An expert panel has recommended a nationwide suspension on the manufacture, sale, and distribution of the popular antacid ranitidine in India, citing potential cancer risks due to high levels of NDMA impurities. The findings, submitted to the Drug Technical Advisory Board (DTAB), may prompt regulatory action after years of delay.

Key Highlights

NDMA Impurities Found in Samples

• Of 42 ranitidine samples tested by the Central Drug Laboratory, Kolkata, 21 exceeded the NDMA limit of 0.32 parts per million.

• NDMA is a probable human carcinogen linked to long-term cancer risk.

Recommendation to DTAB

• The panel’s report was submitted to DTAB, which advises the Drug Controller General of India (DCGI).

• The board is expected to deliberate on suspending ranitidine in India.

Ranitidine Already Banned Globally

• Countries like the US, UK, Europe, and Australia have already banned ranitidine over safety concerns.

• India removed it from the National List of Essential Medicines (NLEM) in 2022 but hasn’t implemented a full ban yet.

CDSCO Under Pressure to Act

• Despite issuing safety advisories, the Central Drugs Standard Control Organisation (CDSCO) has not banned the drug.

• The recent findings increase pressure on regulators to follow international precedent.

Commonly Used OTC Drug

• Sold under popular brands like Rantac, Zinetac, and Aciloc, ranitidine has been widely used for heartburn, GERD, and ulcers.

• Originally developed by Glaxo Holdings in 1981, it has been a household staple for decades in India.

With half of tested samples exceeding global NDMA safety thresholds and several countries already implementing bans, India now appears closer to taking definitive regulatory action on ranitidine. If DTAB moves ahead with the panel’s recommendation, the long-standing OTC antacid may soon disappear from Indian shelves.