Ban on CIPLAs cough drug quashed

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.