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Waiver has been granted under Rule 101 of New Drugs and Clinical Trials Rules, 2019, which allows Drugs Controller General of India (DCGI aka Central Licencing Authority) to specify certain countries for considering waiver of local clinical trials for approval of new drugs.
- Now countries like USA, UK, Japan, Australia, Canada, and EU can supply drugs to India without requiring local trials.
- Waiver covers five categories: Orphan drugs for rare diseases; Gene and cellular therapy products; New drugs used in pandemic situations; New drugs for special defense purposes; and New drugs having significant therapeutic advances over current standard of care.
- Orphan drug means a drug intended to treat a condition which affects not more than 5 lakh persons in India.
- Waiver covers five categories: Orphan drugs for rare diseases; Gene and cellular therapy products; New drugs used in pandemic situations; New drugs for special defense purposes; and New drugs having significant therapeutic advances over current standard of care.
- However, final phase four clinical trials for these drugs will still be mandatory.
- DCGI (head of CDSCO) is final regulatory authority for approval of clinical trials in country.
Significance of Current Waiver
- Ensure availability of latest medicines to treat diseases like cancer, rare and autoimmune disease, etc.
- Reduce costs of public procurement by governments under various schemes like Ayushman Bharat etc.
- Reduce cost incurred by pharmaceutical companies in conducting local trials.
About Central Drugs Standard Control Organisation (CDSCO)
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