Doctors in India have cautioned the general public about Zantac, the popular drug and had asked for an urgent advisory by the Indian drug regulator, days after drug makers and global public health regulators claimed to have taken steps to remove supplies of a popular heartburn medication which is presently under investigation by US-Food and Drug Administration (FDA) for the presence of human carcinogen called NDMA, or N-Nitrosodimethylamine in Zantac and its generic forms.

Novartis AG’s Sandoz unit said earlier this week that it was halting worldwide distribution of generic versions of the stomach drug Zantac after regulators in the U.S. and Europe initiated investigating the drug.

Dr. Shanti Swaroop Dhar, principal consultant, Gastroentorology, Max Super Speciality Centre, Panchsheel Park, said that in India, Ranitidine (some versions of Zantac, also known by the generic name ranitidine) is used for treating gastrointestinal disorders and discomfort. The news regarding the presence of NDMA in Ranitidine is very disturbing as Ranitidine remains the most commonly prescribed medicine for acid peptic disorders and was considered safer than many other medicines. He also said that doctors need to know whether NDMA is present as an additive and if possible to make Ranitidine NDMA-free.

Additional information is needed as to whether the amount of NDMA present is above the threshold and a genuine risk as small amounts of NDMA is present in many common foods. Short of above clarifications it is practical to use caution in prescribing this drug pending the directives from competent authorities. He also said that there is a need to educate the community as the drug is easily available over the counter and a large number of people use this on a regular basis.

In India, Ranitidine is manufactured by Cadila Pharmaceuticals and GlaxoSmithKline Pharmaceuticals. Zantac is manufactured by French pharma major, Sanofi. A senior official at the Central Drugs Standard Control Organization (CDSCO), maintained that while they are aware of the alert issued by the FDA there is no emergency.

Dr. S.L. Broor, senior consultant, Dept. of Gastroenterology, Indraprastha Apollo noted that FDA’s report on NDMA presence does not issue any threatening so far to withdraw the drug from the market. Also it does not say that patients should not take this drug. The level of NDMA found is very small and is present as a contaminant in food, water, vegetables and meat also in very small amounts. The drug has been used very commonly for treatment of acid peptic disorders all over the world and has a very good safety profile. They have not seen any case of cancer due to its usage till now.

Dr. Lalit Verma, Paediatric Gastroenterologist, Surya Hospitals said that NDMA can cause harm in large amounts and FDA’s prelim results suggest that levels of NDMA in ranitidine do not exceed the levels found in common NDMA containing food. They suggest that patients taking over-the-counter drug and medical professionals prescribing should shift to other approved medications until final FDA results are issued.