CDSCO flags 18 drugs as substandard, including four manufactured by Kerala govt-owned firm

New Delhi: The Central Drug Standards Control Organisation (CDSCO) has flagged four widely used medications as spurious in its September update. These include popular calcium supplement Shelcal 500, antacid Pan D, Urimax D for Benign Prostate Hyperplasia (BPH), and Deca-Durabolin 25 Injection for osteoporosis in postmenopausal women.

Kerala Medical Services Corporation Under Scrutiny
The CDSCO's latest report also listed 18 drugs as Not of Standard Quality (NSQ). Among these, five drugs were linked to Kerala, four of which were manufactured by Kerala government-owned Kerala Medical Services Corporation. The state's pharmaceutical sector has come under increased scrutiny as the CDSCO intensifies its crackdown on substandard and spurious drugs across the country.

Fake Companies Behind Spurious Drugs
The flagged drugs were reportedly produced by counterfeit companies, according to the CDSCO. The regulator’s routine monthly updates aim to combat the spurious drug trade, which remains a significant issue in India’s pharmaceutical market.

49 Drugs Declared Substandard
In its broader action, the CDSCO declared 49 drugs manufactured by 40 different companies as NSQ. These drugs failed to meet national and international quality standards and were part of a batch-wise recall of 3,000 drugs. Notable mentions include antibiotic Clavam 625 and antacid Pan 40 tablets, both produced by Alkem Health Science, along with other antibiotics such as Monocef and Ciprodac 500, manufactured by Aristo Pharmaceuticals and Cadila Pharmaceuticals.

Alkem Laboratories Defends Reputation
Responding to CDSCO’s findings, a spokesperson for Alkem Laboratories stated that the flagged drugs were spurious and not manufactured by the company. “We have informed the regulator of the same and will continue to work with the authorities to help curb the spurious drug menace in the country,” the spokesperson said in media reports.

Counterfeit Drug Production
The CDSCO’s intensified scrutiny of the pharmaceutical industry aims to crack down on counterfeit companies producing spurious drugs. The rise of these false medications threatens public health and undermines the credibility of legitimate manufacturers. The regulator continues its efforts to identify and act against such companies.

With IANS inputs