Overview
India’s Central Drugs Standards Control Organization (CDSCO) recently issued a drug quality alert that has raised concerns about the safety and quality of several commonly used medicines. Fifty-three medicines, including popular paracetamol, calcium, and vitamin D3 supplements, failed the CDSCO’s quality test. These findings are part of the CDSCO’s ‘Not of Standard Quality’ (NSQ) alert issued during their routine monthly checks.
This blog takes a detailed look at the medicines that failed the quality test, the manufacturers involved, and what this means for public health.
Understanding the CDSCO’s Quality Test
The CDSCO conducts monthly quality checks by randomly sampling medicines from various states across India. These tests ensure that medicines available in the market meet the required safety and efficacy standards. When a drug fails this test, it’s classified as ‘Not of Standard Quality’ (NSQ). This means the drug doesn’t comply with the prescribed manufacturing standards or has issues such as incorrect composition, contamination, or improper labeling.
The CDSCO released two separate lists in August. The first list contained 48 medicines, while the second added five more, bringing the total to 53.
Drugs that Failed the Quality Test
The medicines that failed the quality test include a variety of commonly used drugs, from fever medications to antibiotics. Here’s a summary of some of the drugs that didn’t meet the CDSCO’s standards:
1. Paracetamol Tablets (IP 500 MG)
- Manufacturer: Karnataka Antibiotics and Pharmaceuticals Limited
- Issue: The quality of these widely-used pain and fever relief tablets was deemed substandard, raising concerns about their effectiveness and safety.
2. Metronidazole Tablets
- Manufacturer: Hindustan Antibiotics Limited (HAL)
- Issue: Metronidazole, commonly prescribed for treating stomach infections, failed the quality test. This is particularly concerning as it is widely used in hospitals and clinics.
3. Shelcal (Vitamin D3 and Calcium Supplement)
- Manufacturer: Torrent Pharmaceuticals (Manufactured by Pure & Cure Healthcare in Uttarakhand)
- Issue: Shelcal is a popular supplement used to manage calcium and vitamin D3 deficiencies, but it did not pass the quality standards.
4. Clavam 625 (Antibiotic)
- Manufacturer: Alkem Health Science
- Issue: The antibiotic failed a test at a Kolkata lab, raising questions about its effectiveness in treating bacterial infections.
5. Pan D (Pantoprazole and Domperidone)
- Manufacturer: Alkem Laboratories
- Issue: This commonly prescribed drug for acidity and gastroesophageal reflux disease (GERD) was found to be substandard in quality.
6. Glimepiride (Anti-Diabetes Pill)
- Manufacturer: Various
- Issue: Glimepiride, used to manage blood sugar levels in diabetic patients, failed to meet quality standards, posing a risk to individuals reliant on this medication for diabetes control.
7. Telmisartan (High Blood Pressure Drug)
- Manufacturer: Various
- Issue: Telmisartan, a medication used to manage hypertension, was also flagged as not meeting the required standards.
8. Cepodem XP 50 (Dry Suspension for Children)
- Manufacturer: Hetero Drugs
- Issue: This medication is often prescribed to children with bacterial infections, making its substandard status a significant concern for pediatric health.
Manufacturers Under Scrutiny
The failed medicines were manufactured by various pharmaceutical companies, including well-known names such as:
- Hetero Drugs
- Alkem Laboratories
- Hindustan Antibiotics Limited (HAL)
- Karnataka Antibiotics and Pharmaceuticals Limited
- Torrent Pharmaceuticals (Shelcal distributor)
- Pure & Cure Healthcare
These manufacturers produce a range of products for different health conditions, and their failure to meet quality standards could have severe implications for public health.
Companies’ Response to the NSQ Alert
In response to the CDSCO’s alert, several pharmaceutical companies have denied responsibility for the substandard medicines, claiming that the products were counterfeit or not manufactured by them. The companies argue that counterfeit drugs with fake labels may have entered the market, which is a common problem in the pharmaceutical industry.
This claim highlights a broader issue of counterfeit medicines infiltrating the supply chain, posing a significant risk to consumers who may unknowingly use ineffective or harmful products.
Previous Actions by the CDSCO
The recent NSQ alert is not an isolated incident. In August, the CDSCO banned over 156 fixed-dose drug combinations (FDCs) from the Indian market due to their potential to cause harm. This list included fever medicines, painkillers, and allergy tablets, underscoring the regulator’s ongoing efforts to ensure the safety and efficacy of medicines available to the public.
What Does This Mean for Consumers?
For consumers, the NSQ alert serves as a critical reminder to be cautious about the medicines they use. Here are some steps to protect yourself:
- Check the Manufacturer: Always check the manufacturer details on the label and avoid medicines from questionable sources.
- Consult Your Doctor or Pharmacist: If you are taking any drugs mentioned in the list, consult your healthcare provider for alternatives or guidance.
- Report Any Adverse Effects: If you experience any unexpected side effects from a medication, immediately report them to your doctor or local health authorities.
Conclusion
The CDSCO’s recent drug quality test failures highlight the importance of stringent quality control in the pharmaceutical industry. While the regulator’s efforts to identify and eliminate substandard drugs are commendable, manufacturers must take responsibility and ensure that only safe, high-quality medicines reach consumers. As patients and consumers, staying informed and vigilant is the best way to protect your health in light of these revelations. Always consult healthcare professionals before making any changes to your medication regimen, and keep an eye out for updates on the CDSCO’s ongoing quality checks.
