The Ministry of Health and Family Welfare on Wednesday banned the manufacture, sale and distribution of 328 fixed dose combination drugs with immediate effect, and placed certain conditions on six others. Fixed dose combination drugs, popularly known as FDCs, are medicines that are a cocktail of two or more drugs sold by the Indian pharmaceutical industry.
Around 6,000 brands are likely to be affected, according to The Times of India. This includes painkiller Saridon, skin cream Panderm, combination diabetes drug Gluconorm PG, antibiotic Lupidiclox and antibacterial Taxim AZ. They are expected to have a combined market size of between Rs 2,000 crore and Rs 2,500 crore, according to News18.
Popular medicines such as cough syrup Corex and D-Cold Total, which were among the drugs prohibited by the government in 2016, have now escaped the ban.
On March 10, 2016, the Central Drugs Standard Control Organisation, or CDSCO as it commonly known, issued a notification prohibiting the manufacture, sale and distribution of 344 Fixed Dose Combinations of drugs. It later added five more FDCs.
The ban was poised to hit the profits of the pharmaceutical industry since there are thousands of FDCs in the market. The pharmaceutical industry challenged the ban on the grounds that the central government had not consulted the Drugs Technical Advisory Board, which is an advisory body set up under Section 5 of the Drugs and Cosmetics Act, 1940.
In December 2016, the Delhi High Court set aside the orders banning the FDCs. Later, this judgement was appealed against by the central government and the Supreme Court overruled the High Court’s ruling, concluding that Section 26A of the Drugs and Cosmetics Act, 1940, does not require the Central government to consult the advisory board. It then ordered the Drugs Technical Advisory Board to examine these drugs and submit a report to the Centre.
On Wednesday, the government said: “The Drugs Technical Advisory Board recommended, amongst other things, that there is no therapeutic justification for the ingredients contained in 328 FDCs and that these FDCs may involve risk to human beings. The board recommended that it is necessary to prohibit the manufacture, sale or distribution of these FDCs under section 26A of the Drugs and Cosmetics Act, 1940 in the larger public interest.”
Based on these recommendations, the government banned the FDCs in a gazette notification dated September 7, 2018.
“With regard to six FDCs, the board recommended that their manufacture, sale and distribution be restricted subject to certain conditions based on their therapeutic justification,” the statement added. “Fifteen FDCs out of the 344 prohibited on the 10th March, 2016, which were claimed to be manufactured prior to 21 September, 1988, have been kept out of the purview of current notifications.”