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Indian pharma is accelerating its push toward global regulatory harmonization as authorities intensify efforts to align domestic standards with stringent International Council for Harmonisation (ICH) and World Health Organization (WHO) norms.
Dr Premnath Shenoy, former director, QA/RA/Patient safety, AstraZeneca Pharma India and Immediate past president IPA, Karnataka said that this move marks a decisive shift toward elevating India’s drug quality benchmarks to match the world’s most advanced regulatory systems.
Pharma companies must ensure BE studies are conducted at compliant centres and meet evolving documentation standards. Regulatory professionals should monitor CDSCO updates and ensure dossiers include validated BE data. Educators and trainers can incorporate these changes into continuing education for pharmacists and technical staff, he added.
Delving on the requirements in India, Dr Shenoy said that here the drug products must demonstrate bioequivalence to their brand-name counterparts through studies that prove their rate and extent of absorption are similar, with the 90% confidence interval for key pharmacokinetic parameters.
This requirement, mandated by the Central Drugs Standard Control Organization (CDSCO), ensures the generic drug is therapeutically equivalent and can be substituted for the brand-name version without affecting safety or efficacy. Here, CDSCO has specific guidelines and protocols for conducting these studies, including requirements for participant demographics and study conditions, he said.
Our regulatory authority has increased scrutiny of study centres requiring periodic inspections, accreditation and compliance with GCP (good clinical practices) and insisting for transparent reporting of adverse events and protocol deviations, Dr Shenoy said at the recently concluded event on ‘Managing Regulatory Changes in Solid Oral Dosage Forms: Technical Insights’, a workshop on bioavailability and bioequivalence organised by the Indian Pharmaceutical Association, Karnataka.
This requirement, mandated by the CDSCO, ensures the generic drug is therapeutically equivalent and can be substituted for the brand-name version without affecting safety or efficacy. It is the regulatory body responsible for approving drugs, including generic versions, after they meet these bioequivalence standards. The regulatory body is strengthening oversight of BA/BE studies and has mandated study centres in India must be approved by it, said Dr Shenoy.
Noting that now novel drug delivery systems, biosimilars, and gene therapies require BE or comparative clinical studies to establish equivalence, Dr Shenoy reinstated that India is aligning its BE requirements with ICH and WHO guidelines, especially for export-oriented generic manufacturers. Emphasis on biowaivers for certain BCS Class I and III drugs are also justified.
Specifically for biosimilars, the 2025 draft guidelines emphasize comparative pharmacokinetic and pharmacodynamic studies to demonstrate similarity with reference biologics. These studies serve a similar purpose to BE studies in small molecules, ensuring clinical interchangeability, he said.
On a concluding note, Dr Shenoy said, India’s accelerated alignment with ICH and WHO standards signals a decisive transformation in its pharmaceutical ecosystem. By enforcing globally harmonized regulations, the country is not only strengthening drug quality and safety but also positioning its pharma industry for greater global competitiveness. This shift cements India’s intent to move beyond volume leadership toward becoming a trusted standard-setter in the global healthcare landscape.
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