In a significant regulatory action, the Drugs Controller General of India (DCGI) has identified 16 commonly used medications as spurious after they failed quality and safety tests. Among these are Glenmark Pharmaceuticals’ Telma H, used for managing blood pressure, and Sun Pharmaceutical’s Ursocol 300, prescribed for gallstone treatment.
The announcement comes in light of recent instances where Indian medicines did not pass quality checks abroad. In response, the Central Drugs Standard Control Organisation (CDSCO) and state drug controllers have conducted over 400 risk-based inspections in the past year. This has resulted in more than 300 enforcement actions, including show-cause notices, production stoppages, and license suspensions or cancellations.
Other medications listed as “not of standard quality” by the regulator include Pulmosil injection for pulmonary arterial hypertension, Pantocid for gastric issues, Paziva 40, Pantomed 40, Cefixime Oral Suspension IP, Moxymed CV, Frusemide Injection IP 20 mg, Tab Nodosis, and Pantoprazole Injection BP 40 mg.
As per the news article published in The Mint Newspaper, The DCGI’s alert stated that the identified spurious products, including Telma H and Ursocol 300, are under investigation, with both Glenmark and Sun Pharmaceutical claiming that the implicated batches were not manufactured by them. They emphasized that the situation is currently being examined.
Quality control measures are in place, with drug inspectors from the CDSCO tasked with ensuring that genuine products are available in the market. According to Union Minister of State for Health and Family Welfare Anupriya Patel, during the 2022-23 period, at least 3,053 drugs were found to be substandard, and 424 were categorized as spurious or adulterated.
In February, the DCGI directed states and Union Territories to enhance vigilance over the quality of medications available, implementing random sampling to create a comprehensive database of spurious and substandard drugs.
Additionally, the Delhi drug regulator recently found Defcort 6 Tablets unsafe; this medication is indicated for treating Duchenne muscular dystrophy (DMD), a rare condition.
