Pharmabiz
 

Interim stay on 6 banned drugs remains as case did not come up for hearing at Madras HC

Ramesh Shankar, MumbaiWednesday, April 27, 2011, 08:00 Hrs  [IST]

The interim stay on the six banned drugs, which the Madras High Court had initially allowed sale on March 15 for two weeks, continues to be in force as the case did not come up for hearing today. Last week, the Madras High Court had postponed the hearing in the case to April 26.

If the court fails to take up the case for hearing in this week, then the hearing in the case may well be postponed to somewhere in June due to the vacation of the court which starts from May 1.

In the stay order dated March 15, the Madras High Court had allowed 15 days time to the drug companies to liquidate the stocks of nimesulide suspension and Phenylpropanolamine (PPA), which were banned in the country on February 10 this year by the union health ministry along with some other drugs that were found to make adverse effects on human health.

But, on March 31 the court had postponed the hearing to April 18 as the respondents, the health ministry and the DCGI, did not appear in the court on March 31. Instead of April 18, the case in fact came up for hearing on April 22, and the case was further postponed to April 26. Now the case may come up for hearing any day now.

The petition on this issue was filed by Confederation of Indian Pharmaceutical Industries (CIPI), an association of thousands of small pharma companies in the country. Earlier on March 23, the court had merged this CIPI case with another similar case filed by pharma major Cipla Ltd.

Hearing the petition filed by Cipla on March 23, the Madras High court had stayed the entire notification of the ministry (GSR 82 E) dated February 10, 2011 in which it had banned six of the most controversial drugs in the country 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.

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.

 
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