Saridon exempted from list of banned drugs by Supreme Court

21-Saridon Representational image | File

Saridon is safe. If you go by the latest Supreme Court ruling, that is. The formulation of the analgesic tablet, manufactured by Piramal Enterprises Limited (PEL), has been exempted from the list of over 300 banned fixed dose combination drugs (FDCs). 

The controversy over Saridon began in September last year when the SC banned 328 FDCs, including a combination of paracetamol, propyphenazone and caffeine (Saridon). That same month, PEL, however, managed to get a stay order for Saridon allowing it to continue manufacturing, distributing and selling the tablet. 

The combination, however, was declared unsafe by an expert committee report under the chairmanship of Dr Nilima Kshirsagar, chair of clinical pharmacology at the Indian Council of Medical Research. According to the 700-page report by the expert committee appointed under the Drugs Technical Advisory Board, the combination of paracetamol, propyphenazone and caffeine, or, Saridon, was one among the 300-odd combinations for which the makers could offer no “convincing scientific/clinical/justification” for the indications that the drug claimed to address.

In the case of Saridon, the problem lies in the ingredient propyphenazone that poses a risk of “adverse reactions such as skin rashes, erythema (skin redness), leukopenia (low count of white blood cells), asthma precipitation”, among other serious conditions. Although uncommon, the committee concluded that these reactions can be “severe and potentially fatal”. “It is also why the ingredient has been withdrawn from other countries,” they wrote in the report.

Propyphenazone is also understood to cause serious side-effects to the bone marrow, Dr Anurag Bhargava, professor, department of medicine, Yenepoya Medical College, Mangaluru had told The WEEK after the drug ban in September 2018. 

According to Bhargava, the original Saridon, manufactured by Roche pharmaceuticals, contained phenacetin. This ingredient, he says, was dropped later because it was found to be carcinogenic, and with side-effects to the kidney. “The current ingredient in Saridon, propyphenazone, also figures on the WHO's 'Consolidated List of Products Whose Consumption and/or sale have been banned, withdrawn, severely restricted or not approved by governments,” he said.

On February 21, after the SC exemption for Saridon, Nandini Piramal, Executive Director, Piramal Enterprises Limited said, “We are pleased with the Supreme Court ruling, as it is an affirmation to our commitment to provide effective and safe healthcare solutions that address unique needs of Indian consumers. We were confident that the law would prevail in our favour... This exemption from the banned list of FDCs validates our intent to serve our customers with the highest levels of integrity. We continue to expand our healthcare product portfolio with an aim to be among the top three OTC (over the-counter) product companies in India by 2020.”

In its press statement, PEL claimed that according to a recent study by A.C. Neilson, the addressable analgesic market is Rs 6,450 crores, of which the analgesic tablet market is Rs 2,050 crores (as of December, 2018). Saridon is amongst India’s most widely distributed analgesic tablets with a strong distribution network across 9 lakh outlets in India, the statement said.