The drug controller general of India (DCGI) will soon initiate strict action against the state licensing authorities (SLAs) who continue to issue licences for FDCs or new drugs despite not having authorization to do so. Though the SLAs from the major states like Maharashtra, Gujarat, Karnataka, etc have stopped issuing licenses to FDCs and new drugs, sources said that the SLAs in some small states are still issuing licenses to the manufacturers.
According to sources, the DCGI is annoyed over some of the SLAs still issuing licenses to FDCs and new drugs and will soon launch strict against such SLAs. As per norms, only DCGI is authorised to issue licenses for new drugs. But, it is learnt that the DCGI has come to know of the fact that some SLAs continue to issue licenses to new drugs and FDCs in violation of rules in collusion with the manufacturers whose drugs may fail to stand the scrutiny of the DCGI office.
Sources said that many manufacturers, especially small and medium companies, still approach the SLAs for permission to launch the product as approaching the SLAs is easier for them than going to DCGI office in Delhi. If they go to DCGI office and fail to get the permission for the new drugs, these manufacturers cannot launch the product in the country. But, if a manufacturer fails to get manufacturing license for his product from a particular state, he may approach the drug authorities in some other state who may issue license for his product and the manufacturer will market the product even in the state where the license for the product was earlier rejected.
It was to end this practice that the union health ministry had brought a proposal to establish a Central Drug Authority (CDA) in the country to centralise the entire drug licensing system. But, the health ministry could not push through the CDA Bill in Parliament due to the pressure exerted by a section of pharma industry in the Prime Minister's Office. Apart from a section of pharma industry, some state FDAs and a group of NGOs had also opposed the introduction of CDA Bill in Parliament.
Once the CDA becomes a reality, the SLAs will have left with the job of issuing marketing licenses only, as they will have no authority to issue manufacturing licences to drug companies. Presently, the SLAs are empowered to issue manufacturing licenses, except that of FDCs and new drugs.