Solan: No relief provided, pharma units start surrendering licence

Tribune News Service

Ambika Sharma

Solan, April 25

With no relief having been granted by the Drugs Controller General of India (DCGI) on permitting dual licences, the pharmaceutical companies have started surrendering the ones availed under the Food Safety and Standards Authority of India (FSSAI).

Pharmaceutical units having dual licences availed under the Drugs and Cosmetics Act, 1940 and under Food Safety and Standards Authority of India (FSSAI) were directed to surrender one licence by the DCGI in February. As many as 58 pharmaceutical companies have been identified in the Baddi Barotiwala Nalagarh industrial area by the drugs control administration who had availed dual licences.

“About four to five such units have surrendered their licences availed under the Food Safety and Standards Authority of India (FSSAI) while they have retained the licence granted under the Drugs and Cosmetics Act, 1940,” confirmed an official of the Drugs Control Administration (DCA) at Baddi.

The DCGI had sought a report from the state’s DCA in February after directing the state authorities that a manufacturing facility approved for drugs should not be used for manufacturing any other product.

This had caused panic among the manufacturers as they have invested crores in setting up both the facilities.

The DCGI had taken this step after reports of units having food licences using their manufacturing facility for producing unlicenced spurious drugs came to fore in the Baddi industrial area. The National Human Rights Commission has taken a strict view of this irregularity after it was highlighted by the media.

Dr Rajesh Gupta, president, Himachal Drug Manufacturers Association, said that these manufacturers had set up dual facilities after they were permitted by the DCGI as per a notification issued on March 1, 2007.

“The conclusion to permit dual licencing had been drawn from the 37th Drugs Consultative Committee meeting which had stated that there was no harm in allowing products similar in nature to be manufactured in existing facilities to utilize spare capacity,” observed Dr Rajesh Gupta, president, HDMA.

He said no relief has been given as of now but more than 70 per cent manufacturers have not surrendered their licenses as of now.

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