No clearance, no licence: Drug licensing gets bitter dose

New Delhi, March 2016: The Union Health Ministry has pulled up the State Licensing Authorities (SLA) for granting licences to manufacturers of Fixed Dose Combinations (FDCs) without prior clearance from the Central Standard Control Organisation (CDSCO). Around 344 FDCs were recently banned in India after it was found that SLAs continued to grant licence to FDCs despite ministry's warnings.

"Permission from the office of the Drugs Controller General of India (DGCI) is required in respect of FDCs falling under definition of "New Drugs" before these are licensed by SLAs for manufacture for sale in the country. However, SLAs were granting licences without due approval from the DCGI," said a senior health ministry official. "In order to address the issue, the Health Ministry had also issued repeated statutory direction under section 33P of the Drugs and Cosmetics Act to the state governments to instruct their respective drugs licensing authorities to refrain from granting such licences," the official said.

The Ministry says the last such direction was issued in a letter dated October 1, 2012. The Parliamentary Standing Committee on health and family welfare in its 59th report on the functioning of CDSCO had also observed that some of the SLAs have issued manufacturing licences for a very large number of FDCs without prior clearance from the CDSCO. "This has resulted in the availability of many FDCs in the market which have not been tested for efficacy and safety. This can put patients at risk," the official said.

The DCGI later requested all the States' Drug Controllers to ask the concerned manufacturers in their states to prove the safety and efficacy of such FDCs before the office of DCGI within 18 months failing which such FDCs would be considered for being prohibited for manufacture and marketing in the country. The ministry also constituted 10 expert committee for examining the safety and efficacy of these FDCs. "In order to expedite the review, the ministry in September 2014 further constituted a committee for examining the safety and efficacy of these FDCs. A series of meetings were conducted by the committee for examination of these FDCs. The Committee categorised these FDCs into four categories, i.e. FDCs found irrational, FDCs requiring further deliberations. FDCs found to be permissible for continued marketing and FDCs requiring Phase IV trials," the official added.
For FDCs considered as irrational by the committee, show-cause notices were issued to the applicants as to why manufacturing licenses in respect of such FDCs may not be deemed to have been cancelled. The replies and clarifications in respect of show cause notices issued to the applicants were examined by the committee. The committee made its detailed recommendations in respect of each FDC and where data submitted by the firms and available peer reviewed scientific evidences didn't support the rationality, those FDCs were considered as irrational by the committee.

As these FDCs were examined twice by the expert committee and were found to be irrational or without any therapeutic justification and unsafe for the public health and whereas safer alternatives are available to these FDCs, therefore, the government prohibited the manufacturing for sale and sale of these 344 FDCs with immediate effect in the public interest. SMail Today