Alkem Labs Denies Claims of Substandard Quality in 'Pan-D' and 'Clavam-625' Batches

Alkem Labs Refutes Claims of Substandard Pan-D and Clavam 625 Batches: Alkem Laboratories has firmly denied allegations that certain batches of its popular products, Pan-D and Clavam 625, are of substandard quality. The clarification comes after India's Central Drugs Standard Control Organisation (CDSCO) flagged over 50 drugs, including paracetamol, Pan D, calcium and vitamin D3 supplements, and anti-diabetes medications, as "not of standard quality" in a recent report.

Read More: Indian Pharma Companies Under Scrutiny as 53 Drugs Fail Quality Tests

In an official statement, Alkem Laboratories stated that it conducted a detailed investigation, comparing the CDSCO-collected samples with the actual batches manufactured by the company. The findings revealed that the samples tested by CDSCO were counterfeit and not produced by Alkem.

“The conclusion is based on distinct differences between the CDSCO samples and Alkem’s original batches in terms of physical appearance, color, and text on the labeling of both products,” the company explained.

Alkem has submitted a comprehensive response to the CDSCO, along with an assessment report confirming that the flagged samples were spurious and not manufactured by Alkem. To further combat the issue of counterfeit drugs, Alkem has introduced unique features and QR codes in the packaging of both Pan-D and Clavam 625, helping consumers distinguish genuine products from fake ones.

Read More: Here's the Full List of 48 Drugs That Failed Quality Tests, Check Here...

CDSCO Highlights Quality Concerns in Drugs

The CDSCO's latest report listed more than 50 drug samples, including well-known products such as paracetamol, vitamin supplements, and anti-diabetic pills, as failing to meet quality standards. Batches from companies like Hindustan Antibiotics Limited, Hetero Labs, Karnataka Antibiotics and Pharmaceuticals, and others were flagged.

Medications such as Shelcal, Vitamin B Complex with Vitamin C Softgels, and Ciprofloxacin tablets were identified in the CDSCO’s drug alert. Additionally, antibiotics like Amoxicillin and Potassium Clavulanate tablets and high blood pressure medications, including Telmisartan and Atropine Sulphate, were listed as "not of standard quality."

Read More: Drugs Continue Under Scrutiny: Now CDSCO Flags 16 Drugs Fail in Quality Test in Himachal

The report highlighted that some drugs failed tests for dissolution, assay, water content, and uniformity of volume, while others were deemed spurious. An official source stated that the CDSCO releases a monthly list of drugs failing quality standards to ensure consumer safety, with actions taken against manufacturers when necessary.

According to the CDSCO, drug licensing authorities in several states, including Andhra Pradesh, Bihar, Gujarat, and Tamil Nadu, did not submit data regarding the quality alert for August 2024. Additionally, territories such as Delhi, Telangana, and Pondicherry were also noted for not submitting the required information.