CDSCO flags 4 drugs as spurious and 48 as not of standard quality

The Central Drug Standards Control Organisation (CDSCO) on Thursday flagged select batches of four drugs, including calcium supplement Shelcal 500 and antacid Pan D, as spurious and listed 48 drugs and formulations as not of standard quality.

 

Other drugs flagged as spurious in CDSCO’s recent monthly update for September include Urimax D, used to treat Benign Prostate Hyperplasia (BPH) or enlargement of the prostate gland and Deca-Durabolin 25 Injection, used to treat osteoporosis in post-menopausal women.

 

While manufacturers of these drugs are still under investigation, the CDSCO alert does not name them, as was the case last month. The alert, though, includes replies from unnamed companies under investigation. 

 

 

“The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. The product is purported to be spurious, however, the same is subject to the outcome of investigation,” the replies state.

 

The apex drug regulatory body also listed 48 drugs and formulations, manufactured by 40 companies, as not of standard quality (NSQ). NSQ drugs are those that do not meet the quality standards set by national or international authorities.

 

These drugs include batches of antibiotic Clavam 625 and antacid Pan 40 tablets, manufactured by Alkem Health Science, and other antibiotics Monocef and Ciprodac 500, manufactured by Aristo Pharmaceuticals and Cadila Pharmaceuticals respectively. 

Highlighting that the company is committed to offering quality drugs to patients, a spokesperson for Alkem Laboratories said that the company has checked the samples collected by the CDSCO and compared them with the actual batches of both products manufactured by Alkem. 

 

“It has been found that the samples picked by the CDSCO were spurious and not manufactured by Alkem. 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 added. 

 

Most of these units are located in cities such as Himachal Pradesh’s Baddi and Uttarakhand’s Haridwar and Roorkee, whereas samples were tested by the central laboratories, including those in Kolkata, Mumbai, Hyderabad, Guwahati, and Chandigarh.

 

The CDSCO also released a state list of 18 drugs, manufactured by 14 companies that were found to be NSQ under various degrees of counts. These include seven drugs manufactured out of Uttarakhand and five from Kerala, including four drugs manufactured by the Kerala Medical Services Corporation.

 

Three drugs manufactured by units based in Baddi were also classified as NSQ in the state list.