In a highly anticipated move aimed at curbing the misuse of fixed dose combinations (FDCs) throughout the country, the Central Drugs Standard Control Organisation (CDSCO) is expected to come out with a clean basket of FDCs in eight months time. It is understood that the Centre is working very hard to identify and include only those FDCs which are essential and are rational for use, whereas work is in process to weed out the rest.
It is understood that there are over several 1000 FDCs which has not been tested for efficacy and safety having the potential to put patients at huge risk, a result of SLAs permitting the pharma cos to market FDCs without the concurrence of the DCGI, a clear violation of the Drugs & Cosmetics Act for many decades. Owing to unconstitutionality and the report of the standing committee, the DCGI had two years back directed the pharma companies to file safety and efficacy data of FDCs permitted by the SLAs but not approved by DCGI before October 1, 2012. The last date for submitting the efficacy data of SLA approved FDCs to the DCGI office was September 30, 2013.
Now finally the Centre has started making positive advance towards this weeding out processes, through which the Centre plans to regulate the sale and use of FDCs in the market which were found to be available uncontrollably, a severe cause of concern for many healthcare providers due to its irrationality and lack of science based evidence. Dr G N Singh, drug controller general of India, informed that the expert panel set up by the Centre is already assessing the efficacy and safety profile of the available FDCs in the market in a phase wise manner.
He further stressed that final call will be taken on the same after analysing the safety profile, necessity and requirement of the FDCs. Dr Singh added, “With our mission to safeguard the life and health of the patients of this country, we have decided to drastically streamline this segment by keeping only those FDCs that are not only science based with proven safety and efficacy parameters but also have projected their rationality and therapeutic value. Most importantly, through this exercise we want to regularise the rampant availability of FDCs in the country by flushing out irrational combination drugs from the market that threaten to impact and have an alarming affect on the health of the patients.”
He also added that key focus is also given on studying and analysing the safety profile of the anti-biotic FDCs available in the market, especially because curbing the rampant use of antibiotics is also one of their main agenda.