India eases drug approval process, waives local trials for advanced therapies

In a major policy shift, the Indian government has waived local clinical trial requirements for drugs and vaccines approved by major international regulators (US, UK, Japan, Australia, Canada, EU). This move, aimed at expediting access to advanced therapies like CAR T-cell therapy and Sacituzumab govitecan, still ensures post-marketing surveillance by the CDSCO.

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