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Illegal drug trials conducted on 400 women

News of illegal drug trials on women comes as no surprise to doctors in Kerala. In Kottayam, an anti-cancer drug is being routinely given by doctors to induce ovulation in women

Even before Union health minister Sushma Swaraj could ask the Mumbai-based Sun Pharmaceuticals to stop the sale of Letrozole, a drug meant to treat breast cancer, researchers had already carried out tests on 400 women to see whether the drug helped in ovulation. Letrozole has reportedly been tested illegally in Nagpur, Jodhpur, Kolkata, Hyderabad and Amritsar.

The trials, listed in the literature provided to doctors, were conducted without permission from the Drug Controller General of India (DCGI). Sun Pharmaceuticals used the results to promote Letrozole as a drug that induces ovulation.

Company spokesperson, Meera Desai, refused to comment on the issue.

According to norms, all drug trials require prior approval from the DCGI and Indian laws. If a drug meant for a specific disease is to be used for a new disorder, the drug is considered a 'new drug' (as defined in Rule 122-E of the Drugs and Cosmetics Rules), and requires fresh government approval for tests on both animals and human beings.

Letrozole, globally approved for use only on post-menopausal women suffering from breast cancer, is not approved for any other use anywhere in the world, says Dr C M Gulhati, former WHO drugs expert and editor of the Monthly Index of Medical Specialities (MIMS). "Administering a drug for unapproved indications can lead to legal action both against the prescriber and producer under various laws, including the Consumer Protection Act," he says.

Literature provided by Sun Pharmaceuticals quotes Letrozole as having been tested by doctors Vandana Batra, Sanjay Makwana and Renu Makwana on 60 women at two infertility clinics in Jodhpur. Surprisingly, Dr Batra is not even a qualified gynaecologist and has only a diploma on the subject. When contacted, one doctor said the drug had been tested on 50 women only.

Dr Renu Makwana from the Vasundhara Hospital and Fertility Research Centre, Jodhpur, says they gave very small doses (2.5 mg) of the drug, for five days, to the women. She sees nothing wrong in the tests and says the drug has been tested abroad as well.

According to the researchers, the company approached them with articles published in a US fertility journal and asked them to test the drugs. Dr Sadhana Patwardhan, who, along with Dr Mangala Ketkar, allegedly tested the drug on 20 women in Nagpur, said they had accepted the company's plan and had done a pilot study on five-seven women. According of them, the drug was safe.

Dr G Padamasri of the Hyderabad-based Fertility and Research Centre allegedly tested the drug on 111 patients.

Interestingly, news of illegal drug trials on women comes as no surprise to doctors in Kerala. Kottayam is one of the places where Letrozole is being widely given by doctors, illegally, to induce ovulation in women.

Leading oncologist V P Gangadharan, who prescribes the medicine to his patients, isn't surprised that the drug was being put to other uses. "Did anything happen to those who (illegally) conducted unethical trials of a drug developed in the US to treat oral cancer on patients at the RCC in Thiruvananthapuram a few years ago," he asks.

Source:, December 22, 2003
--Indo-Asian News Service, December 22, 2003