Three hundred women in India were subjected to unapproved clinical trial for the infertility use of letrozole by Sun Pharmaceuticals during the last couple of years, it is learnt. The trials were carried out by a handful of doctors at private clinics in various parts of the country.

The doctors have clearly stated that the objective of their study was to "examine the efficacy of letrozole for ovulation", "to study the role of rosiglitazone, metformin and letrozole combine therapy to estimate the success in ovulation induction, conception and maintenance of pregnancy" etc. It is known that none of them were part of any approved clinical trial over the new usage of the drug.

When contacted, the doctors informed that they were never aware of the regulations involved in carrying out such trials for this use. Some of them admitted that representatives of Sun Pharmaceuticals had asked them to undertake such studies. The company also suggested the protocols, they informed.

While the doctors admit that they had informed the patients about the "new drug" that are being administered to them, none of them were in a position to assert that they had informed the patient about the "dangerous side effects" of the drug. Neither they felt the need for a prior approval from the regulatory authorities for conducting such trials.

It should be noted that the records submitted by the innovator of the drug to both US FDA and British Medicines and Healthcare products Regulatory Authority (MHRA) have labeled letrozole as embryotoxic, fetotoxic and teratogenic at miniscule doses.

If the published reports are to be believed these half a dozen self-styled researchers have subjected over 300 unsuspecting women to the trials. The fact that they were willing to get their "research findings" published and circulated by Sun Pharmaceuticals reveal their ignorance of the illegal nature of the act that they had done.

Legally all clinical trials require the permission of the Drugs Controller General of India and approval by the concerned hospital ethics committees. Research can only be conducted at recognized centres by duly qualified and experienced investigators. Unfortunately the companies are encouraging the doctors to take up clinical trials without any such permission.

The clinicians had presented their findings in foray like Indian Congress on Gynecologic Endoscopy, Infertility and ART Jodhpur, ISAR 2003 Indore and AICOG, Banglore. The clinics where the trials were conducted are Institute of Reproductive Medicine, Kolkata, Nagpur Test Tube Baby Center, Nagpur, Hyderabad Fertility & Research Centre, Hyderabad, Civil Hospital, Ajnala, Amritsar, Fertility Research Centre Jodhpur etc.

The doctors who had substantiated their claims in various medical conferences are likely to be in trouble as the companies who had prompted them to take up the trials have publicly admitted their mistake in promoting the drug for unapproved use and have also announced to withdraw all letrozole brands that were targeted at infertility patients from the market. This was after the office of the DCGI, responding to media reports on the illegal use of letrozole, threatened the companies of grave action.