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.
“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.
The total market for nimesulide in India is nearly Rs 300 crore.
Nimesulide is banned in developed nations such as the UK, Canada, New Zealand, Australia and Denmark. [Source: Economic Times]