Pan-D and (paracetamol ) quality tesAmoxicillin among 48 drugs under scanner in CDSDO quality test
Introduction
Batches of 48 drugs, including paracetamol, calcium and vitamin D3 supplements, high blood pressure medications as well as anti-diabetes pills have failed the quality test of the Central Drugs Standards Control Organisation (CDSCO), the drug regulator of India. This has raised multiple concerns regarding their usage.
In its latest monthly drug alert report for August 2024, the central drug regulator has identified dozens of medicines under the “Not of Standard Quality (NSQ) Alert”.
These alerts are from random monthly sampling conducted at various labs by state drug officers, India Today reported.
Senior official sources told ANI, “Such list is released every month and this shows that the Drugs Controller General of India (DCGI) is constantly monitoring the quality of medicines and taking action against manufacturing companies who are selling drugs which are of NSQ (Not of Standard Quality). NSQ is mostly minor in nature which is not life-threatening.”
Product
Batches of four dozen high-selling drugs have failed to meet the quality standards of CDSCO. Among these are Paracetamol (IP 500 mg tablets), Shelcal (Vitamin C and D3 tablets), vitamin B complex and vitamin C soft gels, Pan-D (anti acid), Glimepiride (anti-diabetic drug) and Telmisartan (for high blood pressure) and several others.Metronidazole, a highly recommended drug for treating stomach infections, is among the ones that failed in quality tests. It is produced by Hindustan Antibiotic Limited.
Also on the list is Shel cal, which is distributed by Torrent Pharmaceuticals and is a popular calcium and vitamin D3 supplement. Additionally, Alkem Health Science’s antibiotics Clavam 625 and Pan D were deemed spurious by a Kolkata-based drug-testing lab.
The same lab has termed Cepodem XP 50 Dry Suspension, prescribed to children with severe bacterial infections, as substandard. Besides them, the list also includes Paracetamol tablets from Karnataka Antibiotics & Pharmaceuticals Ltd.
CDSCO has shared lists of medicines that have failed to pass the quality tests. The list includes a total of 48 drugs and only three drugs have been found 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. The product is purported to be spurious, however, the same is subject to the outcome of the investigation,” the column for the drug makers read one of the replies.
In August this year, CDSCO banned more than 156 fixed-dose drug combinations which are ‘likely to involve risk to humans’. Among these were several fever drugs and painkillers.