India flags quality issues with widely used antacids and paracetamol

India’s drug regulator has found more than 50 drugs, including some batches of widely used antacids and paracetamol, to be substandard or fake, according to government documents.

The regulator, Central Drugs Standard Control Organisation, releases a monthly list of substandard or fake medicines sold in the country after routine tests across the country by multiple agencies.

The regulator found some drugs as “not of standard quality”, including a batch each of Alkem Laboratories’ popular antacid Pan-D, Hetero’s anti-infective Cepodem and Shelcal, a vitamin and calcium tablet brand made by privately-owned Pure & Cure Healthcare, and several antibiotics, according to the lists for August.

Sun Pharmaceutical Industries separately informed the regulator of a fake batch of Pantocid, a popular Indian brand of an antacid called pantoprazole. The agency said it is investigating the matter.

Fake, or “spurious”, batches of Sun’s drug Pulmosil, used to treat high blood pressure in the lungs, and Glenmark Pharmaceuticals’ anti-hypertension drug Telma H, among others, were also notified by the companies to the regulator and were being investigated.

“When a medicine is found to be below quality standards, the drug regulator sends a notice to the manufacturer to check and recall that batch of product. Companies too conduct their own tests on leftover samples to check for the possibility of counterfeit,” said Rajiv Singhal, general secretary of drug retailer body All India Organisation of Chemists and Druggists.

The companies did not immediately respond to Reuters’ request for comment.
Gastrointestinal, anti-diabetic, vitamins and nutraceutical drug sales were one of the top contributors to the domestic pharma market growth in August, according to research firm Pharmarack.

India, one of the world’s largest drug producers and exporters, is working to restore confidence after Indian-made cough syrups were linked to the deaths of children in Gambia, Uzbekistan, and Cameroon.