CDSCO Identifies 53 Failing Drugs, Including Popular Medications Paracetamol and Pan-D

In its August 2024 drug alert report, the Central Drugs Standards Control Organisation (CDSCO) has flagged numerous medicines for failing quality standards, raising serious concerns about their safety and efficacy.

Overview of the Drug Alert

The CDSCO has identified over 50 medicines under the “Not of Standard Quality (NSQ) Alert.” This alert was issued following random sampling conducted by state drug officers in various laboratories across India. The findings emphasize the importance of regulatory oversight in ensuring drug safety for consumers.

Medicines Identified in the Report

The report highlights a total of 53 high-selling drugs that did not meet CDSCO's quality benchmarks. Some notable medications on this list include:

• Paracetamol (IP 500 mg tablets): A commonly used analgesic and antipyretic medication.

• Shelcal: A widely used calcium and vitamin D3 supplement, produced by Torrent Pharmaceuticals.

• Pan-D: An anti-acid medication used for treating acidity and gastric disorders.

• Glimepiride: An anti-diabetic drug that helps control blood sugar levels.

• Telmisartan: A medication used to manage high blood pressure.

Other medications listed include vitamin B complex and vitamin C soft gels, as well as antibiotics such as Metronidazole, which is often prescribed for stomach infections.

Impact on Public Health

The failure of these drugs to meet quality standards raises multiple concerns regarding their safety and efficacy. Poor quality medications can lead to inadequate treatment, adverse effects, and contribute to the growing issue of antibiotic resistance. The identification of these substandard products underscores the need for vigilance and stringent quality control in the pharmaceutical industry.

Leading Manufacturers Involved

The report specifies that these failing products are manufactured by several prominent companies, including:

• Alkem Laboratories

• Hetero Drugs

• Karnataka Antibiotics & Pharmaceuticals Ltd

• Hindustan Antibiotics Limited

• Pure & Cure Healthcare

These manufacturers are well-known players in the Indian pharmaceutical sector, and the identification of their products as substandard can significantly affect their reputation and consumer trust.

Specific Failures Noted

Among the highlighted failures, Metronidazole stands out as a crucial antibiotic for treating infections. Its quality issues are particularly alarming given its widespread use. Additionally, Alkem Health Science's products, including Clavam 625 and Pan D, were deemed spurious by a Kolkata-based drug-testing laboratory. The same lab also categorized Cepodem XP 50 Dry Suspension, used for treating severe bacterial infections in children, as substandard.

The report also mentions specific batches of Paracetamol tablets from Karnataka Antibiotics & Pharmaceuticals Ltd that failed the quality tests. These findings emphasize the urgent need for quality assurance processes within pharmaceutical manufacturing.

Regulatory Action and Manufacturer Responses

The CDSCO has provided two lists detailing the medicines that did not pass quality tests. The first list includes 48 drugs declared “not of standard quality,” while the second contains five additional medications along with responses from manufacturers.

One of the replies indicates that the manufacturer, as per label claims, has stated that the affected batch was not produced by them and is considered spurious. Such responses highlight the complexities involved in drug manufacturing and distribution, particularly concerning counterfeit products.

Previous Regulatory Measures

In August 2024, the CDSCO took proactive steps by banning over 156 fixed-dose drug combinations deemed ‘likely to involve risk to humans.’ This action included several fever medications and painkillers, reinforcing the regulator’s commitment to ensuring drug safety in the market.

Conclusion

The August 2024 CDSCO drug alert report serves as a critical reminder of the ongoing challenges within the pharmaceutical sector regarding drug quality and safety. With numerous widely-used medications failing to meet established standards, both regulatory bodies and manufacturers must prioritize stringent quality control measures. This situation not only affects public health but also the credibility of the pharmaceutical industry in India. As the CDSCO continues its efforts to monitor and improve drug quality, the importance of consumer awareness and regulatory compliance cannot be overstated.