India’s pharmaceutical industry continues to grow, ranking 11th globally in value terms in 2023 and accounting for 3% of total pharmaceutical exports, according to a Bain & Company report. Recognizing its role as a key player in the global medicine supply chain, the Indian government has undertaken significant regulatory reforms to enhance drug quality, safety, and compliance.

The Central Drugs Standard Control Organisation (CDSCO) and the Ministry of Health and Family Welfare have intensified efforts to ensure regulatory compliance through risk-based inspections, revised manufacturing standards, and stricter enforcement actions.

Strengthening Drug Regulations: Key Measures

1. Risk-Based Inspections and Enforcement Actions

Since December 2022, CDSCO, in collaboration with state regulators, has conducted 905 risk-based inspections of drug manufacturing and testing units. These inspections have led to:

• 694 enforcement actions, including production stoppages, license suspensions, and official warnings.
• Improved compliance with Good Manufacturing Practices (GMPs).
• Strengthened drug safety and quality standards.

2. Schedule M Amendments and Compliance Deadlines

The government amended Schedule M of the Drugs Rules, 1945, enhancing Good Manufacturing Practices (GMP) requirements. The revised Schedule M, notified on December 28, 2023, enforces stricter compliance deadlines:

• Manufacturers with a turnover above Rs. 250 crore (US$ 28.68 million): Compliance effective from June 29, 2024.
• Smaller manufacturers (turnover up to Rs. 250 crore): Extended deadline until December 31, 2025.

These changes ensure higher-quality pharmaceutical production, aligning India’s standards with global regulatory frameworks.

3. QR Codes for Drug Authentication and Tracking

To enhance drug traceability and prevent counterfeit medicines, the government introduced QR codes on packaging labels:

• From August 1, 2023: QR codes became mandatory on the top 300 drug brands for authentication.
• From January 18, 2022: All active pharmaceutical ingredients (APIs) must carry QR codes for tracking and tracing.

These initiatives enhance transparency, allowing authorities and consumers to verify drug authenticity and reduce the risk of counterfeit medicines.

Strengthening Accountability and Legal Framework

1. Stricter Drug Quality Compliance

A 2020 amendment to the Drugs Rules made manufacturers and marketers accountable for drug quality and regulatory compliance. This shift ensures that:

• Pharmaceutical companies bear legal responsibility for any lapses in drug safety.
• Non-compliant firms face stringent penalties under the Drugs and Cosmetics Act, 1940.

2. Special Courts for Faster Drug-Related Cases

Recognizing the need for swift legal action against spurious drug manufacturers, the government established special courts to:

• Fast-track cases involving the production of fake or substandard medicines.
• Enforce harsher penalties, deterring unlawful activities in the pharmaceutical sector.

Boosting India’s Pharmaceutical Workforce and Infrastructure

To ensure effective regulation and enforcement, CDSCO has significantly increased sanctioned posts over the past decade. Additionally, since April 2023, over 35,000 personnel have undergone training in pharmaceutical quality control, compliance, and drug safety monitoring.

India’s Growing Role in Global Pharma Exports

India's 11th-place global ranking in pharmaceutical exports highlights the country’s expanding role in international markets. With the implementation of stricter regulations, improved manufacturing practices, and enhanced drug tracking systems, India is well-positioned to increase its global market share.

Conclusion: A Stronger Pharma Industry for a Global Future

India’s pharmaceutical sector continues to evolve, with stringent quality measures, advanced tracking systems, and regulatory enforcement ensuring higher drug safety standards. As India strengthens its global presence, these reforms will enhance trust in Indian medicines, paving the way for higher exports and improved healthcare accessibility worldwide.

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