New Delhi: At present, there is no proposal to prohibit the manufacture, distribution and sale of Ranitidine, a medication used to reduce stomach acid, in the country, Minister of State for Health Anupriya Patel told the Rajya Sabha on Tuesday (December 17, 2024).
She was responding to a question on whether the government has reviewed the findings of international regulatory bodies, USFDA and EMA, on the presence of N-nitrosodimethylamine (NDMA) in Ranitidine and its health implications and if there are plans to issue an order under Section 26A of the Drugs and Cosmetics Act, 1940, to prohibit the manufacture and sale of the drug in the country.
The Central Drugs Standard Control Organisation (CDSCO) under the Union Health Ministry has taken various actions including testing of Ranitidine samples for the impurity and communication with the State Drugs Controllers to instruct the manufacturer of Ranitidine API and formulations to verify/ test their products and take appropriate measures to ensure patient safety, Patel said in a written reply.
The CDSCO had also instructed zonal offices for drawing of samples for testing the level of N-nitrosodimethylamine (NDMA) impurity in ranitidine, the minister said.
“At present, there is no proposal to prohibit the manufacture, distribution and sale of Ranitidine in the country,” she said.
The Indian Pharmacopoeia Commission has published a General chapter on Nitrosamine Impurities in the 9th edition of Indian Pharmacopoeia (IP) 2022.
This chapter provides the methods of analysis of the nitrosamine impurities including the NDMA along with their acceptable intake (AI) limits.
