The Ministry of Health and Family Welfare of India has banned the manufacture, sale, and distribution of 328 Fixed Dose Combination (FDCs) of drugs with immediate effect. The ban on the drugs has ended the legal battle between the manufacturers and the Ministry. The Health Ministry was working since 2016 to get these unsafe medicines banned.
The popular drugs that have been banned include analgesic Saridon, the skin cream Panderm, antibacterial Taxim AZ and combination diabetic drug Gluconorm PG and antibiotic Lupidiclox. The famous cough syrups including Corex and D Cold Total which were among the drugs banned by Ministry in 2016 have now escaped the ban. The prohibition on manufacture and sale of these drugs will affect around 6000 medicine brands belonging to different companies will vanish from the drugs market in India.
A notification prohibiting the manufacture, sale, and distribution for human use of 344 FDCs of Drugs was issued by Central Drugs Standard Control Organisation (CDSCO) under section 26A of Drugs and Cosmetics Act, 1940 on 10th March 2016. Later on, five more FDCs were added under the same provisions. Fixed Dose Combination of drugs contains two or more therapeutic ingredients in a single dose. The pharmaceutical industry immediately challenged the ban in High Court and demanded stay on the decision. The Government moved the petition to the Supreme Court. Supreme Court ordered the Drugs Technical Advisory Board (DTAB) to submit the examination report of these drugs to the Centre.
According to the Drugs Technical Advisory Board, these 328 FDCs were not able to provide justification of the therapeutic ingredients present in them and these drugs may be harmful to human beings. DTAB mentioned that these combinations of drugs may lead to overuse. The patients should not be exposed to so many drugs if only one can do the same function. So the notification was issued to prohibit the manufacture, sale, and distribution of these 328 FDCs in the larger public interest
Based on the recommendations of the DTAB the Government has banned the drugs. The ban is welcomed by The All India Drugs Action Network and it also demanded quick action from the Government on the excluded 15 FDCs.