The health ministry has directed all states and union territories to verify the formulation of Ranitidine, a popular anti-acidity drug after several countries found the presence of ‘carcinogen’ in several Ranitidine brands. Ranitidine is an oral tablet that is used to treat several ailments like intestinal and stomach ulcers, gastroesophageal reflux disease (GERD), erosive esophagitis conditions where the patient’s stomach makes too much acid.

Dr V G Somani, director of the Drug Controller General of India (DCGI) under the health ministry, has directed directorates of drug controls across states and UTs saying, “It has been reported from other countries that some ranitidine medicines contain nitrosamine impunity called N-nitrosodimethylamine (NDMA) at low levels.” “The N-nitrosodimethylamine has been classified by the International Agency for Research on Cancer (IARC) as probably carcinogenic to humans,’’ Dr Somani said in the directive adding, “the drug Ranitidine is approved for multiple indicat ions in the country and available in various formulations including tablets, injections etc.”

“In view of this you are requested to communicate to the manufacturers of Ranitidine API and formulations under your jurisdictions to verify their products and take appropriate measures to ensure patient safety,” he directed. Dr Sunita Grover, director of the West Bengal Directorate of Drug Control, told The Statesman, “We have received the directive of DCGI and our officials have al ready been asked to sensitise the manufacturers of the Ranitidine group drugs to verify their formulations.” “We may also collect samples of the drugs from whole sellers and retailers to get these products checked in the state drug research laboratory in the city,” she added.

Alarmed with the development, a drug major in the country has already pulled the product off their shelves at a time when the Central Drugs Standard Control Organisation, which monitors quality, standard and efficacy of medicines in India, has already referred the issue to an expert committee for verification, it is learnt. “I have no idea about the development in connection with the Ranitidine drug. Nowadays, I hardly prescribe the medicine because several other advanced medicines have already hit the market,” said professor Dr Abhijit Chowdhury, head of the hepatology department at the Institute of Post Graduate Medical Education & Research as well as SSKM hospital.

“We have not yet received any directives either from the Centre or state government so far. We will definitely follow the directive if the government imposes any restrictions on the use of the Ranitidine, which is a very common drug,” said Mr Samirranjan Das, former secretary of the Bengal Chemists and Druggists Associat ion (BCDA).