this contraceptive has been tested up to only the second phase of clinical research. The mandatory Phase III and Phase IV clinical trials which are necessary to determine the safety, efficacy and suitability of the drug under Indian conditions have been bypassed.
Our contentions are supported by the Additional Director General of ICMR who has been on record saying that NORPLANT® studies should be carried out only in medical colleges which alone have adequate expertise and facilities available. We are shocked to find that the government has decided to throw caution to the winds in introducing NORPLANT® through NGOs which will not be in a position to monitor women. At any rate, even if the aid programme were to enhance the capabilities of NGOs in this regard, we would like to know how such a lopsided development of medical facilities for the exclusive pursuit of population control is justified in a country where even essential drugs are not available for other national programmes of health.
It may not have come to your notice but it is a fact that even under experimental conditions, with the best facilities available, medical college hospitals managed to loose track of 12 percent of the women who were enrolled in a three year trial programme with another implant NORPLANT®. Today there are over 300 women still carrying in their bodies, an ineffective implant which is exposing them to the risk of ectopic pregnancy - a life threatening condition. Apart from being a personal tragedy for the women concerned, this is a prime example of the complete inadequacy of our health system in delivering a "sophisticated" contraceptive such as NORPLANT®.
Finally, we are concerned about the fact that a device like NORPLANT® has an immense potential for abuse. Long-acting contraceptives which cannot be removed by women at will have been known to be used by the medical system to coerce women to accept contraception whenever they approach doctors for treatment. Despite complaints and medical problems these devices are not removed on request. While most women need contraception, such contraceptives rarely serve their needs but are geared to minimizing contact with the user without loosing out on effectiveness. As such, we are against the introduction of such contraceptives in the national Family Planning Programme.
In view of the above we demand that:
All plans for introduction of NORPLANT® in the Family Planning Programme be dropped immediately. The introduction of any other long-acting invasive contraceptive such as NET-EN, nasal spray, anti-fertility vaccine, etc. be banned, both on grounds of inadequacies of the health services and loss of user control. Information on safety aspects of NORPLANT® and the basis on which the Drugs Controller has granted his approval is made public. It is also imperative that the data on procedural complications, adverse effects, return of fertility and research design is made public. This information should also include the current health status of all women who have ever been recruited for the trials.
Each and every one of the hundreds of women who still have ineffective NORPLANT® implants in their bodies should be located and these implant should be removed most expeditiously.
All hormonal contraceptive preparations be banned in the social marketing programme as their use involves extensive monitoring.
Signatories: Action India, AIDS Bhed Bhav Virodhi Aandolan, All India Democratic Women's Association, Ankur, Indian Social Studies Trust, Jagori, Kali for Women, Karmika, National Federation of lndian Women, People's Union for Democratic Rights, Saheli, Sabla Sangh.