Paracetamol among 53 drugs to fail quality test, raises safety concerns

The Central Drugs Standards Control Organisation (CDSCO) of India has raised significant concerns regarding the safety and efficacy of pharmaceutical products in the country. In its latest monthly drug alert list, the CDSCO declared 53 drugs, including popular calcium and vitamin D3 supplements, anti-diabetes pills, and high blood pressure medications, as “Not of Standard Quality (NSQ) Alert.” This alarming revelation highlights ongoing issues within the pharmaceutical industry, particularly regarding compliance with quality standards.

Details of the NSQ Alert

The NSQ alerts are generated from random monthly sampling conducted by state drug officers, aimed at ensuring the safety and effectiveness of medications available to the public. Among the 53 drugs flagged by the CDSCO are well-known products such as Shelcal (vitamin D3), vitamin B complex and vitamin C softgels, the anti-acid Pan-D, Paracetamol tablets (IP 500 mg), the anti-diabetic drug Glimepiride, and the high blood pressure medication Telmisartan. These products are often relied upon by consumers for their health needs.

The manufacturers of these drugs include major companies such as Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Limited (HAL), Karnataka Antibiotics & Pharmaceuticals Ltd, Meg Lifesciences, and Pure & Cure Healthcare, among others. This list raises serious questions about the quality control measures implemented by these manufacturers.

Specific Drugs Identified

The CDSCO’s findings also revealed specific drugs that failed to meet the required quality standards. For instance, Metronidazole, a widely used drug for treating stomach infections, produced by HAL, was flagged in the report. Additionally, Shelcal, distributed by Torrent Pharmaceuticals and manufactured by Uttarakhand-based Pure & Cure Healthcare, also did not pass quality testing.

A Kolkata drug-testing lab further identified Clavam 625 and Pan D, antibiotics manufactured by Alkem Health Science, as spurious. Moreover, the lab flagged Hetero’s Cepodem XP 50 Dry Suspension, a medication prescribed for children with severe bacterial infections, as substandard. Concerns were also raised regarding Paracetamol tablets from Karnataka Antibiotics & Pharmaceuticals Ltd.

Manufacturer Responses

In a notable aspect of the CDSCO report, the regulator shared two lists of drugs that failed quality tests. The first list includes 48 popular drugs, while the second features an additional five drugs along with responses from the pharmaceutical companies involved. Notably, many companies have denied responsibility for the drugs in question, labelling them as “spurious.”

“The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug,” reads the response column from drug makers. The companies maintain that further investigation is required to ascertain the origins and authenticity of the flagged products.

Broader Context

This incident follows a broader trend in the Indian pharmaceutical sector, where concerns over drug quality have been mounting. In August, the CDSCO banned over 156 fixed-dose drug combinations from the Indian market that were deemed “likely to involve risk to humans.” This crackdown included widely used fever medications, painkillers, and allergy tablets, underlining a growing regulatory focus on ensuring drug safety for consumers.

As India continues to grapple with these quality issues, patients are left with pressing concerns about the medications they rely on for their health and wellbeing. The latest findings from the CDSCO serve as a reminder of the critical importance of stringent quality control measures in the pharmaceutical industry, as well as the need for transparency and accountability among drug manufacturers.

Conclusion

The CDSCO’s declaration of 53 drugs as “Not of Standard Quality” raises serious alarms regarding drug safety and efficacy in India. As consumers depend on these medications for their health, it is essential that regulatory bodies remain vigilant in enforcing quality standards and holding manufacturers accountable. The ongoing investigation into these flagged products is crucial to ensuring that only safe and effective medications reach the public.