{"id":28131,"date":"2025-07-28T18:48:22","date_gmt":"2025-07-28T18:48:22","guid":{"rendered":"https:\/\/www.newsbeep.com\/au\/28131\/"},"modified":"2025-07-28T18:48:22","modified_gmt":"2025-07-28T18:48:22","slug":"ask-antacid-ranitidine-makers-to-monitor-chances-of-cancer-causing-impurity-drug-controller-to-states-india-news","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/au\/28131\/","title":{"rendered":"Ask Antacid Ranitidine Makers To Monitor Chances Of Cancer-Causing Impurity: Drug Controller To States | India News"},"content":{"rendered":"

Last Updated:July 27, 2025, 07:00 IST<\/p>\n

NDMA presence in the acid-reflux drug under scrutiny again; states told to ensure manufacturers take risk-based safety steps\"Ranitidine<\/p>\n

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. (Representational pic\/Reuters)<\/p>\n

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\u2014a commonly used medicine for acidity\u2014monitor levels of NDMA, a potential cancer-causing impurity, in their formulations.<\/p>\n

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.<\/p>\n

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\u2019s apex drug advisory body. The DTAB, in its 92nd meeting held on April 28, reviewed the expert panel\u2019s report on the NDMA contamination issue that has shadowed Ranitidine for several years.<\/p>\n

\u201cThe 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.<\/p>\n

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\u2014particularly 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.<\/p>\n

News18 first reported<\/a> the recommendations of the expert panel on April 29.<\/p>\n

Critically, the DTAB advised that \u201cmanufacturers should monitor the NDMA levels in the API\/formulation and also take risk-based measures such as reducing the shelf life” of the product.<\/p>\n

Following this, the DCGI has asked state drug controllers to instruct Ranitidine manufacturers in their jurisdiction to initiate these monitoring and mitigation efforts immediately.<\/p>\n

\u201c\u2026as 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.”<\/p>\n

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\u2019s safety have persisted, although the drug remains on the market.<\/p>\n

With the DTAB\u2019s latest push, the spotlight is once again on the need for proactive safety checks and strict quality surveillance by drugmakers, especially for older drugs that continue to see wide usage.<\/p>\n

\"authorimg\"Himani Chandna<\/a><\/p>\n

Himani Chandna, Associate Editor at CNN News18, specialises in healthcare and pharmaceuticals. With firsthand insights into India’s COVID-19 battle, she brings a seasoned perspective.
\nShe is particularly pass…Read More<\/p>\n

Himani Chandna, Associate Editor at CNN News18, specialises in healthcare and pharmaceuticals. With firsthand insights into India’s COVID-19 battle, she brings a seasoned perspective.
\nShe is particularly pass… Read More<\/p>\n

view commentsFirst Published:News<\/a> india<\/a> Ask Antacid Ranitidine Makers To Monitor Chances Of Cancer-Causing Impurity: Drug Controller To StatesDisclaimer: Comments reflect users\u2019 views, not News18\u2019s. Please keep discussions respectful and constructive. Abusive, defamatory, or illegal comments will be removed. News18 may disable any comment at its discretion. By posting, you agree to our Terms of Use<\/a> and Privacy Policy<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"Last Updated:July 27, 2025, 07:00 IST NDMA presence in the acid-reflux drug under scrutiny again; states told to…\n","protected":false},"author":2,"featured_media":28132,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[27052,64,63,1617,6013,137,490,1679,27051],"class_list":["post-28131","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medication","tag-antacid","tag-au","tag-australia","tag-cancer","tag-drug","tag-health","tag-medication","tag-medicine","tag-ranitidine"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts\/28131","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/comments?post=28131"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts\/28131\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/media\/28132"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/media?parent=28131"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/categories?post=28131"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/tags?post=28131"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}