FDCs licenced prior to Sept 21, 1988 excluded from proving safety, efficacy to DCGI

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Thousands of FDC drug manufacturers in the country engaged in production of drugs licensed prior to September 21, 1988, can now heave a sigh of relief as the Drugs Controller General of India (DCGI) has excluded such drugs from the requirement of proving the safety and efficacy of FDC drugs licenced by the SLAs without due approval from the DCGI.

On January 15 last year, 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 State licencing authorities (SLAs) from October without the permission of the DCGI will be considered for ban.

“An issue has been raised regarding applicability of above requirements for FDCs licensed by State licencing authorities before 21.09.1988, after which all relevant provisions relating to New Drugs were introduced in Drugs and Cosmetics Rules.  The matter has been considered by this office and it is hereby clarified that requirements of providing safety and efficacy as mentioned above is not applicable for such FDCs which are licensed prior to 21st September 1988”, DCGI Dr GN Singh clarified in a letter addressed to all the state drug controllers in the country.

The DCGI’s clarification comes at a time when the DCGI’s office is conducting the massive exercise of examining the rationality of thousands of FDCs permitted by the SLAs without due approval from the DCGI.

The union health ministry had earlier constituted expert panels for the exercise of examining and regularising the thousands of fixed dose combinations (FDCs) permitted for manufacture and sale in the country without due approval from the DCGI. The expert panels have already held three meetings and the fourth meeting is scheduled for June 11.

Source: PharmaBiz

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