Central Drugs Standard Control Organization, Government of India has recently published their updated list of banned drugs in India.  The said list of drugs are prohibited for manufacture/ import and sale in India. The Government of India has issued various Gazette Notifications under Section 26 A of Drugs and Cosmetics Act, 1940 to ban the enlisted drugs. This list is updated as on 22.11.2021.

The list contains a total of 518 drugs and Fixed Dose Combinations which are banned in the country. No firm or individual can import or manufacture these drugs for sale in India. However, this may be noted that any manufacturer who intends to manufacture these drugs for export to other countries as per the requirements of specific country may take an Export NOC from State Licensing Authority followed by product permission and manufacture the same for export purpose only.

We had also published an article entitled Chronicles of FDC ban in India wherein we had discussed at length regarding the events that led to ban of many Fixed Dose Combinations infamously called cocktail drugs. Fixed Dose Combinations popularly known as FDCs are a combination of two or more active drugs formulated in a single unit dose. They are very popular among physicians for ease of prescription, among patients for lower cost and among pharma companies to have a varied portfolio of drugs. These FDCs are quick-fixes for pharma manufacturers as it is far cheaper and quicker to combine existing active ingredients to make new products than to discover new medicines and manufacture them separately. In rush of delivering new and unique FDCs, the manufacturers do not pay the required attention for generating the clinical safety and efficacy data. Hence, many irrational and sometimes even absurd combinations are available in the market. These FDCs by the means of ‘innovative’ and ‘sophisticated’ marketing strategies found their way right on to our shelves.

Central  Drugs Standard Control Organization (CDSCO) under the aegis of Ministry of Health and Family Welfare, Government of India has taken many steps to control this menace and vide various notifications has banned several FDCs on the grounds of irrationality and unproven safety and efficacy.

Click here for Updated List of Banned drugs in India.