A report, prepared by a sub-committee of the Drugs Technical Advisory Board has recommended that 343 FDCs be prohibited and six others be either restricted or regulated for specific indications or quantities.
This report is likely to be sent to the health ministry in the next two weeks, following which the government will decide the fate of these drugs.
In 2016, the health ministry had banned 349 FDCs claiming they were “unsafe” and “irrational” for consumption. The move was estimated to affect around 6,000 medicine brands.
Hundreds of pharma companies moved the Delhi High Court against the move, following which the court lifted the ban on the manufacture and sale of these medicines later that year. The government took the matter to the Supreme Court, which in December 2017, mandated that DTAB decide the fate of these FDCs.
DTAB subsequently decided to set up a sub-committee under Nilima Kshirsagar to decide the same and in May said it would be forwarding these recommendations to the central government for a final decision.
The sub-committee had found that “most” of the companies appealing the ban had not generated safety and efficacy data of their own for their FDCs.
Almost 95% of these appellants is said to have failed to prove safety, rationality and compatibility of these FDCs.
The published literature they provided to justify the FDCs was “not relevant” and relied on a few “biased” studies. (Source Economic times)
Why FDCs are promoted and has a market
- It shifts the drugs from NLEM to non NLEM (National list of essential medicines) lists
- They are more used by quacks and non-qualified doctors as it covers multiple infections or diseases with single drug
- The risk is safety, and developing multi drug resistance