New Delhi: India will continue testing for known carcinogen N-nitrosodimethylamine (NDMA) in popular antacid ranitidine, two senior officials of the Central Drugs Standard Control Organization (CDSCO) said, even as the US regulator, which had flagged the issue first, has downplayed the risk.
“The venom that the information (of US FDA) was carrying of a public danger, that is removed now. But still it will be tested," one of the two people cited above said on condition of anonymity.
Earlier this month, the US Food and Drug Administration (FDA) downplayed the risk associated with ranitidine, saying that levels of the carcinogen in most ranitidine samples were similar to those found in common food items. The regulator, though, asked pharmaceutical companies to voluntarily recall ranitidine products if the contaminant breaches the limit in their products. The US FDA considers 96 nanograms per day, or 0.32 parts per million, as the acceptable limit for ranitidine.
The statement followed a safety warning by the US regulator in September, citing traces of NDMA, a known carcinogen, in ranitidine.
Following the US regulator’s safety alert, the Drug Controller General of India (DCGI) V.G. Somani, head of CDSCO, had also issued a directive to all state regulators asking them to get manufacturers to test anti-acidity drug ranitidine for the impurity. Many other drug regulators the world over also issued similar advisories and are conducting tests.
“It is unlikely that drug manufacturers will reintroduce ranitidine products as of now. They would look at how regulators globally would react on the product. While the ranitidine market has been hit, there are substitute for antacids," Surajit Pal, an analyst with Prabhudas Lilladher, said.
The safety alert triggered considerable chaos in the pharmaceutical sector worldwide, with many companies withdrawing sale of the medicine.
On 25 September, GlaxoSmithKline Pharmaceuticals Ltd suspended the distribution and supply of ranitidine hydrochloride products to all markets, including India, as a precautionary measure. The move by GSK came after the European Directorate for the Quality of Medicines (EDQM) suspended the certificate of suitability of its bulk drug supplier Saraca Laboratories Ltd.
Somani had in his letter sought reports from manufacturers, including GSK, on their internal tests in September, but two months later, the CDSCO continues to await the results, the second official said. “The test is very, very expensive. But we will still test the samples to make sure the drug is safe."
Dr Reddy’s Laboratories had also initiated a voluntary recall of the medicine in the US on 1 October after the US FDA’s caution note. Dr Reddy’s does not sell ranitidine products in India.
In India, GSK Pharma manufactures the drug under the Zinetac brand, the second-largest brand for the product. The most popular brand of ranitidine in India is Cadila Pharmaceuticals’ Aciloc.
GSK’s suspension of ranitidine sales aided sales of Cadila Pharmaceuticals’ Aciloc in October, data from market research firm AIOCD-AWACS shows. In October, the first full month of suspension of supply, ranitidine sales of GSK dropped to just ₹6 crore from ₹18 crore in August, the data showed. For September, the sales had slipped to ₹15 crore.
On the other hand, Cadila Pharmaceuticals Ltd clocked a 16% rise during the same period to ₹24.8 crore in October, the data showed.