The North News
New Delhi, March 11
India’s pharmaceutical exports ranked 11th globally by value in 2023, accounting for 3% of the world’s total pharmaceutical exports, according to a market analysis published by Bain & Company in 2025. The details were shared by the Union Minister of State for Chemicals and Fertilizers, Anupriya Patel, in a written response to a question in the Rajya Sabha.
In response to concerns over drug quality and safety, the Central Drugs Standard Control Organisation (CDSCO) and the Ministry of Health and Family Welfare have implemented a series of regulatory measures.
To enhance oversight, CDSCO, in collaboration with state regulators, introduced risk-based inspections of drug manufacturing and testing facilities in December 2022. A total of 905 units have been inspected, resulting in 694 enforcement actions, including production halts, licence suspensions, and warnings for non-compliance.
The government has also amended the Drugs Rules, 1945, to strengthen Good Manufacturing Practices (GMP). Effective from June 2024, the revised Schedule M regulations apply to pharmaceutical companies with turnovers exceeding ₹250 crore, while smaller firms have until December 2025 to comply.
To enhance drug traceability and combat counterfeit medicines, new labelling rules now require top-selling drug formulations to feature barcode or Quick Response (QR) codes. This rule, effective since August 2023, applies to drugs listed under Schedule H2 of the Drugs Rules, 1945. Additionally, from January 2022, active pharmaceutical ingredients (APIs) must carry QR codes at all packaging levels to facilitate tracking.
Regulatory amendments have also expanded accountability for drug quality. Since March 2021, marketers who sell or distribute medicines are held responsible for their compliance. Meanwhile, the 2008 amendment to the Drugs and Cosmetics Act, 1940, introduced stricter penalties for manufacturing spurious and adulterated drugs, making certain offences non-bailable. To expedite legal proceedings, special courts have been established across states and union territories to handle drug-related offences.
The number of sanctioned posts in CDSCO has risen significantly in the past decade, bolstering regulatory oversight. Coordination between central and state drug control authorities has also been enhanced through regular consultations.
Since April 2023, over 35,000 officials from CDSCO and state regulatory bodies have received training on Good Manufacturing Practices through residential and regional workshops.
