On Wednesday, 328 Fixed Combination Drugs (FDC) are banned by the Government in consultation with the Ministry of Health and Family Welfare. The ban on FDC drugs is expected to affect around 6000 brands of Indian Pharmaceutical Industry leading to an estimated jolt to a market size of 2000 to 2500 crores.
FDCs medicines are the combination of two or more drugs, which according to The Drugs Technical Advisory Board do not support any therapeutic justification for the ingredients; concluding them as harmful for human body.
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.
These FDCs include painkiller Saridon, skin cream Panderm, combination diabetes drug Gluconorm PG, antibiotic Lupidiclox and antibacterial Taxim AZ.
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.
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.