New Delhi: Apex drugs regulatory body CDSCO has directed drug controllers of all states and Union territories to stop manufacture, sale and distribution of unapproved 35 fixed-dose combination drugs that include painkillers, nutrition supplements and anti-diabetics.
They have also been asked to review their approval process for such fixed dose combination drugs (FDC) and ensure strict co-mpliance of the provisions of the Drugs and Cosmetics Act 1940 and rules.
FDC drugs are those which contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio.
The regulator issued the directions after it found that certain FDC drugs have been licensed for manufacture, sale, and distribution without prior evaluation of safety and efficacy, posing a serious risk to public health and safety. In a communication sent on April 11, Drugs Controller General of India (DCGI) Dr Rajeev Raghuvanshi referred to the letter issued by his office on January 2013 where concerns were raised regarding the grant of manufacturing licenses for sale of FDC drugs that fall under the definition of a “New Drug” in the country without due approval from DCGI.
