A public interest litigation (PIL) seeking a ban on manufacturing and marketing of the levo norgestrel products, the hormonal emergency contraceptive pills (ECPs), in the Indian market has been filed in the Andhra Pradesh High Court.

The Writ Petition filed by a Hyderabad-resident, C S Ranga Rajan, against the Drug Controller General of India (DCGI) and three other parties refers to scientific studies concluding 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 iPill manufactured and marketed by Cipla Ltd, Unwanted 72 by Mankind Pharmaceuticals and Norlevo by Win-Medicare.

The publicity created by these ads on the products and the increased accessibility of ECPs 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.

Considering the argument of the petitioner, the High Court has ordered the Andhra 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 has submitted its report on the quality standards of the products after sample tests, informed state officials.

The state drug control officials has also asked the pharmacists to provide necessary advice on the use of the product and dangers of its misuse. However, 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.

It is to be noted that the no-holds-barred advertisements being aired in the national and regional electronic media on the ECP brands were under the scanner of DCGI after doctors and non governmental organisations raised objections. The Union Health Ministry is considering options to ban the advertisement of emergency contraceptive pills, according to reports. The Delhi-based Mankind Pharma has already declared that it has voluntarily stopped advertising its brand Unwanted-72 from November, 2009.