Drug Standards Enforcement in India
The Drug Consultative Committee (DCC), a statutory body under the Central Drug Standards Control Organisation (CDSCO), has recommended measures to address non-uniform implementation of drug standards across states.
67th Meeting Recommendations
- Encourage states to take proactive steps to address issues such as the lack of uniform implementation of drug standards and inadequate testing facilities.
- Highlight the need for necessary infrastructure as per the Centre’s State Health Regulatory Excellence Index (SHRESTH), which uses a virtual gap tool for evaluating states' progress toward maturity certification.
- Focus on ensuring drug safety, quality, and efficacy across all states and Union Territories (UTs).
Concerns Raised
Discussions highlighted the lack of uniformity in drug standards, especially after deaths linked to contaminated oral formulations like cough syrups surfaced in October.
- Issues with low conviction rates due to insufficient investigations, delayed testing results, and ineffective prosecution services.
- Call for rigorous scrutiny of adulteration in imported pharmaceutical products.
Action Steps by Drugs Controller General of India (DCGI)
- State licensing authorities (SLAs) instructed to prepare for inspections at pharmaceutical manufacturing units to verify compliance with revised Schedule M advocating good manufacturing practices (GMP).
- Urging states and UTs not yet on the Online National Drugs Licensing System (ONDLS) to register, facilitating streamlined drug licensing and regulatory compliance.
Current ONDLS Status
As of the report, only 18 state and UT drug control authorities have onboarded the ONDLS portal, a digital, single-window platform for processing drug-related licenses in India.
