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State DCs plan action on DCGI directive to verify product safety of widely used ranitidine

Shardul Nautiyal, Mumbai
Friday, September 27, 2019, 08:00 Hrs  [IST]

State drug controllers across the country are contemplating action on the recent Drugs Controller General of India (DCGI) directive to verify product safety of widely consumed acidity drug ranitidine following US FDA alert for carcinogenic impurity.

Drug controllers have raised serious concern about N-nitrosodimethylamine (NDMA) impurity detected by USFDA recently. More so as it does not find mention in the major pharmacopoeias like Indian Pharmacopoeia (IP), British Pharmacopoeia (BP) and US Pharmacopoeia.

A Central Drugs Standard Control Organisation (CDSCO) official, on condition of anonymity, said that it is high time now that ranitidine, which is the cheapest antacid available to the masses today, should be tested for impurities like NDMA which is carcinogenic in nature.

NDMA has been classified by International Agency For Research On Cancer (IARC) as carcinogenic to humans.

The point of contention raised is also about the fact that the side effects of ranitidine has never been reported through pharmacovigilance and hence it becomes the collective responsibility of manufacturers, regulators and consumers to report adverse events due to ranitidine.

The US FDA on September 13 detected low level of cancer causing impurity NDMA in samples of acidity medicine ranitidine.

There are two major API manufacturers of ranitidine in the country based out of Telangana and Gujarat- Saraca Laboratories and Orchev Pharma Pvt Ltd. Following US FDA alert, Orchev Pharma got its samples of ranitidine tested for impurity in a US FDA certified lab in Mumbai. No impurity was detected in the test results.

In India, various drug makers such as Dr Reddy's, Sun Pharma, Cadila Pharma, GlaxoSmithKline, JB Chemicals and Zydus Cadila sell over 180 products based on ranitidine. The domestic market sales are pegged at around Rs.700-750 crore. Aurobindo Pharma, Granules India and Strides Shasun are some of companies that got approval to sell this product in the US.

Strides Pharma Science (Formerly Strides Shasun) has received an Information Request (IR) from USFDA to provide test data for ranitidine tablets in the next 30 days. The company is in the process of responding to the IR comprehensively.

The company has also received an approval from US FDA for prescription and over the counter (OTC) ranitidine tablets for the US market and is only commercialising the prescription product currently.

Dr Reddy's Laboratories, a global supplier of ranitidine suspended its distribution as a precautionary measure. Another Hyderabad-based manufacturer of ranitidine SMS Pharmaceuticals said the USFDA has sought a 'DMF information request' to provide the information to demonstrate SMS's ranitidine active pharma ingredient (API) manufacturing process does not contain the impurity.

Regulatory agencies such as the Health Canada and Health Sciences Authority (HSA) of Singapore have also initiated action.

HSA has tested all locally-marketed brands of ranitidine and found trace amounts of the NDMA that exceed internationally acceptable level in eight brands including that of GlaxoSmithKline (GSK).

GSK has stopped manufacturing and recalled its branded products Zinetac tablets (150mg and 300mg) from pharmacies and retail outlets, according to sources.

Health Canada has also asked ranitidine manufacturers to stop its distribution.

According to CDSCO notice, it has been reported from other countries that some ranitidine medicines contain low levels of nitrosamine impurity called N-nitrosodimethylamine.

The drug ranitidine is approved for multiple indications in the country and available in various formulations including tablets and injections etc.

While US FDA has so far not asked people to stop taking ranitidine, the agency has advised patients who wish to discontinue to consult their doctors about other treatment options.


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