Even as Drugs Controller General, India (DCGI) has sought explanation from Mumbai-based Sun Pharmaceuticals for unlawfully promoting anti-cancer drug letrozole in the treatment of female infertility, three more companies are allegedly engaged in similar activity.

According to trade sources, Delhi-based Dabur India Ltd, Chennai-based Fourrts Laboratories Ltd. and Hyderabad-based Natco Pharma Ltd have been promoting their own brands of letrozole to gynaecologists as infertility treatment. DCGI has approved the drug for the treatment of breast cancer only. Worldwide, letrozole is not used for any disorder except breast cancer.

Dabur is selling the same drug under two brand names: Trozet for cancer and Foliripe for infertility. The brand name Foliripe is suggestive of ripening of ovarian follicles.

Fourrts is selling the drug under the trade name of Letrofil while Natco's brand name is Letronete. As reported earlier Sun Pharma is marketing the drug under two brand names: Letroz and Letoval.

It should be noted that the promotion of medicines for unapproved uses is unlawful and such drugs are deemed as misbranded under the provisions of Drugs and Cosmetics Act. The manufacturers are punishable with fine and imprisonment ranging from one to two years.

According to sources in the retail trade, sales representatives of some companies have been advising them to remove the package insert while selling letrozole. Government-approved package insert recommends the use of letrozole in cancer only. This is being done so that patients prescribed letrozole for infertility do not ask inconvenient questions.

According to medical experts, the Western countries ensure that all medicines supplied to public carry approved labeling and patient information leaflet duly cleared by the drug regulators. This ensures that consumers get accurate information on medicines. It is known that the system is not yet in place in India.