The Drugs Controller General of India (DCGI) will soon initiate action to prohibit several fixed dose combination (FDC) drugs in the country which were approved before October 1, 2012 by the State Licencing Authorities (SLAs) without the permission of the DCGI.
The DCGI's action in this regard comes in the backdrop of the fact that in spite of giving considerable amount of time and several reminders to the companies, hardly any firm has submitted phase-IV trial protocol of these controversial FDCs as was mandated by the DCGI way back in January 2013.
In January 2013, the DCGI had asked the manufacturers to prove the safety and efficacy of the FDCs approved before October 1, 2012 and had made it clear that those FDCs approved by the SLAs from October 1, 2012 without the permission of the DCGI will be considered for ban. The DCGI had then directed the state drug controllers to ask the concerned manufacturers to prove the safety and efficacy within 18 months, failing which such FDCs will be considered for being prohibited for manufacture and marketing in the country.
After examination of such applications received by the DCGI office in consultation with the Expert Committee, the concerned firms were requested to submit phase IV clinical trial protocol as per usual procedure. But, even after giving considerable time, the companies failed to submit the phase IV clinical trial protocols to the DCGI office. Irked by the indifferent attitude of the companies in this matter, the DCGI on June 17 this year once again asked the companies to submit the trial protocol as per appendix X of Schedule Y of Drugs and Cosmetics Rules, 1945.
But, hardly any firm has submitted the trial protocol so far, forcing the DCGI to come out with a warning to the erring companies.
“It was observed that hardly any firm has submitted trial protocol and the same has been viewed very seriously by this Directorate. It is again requested that all the applicants who have not submitted phase IV trial protocol shall submit the same in accordance with Schedule Y of Drugs and Cosmetics Rules, 1945. This may be treated as regulatory reminder for further necessary action”, the DCGI in an order said.
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