Glenmark’s Telma H and Sun Pharma’s Ursocol 300 Declared Spurious by DCGI

Glenmark’s Telma H, Sun Pharma’s Ursocol 300 Among Spurious Drugs

The Drugs Controller General of India (DCGI) has recently identified a total of 16 medicines, including Glenmark Pharmaceuticals’ Telma H and Sun Pharmaceutical’s Ursocol 300, as spurious after they failed quality and safety tests. This is a troubling development for the pharmaceutical industry, particularly as these drugs are commonly prescribed.

Impact of Quality Tests

Among the drugs flagged, Pulmosil injection, used to treat pulmonary arterial hypertension, and Pantocid, which addresses gastric issues, were also implicated. This revelation emanates from rigorous assessments conducted by the Central Drugs Standard Control Organisation (CDSCO), stemming from reports of Indian medications failing international quality checks.

Response from Pharmaceutical Companies

Glenmark and Sun Pharma have responded to the accusations, stating that the implicated batches were not manufactured by them, labeling the findings as spurious. Both firms continue to investigate the matter, even as the DCGI has escalated actions against poorly manufactured drugs.

Ensuring Drug Safety

The CDSCO's proactive measures over the past year—conducting inspections on more than 400 pharmaceutical facilities—have resulted in significant actions, including show-cause notices and license suspensions for over 300 entities due to violations of drug regulations.

Recent Drug Safety Statistics

• During 2022-23, at least 3,053 drugs were found substandard.
• 424 drugs were categorized as spurious or adulterated.
• Random sampling initiatives are being employed to maintain market integrity.

This concerted effort strives to ensure that genuine and safe medicines are accessible to the public, reflecting a serious commitment to drug safety in India.