Phenylpropanolamine (PPA), one of the six drugs banned by the Union health ministry early this year for its adverse effects, can now be manufactured and marketed by the pharma companies in the country as the Madras High Court has quashed the ban on PPA.
Delivering its final judgment on September 9 on a writ petition filed by drug major Cipla Ltd, the Madras High Court has quashed the Union health ministry's notification dated February 10, 2011, insofar as Phenylpropanolamine is concerned. In the notification, the ministry had banned six of the most controversial drugs--- nimesulide (below 12 years age), cisapride, PPA, human placenta extracts, sibutramine & its formulations and R-sibutramine & its formulations.
Cipla had filed a writ petition in the Madras High Court on March 23 this year, praying to allow the company to manufacture and market PPA. But, the court merged the Cipla case with that of a similar case filed by manufacturers association Confederation of Indian Pharmaceutical Industries (CIPI) and after hearing the parties, the court in its interim order stayed the entire notification of the ministry (GSR 82 E) dated February 10, 2011.
In yet another case filed by Unichem Laboratories for marketing nimesulide (below 12 years age), the court is yet to deliver the final judgment.
In the gazette notification dated February 10, the ministry had banned these controversial drugs for their adverse effects on human health. The ministry's decision was based on the recommendations of the Drugs Technical Advisory Board (DTAB) 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 their side-effects.