09 May 2012
By Kounteya Sinha
New Delhi India
Officials in Central Drugs Standard Control Organization seem to have “colluded with private interests” to get the controversial drug Letrozole approved in India “in clear violation of laws” for use against infertility.
Now, the parliamentary standing committee on health and family welfare has asked the Union health ministry to take action against those involved. Though globally the drug is used for treatment of breast cancer, India was the only country where it was being administered to young infertile women to help them conceive. The drug’s side–effects are believed to have led to severe genetic abnormalities among babies born to infertile women.
Though its use for infertility was banned recently, the standing committee in a scathing report submitted on Tuesday said, “It is a gross violation of laws by the CDSCO. First, in approving the drug for use in case of female infertility. And, thereafter in exhibiting overt resistance in taking timely corrective steps favouring suspension of use of the drug for infertility.”
The panel said Letrozole, discovered by Novartis, is an anti–cancer drug for use only in postmenopausal women and is contraindicated (not permitted) to be used in women of reproductive age. On April 10, 2007, the Drug Controller General of India approved the use of Letrozole for improving female fertility.
The committee said the Drugs and Cosmetic Rules require that while approving a drug for use in females of reproductive age, animal studies are to be done in this specific group. Its report said, “No such studies were done in India... or abroad as there was no plan to use Letrozole in women of reproductive age.”
The committee said that after the approval, sponsor Sun Pharmaceuticals did not submit periodic Post–marketing Periodic Safety Update Reports (PSURs), which are needed every six months as per the law to monitor the safety of a drug after it has been released in the market to look for serious side–effects.