Fast-Tracking Drug Approvals: New Testing Protocol Unveiled
The government has expedited the drug approval process by allowing immediate laboratory testing post-application, bypassing preliminary scrutiny. The Central Drugs Standard Control Organization's new protocol mandates companies submit finalized specifications based on pharmacopoeial standards. Technical scrutiny will be deferred, with potential re-testing if specifications are revised.
- Country:
- India
In a significant move to accelerate the approval process for new drugs, the government has revamped the testing permission framework, allowing pharmaceutical companies to start lab testing right after submitting applications.
According to an official circular from the Central Drugs Standard Control Organization (CDSCO), a 'No Objection Certificate' (NOC) for drug sample testing is now issued immediately upon application receipt. This shift aims to enable faster file movement while maintaining technical scrutiny at later stages.
Applicants are now required to submit finalized regulatory specifications based on prevailing pharmacopoeial standards up front. The new system encourages efficiency but requires re-testing if specifications undergo changes or updates post-review.
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