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DCC recommends removal of cough syrups from Schedule K
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Gireesh Babu, New Delhi
November 27 , 2025
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The Drugs Consultative Committee (DCC), the advisory committee that advises the Central and State Governments on matters that require uniform implementation of drug laws across the country, has recommended removal of cough syrups from Schedule K list, to make its sales strictly under prescription of a doctor.
The Committee also directed the Central Drugs Standard Control Organisation (CDSCO) to hold consultations with the stakeholders regarding the concerns on the use of propylene glycol and its impurities such as the diethylene glycol (DEG) and ethylene glycol (EG) and the use of alternative excipients.
The move comes in the backdrop of the recent death of over 20 children in Madhya Pradesh owing to contaminated cough syrup and taking into account the past incidences where death of children reported in other countries due to the contaminated cough syrups exported from the country.
The DCC, in its meeting held on November 17, 2025, under the Chairmanship of Drugs Controller General (India), Dr Rajeev Singh Raghuvanshi, deliberated the recent incidents due to contaminated cough syrup and a proposal to delete the exemption provided under Entry no.13 of Schedule K of Drugs Rules, 1945 in respect of syrups for cough.
"DCC deliberated the matter and approved the proposal," said the minutes of the meeting.
The Committee was also apprised that various cases regarding concerns on the use of propylene glycol and its related impurities i.e. DEG and EG in the syrups for usage in the paediatric population for therapeutic use have been reported.
It observed that many oral liquid formulations are manufactured using high risk solvents including propylene glycol. Therefore, there is risk of contamination of these formulations with DEG/EG.
The DCC also discussed the possibility of using alternative excipients and formulations in the place of propylene glycol.
The Committee opined that the "CDSCO may initially have consultation with the stakeholders to take stock of the situation and to collate the details of the formulations that are manufactured using high risk solvents for taking further appropriate action."
It may be noted that the presence of DEG or EG has been identified in cough syrup products following the recent incidence in Madhya Pradesh. The World Health Organisation (WHO), in 2022, alleged that the presence of DEG in cough syrups exported from India was the cause of death of several children in Gambia.
Following the death of children in Madhya Pradesh, Union health ministry has said that samples of Coldrif cough syrup tested by the state drug regulator from Sresan Pharma in Kanchipuram, Tamil Nadu, turned out to contain DEG beyond the permissible limit, according to the Union health ministry.
The Central drug regulator recommended cancellation of the manufacturing license of the manufacturer of cough syrup Coldrif, based on inspection findings. Criminal proceedings have also been initiated, said the authorities.
Following this, CDSCO has requested all drug controllers in the states and Union Territories (UTs) to ensure testing of raw materials and excipients before manufacturing and release of the batch to the market.
It also mentioned that as per Drugs Rules including rule 74 (c) and rule 78 (c) (ii), the licensee shall either in his own laboratory or in any laboratory approved by the licensing authority test each batch or lot of the raw material used by him for the manufacture of his product and also each batch of the final product and shall maintain records or registers showing the particulars in respect of such tests as specified in Schedule U.
"All the state/UT Drug Controllers are requested 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, etc." said Dr Rajeev Singh Raghuvanshi, Drugs Controller General of India (DCGI).
"Further, it shall also be ensured that the manufacturers have robust vendor qualification system in place and use raw materials including excipients from reliable approved vendors only," added the official.
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