Emergency pills to maintain OTC drug status

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New Delhi: In what comes as a relief to the largest domestic drug firm Cipla and Delhi-based Mankind Pharma which were accused for going overboard with promotion of ‘morning after pills’, the emergency contraceptive pill would remain an over the counter drug in India.

A decision to the effect was taken by the Drug Technical Advisory Board (DTAB), the highest body under the health ministry on technical matters of the pharma sector in the country in a meeting held on Monday. The government decided against making the drug prescription-based as it felt such a move would defeat the purpose of the drug which is meant to be taken within 72 hours of unsafe sex. “If you have to go for prescription, it may cause delay and result in unwanted and undesired conception of women. So we decided to keep it OTC,” a member of DTAB told FE.

However, the decision comes with a caveat. An expert committee has been constituted which include representatives from gynecologists, information and broadcasting ministry and other stakeholders which would decide on the modalities and constituents of the advertising of such pills and give its report by the end of this month.

“The committee would also call on the industry people to hear their side before arriving at a final decision,” a DCGI official said. The committee would decide on the mandatory educational information that should accompany such an ad, which would include the side effects warning, the minimum interval to be maintained between two successive doses and guidelines related to decency in portrayal of women and issues of obscenity and ethics involved in such ads.

Another committee has been formed to take a call on the breast cancer drug Letrozole, a research molecule of Novartis, marketed in the country by Sun Pharma. The committee constitutes of gynecologists, pharmacologists representing Postgraduate Institute of Medical Education and Research (PGIMER) Chandigarh, AIIMS, and other reputed medical institutes to review data of last two to three years and decide on whether the drug has had any side effects on the subjects when it is indicated for sub-fertility in young menstruating women. The committee would also call upon industry to give their feedback on the performance of the drug.