Medication Quality Concerns: CDSCO's Alarming Findings

CDSCO raises alarms as 58 medication samples fail quality standards. Learn about the implicated drugs and reasons for regulatory concerns.

CDSCO's Concerns over Medication Samples

The Central Drugs Standard Control Organisation (CDSCO) has raised concerns over 58 samples of commonly used medications after they failed to meet the latest drug safety standards outlined by the regulatory body in March.

Quality Assessment Results

In its monthly list, CDSCO has identified medicines that fell short of quality benchmarks in February out of a total of 1,167 samples assessed. Notably, 1,018 drug samples were classified as meeting standard quality criteria, while 2 samples were flagged as spurious.

Identified Medications

The drugs investigated are

Amoxicillin
Vitamin D3 pills
Ofloxacin
Heparin
Clarithromycin
Paracetamol
Oseltamivir
Deferasirox
Pantoprazole gastro-resistant tablets
Telmisartan

Pharmaceutical Companies Implicated

The list includes samples from several well-known pharmaceutical companies, including

Glenmark Pharmaceuticals
Micro Labs
Sun Pharmaceuticals
Glenmark Lifesciences
Alkem Laboratories

Reasons for Failure Identified by the Drug Regulator

The drug regulator identified several reasons for the failure, including disintegration, stability, uniform dispersion, assay, and dissolution.

CDSCO stands for the Central Drugs Standard Control Organization. It is the national regulatory authority in India that regulates pharmaceuticals, medical devices, and cosmetics. CDSCO functions under the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India. Its primary responsibilities include regulating the quality, safety, efficacy, and manufacturing standards of drugs, medical devices, and cosmetics in India, as per the Drugs and Cosmetics Act, 1940 and Rules, 1945. CDSCO plays a crucial role in ensuring the availability of safe and effective healthcare products to the public while also overseeing clinical trials and issuing licenses for the import and export of drugs and medical devices.

Source: Inputs from various media Sources