0
0
NEW DELHI – In a significant move to safeguard public health, the Central Drugs Standard Standard Control Organization (CDSCO) and the Ministry of Health and Family Welfare have implemented a series of stringent regulatory and enforcement measures to prevent the circulation of adulterated and substandard drugs in the market. The measures, detailed in a recent statement by Union Minister of State for Health and Family Welfare, Smt. Anupriya Patel, highlight a multi-pronged approach combining on-the-ground inspections with modern tracking technology.
A key initiative has been the launch of risk-based inspections targeting drug manufacturing and testing facilities across the country. Since December 2022, CDSCO, in partnership with state regulators, has inspected 905 units. These inspections have led to 694 enforcement actions, including Stop Production Orders, license suspensions, and cancellations, underscoring a zero-tolerance policy for non-compliance. According to the Ministry, these actions have resulted in “noticeable improvements in the regulatory framework” and provided crucial insights into manufacturing practices.
To empower consumers and enhance supply chain integrity, the government has mandated the use of Quick Response (QR) codes and barcodes on drug packaging. Since August 1, 2023, the top 300 drug formulation brands listed in Schedule H2 of the Drugs Rules, 1945, are required to carry these codes on their labels. This measure allows for easy tracking and verification of drug authenticity by both consumers and regulatory bodies. The mandate also extends to Active Pharmaceutical Ingredients (APIs) since January 2022, ensuring traceability from the very beginning of the supply chain.
Transparency and quality monitoring have also been bolstered through several digital initiatives. The CDSCO’s website now features a monthly Drug Alert to publicly list samples that have failed quality checks. Furthermore, the SUGAM Labs portal, operational since September 2023, has automated the entire testing workflow for medical products, allowing for better quality control and traceability within government labs. New regulatory guidelines published in February 2024 also standardize the sampling of drugs, cosmetics, and medical devices to ensure uniform surveillance across the country.
In addition to these measures, the government has strengthened the legal framework and infrastructure. The Drugs and Cosmetics Act, 1940, has been amended to impose more stringent penalties for manufacturing spurious drugs, and special courts have been established in various States and Union Territories for the speedy trial of such offenses. The number of sanctioned posts within the CDSCO has been significantly increased over the past decade to support these expanded regulatory activities.
Disclaimer: This article is for informational purposes only and does not constitute medical advice. Readers should consult a qualified healthcare professional for any health-related concerns.
Reference:
- PIB Delhi. (August 12, 2025). Steps taken to Prevent Sale of Adulterated Drugs. Press Information Bureau, Government of India.
