Court quashes Central notification banning drug

The Madras High Court has quashed a notification issued by the Centre in February this year in so far as it related to banning of manufacture, sale and distribution of Phenylpropanolamine (PPA).

The drug is an ingredient in various formulations used in the treatment of common cold, body pain and fever.

In his order on a writ petition challenging the ban, Justice V. Dhanapalan said that when the government decided to prohibit drugs in general and PPA in particular even assuming that its continued use would harm the public, the government should arrive at a subjective satisfaction in public interest.

In the present case, in the absence of the same, the prohibition of the drug alone of the impugned notification of February 10, 2011, was unsustainable and ultra vires the Drugs and Cosmetics Act. Therefore, the notification to such extent should be quashed.

In its petition challenging the notification, Cipla said that it had been selling products with PPA for the past 20 years. The decision to ban the drug should have been taken after consulting all stake-holders as the drug was openly available in most countries on prescription or over the counter, it said.

Countering it, the Centre said it had banned the drug in public interest on the recommendations of an expert committee as its continued usage was associated with harmful effects.

Allowing the petition, Mr. Justice Dhanapalan observed that before arriving at a subjective satisfaction the notification could not be issued. The opinion of the Drugs Technical Advisory Board and the Drugs Consultative Committee was not obtained by the authorities before issuing the notification.

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