The Union health ministry is seriously contemplating to move Supreme Court against the Madras High Court's interim stay on the notification of the ministry (GSR 82 E) dated February 10, 2011 in which it had banned six of the most controversial drugs--- the non-steroid anti-inflammatory drug nimesulide (below 12 years age), gastroprokinetic agent Cisapride, decongestant drug Phenylpropanolamine (PPA), human placenta extracts Sibutramine & its formulations and R-Sibutramine & its formulations in the country with immediate effect.
Senior officials in the health ministry said that the government is seized of the seriousness of the issue as it involves public health at large. This is an extraordinary situation as the ministry had banned these drugs on the recommendation of the experts who have found these controversial drugs to make adverse effects on human health. The stay order of the court on the notification has defeated the intended objective of the ministry, the official said.
Considering the public health in mind, the ministry is seriously contemplating to move Supreme Court very soon and the formalities to move the court are going on, the official said.
Earlier on March 23, hearing a petition moved by pharma major Cipla Ltd, the Madras High Court had allowed an interim stay on the notification.
Earlier on March 15, the Madras High Court had allowed the drug companies to liquidate the stocks of nimesulide suspension and Phenylpropanolamine (PPA). In the interim order, the court had given 15 days time to the companies to liquidate their stocks in the market. The Madras High Court was hearing a petition in this regard filed by Confederation of Indian Pharmaceutical Industries (CIPI), an association of thousands of small pharma companies in the country.
In a gazette notification dated February 10, the ministry had banned these controversial drugs due to its adverse effects on human health. The ministry's decision in this regard was based on the recommendations of the Drugs Technical Advisory Board (DTAB), which is the highest decision-making body under the union health ministry on technical matters and its recommendations are normally followed by the ministry. Earlier, the DCGI had brought these controversial drugs under the radar of the DTAB in the wake of serious concern raised by the medical experts in the country over the side-effects of these drugs.