Government Expands CDSCO Workforce to Boost Drug Quality Control
Why in the news?
The government plans to add 250 new CDSCO positions, strengthening oversight of drug and medical device quality amid global scrutiny and to uphold Good Manufacturing Practices standards.
Key Initiatives to Strengthen CDSCO:
- The government aims to double the staffing at the Central Drugs Standard Control Organization (CDSCO) by creating 250 new positions. This includes appointing a second drug controller, four joint drug controllers, 11 deputy drug controllers, 85 drug inspectors (with a focus on medical devices), and assistant drug controllers.
- A new recruitment drive will also attract specialised inspectors with backgrounds in fields like biomedical engineering, chemical engineering, and polymer engineering to oversee medical device regulations effectively.
Improving Good Manufacturing Practices (GMP):
- The new hires will assist the Drugs Controller General of India (DCGI) in enforcing GMP standards for medicines and medical devices, a move motivated by recent issues with Indian-made cough syrups linked to child fatalities overseas.
- This recruitment is part of a broader effort to maintain drug quality and ensure compliance with international standards, especially after incidents that led to global scrutiny of India’s pharmaceutical exports.
How Drugs Are Regulated in India:
- The Drugs and Cosmetics Act, 1940: Provides guidelines for drug and cosmetic regulation; oversees licensing for Ayurvedic, Siddha, and Unani medicine manufacturing.
- Central Drugs Standard Control Organisation (CDSCO): Sets standards to ensure drug, cosmetic, diagnostic, and device safety, efficacy, and quality; regulates new drug approvals and clinical trials.
- Drugs Controller General of India (DCGI): Heads CDSCO; responsible for licensing drugs like blood products, IV fluids, vaccines; establishes manufacturing, sales import, and distribution standards.
Related Government Initiatives
- Production Linked Incentive (PLI) Scheme for Pharmaceuticals: Encourages domestic production of high-value pharmaceutical goods and reduces import dependence.
- Promotion of Bulk Drug Parks Scheme: Supports creation of bulk drug parks for cost-effective manufacturing.
- Strengthening Pharmaceuticals Industry (SPI) Scheme: Enhances infrastructure for pharmaceutical SMEs.
- National Medical Devices Policy, 2023: Aims to make India a global medical devices hub through innovation and self-reliance.
Sources Referred:
PIB, The Hindu, Indian Express, Hindustan Times