The Central Drugs Standard Control Organisation (CDSCO) has flagged 49 commonly used medicines for failing quality tests in the latest monthly drug alert.
In its monthly alert list issued for September 2024 on Thursday, popular medicines like Nimesulide & Paracetamol Tablets by Innova Captab Limited, Pantoprazole Gastro-resistant Tablets by Alkem Health, Cefpodoxime Tablets by Aristo Pharmaceuticals Pvt. Ltd., Amoxicillin And Potassium Clavulanate Tablets by Alkem Health, Ciprofloxacin Tablets by Cadila Pharmaceuticals Limited and many more were identified as Not of Standard Quality (NSQ) drugs.
These medicines are prescribed to treat conditions like osteoarthritis, heartburn, bacterial infections etc.
“Vigilant action and monitoring of drugs by CDSCO drastically brings down the percentage of less efficacious drugs. Out of nearly 3000 samples tested, 49 drugs were asked to be recalled as they were found less efficacious (NSQ). Only nearly 1.5% of the total drugs sampled found to be less efficacious,” Dr. Rajeev Singh Raghuvanshi, DCGI, said.
As part of the continuous regulatory surveillance, drug samples are picked from sales/distribution point, analyzed and list of Not of Standard Quality (NSQ) drugs are displayed on CDSCO portal on monthly basis. The purpose of displaying the NSQ list is to make stakeholders aware about the NSQ batches identified in the market, the drug regulator stated.
Meanwhile, four drug samples were declared as spurious in another alert list by CDSCO. The regulatory body is currently investigating the manufacturing details of these spurious medicines.
The purpose of displaying the spurious drugs list is to make stakeholders aware about the spurious drug batches identified in the market, CDSCO stated.
Samples of Tamsulosin and Dutasteride Tablets, Calcium and Vitamin D3 Tablets, Pantoprazole Gastro-Resistant and Domperidone Prolonged Release Capsules and Nandrolone
Decanoate Injection were declared as spurious. CDSCO declared in its list that “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 outcome of investigation.”
According to CDSCO, A drug shall be deemed to be spurious;
- If it is manufactured under a name which belongs to another drug; or
- if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or
- If the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or
- If it has been substituted wholly or in part by another drug or substance; or
- If it purports to be the product of a manufacturer of whom it is not truly a product.
Meanwhile, Not of Standard Quality (NSQ) drugs are those medicines that fail to meet the quality standards or specifications are known as Not of Standard Quality (NSQ) drugs.
