The Andhra Pradesh High Court has issued notices to the Drug Controller General of India (DCGI) asking him to provide details about the marketing permission given to some of the pharma companies on the levo norgestrel products, better known as emergency contraceptive pills, in the Indian market which has created public furore over its possible misuse by the young people.
The High Court notice is 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.
The High Court had earlier ordered the Andhra Pradesh state drug controller to file technical data on the product, such as the safety of the medicine and the chances of misuse due to the frequent advertisements. The AP Drug Control Administration is learnt to have already submitted its report on the quality standards of the products after sample tests.
But, the main concern of the petitioner would be only addressed by the DCGI, as the central drug regulator has the authority to issue OTC license and to take decision on the advertisements on the products.