India Recalls Over 50 Substandard Medicines Amid Quality Control Crackdown
India’s Drug Regulator Identifies Over 50 Substandard or Fake Medicines
India’s drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has identified more than 50 substandard or counterfeit drugs in its latest round of routine testing. The findings, released in monthly lists, come from tests conducted by multiple agencies nationwide.
Among the notable drugs found to be substandard are Alkem Laboratories’ antacid Pan-D, Hetero’s anti-infective Cepodem, and Pure & Cure Healthcare’s vitamin and calcium tablet Shelcal. Several antibiotics were also included in the list of substandard medications.
In addition to substandard drugs, the regulator has uncovered several cases of fake medicines. Sun Pharmaceutical Industries reported a counterfeit batch of its antacid Pantocid. Fake batches of Sun’s Pulmosil, used to treat high blood pressure in the lungs, and Glenmark Pharmaceuticals’ anti-hypertension drug Telma H were also identified. Investigations into these cases are currently ongoing.
In response to these findings, the drug regulator has issued notices to manufacturers, instructing them to check and recall substandard batches. Companies are conducting their tests on leftover samples to verify the presence of counterfeits. As of now, the companies involved have not provided immediate responses to Reuters’ request for comment.
This development comes at a time when India’s pharmaceutical market is experiencing significant growth, particularly in gastrointestinal, anti-diabetic, vitamin, and nutraceutical drug sales. As a major drug producer and exporter, India is working to restore confidence in its pharmaceutical industry following incidents where Indian-made cough syrups were linked to child deaths in Gambia, Uzbekistan, and Cameroon.
The identification of these substandard and fake drugs underscores the ongoing challenges faced by regulators and manufacturers in ensuring the quality and safety of pharmaceutical products in the Indian market.
