The Drug Controller General of India (DCGI) has replied to the Andhra Pradesh High Court on the issue of the controversial permission given to some of the pharma companies on the levo norgestrel products, better known as emergency contraceptive pills.
Acting on the High Court notice, in which the court asked him to provide details about the marketing permission given to some of the pharma companies for the emergency contraceptive pills in the Indian market which has created public furore over its possible misuse by the young people, the DCGI has replied to the court that his office has taken the necessary action on the issue, it is learnt.
He is learnt to have argued that his office has issued show-cause notices to the companies and the companies have since discontinued the advertisements on the controversial drug.
The Andhra Pradesh High Court had issued notice to the DCGI in June this year. The notice was in response to a public interest litigation (PIL) filed by a Hyderabad-resident, C S Ranga Rajan, against the DCGI and three other parties seeking a ban on manufacturing and marketing of the levo norgestrel products, the hormonal emergency contraceptive pills (ECPs), in the Indian market. The PIL was filed in December last year.
In his petition, Ranga Rajan, referring to the scientific studies, contends that the use of levo norgestrel will result in various side effects and argues that permitting sales of the said product as over the counter (OTC) will result in serious consequences on the public. Major levo norgestrel products available in the country are I-Pill and Unwanted 72 promoted by well known pharma companies like Mankind Pharmaceuticals and Piramal Healthcare. 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.
The publicity created by these ads on the products and the increased accessibility of these pills in retail stores will lead to misuse of the products by public, alleges the petitioner. While these products are advertised for consumption within 72 hours after unprotected coitus, there are cases where conception will happen within 24 hours. The petitioner, with the help of studies, argues that the side effects of the product in such cases will be more serious.