Solan: Pharmaceutical units having dual licences availed under the Drugs and Cosmetics Act, 1940 and under Food Safety and Standards Authority of India (FSSAI) will have to surrender one licence as per the recent directions of the Drugs Controller General of India (DCGI).
As many as 58 pharmaceutical companies have been identified by the Drugs Control Administration (DCA), Baddi, which are having dual licences. Its report was submitted by the DCA to the Drugs Controller General of India (DCGI), who had sought the report in February after directing the state authorities that a manufacturing facility approved for drugs should not be used for manufacturing any other product.
This has caused panic among the manufacturers as they have invested crores in setting up both the facilities.
The Himachal Drugs Manufacturers Association (HDMA) has represented its case before the State Drugs Controller after they drew a list of 58 such units.
The association stated 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 licensing 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.
“Following this, dual licences were granted for manufacturing nutraceuticals and drugs in the same premises,” he said.
The association also stated this permission was, however, contrary to Schedule M of Good Manufacturing Practices and requirement of premises that no other manufacturing activity shall be undertaken and the premises should be exclusively used for production of drugs in units prior to December 11, 2001.
“Since two contrary views are expressed in these orders and rules, we have requested the DCGI to look into the matter and devise uniform guidelines,”said Dr Rajesh Gupta.
“No one among these units is a law violator as they manufactured both products following the decision of an apex body taken in 2007 as it was noted that food supplements do not pose any risk to the drug manufacturing on the premises.
Following GMP ensures that there is neither a mix-up nor contamination of products,” added Gupta.
The DCGI has referred to a case of National Human Rights Commission where questions had been raised over lack of regulation over nutraceutical manufacturing units.
The association, however, pointed out that case proceedings do not recommend disallowing dual licences.
Since huge investment has been made by the units for fulfilling the requirements, a sudden closure will cause financial losses and could lead to job losses.
Consumers would also face disruption of the supply of essential products like drugs and food supplements.
The association has demanded withdrawal of the directions to avert losses to the industry.
