High Court OrderHow Can Government Ban a Drug Without Cancelling Licence

April 5, 20160

Delhi High Court has observed that power given under Drugs and Cosmetics Act to prohibit the manufacture of certain drugs in public interest could only be regulatory in nature and asked how could the Centre invoke this provision without cancelling the licence given to manufacturers.

The pharma companies  like Pfizer, Glenmark, Procter and Gamble and Cipla,pleaded before  the court that several state governments have issued public notices in connection with Centre’s notification and drug inspectors are enforcing them .

While hearing 150 petitions filed  by the aforesaid pharma companies challenging government’s March 10 notification banning 344 FDCs,Justice Rajiv Sahai Endlaw while staying the decision of the Governement of India , asked that

So after you have granted licence, the only power is to cancel the licence. So can you invoke the regulatory provision without cancelling the licence,”

It is pertinent to note that in terms of “Section 26A of Drugs and Cosmetics Act, the  central government is empowered to prohibit manufacture, etc., of drug and cosmetic in public interest. But such power is more of a regulatory power .

However, the Aditional Solicitor General(ASG) , pleaded in teh court that

irrespective of licence, if a drug or FDC has no therapeutic justification, then it has to be banned. There is no question of cancelling the licence. Administrative process of cancelling licence will go on and on and during that time the drug will continue to be sold in the market.

At the same , it must be noted that it all perspired after the recomendtation of Kokate Panel .The March 10 notification has wording that “on the basis of recommendations of an expert committee, the central government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition of manufacture for sale, sale and distribution for human use of said drugs in the country.

Hence , the ASG also submitted that

the companies and their various groups, like the Indian Drug Manufacturers’ Association (IDMA), were aware of the exercise being carried out by the Kokate panel and that it was dealing with safety, efficacy and rationality of FDCs.

The court’s interim stay order has resulted lifting of  the ban on sale of well known medicines like Pfizer’s Corex cough syrup, P&G’s Vicks Action 500 extra, Reckitt Benckiser’s D’Cold, Piramal’s Saridon and Glenmark’s Ascoril and Alex cough syrups

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