New Study Supports India Women Fighting Birth Control Injections

by Ranjit Devraj

Last week's release of a study by the non-government organization "SAMA" is the latest episode in a two-decade old, see-saw battle between rights groups and the Union Health Ministry, which is under intense pressure from trans-national pharmaceutical companies to introduce the drugs Net En and Depo Provera into the health care system without adequate testing or safeguards.

Sustained campaigning by SAMA and other women's groups resulted in the Health Ministry announcing last January that plans to introduce injectables into the Family Welfare Program (FWP) were being dropped but added the rider that they were being allowed in the private sector "to give women a wider choice".

But free availability of the injectables, coupled with increasing privatization of health care, means the drugs are being dispensed without the mandatory follow-up and counselling and no recompense for the side-effects they were causing to users.

And as a research team from SAMA led by Dr. N.B. Sarojini discovered, the drugs were in fact being dispensed through government hospitals as part of the family welfare program in spite of the official assurances and in contravention of Supreme Court directives that effectively restrict their use to private use.

SAMA's study was basically a follow-up of 52 women who were given Depo Provera injections manufactured by Upjohn/Pharmacia between October 1999 and June 2000 at the government's Deen Dayal Upadhyay Hospital in the capital, the only one that cooperated and provided lists.

"We were provided with a bigger list but constraints such as difficulty in tracing addresses, changed residences, incomplete addresses left us with a sample of just 52 women," Sarojini said.

She said although the sample was small the researchers felt it was important to go ahead with the study because it would provide the only available first-hand account of the experiences of women in India with Depo Provera and its administration.

Painstaking personal interviews were conducted with each of the women, who were mostly housewives aged between 21-40 and having levels of education ranging from no formal schooling to having post graduate degrees.

The results confirmed the worst fears of health activists. To begin with, there was no evidence of the use of "informed choice" with 42 of the 50 women saying they were never told about the probable side-effects such as changes in the menstrual cycle or even complete cessation.

As regards "choice," 31 of the women were given no other option. Of those who were given an option, seven were offered permanent methods which they naturally rejected while ten were offered implantation of an intra-uterine device (IUD) which they found less appealing.

No screening was done on 26 of the women although World Health Organization (WHO) guidelines stipulate that "women should be medically screened, if possible examined, and thoroughly counseled by trained personnel before they are given injectable contraceptives."

Even Upjohn/Pharmacia's package insert clearly says that "pretreatment and annual history and physical examination should include special reference to breast and pelvic organs as well as pap smear." In fact not one of the women underwent breast examination or pap smear.

SAMA's study showed that several of the women had a history of diabetes or heart disease in the family, had migraine, jaundice, heavy bleeding, abnormal pregnancies and hypertension and these were never taken into account.

On the "follow-up" count, the study found that 48 of the women had discontinued using Depo Provera for various reasons, most of them for the side-effects or because the drug was no longer available free or subsidized at the hospital and the women found it too expensive to buy in the market.

The study raised several questions starting with how government hospitals could provide Depo Provera when the Supreme Court had expressedly forbidden use of injectable contraceptives as part of the national program.

There has been no comment from the government on the study that was released last Thursday.

"Our findings effectively demonstrate that the health delivery system is grossly inadequate in meeting the minimum infrastructural requirements for introducing an injectable such as Depo Provera," Sarojini said.

Originally introduced in the United States in 1967 by Upjohn -- which later merged with Pharmacia -- Depo-Provera made its appearance in India in 1994 soon after this country embarked on its globalization program.

A leading world authority on injectables with formidable research on the subject to her credit, Dr. C. Sathyamala pointed out that in spite of the claimed 30 million users worldwide, overall use of injectables was low and that it was not a popular choice in the developed world but was being pushed into developing countries.

According to Sathyamala, who trained at the London School of Hygiene and Tropical Medicine, Depo-Provera is a long-term, systemic, invasive contraceptive, which acts at multiple levels but its potency and the ease of administration have been cited as reasons for its promotion in sections with "high birth rates and low motivation levels".

"Pharmaceutical lobbies, international funding agencies and development banks have made population control a condition for loans and grants to Third World governments and have come to play a significant role in family welfare programs of countries such as ours," Sathyamala said.

Of present concern to SAMA and other women's rights groups such as the All-India Democratic Women's Federation (AIDWA) is the fact that the injectables are being introduced amidst increasingly coercive policies aimed at stabilizing population growth in a country of one billion people projected to increase to 1.63 by 2050.

An example is the family-welfare linked social insurance scheme for poor couples available only to those with less than two children and rewards for those that accept sterilization after the second child.

Already six states prohibit couples with more than two children from running in local elections and these are southern Andhra Pradesh, northern Himachal Pradesh, Haryana and Rajasthan, eastern Orissa and central Madhya Pradesh.

Western Maharashtra has recommended withdrawal of subsidized food entitlements, educational facilities and welfare schemes for the third child onwards while Rajasthan provides that those with more than two children cannot be given government jobs and if already in service cannot avail of promotions.

India first introduced family planning in 1951 aimed at a two-child norm but poor infrastructure, high illiteracy rates and resistance to coercive methods have resulted in general ineffectiveness of the program.