India’s Pharmaceutical Exports and Regulatory Measures for Drug Quality

India is a major player in the global pharmaceutical industry, ranking 11th worldwide in pharmaceutical exports in 2023 and accounting for 3% of total pharmaceutical exports. The Central Drugs Standard Control Organisation (CDSCO) and the Ministry of Health and Family Welfare have implemented various measures to ensure drug quality, safety, and efficacy. These steps include risk-based inspections, regulatory amendments, stricter penalties for non-compliance, and training programs to enhance manufacturing standards. This article provides an overview of these initiatives and their impact on the pharmaceutical sector.

Key Highlights of India’s Pharmaceutical Sector & Regulatory Measures

India’s Position in Global Pharmaceutical Exports

• Ranked 11th globally in value terms in 2023.
• Contributed 3% of the total pharmaceutical exports worldwide.

Regulatory Measures for Drug Safety & Quality

1. Risk-Based Inspections for Compliance

• Initiated by CDSCO in December 2022 in collaboration with State regulators.
• 905 drug manufacturing units inspected.
• 694 actions taken, including:
• Orders to stop production.
• Orders to stop testing.
• Suspension or cancellation of licenses.
• Warnings or notices to show cause.

2. Amendments to the Drugs Rules, 1945

• Revised Schedule M for Good Manufacturing Practices (GMP),
• Effective from June 29, 2024, for manufacturers with turnover over ₹250 crore.
• Extended deadline till December 31, 2025, for manufacturers with turnover up to ₹250 crore.
• Barcode or QR Code on Top 300 Drug Brands: Mandatory from August 1, 2023, to enhance drug authentication.
• QR Code on Active Pharmaceutical Ingredients (APIs): Implemented on January 18, 2022, for tracking and tracing at all packaging levels.
• Shared Responsibility for Drug Quality: From March 1, 2021, marketers selling drugs are also responsible for quality compliance.

3. Strengthening Penalties & Legal Framework

The Drugs and Cosmetics Act, 1940 was amended in 2008 to introduce stricter penalties for,

• Manufacturing spurious and adulterated drugs.
• Certain offences were made cognizable and non-bailable.
• Special courts established for speedy disposal of drug-related cases.

4. Enhancing Drug Testing & Approval Standards

• Bioequivalence studies are now required for some oral dosage drugs before granting a manufacturing license.
• Applicants must submit stability & safety data of excipients to the State Licensing Authority before receiving manufacturing approval.

5. Strengthening Drug Regulatory Authorities

• Significant increase in sanctioned posts in CDSCO over the last decade.
• Better coordination between CDSCO and State Drug Control Organisations via the Drugs Consultative Committee.
• Over 35,000 personnel trained since April 2023 on Good Manufacturing Practices (GMP) through residential, regional training, and workshops.