India's senior drug advisory committee has put off taking action on banning Ranitidine, a common antacid, even as there have been recent suggestions from an expert committee and global regulatory suspensions due to cancer-related impurities. The Drugs Technical Advisory Board (DTAB) will constitute a bigger committee to further evaluate the safety profile of the drug.

Key Highlights

International Withdrawals and Safety Alerts

• Ranitidine is removed or taken off the market by regulatory agencies like the USFDA, European Medicines Agency (EMA), and Australia's TGA.

• It is due to the availability of NDMA (N-nitrosodimethylamine), which is a known carcinogen.

Ranitidine Market Presence in India

• It is abundantly marketed in India by brands such as Aciloc, Rantac, and Zinetac.

• Even after worldwide actions, it can still be manufactured and sold in India.

DTAB Decision and Further Review

• DTAB has delayed immediate suspension and suggested constituting a bigger committee to examine the issue in-depth.

• The board also suggested ICMR doing a thorough safety study on the drug.

Test Results and Recommendations of Expert Committee

• 42 Ranitidine samples were analyzed in the Central Drug Laboratory, Kolkata.

• 21 samples had NDMA content more than 0.32 parts per million (PPM), higher than globally accepted standards.

• The expert committee had suggested suspension of the production, sale, and distribution of Ranitidine based on these observations.

Advice for Patients
The committee advised people who were on Ranitidine to seek their doctor's advice for safer alternative treatment.In spite of global regulatory measures and proof of NDMA contamination in samples subjected to testing, Indian officials have opted to put off the suspension of Ranitidine until they conduct more investigations. The decision indicates restraint by Indian regulators as they weigh the safety of public health against drug availability.