Did not Manufacture Drugs Flagged in CDSCO Report, Say Leading Pharma Companies

Drug companies, including Sun Pharma and Torrent Pharma, on Thursday termed the medicines flagged in the central drug regulatory authority's report as "counterfeits" and not manufactured by them while asserting that their products conform to quality standards.

The Central Drugs Standard Control Organisation (CDSCO) has listed samples of more than 50 drugs, including paracetamol, Pan D, calcium and vitamin D3 supplements, and anti-diabetes pills, as "not of standard quality" in its latest report.

When contacted, a Sun Pharma spokesperson said the company has investigated the matter and found that Pulmosil (Sildenafil Injection), batch no KFA0300; Pantocid (Pantoprazole Tablets IP), batch no SID2041A and Ursocol 300 (Ursodeoxycholic Acid Tablets IP), batch no GTE1350A are spurious.

"The said batches tested by the regulatory authority are not manufactured by Sun Pharma," it stated.

The company is taking several steps to ensure patient safety, it added.

"Some of our leading medicine brands now come with QR codes printed on the label, allowing patients to easily verify their authenticity by scanning them. Additionally, we have incorporated a 3D security strip for further protection," the drug maker noted.

Torrent Pharmaceuticals stated that to verify the genuineness of the sample collected by the CDSCO, it carried out an evaluation of the same batch of Shelcal 500. "The outcome of the analysis concluded that the sample seized by CDSCO is not manufactured by Torrent and is in fact non-genuine and spurious," it stated.

As anti-counterfeit measures, the company has implemented QR codes on Shelcal, displaying batch manufacturing details to verify its authenticity, which was found to be lacking in the sample seized by CDSCO, it added.

"Our assessment of establishing authenticity of samples including physical appearance, QR code and labelling text comparison establishes that the NSQ (non-standard quality) sample is non-genuine and counterfeit, whereas our controlled sample matches with pre-defined specifications," the drug firm said.

Torrent has already submitted a formal response along with an assessment report, concluding the seized sample as spurious to CDSCO, it noted.

An Alkem Laboratories spokesperson said the drug firm gives utmost importance to quality.

"The products mentioned seem to be spurious and not manufactured by Alkem. The company is engaging with the authorities on this matter," the spokesperson stated.

A Glenmark spokesperson said: "At the outset, we would like to categorically state that the product mentioned in the list is counterfeit and has not been manufactured or distributed by Glenmark. This has been confirmed by the regulatory authorities in the list you are referring to."

As a responsible organisation, the drug firm has always prioritised patient safety and the quality of products, the spokesperson said.

"To deal with the menace and tackle this issue of counterfeit products, we have implemented advanced security measures to ensure the authenticity of our products," the spokesperson said.

"In light of these issues, we urge all pharmacy outlets to ensure they source Glenmark products exclusively from our authorised stockists. This is crucial for maintaining the integrity and quality of the medications provided to patients," the spokesperson added.

The CDSCO's drug alert for August included samples from batches of medications such as Shelcal, Vitamin B Complex with Vitamin C Softgels, vitamin C and D3 tablets and Ciprofloxacin tablets.

High blood pressure medications Telmisartan and Atropine Sulphate and antibiotics such as Amoxicillin And Potassium Clavulanate tablets have also been categorised as not of "not of standard quality".

While batches of some drugs failed the 'dissolution test' as per Indian Pharmacopoeia and failed the 'Assay' and 'water' test as per IP, some were identified as spurious or having uniformity of volume issues.