Heritage brand Saridon looks set to continue in the marketplace with the Supreme Court exempting it from the list of banned fixed dose combination (FDC) medicines.

“The SC accepted our contention that the brand was a pre-1988 product,” Nandini Piramal, Executive Director with Piramal Enterprises, told BusinessLine , adding that she did not expect fresh headaches to emerge in terms of a review of pre-1988 drugs or a fresh registration of the product with the Central regulatory authority. Pointing out that the ₹100-crore painkiller Saridon had been in India for over 50 years, she said: “We have advertisements dating back to the 1950s and ’60s.” The product had not gone off the market even as the FDC drugs issue went through law courts, expert and technical committees. The drug will see more brand extensions in the pain killer category, Piramal said.

Saridon reportedly sees 31 tablets sold in the country every second. Industry estimates peg the analgesic market at ₹6,450 crore, of which tablets are about ₹2,050 crore.

FDC drugs, which involve a combination of two or more medicines, have been under the regulatory scanner for many years now. Last year, following a technical report, the Centre banned 328 drugs. Later, 15 received a reprieve on the grounds of having received marketing approvals before 1988.

Health advocacy experts question the rationale of allowing combination drugs on the basis of a technicality like a cut-off date, rather than evaluating its benefits from a health standpoint.

Last September, Piramal received a stay order on the ban. The latest ruling appears to put the lid on the controversy for now.

 

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