Pharma Industry Seeks Clarity on Batch-Wise Solvent Clearance, Flags Supply Disruption Risks: Report
New Delhi, Nov. 4 -- The pharmaceutical industry has sought clarity on the applicability of the Centre's new batch-wise digital clearance requirement for high-risk pharmaceutical solvents to export-oriented manufacturers, citing concerns over possible supply disruptions and delays.
The Central Drugs Standard Control Organisation (CDSCO) has directed state and Union Territory drug controllers to require manufacturers and suppliers of specified pharma-grade solvents to register on the Online National Drugs Licensing System (ONDLS) and obtain a no-objection certificate (NOC) before distributing each batch.
Industry executives said the directive does not distinguish between supplies for domestic consumption and exports, creating uncertainty...
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