India’s top drug regulatory body, the Central Drugs Standard Control Organisation (CDSCO), has identified 53 drug samples that failed to meet quality standards, according to a report by NDTV.
Pharmaceutical firms such as Sun Pharma Laboratories Ltd., Glenmark Pharmaceuticals Ltd., and Alkem Health Science Ltd. have been cited in this quality breach, as per CDSCO’s August findings.
The CDSCO released two lists highlighting the drugs that did not meet quality criteria. The first list includes 48 commonly used drugs, while the second features five additional items, along with responses from the involved pharmaceutical companies.
The list includes commonly used drugs like Pantocid, Paracetamol tablets, and Calcium and Vitamin D supplements. Sun Pharma’s Pantocid tablets for acid reflux, Pulmosil injections for high blood pressure, and Ursocol 300 tablets were all marked as adulterated. Glenmark’s Telma H tablets, prescribed for hypertension, were similarly flagged.
Alkem’s Clavam 625 antibiotic and amoxicillin with potassium clavulanate tablets were also flagged for quality issues. Additionally, Calcium and Vitamin D tablets (Shelcal) from Pure and Care Healthcare Pvt. Ltd. did not pass the quality tests.
Paracetamol tablets, a widely used drug, produced by Karnataka Antibiotics & Pharmaceuticals Ltd., also failed to meet the required standards.
Other flagged medications include Pantomed-40 (batch GTEO230C), Cefixime (batch CADA-02), and Pantoprazole Injection BP 40 mg (batch D0726/24-25). Bhaskara Vilasam Vaidyasala’s Haridrakhandam and Yogaraja Guggulu also failed quality tests.
Pharmaceutical companies like M/s. Gnosis Pharmaceuticals, Digital Vision 176, Nestor Pharma, Alexa Pharma, Bala Herbals, Steadfast Medishield, and Aglomed Ltd. had products that did not meet standards.
Several manufacturers have contested the findings, asserting that the flagged batches are counterfeit and were not produced by them.
The CDSCO oversees drug imports, new drug approvals, and clinical trials. Paying attention to these alerts ensures drug safety and helps prevent adverse effects, treatment failures, or toxicity. Staying informed protects public health and maintains trust in medical treatments.
This incident comes on the heels of a prior ban imposed by the Indian government on 156 fixed-dose combination drugs, which included widely used antibiotics, painkillers, and multivitamins, citing safety concerns.
Impact on share price of Pharma Stocks
Following the CDSCO report, the share prices of several major pharmaceutical companies saw declines. Alkem Laboratories Ltd. dropped by 1.05 percent to Rs.6,161.5, Cipla Ltd. fell by 1.5 percent to Rs.1,619.0, Lupin Limited decreased by 1.3 percent to Rs.2,193.00, and Aurobindo Pharma Ltd. slipped by 1.23 percent to Rs.1,508.00.
In contrast, Sun Pharma’s share price rose by 1.9 percent to Rs.1,905.00, while Glenmark Pharma saw a slight increase of 0.3 percent to Rs.1,684.75.
Written by – Siddesh S Raskar
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