Pharma Industry Seeks Clarity on Batch-Wise Solvent Clearance, Flags Supply Disruption Risks: Report

New Delhi, Nov 4 (KNN) 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 over its applicability to export-oriented units.

“A regulatory clarification would help avoid differing interpretations across states, as cough syrups need a Certificate of Analysis from an approved government laboratory before export,” a Delhi-based pharma executive told Business Standard.

Small Manufacturers Face Higher Compliance Burden

While the industry has broadly welcomed stronger traceability of pharmaceutical inputs, concerns have emerged over the capacity of state drug control departments to process a large volume of batch-wise clearance requests.

Rishi Agrawal, co-founder and CEO, TeamLease Regtech, said drug control departments in several states already face staff shortages, which could delay NOC approvals and disrupt solvent supplies to formulation manufacturers, Business Standard reported.

Smaller manufacturers could be more vulnerable because of limited inventories, dependence on regional suppliers and lower preparedness for digital registration and batch-wise approvals. Such delays could affect medicine availability, particularly in rural markets, Agrawal added.

India's cough and cold medicine market is estimated at around Rs 7,000 crore. Industry executives have flagged potential risks to rural markets in Uttar Pradesh, Madhya Pradesh, Vidarbha in Maharashtra and Rajasthan, where smaller manufacturers and regional suppliers play an important role.

Arushi Jain, Director, Contract Drug Manufacturing Organisation (CDMO) Akums Drugs, noted that clearly defined timelines and coordination among regulators, suppliers and manufacturers would be necessary to ensure that tighter quality controls do not affect medicine availability.

Move Follows Cough Syrup Safety Concerns

The directive follows heightened scrutiny of pharmaceutical manufacturing after 24 children died in Madhya Pradesh in 2025 in an incident linked to Coldrif cough syrup, which was found to contain high levels of diethylene glycol (DEG), a toxic industrial chemical.

DEG can be mistakenly or illegally used as a substitute for propylene glycol, a solvent used in liquid medicines.

The new tracking requirement covers glycerin, propylene glycol, sorbitol, maltitol, polyethylene glycols, polysorbates and ethyl alcohol. These ingredients are used in several pharmaceutical formulations, including oral liquids, tablets, capsules, ointments and injectables.

The industry has called for clarity on export applicability and timely processing of clearances to ensure that stronger input-level monitoring does not create bottlenecks in pharmaceutical production and distribution.

(KNN Bureau)