The Indian medical drugs and device market is rapidly evolving with the norms for high quality drugs in India being issued by the Health Authorities. They are aiming at making a universal standard for regulations at par with the global markets. Other countries in the South East Asian region including Thailand, Indonesia, Philippines, and Singapore are also working towards following universal regulatory standards. A new research shows that the state licensed fixed dose drug combinations (FDC’s) are sold in India without the approval of the medical device and drugs regulatory approval body of India – CDSCO (Central Drugs Standard Control organization). This means the lives of patients could be at risk as the drugs may not be fully examined or tested. FDC’s are used for many effective treatments including HIV, Malaria, TB etc.
“India needs to ban the unapproved fixed dose drug combinations sales and manufacturing and also should ban the internationally banned or unapproved drugs” said Dr Patricia McGettigan leader of the study at Queen Mary University of London. The research is done in four main therapeutic areas, and only 60 of the 175 FDC formulations marketed in India has the CDSCO approval. READ ALSO: How to get a CDSCO approval? – Contact Us, Contact a Indian Authorized regulatory consultant for registration. Professor Allyson Pollock, co – author said “we urge the government of India to take steps on the new drugs bill as a priority”. The PLOS Medicine published the above study.
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