India: regulator’s list of 50 substandard drugs raises questions about oversight and manufacturing

Medical leaders in India have expressed alarm over a drug alert issued by the country’s drug regulator that lists 50 products as “not of standard quality.”

The list, issued by the Central Drugs Standards Control Organization (CDSCO) in August, includes vitamin C tablets, Shelcal, vitamin B complex, vitamin C softgels, Pan-D, paracetamol tablets, the anti-diabetic drug glimepiride, and the high blood pressure medication telmisartan, among others.1

Several leading companies, including Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics, Karnataka Antibiotics and Pharmaceuticals, Pure and Cure Healthcare, and Meg Lifesciences, have been named as manufacturers of the medicines. Other companies, including Sun Pharma and Torrent Pharma, claim that medicines flagged in the report are “counterfeits” and that their products conform to quality standards.

CDSCO’s list is based on …