Highlights
- The CDSCO has flagged over 50 drugs, including paracetamol and anti-diabetes pills, as not meeting quality standards.
- Major manufacturers involved include Alkem Laboratories and Hindustan Antibiotics.
- The drug regulator emphasizes ongoing monitoring and random testing to ensure public safety.
News Rewrite
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has reported that samples of more than 50 drugs are “not of standard quality.” This includes widely used medications such as paracetamol, Pan D, calcium, vitamin D3 supplements, and various anti-diabetes pills.
The monthly drug alert for August lists these substandard products and highlights concerns about their manufacturing by companies like Alkem Laboratories, Hindustan Antibiotics Limited, and Hetero Labs Limited, among others.
CDSCO routinely releases this alert to protect public health by ensuring that medicines on the market meet quality standards. Alongside the mentioned drugs, high blood pressure medications like Telmisartan and Atropine Sulphate, as well as antibiotics such as Amoxicillin and Potassium Clavulanate, have also been identified as substandard.
Issues noted include failures in critical quality tests, such as the dissolution test and the assay test, which are part of the Indian Pharmacopoeia standards. Some products were even found to be spurious or exhibited problems with uniformity of volume.
Despite these concerns, authorities in several states—including Andhra Pradesh, Arunachal Pradesh, Assam, and Bihar—have not submitted required data regarding the Not of Standard Quality (NSQ) alert for August 2024. The CDSCO noted that many other states also failed to report.
An official source stated that the drug regulator continuously monitors pharmaceutical products, conducting random tests each month to uphold safety standards. When drugs are deemed not of standard quality, appropriate actions are taken against the manufacturers involved.
The CDSCO remains committed to ensuring that only safe and effective medicines are available to the public.