Even before Union Health Minister Sushma Swaraj could ask the Mumbai-based Sun Pharmaceuticals to stop the sale of Letrozole, some researchers had already used the anti-cancer drug on 400 unsuspecting women to test whether the medicine helped in ovulation.The trials, listed in the literature provided to doctors, were conducted without any permission from the Drug Controller General of India (DCGI) and the results were extensively used by Sun Pharma to illegally promote Letrozole for inducing ovulation. ‘‘We cannot comment on this issue,’’ said company spokesperson Meera Desai when contacted by The Indian Express. According to norms, all drug trials are required to be approved by the DCGI and Indian laws. If a drug cleared 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 is globally approved for use only on post-menopausal women afflicted with breast cancer. ‘‘The drug is not approved for any other use anywhere in the world. 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,’’ said Dr C.M. Gulhati, former WHO drug expert and editor of the Monthly Index of Medical Specialities (MIMS).The literature provided by the company says the drug was tested by doctors Vandana Batra, Sanjay Makwana and Renu Makwana on 60 women in two infertility clinics in Jodhpur. Interestingly, Dr Batra is not even a qualified gynaecologist and has only a diploma on the subject. Also, when contacted, one of the doctors said the drug was tested on 50 women only.‘‘This drug has been tested abroad so we gave it in very small doses of 2.5 mg for five days to the ladies. There is nothing wrong. The doses were small and the drug has been tested abroad as well,’’ said Dr Renu Makwana from Vasundhara Hospital and Fertility Research Centre, Jodhpur. 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 had allegedly tested the drug on 20 women in Nagpur, said: ‘‘ The company came to us with a plan and it seemed workable. But we just did a pilot study on five-seven women and the drug is safe.’’But health experts beg to differ. ‘‘It is an anti cancer drug and based on documents submitted by the innovator Novartis, both the US Food and Drug Administration (USFDA) and the British Medicines and Healthcare Products Regulatory Authority (MHRA) have labeled Letrozole as embryotoxic, featotoxic and teratogenic even at miniscule doses,’’ said Dr Gulhati.Researchers like Dr G. Padamasri of the Hyderabad-based Fertility and Research Centre, who had allegedly tested the drug on 111 patients, were not available for comment on the toxic effect of Letrozole.‘‘Letrozole being a drug for cancer belongs to Schedule G and can only be sold against prescriptions from cancer specialists. This warning is clearly printed on every strip of the medicine,’’ Dr Gulhati said.‘‘In a communication to the MIMS INDIA, lead researcher Dr Robert F. Casper has informed that no controlled trials, acceptable to regulatory agencies (such as USFDA), have been conducted so far in any country, particularly in the West. No country has permitted the use of Letrozole in female infertility,’’ he added.
