India’s pharmaceutical industry continues to be a key player in global medicine exports, ranking 11th worldwide in value terms in 2023 and accounting for 3% of total pharmaceutical exports, according to a report by Bain & Company. The Ministry of Chemicals and Fertilizers, along with the Central Drugs Standard Control Organisation (CDSCO), has taken multiple measures to ensure the quality, safety, and efficacy of medicines in the country.
Strengthening Drug Regulations and Compliance
To improve regulatory compliance, the CDSCO, in collaboration with state regulators, conducted risk-based inspections of drug manufacturing units starting in December 2022. So far, 905 units have been inspected, resulting in 694 enforcement actions, including orders to stop production, license suspensions, and warnings. These measures aim to enhance manufacturing standards and improve drug safety.
Additionally, the government amended the Drugs Rules, 1945, to upgrade Good Manufacturing Practices (GMPs) for pharmaceutical firms. From June 29, 2024, companies with annual revenues exceeding ₹250 crore must comply with revised GMP standards, while smaller firms have until December 31, 2025, to meet the new requirements.
To curb counterfeit drugs, the government also mandated barcode or QR code labeling for the top 300 drug brands under Schedule H2, effective from August 1, 2023. This measure helps authenticate medicines and enhances transparency in drug distribution.
Stricter Penalties for Non-Compliance
The Drugs and Cosmetics Act, 1940, was amended in 2008 to introduce stricter penalties for manufacturing spurious and adulterated drugs. Several offenses were made cognizable and non-bailable, and special courts were established to fast-track cases related to drug violations.
Furthermore, amendments to the Drugs Rules, 1945, now require manufacturers to submit bioequivalence studies for oral dosage forms before obtaining manufacturing licenses. The government has also increased the sanctioned workforce in CDSCO over the last decade to ensure effective regulation and compliance.
Training and Coordination for Drug Regulators
To maintain uniformity in the enforcement of drug regulations, the central government regularly conducts training programs for regulatory officials at the CDSCO and State Drug Control Authorities. Since April 2023, over 35,000 personnel have been trained in Good Manufacturing Practices (GMPs) and other critical areas.
The Indian pharmaceutical sector plays a crucial role in the global healthcare ecosystem. With these regulatory updates, the government aims to strengthen its position as a leading exporter of high-quality medicines while ensuring stringent compliance with international standards.
