Notice to Central Government over safety review of acidity drug Ranitidine

The Delhi High Court has issued a notice to the Central Government over the delay in the ongoing review regarding the safety of Ranitidine, a well-known drug used in the treatment of acidity. A bench comprising Acting Chief Justice Nitin Sambre and Justice Sanjay Sharma has sought a response from the Central Government, Central Drugs Standard Control Organization (CDSCO), Drugs Technical Advisory Board (DTAB), and the Indian Council of Medical Research (ICMR) in this matter. The next hearing for this case will be held in the month of February.

The petition filed by Advocate Dr. Chandresh Jain argues that the safety of Ranitidine has been a matter of concern since September 2019. At that time, foreign drug regulators had warned about the presence of a potential carcinogen called NDMA in this drug. According to the petitioner, countries like America, the European Union, and Australia had taken regulatory measures regarding this as early as 2020, but the Indian drug regulator has not taken any final or public decision despite years having passed.

The petition further states that on 24 April 2025, the DTAB had referred this matter to a committee and for a study by the ICMR. The Central Government had set a three-month deadline to submit this report, which was fixed for 24 July 2025 and expired on 24 October 2025. However, even on 7 October 2026, the CDSCO stated that the report was awaited and the matter was still under review.

The petitioner has emphasized in his submission that this drug is cheap and easily available, often purchased without a prescription. Therefore, those who do not have other options are falling victim to this indecisive situation. Countries like America, the European Union, Australia, Canada, the United Kingdom, and Singapore have taken some form of decision regarding this drug following the 2019 warning.

Ranitidine is a drug commonly used for the treatment of acidity and to reduce the amount of acid in the stomach. However, after concerns were raised in 2019 about it containing carcinogenic elements, questions were raised globally regarding its safety, and several countries imposed restrictions on its sale or consumption.