Madras High Court revokes ban on manufacture and sale of paediatric drugs nimesulide and PPA

Tuesday, September 13, 2011

Madras High Court has revoked a ban on manufacture and sale of paediatric drugs nimesulide and phenylpropanolamine (PPA). Early this year, the union health ministry had banned sale of anti-inflammatory drug nimesulide for use in children below 12 years of age and decongestant formulation PPA used in cough syrups citing their adverse impacts on human health, including liver toxicity. The ban was challenged by writ petitions filed by drug makers Cipla and Unichem. It is paramount consideration for the government to arrive at a subjective satisfaction in public interest, Madras High Court said in its judgement, adding that the matter was not discussed with concerned parties. The ban by the government is without proper recommendation and hence illegal, said advocate AA Mohan of Mohan Associates, a representative of Unichem in the case. The ban on PPA without any reported side effects in India is completely un-thought of in as much as the drug PPA which is in use for the last 20 years does not have any reported side effects, said Cipla in its affidavit.

Court revokes ban on manufacture and sale of Paediatric drugs Nimesulide and PPA
Divya Rajagopal, ET Bureau Sep 13, 2011, 04.12am IST MUMBAI: Paediatric drugs nimesulide and phenylpropanolamine (PPA) will soon be available with chemists after a court order revoked a ban on manufacture and sale of these controversial formulations. Early this year, the health ministry had banned sale of anti-inflammatory drug nimesulide for use in children below 12 years of age and decongestant formulation PPA used in cough syrups citing their adverse impacts on human health, including liver toxicity. The ban was challenged by writ petitions filed by drug makers Cipla and Unichem. Both nimesulide and PPA are non-prescription drugs and sold over the counter. "It is paramount consideration for the government to arrive at a subjective satisfaction in public interest," the Madras High Court said in its judgement, adding that the matter was not discussed with concerned parties. The ban by the government is without proper recommendation and hence illegal, said advocate AA Mohan of Mohan Associates, a representative of Unichem in the case. "The ban on PPA without any reported side effects in India is completely un-thought of in as much as the drug PPA which is in use for the last 20 years does not have any reported side effects," said Cipla in its affidavit, a copy of which is available with ET. The total market for nimesulide in India is nearly 300 crore. Nimesulide sale has shrunk since the ministry's order banning the usage of the drug in children, experts said. Dr Reddy's brand Nise is the largest selling nimesulide drug in India. Nimesulide is banned in developed nations such as the UK, Canada, New Zealand, Australia and Denmark.

Madras HC quashes ban on PPA, verdict on nimesulide yet to come (13/9/11)

Mumbai, 14 Sept: 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 Rsibutramine & 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.

CHENNAI: A notification dated February 10 this year of the Union Ministry of Health and Family Welfare, which prohibited CIPLA from manufacturing and selling Phenylpropanolamine (PPA) drug in India, has been quashed by the Madras High Court. The drug was commonly used to treat cough, cold, nasal congestion and other respiratory problems. It was sold for the past 20 years in India and 50 years in other countries. Justice V Dhanapalan quashed the notification, while allowing a writ petition from CIPLA, and referred the matter back to the Union Health Ministry for consideration afresh. It was conspicuous that the opinion of the expert bodies such as Drugs Technical Advisory Board or Drugs Consultative Committee was not obtained by the Ministry before issuing the notification, the judge pointed out. It was not issued with subjective satisfaction of the government. Before arriving at a decision to prohibit drugs in general and PPA in particular under Sec 26 of the Drugs and Cosmetics Act, even assuming that its continued use would harm the public, it was paramount for the government to arrive at a subjective satisfaction in public interest. In the absence of the same, the prohibition of the drug alone was unsustainable and ultra vires of the provisions of the Act. Therefore, the notification to such extent had to be quashed, the judge said, and accordingly quashed it. With regard to other drugs mentioned in the notification, the judge said he was not expressing any opinion as they were not subject matter in the writ petition. The judge remanded the matter back to the Union Health Ministry for deciding afresh as per the provisions of the Act and also taking into account the larger interest involved in the matter and for passing appropriate orders after giving an opportunity to CIPLA as quickly as possible.

14/09/2011

HC quashes Centre''s ban on Phenylpropanolamine

Chennai, Sep 13 (PTI) The Madras High Court today quashed the Centre''s ban on Phenylpropanolamine (PPA) manufactured by pharmaceutical company Cipla observing that before arriving at a subjective satisfaction the ban could not come into force. PPA is being used for the last 20 years to treat nasal congestion associated with the common cold, allergies, hay fever or other respiratory illnesses. In the order on a petition filed by Cipla (Chemical Industrial and Pharmaceutical Laboratories) challenging a February 10 last notification by Union Ministry of Health and Family Welfare banning PPA, Justice V Dhanapalan said "it is conspicuous that opinion of expert bodies such as the Drug Technical Board and Drugs Consultative committee was not obtained by the union government before issuing the notification.'' The Judge said that before arriving at a decision to prohibit use of some drugs in general and PPA in particular under section 26 of Drugs and Cosmetics Act, it was paramount for the government to arrive at a subjective satisfaction in public interest even assuming that continued use of the drug could harm the public. Holding that the notification was unsustainable and ultra vires of the provisions of the Act, the Judge said "therefore, the notification to such extent has to be quashed." The Judge remanded the matter back to the ministry for deciding afresh as per the provisions of the Act, also taking into account the larger public interest involved in the matter and for passing appropriate orders, as expeditiously as possible. Banning the drug,the Centre contended that there were risks in the use of PPA and that safer alternatives were available. PTI GR RC