DGCI finds 49 drug samples are not of standard quality
Context
Recently, Drugs Controller General of India (DCGI), ordered a recall of 49 medicines after samples failed to meet quality standards.
Relevance:
GS-02 (Government policies and interventions)
Key Highlights
- The DCGI directed the manufacturers of 49 drug samples to withdraw their products that did not meet the required quality standards.
- These samples included- ○ Painkillers ○ Antifungal medications ○ Diabetes drugs
- The recalled drugs include common medications like
- Metronidazole from Hindustan Antibiotics
- Oxytocin by Pushkar Pharma
- Metformin hydrochloride from Swiss Biotech Parenterals
- Paracetamol by Innova Captab Limited
- Pantoprazole by Alkem Health, and
- Ciprofloxacin by Cadila Pharmaceuticals.
- Spurious Drug Cases: In addition to the quality issue, four drugs produced by unauthorized companies were identified as spurious. The DCGI has taken action to prosecute these manufacturers, underlining the agency’s commitment to tackling unapproved and harmful drugs in the market.
Central Drugs Standard Control Organization (CDSCO):
- Central Drugs Standard Control Organization is the National Regulatory Authority (NRA) for the medical devices industry in India.
- It’s headquarter is at New Delhi.
- It works under the Ministry of Health & Family Welfare.
- It is headed by Drugs Controller General of India (DCGI).
- CDSCO is responsible for: Approval of New Drugs; Conduct of Clinical Trials; Laying down the standards for Drugs; Control over the quality of imported Drugs in the country; Coordination of the activities of State Drug Control Organizations;
- CDSCO and state regulators are responsible to grant licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.
Conclusion:
This action highlights ongoing efforts by the DCGI to ensure public health safety and maintain stringent checks on the quality of pharmaceuticals in the Indian market.
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