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CDSCO Flags Over 50 Drugs, Including Paracetamol and Shelcal, in Quality Alert

Many of the pharmaceutical firms whose products were listed have denied responsibility, claiming the flagged batches were “spurious” and not produced by their facilities.

• By PharmaNews Live Desk
• New Delhi
• Sep 25, 2024

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India’s drug regulator, the Central Drugs Standards Control Organisation (CDSCO), has flagged over 50 drugs, including widely used calcium and vitamin D3 supplements, anti-diabetic pills, and blood pressure medications, for failing to meet quality standards.

In its latest monthly alert, the CDSCO listed 53 drugs under its “Not of Standard Quality” (NSQ) category, following routine inspections across the country.

Drugs Flagged in Routine Sampling

The NSQ alerts are based on random sampling conducted by state drug officers, who identified several commonly prescribed medications as substandard. The list includes popular drugs such as Shelcal (a calcium supplement), Glimepiride (an anti-diabetic drug), and Telmisartan (for high blood pressure), all of which failed quality tests.

Among the drugs flagged were products from major pharmaceutical manufacturers, including Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Limited (HAL), and Karnataka Antibiotics & Pharmaceuticals Ltd. Metronidazole, a common treatment for stomach infections, and Paracetamol tablets were also found to be of substandard quality.

Pharma Companies Deny Allegations

Many of the pharmaceutical firms whose products were listed have denied responsibility, claiming the flagged batches were “spurious” and not produced by their facilities.

Torrent Pharmaceuticals, which distributes Shelcal, and Hyderabad-based Hetero Drugs, whose Cepodem XP 50 Dry Suspension (used for treating severe bacterial infections in children) failed the test, are among the companies contesting the results.

Alkem Health Science’s antibiotic Clavam 625 and the antacid Pan D were also flagged by a Kolkata-based drug-testing lab, which deemed the products spurious.

Several manufacturers, including Sun Pharma, Glenmark, and Macleods Pharma, have similarly refuted the findings, insisting the flagged drugs do not originate from their production lines.

Quality Failures and Global Concerns

The failure of essential medicines to meet quality standards has raised alarms within the healthcare sector. According to several media outlets, doctors fear that substandard drugs may prolong treatment, lead to higher healthcare costs, and increase risks for patients. There is also growing concern over the impact on antimicrobial resistance (AMR), a major issue in India that could be exacerbated by poor-quality antibiotics.

India’s global reputation as a pharmaceutical hub is also at stake. Since late 2022, the country has faced accusations of exporting contaminated or low-quality drugs to several nations, including The Gambia, Uzbekistan, and the United States.

Popular Drugs Affected

Some of the most widely used medications listed in the NSQ alert include:

• Shelcal: A calcium and vitamin D3 supplement.

• Glimepiride: Used to treat diabetes.

• Telmisartan: A common medication for high blood pressure.

• Pan D: An antacid for gastrointestinal issues.

Pharmaceutical companies have responded to the regulator’s findings, with some stating that the products in question are counterfeit and not their responsibility. Sun Pharma’s erectile dysfunction drug Pulmosil, Glenmark’s Telma H for hypertension, and Macleods Pharma’s arthritis drug Defcort 6 were among the flagged products.

Ongoing Scrutiny and Industry Impact

The CDSCO’s latest alert follows an earlier crackdown in August when the agency banned 156 fixed-dose drug combinations considered harmful. The recent findings are part of an ongoing effort by India’s drug regulator to address quality concerns in the pharmaceutical industry.

As investigations continue, both the public and healthcare professionals are awaiting further clarification from the authorities and the implicated pharmaceutical companies.