Government Ban Works: Unsafe FDC Medicine Sales Down By 56.4 Per Cent, Non-FDCs Up By 9.2 Per Cent

Following a government ban, the market for fixed-dose combination (FDC) drugs in the country has shrunk by as much as 56.4 per cent, reports Business Standard (BS).

On the other hand, the non-FDC market expanded by 9.2 per cent and single molecule drugs segment grew by 9.4 per cent. An FDC drug is one that is made up of two or more active pharmaceutical ingredient (API) in a fixed-dosage ratio.

In September 2018, the government banned the manufacture, sale and distribution of 328 fixed-dose combinations (FDCs) of drugs with immediate effect, terming them as “irrational” and “unsafe.”

It appears that the ban had the intended effect and manufacturers have reduced their exposure to FDCs.

"Before the ban came mid last year, we had braced for the same and weeded out FDCs from our domestic portfolio. Henceforth we have been cautious about launching new combination drugs. As such the government is studying the efficacy of another 940 FDCs and therefore, there is a sense of uncertainty in this market," said the head of a pharma company to BS.

Self Regulation

It is also reported that some market players are exercising self-restraint in launching new FDCs. "Companies have consciously moved away from FDCs that are already under the scanner and a ban is probable in the near future,” said Sudarshan Jain, secretary general of the Indian Pharmaceutical Alliance (IPA).

Also Read: Why Indian Pharma Sector Should Move From Generic To Innovation