After Torrent Pharma, Alkem Labs Denies Claims on Drug Failing Quality Test

After Torrent Pharma Ltd. refuted claims of its Vitamin D supplements failing Central Drugs Standard Control Organisation's quality test, Alkem Laboratories Ltd. has also disputed claims about its subsidiary's Amoxicillin and Potassium Clavulanate tablets failing quality checks, citing that samples tested are spurious and are not manufactured by the company.

"Alkem 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", said Alkem Laboratories in a clarification sent to NDTV Profit.

Alkem Health Sciences Pvt Ltd.'s Amoxicillin and Potassium Clavulanate tablets are widely used to treat varied bacterial infections in human body.

Apex regulator CDSCO on Wednesday flagged 53 drug samples for failing to meet quality standards in its August 2024 report. Pantocid, Paracetamol tablets, and Calcium and Vitamin D tablets are among the widely-used medications that are part of the list of drugs identified by the regulator for quality lapse.

This incident follows an earlier ban by the Indian government on 156 fixed-dose combination drugs, which included commonly used antibiotics, painkillers, and multivitamins, due to safety concerns.

After the notification sent by CDSCO, Torrent Pharma on Thursday notified the exchanges disputing the claim that Shelcal 500, a vitamin D and calcium supplement sold by the company, and said that the tested sample of Shelcal 500 was "non-genuine and spurious."

Sun Pharmaceuticals Ltd. had already informed the drug regulator about the samples being "spurious". "We have investigated the matter and found that Pulmosil (Sildenafil Injection), Pantocid (Pantoprazole Tablets IP), and Ursocol 300 (Ursodeoxycholic Acid Tablets IP), are spurious", the company said in its latest statement after the notification.

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

"We are taking several steps to ensure patient safety. 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," it further said.

Analysts are of the view that spurious drugs have remained a concern for drug manufacturers, with sales of original manufacturers getting affected due to sales of spurious samples sold in the market.

Vishal Manchanda, senior Vice-President Institutional Research at Systematix Group and a former pharma analyst, said that an organised structure will help in curtailing the incidents of spurious drugs.

"Wholesalers are very fragmented in India, so bigger wholesalers can buy drugs directly from the manufacturers but not smaller wholesalers," he said, adding that smaller wholesalers usually buy original drugs from another "middleman" that increases chances of any "corruption".

On companies, that have not declared their samples tested as spurious, the analyst said it will be "too early to understand the implication of the notification on such companies", unless both the regulator and companies come up with details about the tests done.

Some impact on sales in the near term is possible, but that is also subjected to the details of the tests, according to analysts.