EP Drugs Banned

Souvenir 1988

The campaign against EP drugs (high dose fixed combination of estrogen and progesterone) will be a milestone in the history of drug activism in India. Stretching over a period of six years, this campaign culminated in public hearings, the first of their kind, to decide the fate of these drugs. On June 30, 1988 the manufacture and sale of these drugs was banned in India. Saheli participated in this campaign right from the beginning.

In the early 1980s, in EP drugs were being sold over the counter and were prescribed freely by doctors to test pregnancy, to postpone menses as abortifacients. This was despite the fact that countries had banned their use, either totally or in pregnancy testing. The WHO had circulated this information to all member countries and advised that these drugs were hazardous, because of their association with congenital malformation when administered to pregnant women.

The Drug Controller of India sought expert advice, but due to the pressure from the powerful lobby of gynaecologists and drug manufacturers, refrained from banning the drug outright. Instead, it was made mandatory for manufacturers to carry a warning on their packaging and promotional literature, stating that the drug was not to be used in pregnancy. Fresh reports of the drugs causing congenital malformation, and media reports about the misuse of these drugs, once again made the Drug Controller review his decision in 1979, but with the same results.

The drug remained in the market. However, the Indian Medical Association and Federation of Obstertrics and Gynaecological Societies of India were requested to inform their members that EP drugs were not to be used in suspected pregnancy or as pregnancy tests.

In practice, widespread misuse of these drugs continued. In 1982, several drug action, health and women’s groups came together to highlight this malpractice. Since women were the sole consumers of these drugs, it was decided to launch the campaign on March 8, International Women’s Day.

Our first effort was towards gathering evidence of misuse. Even though these drugs were to be sold only on prescription, Saheli volunteers went to chemists and bought the drugs over the counter without any difficulty. In the process we discovered that some drug companies had not printed the warning against use in pregnancy on their packaging. Others had printed the warning but in miniscule letters and only in English. Saheli volunteers also visited qualified gynaecologists and, by posing to be pregnant, found that EP drugs were being prescribed for pregnancy testing as well as for inducing abortions.

Along with the Voluntary Health Association of India, letters were written to doctors and chemists, raising these issues, and a signature campaign was started. Our demands consisted of banning this drug for pregnancy testing; stopping its abuse as an abortifacient; and having the warning on drug packs in bold letters and local languages so that it could be read by the women themselves. In order to warn women about the danger of these drugs, a poster was printed, jointly with VHAI and circulated widely throughout India.

As a result of this campaign, pressure was brought to bear from several quarters, and questions were raised in Parliament regarding the sale and manufacture of EP drugs. The Drug Controller, for the third time, reviewed the case, and on the recommendation of the Indian Council of Medical Research, issued a directive banning manufacture of these drugs from December 31, 1982 and their sale from June 30, 1983. This ban, while welcome, granted drug manufacturers a leeway of six months and one year respectively. Using this loophole, the drug companies promptly got a stay order from the respective high courts against the ban, on the grounds that the drug could not be really dangerous if they were being allowed to sell it for a year. The drug remained in the market.

The drug companies also justified their stand by claiming that these drugs were useful in treatment of secondary amenorrhoea and that no substitutes were available. As for the misuse by way of pregnancy testing the companies claimed they could hardly be held liable. However, careful research soon made it apparent that these drugs had in fact no indication in gynaecological practice. Secondary amenorrhoea is a symptom, not a disease, and the drugs were being misused to give symptomatic relief, instead of curing the disease. With no therapeutic benefits, the risk of congenital malformation became highly unacceptable. The widescale use of this drug further compounds the risk. We felt there was no question that the only way to stop this malpractice was by banning the drug outright.

In December 1982, Vincent Panikulangara, a Cochin based lawyer, filed a case in the Supreme Court against the continuing availability of several hazardous drugs, one of them being EP drugs. Four years later, in 1986, the Supreme Court, refusing to take any decision on the case on the grounds of it being a technical issue, directed the Drug Controller to hold public hearings and decide whether the ban should be lifted or not.

This directive of the Supreme Court created a strange situation. To begin with, the Drug Controller had banned these drugs on the recommendation of the Indian Council of Medical Research. He was now being asked to publicly review his own decision! While these hearings would give voluntary agencies and activists a good chance to present their case, could we stand up to the massive resources and influence of drug companies?

At the first two hearings in Madras and Delhi the situation seemed grim. Without enough prior notice given through the press, consumer participation was negligible whereas drug companies had managed to bring in experts from all over India. They had also obtained hundreds of letters from doctors in favour of EP drugs. To add to our dismay, consumer and health groups were not told that the second hearing (in Delhi) was to be the last.

It took considerable public pressure to get two more hearings – at Calcutta and Bombay. Realising the gravity of the situation, concerned doctors, lawyers, journalists, health groups, women’s groups, science groups, consumer groups and activists pooled their strength to present evidence at these last hearings and fight for a re-instatement of the ban.

While a lot of hard work and mobilising went into ensuring a fair representation of our point of view, the dice still seemed to be loaded against us. The Drug Controller, drug companies and sections of the medical community fought to keep the ambit of the hearings confined to a technical debate on the usefulness of the drugs. They fought to scuttle all issues related to misuse, and therefore the hazard posed to thousands of pregnant women. Further, since EP drugs come in varying strengths, considerable confusion was created by trying to keep the terminology vague and ambitious.

Those of us in favour of the ban however insisted that the social aspects of the situation be given due consideration. Doctors had been taking advantage of the ignorance of their patients and their anxiety over possible pregnancy to indiscriminately prescribe EP. The fact that it is far cheaper than the conventional urine test for pregnancy provided added incentive. There were also many cases of self-medication, aided by chemists’ willingness to sell drugs without prescription.

The heated exchange of views at these public hearings raised important issues for all drug related campaigns. Some of them are:

· Technically speaking, it is incumbent upon the drug company to prove that a drug is safe. However, if we dispute the safety, then it is for us to provide evidence of hazard.

· Since most studies are done by drug companies or research institutions which are not always unbiased, we have no scope for generating alternative information which will provide conclusive proof.

· If the debate on safety is thrown open to the medical community, it becomes the word of one expert vs. the other and decisions can be hard to reach.

· The Court considers such matters to be too technical in nature for it to intervene.

· The Drug Controller, the drug companies and the law do not consider misuse sufficient ground for banning a drug, because everything has the potential for being misused.

· There is no way in which doctors can be sued for malpractice at present in our country because doctors, especially private practitioners, do not maintain patient records. Prescriptions do not state the diagnosis, and patients themselves are often unaware that a subsequent health problem could be drug related.

· The medical community does not regulate itself in any way.

· There is no way in which drugs sold over the counter can be regulated.

· The pricing of drugs/tests can make even hazardous drugs a popular option among consumers and doctors.

· Consumer education is a vital but mammoth task.

Given this situation, seeking redress for the thousands of victims of drug abuse and misuse can be an impossible task. In India, women are subjected to a large number of harmful hormonal drugs to treat gynaecological problems, or as contraceptives. The prolonged EP campaign has come to a successful end with the June 1988 ban, which removes one harmful preparation from the market. It will need all the experience gained from this campain to continue our struggle against other hazardous drugs.