At the Global Pharmaceutical Quality Summit-2024 in Mumbai, India’s Drugs Controller General, Rajeev Raghuvanshi, emphasized the urgent need for the pharmaceutical industry to bolster its quality management, documentation, and validation processes. He revealed that recent inspections had revealed alarming findings: approximately 36 percent of inspected pharma manufacturing units had to cease operations due to failing to meet standards. Out of these, around 10 percent opted to permanently exit the industry rather than comply, while others returned with plans to rectify their shortcomings.
Raghuvanshi noted that these stringent measures had a positive impact, citing a significant reduction in international quality complaints since July 2023. Previously, India faced frequent complaints, notably following the Gambia cough syrup tragedy.
India hosts roughly 10,000 pharma units, primarily micro-small and medium-scale enterprises, with the majority undergoing scrutiny to ensure compliance with revised guidelines. The Central Drug Standards Control Organisation (CDSCO) has intensified its audits, extending beyond manufacturing sites to include testing labs and clinical research organizations. Looking ahead, larger pharma units will face audits starting next month under new guidelines.
To streamline regulatory processes, plans include enhancing digital infrastructure with the Digital Drug Regulatory System (DDRS), aimed at consolidating all pharmaceutical regulatory activities onto a unified platform. This system aims to track the entire supply chain from raw materials to patient distribution, integrating various stakeholders including state drug controllers and research bodies like the Indian Council of Medical Research.
Raghuvanshi also highlighted the need for an internal scientific cadre within CDSCO to enhance the efficiency and consistency of regulatory decisions. This proposed cadre would reduce reliance on external expert committees, potentially expediting the review process significantly.