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Cos ask for time to reply on DCGI's show-cause notice on morning-after-pills ads
Ramesh Shankar, Mumbai | Thursday, August 5, 2010, 08:00 Hrs  [IST]

The pharmaceutical companies, who have been served show-cause notices by the drug controller general of India (DCGI) for reviving advertisement on morning-after-pills despite the health ministry's ban, have asked for more time to reply to the notices on the ground that the issue involves several technical matters.

In the first week of July, the DCGI had issued show-cause notices to three major pharma companies--- Mankind Pharma, Piramal Healthcare and Morepan Laboratories----for launching advertisements on emergency contraceptive pills even after the union health ministry's suspension of advertisements on these products till a final decision is taken on the issue by the DTAB.

The DCGI had asked these companies to explain within 10 days why action, including the cancellation of licences for these products issued by the DCGI office, should not be taken against them for launching advertisements on morning-after-pills like 'Unwanted 72', 'Option-72' and 'I-Pill'. While the Unwanted-72 is a product of Mankind Pharma Ltd, 'Option-72' is promoted by New Delhi-based Morepan Laboratories. I-Pill was actually promoted by Cipla Ltd, but in March this year Piramal Healthcare had acquired I-Pill brand for Rs 95 crore from Cipla.

According to sources, the companies have not so far given reply to the show-cause notices and instead asked for at least a month more time to reply to the DCGI's show-cause notice on the plea that the issue involves several technical issues.

Due to public outcry, the health ministry had suspended the advertisement of these pills late last year and had referred the issue to the DTAB for taking a final decision. Drug Technical Advisory Board (DTAB) is the highest authority on technical matters under the union health ministry and has health experts as members. Pending a final decision by the DTAB, the health ministry had suspended advertisements on these products in the country.

Even though the DTAB is yet to deliver its final decision, the pharma companies revived the advertisements on these products, in gross violation of the government order.

Ever since the advertisements began appearing on the electronic media early last year across the country, both the civil society organisations and gynaecologists in the country have been expressing concern over the misuse of the pill by the young generation. It triggered a debate in sexually conservative India with critics arguing that the easy availability of such pills would encourage promiscuity among the millions of young people. There was also criticism that the easy availability of these drugs will also promote unsafe sex among younger generation and may result in an increase of diseases like HIV/AIDS in the country.

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