The Hindu : New Delhi News : Doctors' federation clears controversial contraceptive

Online edition of India's National Newspaper
Thursday, Jun 10, 2004

New Delhi

New Delhi

Doctors' federation clears controversial contraceptive

By Bindu Shajan Perappadan

NEW DELHI, JUNE 9. The Federation of Obstetrics and Gynaecologists Society of India (FOGSI) has "cleared" the controversial three-monthly injectable contraceptive Depo-Provera as safe for "general use". This even as a group of women users in Canada are contemplating a suit against the manufacturer, Pharmacia, now owned by Pfizer, because of extensive adverse reactions to the contraceptive.

In India, though continued opposition from women's and health groups has prevented the contraceptive from being prescribed through the National Family Planning Programme, experts are questioning the wisdom of making this contraceptive "freely" available in the market and making accessibility to the drug so easy that it can be bought over the counter.

Women worldwide have suffered severe reactions to the drug including depression, muscle weakness, weight gain, prolonged vaginal bleeding, haemorrhage, sleep disorders, breathing difficulties, slurred speech, pulmonary embolism, chest pain, confusion, decreased or no libido, convulsions, multiple fractures, and premature menopause. Most of these adverse drug reactions have been reported in the earlier published studies on Depo-Provera.

Meanwhile, in India though the sales of Depo-Provera have not touched anywhere near its potential, experts are worried about the population exposed to it.

"The contraceptive is not reaching the potential `target', that is women from the poor and marginalised sections of society who cannot afford to purchase this expensive drug which is priced at Rs. 180 per vial. It is here that the promoters of Depo-Provera hope that FOGSI's `approval' for general use will persuade the Ministry of Health and Family Welfare to `purchase' the contraceptive and make it available `free' to the women who form the target of population control," explained C. Sathyamala, an expert who has been working in the field.

In India, Depo-Provera was `approved' by the Drugs Controller in 1993 following endorsement by the United States Food and Drug Administration (USFDA). The `approval' in India, however, is illegal claimed experts as it is in contravention to the Schedule Y of the Indian Drugs and Cosmetics Act, 1940.

"Under this schedule (Requirement and Guidelines on Clinical Trials for Import and Manufacture of New Drug), Depo-Provera should have undergone a Phase III clinical trial in the country prior to approval. Instead, the Drugs Controller of India allowed `Post Marketing Surveillance' to replace the mandatory trial," pointed out experts.

Administered as an intra-muscular depot injection every three months, the dose of drug administered per injection is many times higher than that in the daily oral pill.

Moreover, once injected, the drug remains in the body for a period of three months or longer and if the woman develops an adverse reaction there is no way that the drug can be `removed' from the body or dosage brought down.

Dr. Sathyamala explained: "One has to understand that contraceptive drugs are to be used by normal healthy women and one has to weigh it against the possibility of the drug's effect. In the clinical trials carried out by the Upjohn Company and the World Health Organisation (WHO), deaths were reported following the use of the contraceptive. But information about such deaths has been suppressed in the literature provided by the drug company."

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