New Delhi: India's drug regulatory authority has decided to come up with a 'digital monitoring system' to keep an eye on the supply chain of cough syrups and the quality of the high-risk solvents, following recent 'toxic' cough syrup incidents.
The Online National Drugs Licensing System (ONDLS) has been upgraded to register the same, the Central Drugs Standard Control Organisation (CDSCO) said in circular dated October 22, 2025. "The portal has been made live by this directorate for addressing this issue," it said.
CDSCO has asked all state and UT drug controllers to direct manufacturers of pharma grade solvents to obtain a licence through the ONDLS portal. In case the manufacturers already hold the manufacturing licence, they have been asked to register on the ONDLS portal and submit the data through 'Old Licence Management'.
Solvent manufacturers have been asked to upload details on the ONDLS portal regarding each batch manufactured with quantity, certificate of analysis, etc. and details of the vendors to whom the solvents are sold from time to time.
The drug regulator has asked to ensure that no batch is available in the market without complying with the new directions.
There have been recent reports of contamination of cough syrups with diethylene glycol (DEG), raising serious safety concerns. In this regard, a high-level meeting under the chairmanship of the Union health secretary was also held with all states and Union territories earlier this month over drug quality norms and to promote the rational use of cough syrups, especially in paediatric population.
The drug regulatory authority had earlier asked states to take measures to ensure testing before the manufacture and release of the batch to the market by way of monitoring during inspections, sensitising the manufacturers through circulars.
The Online National Drugs Licensing System (ONDLS) has been upgraded to register the same, the Central Drugs Standard Control Organisation (CDSCO) said in circular dated October 22, 2025. "The portal has been made live by this directorate for addressing this issue," it said.
CDSCO has asked all state and UT drug controllers to direct manufacturers of pharma grade solvents to obtain a licence through the ONDLS portal. In case the manufacturers already hold the manufacturing licence, they have been asked to register on the ONDLS portal and submit the data through 'Old Licence Management'.
Solvent manufacturers have been asked to upload details on the ONDLS portal regarding each batch manufactured with quantity, certificate of analysis, etc. and details of the vendors to whom the solvents are sold from time to time.
The drug regulator has asked to ensure that no batch is available in the market without complying with the new directions.
There have been recent reports of contamination of cough syrups with diethylene glycol (DEG), raising serious safety concerns. In this regard, a high-level meeting under the chairmanship of the Union health secretary was also held with all states and Union territories earlier this month over drug quality norms and to promote the rational use of cough syrups, especially in paediatric population.
The drug regulatory authority had earlier asked states to take measures to ensure testing before the manufacture and release of the batch to the market by way of monitoring during inspections, sensitising the manufacturers through circulars.