India Accelerates Alignment of Pharma Regulations with Global Standards

India’s pharmaceutical sector is rapidly aligning domestic regulations with International Council for Harmonisation (ICH) and World Health Organization (WHO) standards, signaling a shift toward globally harmonized drug quality benchmarks.

The generic drugs must demonstrate bioequivalence (BE) to brand-name counterparts, meeting rigorous CDSCO guidelines on study design, participant demographics, and reporting of adverse events. Study centres now require accreditation, Good Clinical Practice compliance, and periodic inspections.

The move extends to novel drug delivery systems, biosimilars, and gene therapies, with comparative clinical studies required to establish therapeutic equivalence. Draft 2025 biosimilar guidelines stress pharmacokinetic and pharmacodynamic comparability to reference biologics.

India’s adoption of ICH and WHO norms enhances drug quality, safety, and global competitiveness, positioning the country as a trusted standard-setter in healthcare.

08-12-2025