Pharma Industry Seeks CDSCO Clarity on Batch-Wise Solvent Clearance, Flags Risk of Medicine Supply Disruptions
New Delhi: The Indian pharmaceutical industry has sought clarification from the Central Drugs Standard Control Organisation (CDSCO) on whether the Centre's newly introduced batch-wise digital clearance requirement for high-risk pharmaceutical solvents will also apply to export-oriented manufacturers. Industry stakeholders have expressed concerns that the implementation of the directive could disrupt solvent supplies and affect pharmaceutical manufacturing and medicine availability.
Under the new directive, CDSCO has instructed state and Union Territory (UT) drug controllers to ensure that all manufacturers and suppliers dealing with specified pharmaceutical-grade solvents register on the Online National Drugs Licensing System (ONDLS). They are also required to obtain a no-objection certificate (NOC) for every batch before distributing the covered solvents.
However, industry representatives have pointed out that the order does not clearly distinguish between solvents intended for domestic consumption and those used in the manufacture of medicines for export markets. Consequently, the requirement appears to extend across the entire supply chain, including manufacturers supplying pharmaceutical formulations to international markets.
A Delhi-based pharmaceutical industry executive highlighted the need for regulatory clarification to avoid different interpretations among state authorities. The executive also noted that cough syrups intended for export require a Certificate of Analysis (CoA) from an approved government laboratory. CDSCO had not responded to queries sent by Business Standard at the time of publication.
Rishi Agrawal, Co-founder and Chief Executive Officer of TeamLease Regtech, stated that export-oriented pharmaceutical units also operate under manufacturing licences issued in accordance with the Drugs and Cosmetics Act. These companies procure solvents through the same supply chain as manufacturers serving the domestic market. He emphasised that medicines manufactured for Indian consumers should meet the same quality standards as those produced for international markets. According to him, the proposed solvent-tracking mechanism strengthens quality assurance by monitoring critical inputs at the source.
While the industry has broadly welcomed the initiative to improve traceability and quality control of pharmaceutical raw materials, concerns remain regarding the operational capacity of state drug control departments. Industry executives have raised concerns that processing a large volume of batch-wise NOC applications could put additional pressure on already understaffed regulatory authorities, potentially delaying solvent supplies to formulation manufacturers.
Agrawal noted that smaller pharmaceutical manufacturers could be particularly vulnerable because they generally maintain limited inventories and depend heavily on regional suppliers. Delays in regulatory clearances could interrupt their production activities and affect medicine distribution, particularly in rural areas.
India’s cough and cold medicine market is estimated to be worth approximately ₹7,000 crore. Industry estimates suggest that rural regions of Uttar Pradesh, Madhya Pradesh, Maharashtra’s Vidarbha region and Rajasthan account for significant consumption of cold medications, particularly cough syrups. These markets are highly price-sensitive and depend considerably on products manufactured by small and regional pharmaceutical companies.
The industry executive further explained that smaller manufacturers frequently procure solvents from local suppliers and traders and may not be adequately prepared for digital registration and batch-wise approval procedures. Delays in obtaining NOCs due to limited regulatory capacity could create supply constraints. In comparison, larger pharmaceutical companies generally maintain higher inventory levels and established supplier networks, enabling them to manage temporary disruptions more effectively. Consequently, smaller manufacturers could be affected first, with potential shortages becoming visible at pharmacies in small towns and villages.
Arushi Jain, Director at contract drug manufacturing organisation (CDMO) Akums Drugs, emphasised that clearly defined approval timelines and effective coordination among regulatory authorities, solvent suppliers and pharmaceutical manufacturers would be essential. She highlighted the importance of ensuring that stricter quality monitoring measures do not compromise medicine availability.
The directive comes amid heightened scrutiny of pharmaceutical manufacturing following the deaths of 24 children in Madhya Pradesh in 2025, which were linked to Coldrif cough syrup. The syrup was found to contain elevated levels of diethylene glycol (DEG), a toxic industrial chemical. DEG is a cheap and colourless liquid that may be mistakenly or illegally used in pharmaceutical formulations as a substitute for propylene glycol, a solvent commonly used to dissolve drugs in liquid preparations.
The solvents covered under the new batch-wise tracking requirement include glycerin, propylene glycol, sorbitol, maltitol, polyethylene glycols, polysorbates and ethyl alcohol. These substances are used across several pharmaceutical dosage forms, including oral liquids, tablets, capsules, ointments and injectables. The proposed monitoring system aims to strengthen oversight of critical pharmaceutical inputs and prevent the use of contaminated or unsuitable materials in medicines, reports Business Standard.
