CDSCO mandates digital batchwise clearance for high-risk pharma solvents

Drug regulator CDSCO has mandated digital clearance for every batch of high-risk pharmaceutical solvents, prompting industry concerns over delays and potential supply disruptions

India’s apex drug regulatory authority, the Central Drugs Standard Control Organisation (CDSCO), has told manufacturers and suppliers of key cough syrup ingredients that no batch can leave the factory until it is registered and cleared through the government’s digital management system (DMS).

 

Drugs Controller General of India (DCGI) Rajeev Raghuvanshi has asked state and Union Territory (UT)-level drug control bodies to direct all manufacturers, vendors and suppliers of high-risk pharmaceutical-grade solvents to register on the Centre’s DMS immediately, according to a document seen by Business Standard.

 

The CDSCO has established a DMS on its Online National Drug Licensing System (ONDLS) portal to ensure robust oversight of supply chain integrity and quality parameters of high-risk pharmaceutical solvents and excipients.

 

“It shall be ensured that no batch of pharmaceutical grade of these solvents should be distributed without uploading the required details sought on the DMS and obtaining system generated no-objection certificate (NOC),” a CDSCO order dated October 27 states.

 

The order includes 10 such excipients, including propylene glycol, glycerine, maltitol and sorbitol. These ingredients are used in liquid medicines and cough syrups, and regulators treat them as high-risk for contamination.

 

Officials in the know told Business Standard that states have been requested to accord high priority to this matter and ensure strict compliance across all manufacturing and supply units.

 

While backing the move, industry executives said that improper implementation could lead to possible clearance delays as licensing and approval requests might come in bulk.

 

“While the notification primarily applies to solvent manufacturers and suppliers rather than formulation manufacturers, its implementation could lead to temporary supply disruptions as manufacturers complete registration and align with the new reporting requirements,” said Saurabh Agarwal, director and chief executive officer (CEO) at Mumbai-based HAB Pharmaceuticals and Research.

 

These are likely to be short-term challenges. “In the longer run, this initiative will help strengthen traceability, improve regulatory oversight and build greater confidence in the pharma supply chain,” he added.

 

A Delhi-based pharma executive said that the move would help prevent solvents that do not conform to pharmacopoeial grade from entering the supply chain and, ultimately, the market at large. India's overall cough and cold market is estimated to be around ₹7,000 crore.

 

Tightening part of reforms after cough syrup deaths

 

The move comes a year after the CDSCO asked states to ensure testing before the manufacturing and release of batches into the market, following the deaths of at least 22 children linked to toxic cough syrups in Madhya Pradesh’s Chhindwara.

 

The apex drug regulatory body subsequently conducted inspections at manufacturing facilities.

 

The inspections found that several licensed drug manufacturers were not testing each batch of excipients to verify compliance with prescribed standards before using them to manufacture formulations and finished products.

 

Coldrif, the cough syrup in question during the Chhindwara deaths, was found to contain the industrial chemical diethylene glycol (DEG), commonly used in making products such as brake fluids and paints, beyond permissible limits.

 

DEG is most commonly used in making products such as brake fluids and paints. It 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.

 

While propylene glycol is safe in regulated amounts, even a small intake of DEG is known to cause severe poisoning, which can lead to kidney problems, especially in children.

 

Consequently, a high-level meeting chaired by Union Health Secretary Punya Salila Srivastava was also held with all states and UTs in October last year to review compliance with drug quality norms and promote the rational use of cough syrups, especially in paediatric populations.

 

The DCGI had further directed all manufacturers of pharmaceutical-grade solvents to obtain a manufacturing licence through the ONDLS portal and upload details regarding each batch manufactured on it.

 

“In case the manufacturer already holds the manufacturing licence, he must register on the ONDLS portal and submit the data through Old Licence Management under ONDLS,” the letter dated October 22, 2025, stated.

 

Last week, the CDSCO asked state drug control bodies to mandate testing of raw materials and finished formulations by manufacturers under their jurisdiction.