NDMA presence in the acid-reflux drug under scrutiny again; states told to ensure manufacturers take risk-based safety steps
In a renewed move to safeguard public health, the Drugs Controller General of India (DCGI) has directed all state and union territory drug regulators to ensure that manufacturers of Ranitidine—a commonly used medicine for acidity—monitor levels of NDMA, a potential cancer-causing impurity, in their formulations.
Ranitidine is a medication that lowers stomach acid production and helps relieve acid-related indigestion and heartburn. It is commonly available under brand names like Aciloc, Rantac, and Zinetac.
The July 24 communication, seen by News18, follows the findings of a government-appointed expert committee and a subsequent meeting of the Drugs Technical Advisory Board (DTAB), the country’s apex drug advisory body. The DTAB, in its 92nd meeting held on April 28, reviewed the expert panel’s report on the NDMA contamination issue that has shadowed Ranitidine for several years.
“The issue related to safety of Ranitidine drug due to presence of NDMA impurity has been under consideration for quite some time and this office has taken various measures from time to time,” the letter said.
Now, a letter from the DCGI notes that while various steps have been taken earlier, the DTAB has recently recommended more robust action, including the setting up of a larger committee to examine all aspects of Ranitidine safety—particularly its storage conditions, which can impact impurity levels. It has also suggested that the Indian Council of Medical Research (ICMR) conduct a safety study on Ranitidine, considering the NDMA concerns.
News18 first reported the recommendations of the expert panel on April 29.
Critically, the DTAB advised that “manufacturers should monitor the NDMA levels in the API/formulation and also take risk-based measures such as reducing the shelf life” of the product.
Following this, the DCGI has asked state drug controllers to instruct Ranitidine manufacturers in their jurisdiction to initiate these monitoring and mitigation efforts immediately.
“…as recommended by DTAB, you are requested to direct the manufacturers under your jurisdiction to monitor the NDMA levels in the API/formulation of Ranitidine and also take risk-based measures such as reducing the shelf life, etc.”
NDMA (N-nitroso dimethylamine) is classified as a probable human carcinogen. The impurity was first flagged globally in 2019, prompting recalls and regulatory reviews in several countries. In India, too, concerns around Ranitidine’s safety have persisted, although the drug remains on the market.
