The Drug Controller General of India (DCGI) has sounded the alarm on 49 medicines that failed to meet quality standards, as per its latest Not-of-Standard-Quality (NSQ) alert for September 2024.
Quality Concerns:
The affected medicines were found to have various quality issues, including:
Inadequate dissolution, improper assay content, particulate matter, microbial contamination, other specific test failures
Some of the medicines that made it to the NSQ list include:
- Metronidazole
- Domperidone
- Oxytocin
- Ceftriaxone
- Gentamycin
- Glimepiride
- Ciprofloxacin
- Pantoprazole
Manufacturers Identified:
The substandard medicines were manufactured by companies across India, specifically in:
- Haryana
- Himachal Pradesh
- Gujarat
- Sikkim
Regulatory Action:
The Central Drugs Standard Control Organisation (CDSCO) tested nearly 3,000 samples, leading to the recall of 49 medicines found to be less efficacious.
Dr. Rajeev Singh Raghuvanshi, DCGI, emphasized that vigilant action and monitoring by CDSCO drastically reduced the percentage of less efficacious drugs, stating:
DCGI's testing reveals 1.5% of sampled drugs lack desired efficacy.
Purpose of NSQ List:
The NSQ list is released monthly to notify stakeholders of substandard drug batches identified across India, ensuring drug safety and efficacy.
Drugs that fail to meet quality standards or specifications are considered NSQ, as defined under Section 16 (1) (a) of the Drugs & Cosmetics Act, 1940.
This alert highlights the importance of regulatory surveillance in maintaining drug quality and safety, emphasizing the need for pharmaceutical companies to adhere to stringent quality control measures.
Key Statistics:
- 49 medicines recalled due to quality issues
- Nearly 3,000 samples tested by CDSCO
- 1.5% of sampled drugs found to be less efficacious
(Input from various sources)
(Rehash/Vaishnavi Dalvi/MSM)