Mid-Year Updates in the Pharmaceutical and Healthcare Industry

Short summary

This article reviews India's pharmaceutical and healthcare regulatory developments in the first half of 2026, including new compounding of offences procedures, clinical trial rules, pharmacovigilance measures, and medical device regulations. The CDSCO issued FAQs, SOPs, and guidelines to implement the compounding framework, which provides immunity from prosecution for cooperating applicants. The developments reflect India's push toward risk-based oversight and regulatory efficiency.

• •CDSCO operationalized compounding of offences framework with FAQs, SOPs, and guidelines
• •Eligible offences include manufacturing, sale, and distribution contraventions under the DCA
• •Immunity from prosecution available for applicants who cooperate and make full disclosure

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