The top drug regulatory body CDSCO has directed the drug controllers of all states and union territories to stop the manufacture, sale and distribution of drug controllers from all states and union territories including painkillers, nutritional supplements and 35 rejected ‘Fixed-Doj Combination’ (FDC) drugs. FDC medicines are those that contain a certain amount of mixture of two or more active medicinal ingredients (APIs). Drug controllers of all states and union territories have been asked to review their approval process for such FDCs and strictly ensure strict compliance of the provisions of the rules under the Drugs and Cosmetics Act, 1940 and it. The regulator issued this directive when it was found that some FDC drugs were licensed for manufacturing, sales and distribution without prior assessment of their safety and efficacy, pose a serious threat to public health and safety.
Reference to 2013 letter
In a letter written on April 11, the Indian Medicine, Dr. Rajeev Raghuvanshi, the Indian Drug Special General (DCGI) cited a letter issued by his office in January 2013, in which without proper approval from DCGI, it was concerned about granting manufacturing licenses for the sale of FDC medicines under the definition of new drugs in the country.
Instructions issued for state licensing officers
Similar concerns have been expressed from time to time and several letters have been issued to the concerned state licensing authorities, which have allowed the manufacture and marketing of unknown FDCs. In February this year, another similar letter was issued.
This has been said in the letter. It has come to the notice of the Directorate that according to the provisions of NDCT Rules 2019 under the Drugs and Cosmetics Act, 1940, license has been given for the manufacture, sale and distribution of some FDC medicines without prior assessment of security and efficacy. It is also being said that this may pose a serious threat to public health and safety.
Ban on the post 35 drugs; Everything from painkillers to diabetes medicines included first appeared on News India Live | Breaking India News, The Indian Headline, India Express News, Fast India News.
