Expansion of Schedule H2 Drugs
The Health Ministry's recent notification to extend Schedule H2 drugs to encompass entire therapeutic classes signifies a shift from revenue-based to risk-based regulation. Originally introduced in 2022-23, Schedule H2 mandated barcodes or QR codes on specific drug packs for authenticity verification.
Key Features of Schedule H2
- The framework includes regulation of active pharmaceutical ingredients and compliance for export-oriented pharmaceuticals.
- Additional symbols encode crucial information: product identifier, manufacturing licence number, and batch number.
Addressing Counterfeits and Quality Control
Counterfeit medicines, especially vaccines, cancer drugs, and antimicrobials, have been a persistent issue, particularly in low- and middle-income countries. The WHO has highlighted the significant presence of fake antimicrobials, contributing to India’s high antimicrobial resistance rates.
- Substandard antimicrobials lead to sub-therapeutic dosing, increasing resistant strains.
- The Narcotics Control Bureau raised concerns over the illicit market penetration of medicinal opioids and psychotropic substances.
Global and Domestic Regulatory Concerns
The U.S. FDA and European Medicines Agency have frequently raised issues about quality control in India, particularly after incidents with contaminated syrups. The U.S. Trade Representative has identified India as a major source of counterfeit medicines.
Policy Changes and Compliance
- The Jan Vishwas Act 2026 differentiates between procedural and substantive non-compliance.
- To reduce corruption, it is crucial to streamline compliance burdens and minimize discretionary enforcement.
- A state-managed database, interoperable software, and scanning infrastructure are essential for the QR code system's effectiveness.
Challenges and Implementation
- Pharmacists and consumers need to develop a practice of verifying medicines before sales.
- MSMEs may face challenges with new packaging requirements and IT integration.
- Prescription data for controlled substances needs careful handling with a yet-to-be-developed digital governance layer.
The success of the new framework in enhancing India’s pharmacy reputation hinges on its effective implementation.
