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CDSCO flags ranitidine over possible presence of carcinogenic impurity

In its letter, a copy of which The Indian Express reviewed, the regulator has also asked states to inform it of any action taken in this matter “at the earliest”.

Written by Prabha Raghavan | New Delhi | Updated: September 25, 2019 3:04:29 am
NDMA, an environmental contaminant found in water and foods, is the same impurity that the US FDA had investigated in blood pressure drugs valsartan and losartan over the last year.

Over a week after the US food and drug regulator raised concerns over popular heartburn drug ‘ranitidine’ being contaminated with cancer-causing substances, India’s top drug regulatory body has begun looking into the issue in India.

The Central Drugs Standard Control Organisation (CDSCO) Monday wrote to state regulators asking them to “communicate to the manufacturers of ranitidine API (active pharmaceutical ingredient) and formulations under your jurisdiction to verify their products and take appropriate measures to ensure patient safety.”

In its letter, a copy of which The Indian Express reviewed, the regulator has also asked states to inform it of any action taken in this matter “at the earliest”.

“It has been reported from other countries that some ranitidine medicines contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels,” stated Drugs Controller General of India (DCGI) VG Somani in the letter.

The letter, however, does not call for any halting of supplies, which means the products — known popularly through brand names like ‘Aciloc’, ‘Zinetac’, ‘Rantac’, ‘R-Loc’ and ‘Ranitin’ — will continue to be marketed in the country.

On September 13, the US Food and Drug Administration (US FDA) said in a release it had learned that some ranitidine medicines, including those commonly known under the brand name Zantac, contained “low levels” of NDMA. It added it was evaluating whether these levels of the substance posed a risk to patients.

“Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods,” the US watchdog added.

While the US FDA too has not called for individuals to stop taking ranitidine at this time, some Indian drug makers have decided to halt supplies of their ranitidine products until investigations are concluded.

Dr Reddy’s Laboratories on Sunday told PTI that it was suspending supply of its ranitidine “worldwide” as a precaution.

NDMA, an environmental contaminant found in water and foods, is the same impurity that the US FDA had investigated in blood pressure drugs valsartan and losartan over the last year.

However, in that case, recalls of batches of these drugs were called due to the levels of the contaminants being at ‘unacceptable’ levels. In India, ranitidine is an over Rs 680 crore market, according to pharmaceutical market research firm AIOCD PharmaTrac.

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