PUDUCHERRY:Nearly two years after the licences of more than 200 fixed dose combination (FDC) drug manufacturers were cancelled, following registration of cases against 29 firms by the CBI, the territorial government has decided to consider their plea to allow production once again. FDC drugs are combination of two or more active drugs in a single dosage form.
Over 500 combination drugs, without mandatory approvals from DCGI and evidence of their safety and effectiveness, were being produced in Puducherry and sold across the country, government sources said.
The licences for production of FDC drugs were given illegally by the former Drug Licensing Authority of Puducherry, Rajkumar, who was suspended after the CBI booked him in 2013. The Department of Drug Control (DDC) cancelled licences of 29 firms as part of its crack down on illegal licences granted prior to 1 October, 2012 for manufacturing unapproved FDC drugs.
Now, following a clarification from the Union Ministry of Health and Family Welfare that it was examining FDCs, the Puducherry government has issued an order stating that FDC manufacturers whose licences were cancelled for not obtaining approval from the DGCI, could prefer an appeal to the government (Administrator) against the cancellation. Such firms have to apply along with proof of submission of application and proof of payment of applicable fees to the DGCI, supporting the safety and effectiveness of the fixed dose combinations being sold without the agency’s approval. The DGCI has asked manufacturers to submit samples of FDC formulations for clinical trials.
With respect to FDCs licensed before 1 October, 2012 but not cancelled so far, the State Drug Controller and the Licensing Authority have decided to maintain status quo subject to the licensee furnishing proof of submission of application to the DCGI and proof of payment of applicable fees. Both the status quo action and the appeal shall be subject to the outcome of the cases filed by the CBI, said the GO. The CBI had filed charge sheets in the case in a special court in Puducherry a month ago.
However, the GO is not applicable to cases where licences were cancelled due to violation of other provisions of Drugs and Cosmetic Act and Rules or to cases of unapproved FDCs for which licenses have been issued after 1 October, 2012.