The Central Licensing Authority (CLA) has specified six countries - US, UK, Japan, Australia, Canada, and the European Union (Specified Countries) - under Rule 101 of the New Drugs and Clinical Trials Rules, 2019, for considering local clinical trial waivers. The new guidelines apply to five categories of new drugs: orphan drugs for rare diseases, gene and cellular therapy products, drugs used in pandemics, drugs for special defense purposes, and drugs with significant therapeutic advances.

Conditions for waiver include (a) the drug being approved and marketed in the Specified Countries, (b) no major unexpected serious adverse events having been reported in respect of such drugs, and (c) no available evidence of differences in Indian population affecting drug safety and efficacy. Every application received under this proposed waiver will be vetted either by the Central Drugs Standard Control Organisation’s (CDSCO) head of department, the Drugs Controller General of India (DCGI); or a subject expert committee under the CDSCO.

Industry experts note that despite existing norms allowing faster approvals, the CDSCO has historically been "ultra-cautious" in approving innovative drugs. This cautious approach has resulted in delayed availability of crucial breakthrough therapies and drugs in India, like Zolgensma by Swiss pharma giant Novartis — a gene therapy used to treat spinal muscular atrophy (a disease that causes muscle-function loss in children) and the dengue vaccine QDenga by Japanese firm Takeda. Some industry observers suggest that these delays (which have been seen to be as long as four years) might be linked to India's data exclusivity period for clinical trial data). The changes proposed by CDA’s order may help address these delays, although the impact of the same remains to be seen. (Order)