Pharma industry seeks clarity on CDSCO solvent order's export ambit

Pharma executives seek clarity on export applicability of CDSCO's batch-wise solvent clearance rules, warning that approval delays could disrupt supplies, particularly in rural markets

The pharmaceutical industry is seeking clarity on the applicability of the Centre’s new batch-wise digital clearance requirement for high-risk pharmaceutical solvents to export-oriented manufacturers, even as concerns mount over possible supply disruptions arising from its implementation.

 

This comes after the Central Drugs Standard Control Organisation (CDSCO) directed state and Union Territory (UT) drug controllers to mandate all manufacturers and suppliers of specified pharma-grade solvents to register on its Online National Drugs Licensing System (ONDLS) and obtain a no-objection certificate (NOC) before distributing every batch.

 

However, industry executives say that the order does not distinguish between quantities intended for domestic consumption and those meant for export, adding that the requirement appears to cover the entire supply chain, including manufacturers supplying formulations to overseas markets.

  

“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 said.

 

The CDSCO did not respond to queries emailed by Business Standard until the time of going to print.

 

Rishi Agrawal, co-founder and chief executive officer of TeamLease Regtech, added that export-oriented units also hold drug manufacturing licences under the Drugs and Cosmetics Act and source solvents from the same supply chain as domestic manufacturers.

 

“Ideally, a medicine made for an Indian patient should meet the same standard as one made for export. The new solvent tracking system supports this because it works at the input level,” he said.

 

While the industry has broadly welcomed the move to strengthen traceability of critical inputs, executives have flagged the capacity of state drug control departments to process a potentially large volume of batch-wise clearance requests.

 

Agrawal noted that as drug control departments in several states are already short-staffed, delays in issuing NOCs could hold up supplies of solvents to formulation manufacturers.

 

“Smaller manufacturers could be particularly vulnerable, given their limited inventories and dependence on regional suppliers,” he said.

 

Executives added that the move could also affect rural distribution in the short term.

 

India's cough and cold market is estimated to be worth around ₹7,000 crore, according to industry estimates. Market experts suggest that rural markets in Uttar Pradesh, Madhya Pradesh, Maharashtra's Vidarbha region and Rajasthan are among the highest consumers of cold medications, especially syrups.

 

“Rural markets are highly price sensitive and heavily lean on inputs manufactured by small and regional manufacturers,” the executive quoted above said.

 

He added that these companies typically buy solvents from smaller suppliers and traders and are not as well prepared for digital registration and batch-wise approvals. Consequently, if NOCs are delayed because of limited regulatory capacity, these manufacturers may feel the pinch.

 

“Large companies hold more stock and have stronger supplier networks, so they can absorb delays. Smaller ones are not resilient enough. A gap at their end would show up first on pharmacy shelves in small towns and villages,” Agrawal said.

 

Arushi Jain, director at contract drug manufacturing organisation (CDMO) Akums Drugs, said that clearly defined timelines and coordination among regulators, suppliers and manufacturers would be essential to ensure that tighter quality controls do not affect medicine availability.

 

The directive comes amid heightened scrutiny of pharmaceutical manufacturing following the deaths of 24 children in Madhya Pradesh in 2025 linked to Coldrif cough syrup, which was found to contain high levels of diethylene glycol (DEG), a toxic industrial chemical.

 

DEG is a cheap and colourless liquid that can sometimes be mistakenly or illegally used in medicines as a substitute for propylene glycol (a solvent that helps dissolve drugs into liquid form) in syrups.

 

The solvents covered under the new tracking requirement include glycerin, propylene glycol, sorbitol, maltitol, polyethylene glycols, polysorbates and ethyl alcohol, which are used across several dosage forms, including oral liquids, tablets, capsules, ointments and injectables.