Following the ongoing probe by the US Food and Drug Administration (FDA), Dr. Reddy’s Laboratories Ltd has said that they will suspend the supply of the drug Ranitidine worldwide. This comes as a precautionary measure because the drug ranitidine contains a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. The Central Drugs Standard Control Organisation (CDSCO) has also started the process of 'checking for any adverse reactions of the drug'. The Drugs Controller General of India (DCGI) V.G. Somani in a letter states that NDMA has been classified by the International Agency for Research on Cancer as “probably carcinogenic” to humans. Ranitidine is an over-the-counter and prescription drug which decreases the amount of acid created by the stomach.
Dr. Reddy’s spokesperson told, “Dr. Reddys is still evaluating the potential impact of the issue. As a precautionary measure, Dr. Reddys is suspending all shipments worldwide of Ranitidine products until the investigation (by the FDA) outcome is available. We have both a prescription and an over-the-counter portfolio of the product”. The USFDA in a release said that some ranitidine medicines, including the brand name Zantac, contained 'low levels' of NDMA.
The FDA in a statement on September 13 had said it is working with international regulators and industry partners to determine the source of this impurity in Ranitidine. Being manufactured by several companies Ranitidine needs examining, in order to identify the levels of NDMA and evaluate any possible risk to patients. Though the FDA is not calling for individuals to stop taking Ranitidine at this time. However, patients taking the prescription and wishing to discontinue its use should talk to their health care professionals about other treatment options, the US drug regulator said.
In other developments, the Uttarakhand High Court, a few months ago, directed a company run by yoga guru Ramdev to share a percentage of its profits with local farmers and communities. The high court gave the order while rejecting a petition of Divya Pharmacy against the Uttarakhand Biodiversity Board (UBB) and upholding the provisions of fair and equitable benefit-sharing as provided under the Biological Diversity Act, 2002. The bench of Justice Sudhanshu Dhulia held that it was a fact that biological resources constitute the main ingredient and raw materials in the manufacture of ayurvedic and nutraceutical products. It ordered the pharmacy to share Rs. 2 crores out of its Rs. 421-crore profit with the farmers of the raw product.