Usha Sharma – Mumbai
Central Drugs Standard Control Organisation (CDSCO) has issued a notice to all fixed dose combinations (FDCs) drug manufacturers, to submit their safety and efficacy reports before August 30, 2013. It may be noted that around six months back, CDSCO has requested all drug controllers across States and Union Territories (UTs), to get their concerned manufacturers to prove the safety and efficacy of such FDCs to the office of Drug Controller General (India) (DCGI). Till now, hardly any manufacturers have approached CDSCO. However, the state licensing authorities (SLAs) have granted the license to 23 new FDCs in mid-March 2013.
In order to avoid such issues in the future, CDSCO is preparing a list and focusing on the safety parameters required for the new drugs. To make the process more accountable and efficient along with the CDSCO experts, members from New Drugs Advisory Committee (NDAC) will be accompanying and helping them in the process of reviewing and examining the reports.
According to the CDSCO, the issue related to the grant of manufacturing licenses for sale of the FDCs which falls under the definition of the term ‘new drug’ in the country without due approval by the licensing authority (the DCGI) has been raised at many fora from time to time. The Parliamentary Standing Committee of the Ministry of Health and Family Welfare in its 59th report on the functioning of CDSCO has also observed that the some SLAs have issued manufacturing licenses for a very large number of FDCs without prior clearance from 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 patient at risk.
Speaking with Express Pharma, Dr GN Singh, DCGI said, “Our aim behind conducting all these practices is to provide safe medicines which are adhered with all safety norms. We want to know about the combinations which are available in the market and they are compliant with Schedule Y as per Drugs and Cosmetics Acts or not. We are continuously evaluating existing FDCs list and our executives are researching it.”
Post the mentioned deadline with the help of NDAC members CDSO experts will review and examine the shared data and then decide if a particular FDC is to be added to the list or not.
Replying on the release of the new list of FDCs publicly, Singh said, “At this point of time it is difficult to comment on how much time we will we take or require for the examination or preparing a list. We will be only able to announce the date of the final list after receiving and analysing the reports.”
The notice also mentions the procedure for filing applications for assessing the safety and efficacy of such FDCs.
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