OPEN APP
Home / Companies / News /  Piramal Enterprises to launch extensions for Saridon after SC lifts ban

Popular painkiller Saridon will continue to be sold, with the Supreme Court on Wednesday exempting it from the list of fixed dose combinations (FDCs) that were banned by the government expert committee in September last year. The news has come as a big relief to Piramal Enterprises Ltd (PEL), which readies itself to launch extensions for the 50-year-old brand. “The removal of uncertainty allows us to invest more in the brand. As we look forward we will launch extensions for the brand. As a business strategy we will continue first in tablets but we may look at other options," said Nandini Piramal, executive director at Piramal Enterprises.

Significantly, Piramal Healthcare did not suffer any revenue loss on account of Saridon following a stay order from the Supreme Court on the ban, “which allowed it to continue manufacturing, distribution and sale of the FDC," the company said. The court allowed them to continue selling the drugs because they were being manufactured before 1988.

“The issue is not the brand name but the ingredients. If Saridon is using the same ingredients and the formulation has not been changed since 1988, it cannot be banned. The ban could not applied to FDCs pre-1988 and Saridon was one of them," said Dr C.M. Ghulati, well-known health expert and Editor of the medical journal

MIMS.

Welcoming the Supreme Court order, Nandini Piramal further said that, “Saridon has been in India for last fifty years. One of the most widely distributed analgesic brand in India. We have been advertising and selling in India and we have some super cool advertisements of 1950 and 60 of Saridon, pretty much everyone in our generation would have heard ‘sirf ek sirf ek… Saridon’. It’s an iconic brand. We are pleased with the ruling."

The government had in September last year prohibited the manufacture, sale or distribution of 328 fixed dose combination drugs for human use with immediate effect after an expert committee found the “irrational".

The expert panel which was probing the efficacy of 349 banned FDCs complied with the December 2017 apex court judgement and gave its report to India’s top drug advisory body, the Drug Technical Advisory Board (DTAB), on 25 July 2018.

The panel after considering these drugs “irrational", citing safety issues and lack of therapeutic justification, recommended continuing the ban.

The expert panel also found that many FDCs were formulated without due diligence, with dosing mismatches that could result in toxicity.

The committee was formed to look into the report submitted on 20 January 2015, by a panel led by Chandrakant Kokate, vice-chancellor of KLE University, Karnataka, which deemed these FDCs irrational, saying they posed health risks and, hence, banned them, pushing some of the firms and the pharma groups to challenge the government’s notification banning FDCs in the court.

In December 2016, the apex court referred the matter to DTAB for a fresh review on whether these drugs should continue to be marketed.

The Supreme Court suggested DTAB decide whether the manufacturing and sale of these drugs should be regulated, restricted or banned outright, and submit its report and recommendations to the government within six months.

An expert panel was then formed under the chairmanship of Nilima Kshirsagar, professor-head clinical pharmacology, G.S. Medical College and KEM Hospital, Mumbai, to review the safety, efficacy and therapeutic justification of these drugs.

An FDC drug contains two or more active ingredients in a fixed dosage ratio.

The health ministry’s ban on FDCs included painkillers, anti-diabetic, respiratory and gastro-intestinal medicines, covering 6,000 brands. 

Subscribe to Mint Newsletters
* Enter a valid email
* Thank you for subscribing to our newsletter.

Never miss a story! Stay connected and informed with Mint. Download our App Now!!

Close
×
Edit Profile
My ReadsRedeem a Gift CardLogout