Popular and esteemed pharmaceutical company, Dr Reddy’s confirmed in a recent statement that they have recalled all the batches of the heartburn drug Ranitidine following the allegations made by USFDA. They issued an alarming caution stating that the drug contained alarming levels of the carcinogenic compound, nitrosodimethylamine, in levels unacceptable.

Addressing the issue, the company did release a statement putting some further clarity on the situation. In the issued statement, the company stated saying, “Dr Reddy’s confirms that it had initiated a voluntary nationwide recall on October 1, 2019, at the retail level for over-the-counter products and at the consumer level for prescription products of all of its ranitidine medications sold in US due to confirmed contamination with NDMA.”

The pharmaceutical company, based out of Hyderabad, India, said that NDMA is considered as a possible human carcinogen, enhancing the risks of cancer, as it came out in some of the results of the conducted lab tests. NDMA is a compound, rather a contaminant, which is often found in fruits, vegetables and the other daily eatables that we rely on for nutrition.

Following the distress, the same even affected the shares of Dr. Reddy which fell by 1% in the Bombay Stock Exchange.

Ranitidine, which is often normally prescribed as an antacid took a big hit following the NDMA scandal, especially for the Indian generic makers situated out of the United States. They are the biggest suppliers of this specific drug.

Following the sign of caution issued by FDA, majority of the Indian as well as the multinational companies had to work on retracting back the drug from the US market.

But, following the scam around, USFDA also suggested saying that some of the third party labs did make use of higher temperatures to test out the levels of the NDMA. This is what further caused the higher levels of NDMA to surface in such labs.

The same drugs were again tested out in the lower temperature labs like the LC-HRMS protocol and found that the levels of NDMA was a lot lesser than what it came before. Some of the international regulators who are using the LC-HRMS protocol also justified the presence of lower levels of NDMA in the ranitidine samples.

Addressing everything, the regular further stated saying, “FDA is continuing to test ranitidine products from multiple manufacturers and is assessing the potential impact on patients who have been taking ranitidine.”

By Somapika Dutta