The Madras High Court's stay order on the Union health ministry's notification dated February 10, 2011, banning six of the most controversial drugs--- nimesulide (below 12 years age), cisapride, phenylpropanolamine (PPA), human placenta extracts, sibutramine & its formulations and R-sibutramine & its formulations—is still valid as the court is yet to vacate the stay, allowed on a petition filed by the pharma major Cipla Ltd.
Putting at rest the confusion about the status of the notification, legal experts said that by virtue of obtaining the stay order by Cipla, the notification is still under stay and the manufacturers can sell the product till further orders from the court.
Manoj Tongra, who is a legal expert and a drugs control officer in Rajasthan, also said that since the court did not vacated the stay, then the stay continues till further orders from the court.
Meanwhile, the hearing on this high voltage case has been concluded and the Madras High Court has reserved its judgment.
Immediately after the notification, the Confederation of Indian Pharmaceutical Industries (CIPI) had moved the Madras High Court, praying to allow time for the companies to liquidate their stocks. In its order on March 15, the court allowed the drug companies to liquidate the stocks of nimesulide suspension and PPA. Later on March 23, the court merged the CIPI case with another similar case filed by pharma major Cipla Ltd. Hearing the petition filed by Cipla, the court had stayed the entire notification of the ministry (GSR 82 E) dated February 10, 2011.
But, confusion prevailed in the market over the status of the notification once CIPI decided to withdraw the case citing several reasons, including short of funds to continue the case in the court. After the exit of CIPI from the case, there were contradicting interpretations about the status of the case, even among the regulatory authorities. There was a plea that since the court has allowed the stay to Cipla, it is applicable to it only.
But, legal experts have now clarified that since the court had stayed the entire notification, it is status quo ante, meaning companies can sell all these products as before the notification.
Due to its adverse effects on human health, the Union health ministry had banned six of the most controversial drugs on February 10 this year with immediate effect. These drugs included 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.