Birth control device okayed without trials.

A NEW contraceptive product -- a vaginal ring -- was introduced in the Indian market on Wednesday without the mandatory clinical studies in the country.

The hormone- based product, Nuvaring, launched by Organon, a part of MSD Pharmaceuticals, interferes with the release of eggs from ovaries. Though it gives the same benefit as hormonal pills, it needs to be changed only once a month. The release of hormones is activated when the ring comes into contact with the vagina.

The company says it had got the approval from the drug controller general of India in 2005. " We got the approval based on data generated in various countries," K. G. Ananthakrishnan, managing director of Organon India, said. He admitted that there were no clinical studies done in India.

The drug controller general Surinder Singh said, " If there were no trials, it becomes an illegal approval. I will have to check it." Experts said the new product could be termed " illegal" as its safety and efficacy had not been proven among Indians.

" It is known that Asians, Caucasians and Africans have difference in their metabolism. Thus, a drug safe for North Americans may not be safe for Indians unless established," C. M. Gulhati, editor of Monthly Index of Medical Specialties , said.

Gulhati said the drug rosuvastatin, a cholesterol lowering drug, has different action on North Americans, Europeans and Indians.

The dosage for Indians is half that of the others. " If we are given the same dosage, there will be a lot of side effects," Gulhati said.

" The approval of this new product is scientifically, ethically and legally wrong," he added.

savita. verma@ mailtoday. in

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