The Central Drugs Standard Control Organisation (CDSCO) has introduced new measures to improve monitoring of pharmaceutical grade solvents and excipients used in liquid medicines such as cough syrups. The changes require manufacturers, vendors and suppliers of solvents to register on the Online National Drugs Licensing System (ONDLS) portal to enable digital monitoring of high risk solvents. The changes are being implemented via two directives issued on 27 October 2026. This requires manufacturers to provide batch information of raw materials via the government’s Digital Monitoring System (DMS).

This will improve transparency within the supply chain for pharmaceutical solvents. It also ensures that solvents used in medicines are not contaminated. This follows increased concerns for cough syrup safety within India following the death of children in Madhya Pradesh due to the contamination of Coldrif cough syrup.

Manufacturers, vendors and suppliers of high risk solvents must now register on the ONDLS portal. This will require them to provide batch information of solvents used.

This includes information about the quantity of solvents manufactured, Certificates of Analysis (CoAs), quantity of solvents provided, vendor details and onward distribution. As per the directive, batches of pharmaceutical grade solvents cannot be distributed until required information has been uploaded and a No Objection Certificate (NOC) has been issued by the system.

The directive applies to 10 high risk solvents or excipients including glycerine, propylene glycol, ethyl alcohol, maltitol, sorbitol and diethylene glycol. These are used in pharmaceutical formulations such as cough syrups, tonics, mouthwashes and other liquid medicines.

This digital system will improve monitoring by officials. It will allow them to better understand where ingredients are coming from in the supply chain. The batch information will also improve transparency within the supply chain, and help identify where contamination could have occurred.

This follows a communication by CDSCO on 22 October 2025 which required manufacturers of pharmaceutical grade solvents to obtain manufacturing licences via the ONDLS portal. Existing licences must be registered on the portal under the Old Licence Management system.

CDSCO has also reminded manufacturers of the requirement to perform batch testing of all raw materials including active pharmaceutical ingredients (APIs) and excipients.

A separate directive has been issued (27 October 2026) requiring State and Union Territory drug controllers to ensure strict adherence to the Drugs Rules 1945 for raw material testing.

This follows previous inspections and investigations into Not of Standard Quality (NSQ) drugs. During these investigations it was found that not all manufacturers performed batch testing of active ingredients and excipients as per required standards.

As per Rules 74(c) and 78(c)(ii) of the Drugs Rules 1945, manufacturers must perform batch/lot testing of all raw materials used in production and testing of all batches of the finished product. This can be done within the manufacturer's own laboratory or an approved one. Records must be kept in line with Schedule U.

The latest directive requires state regulators to ensure compliance is being achieved. This can be done by performing inspections. Manufacturers must also be made aware of their requirements. It also places emphasis on having strong vendor qualification systems in place and obtaining raw materials, including excipients, from reliable and approved sources.

This will be especially important for liquid formulations.

These new measures have been introduced following the deaths of children in Chhindwara district in Madhya Pradesh in 2025. This was due to the consumption of contaminated Coldrif cough syrup manufactured by Sresan Pharmaceuticals.

During laboratory investigations it was found that the cough syrup contained diethylene glycol (DEG). This is a toxic industrial chemical. It was reported that the product contained 48.6% DEG. This was far above the allowed limit.

DEG is an industrial solvent used in items such as antifreeze, brake fluids and paints. It can cause serious toxicity if consumed. The kidneys are particularly at risk. This can cause Acute Kidney Injury in children.

This has raised concerns regarding the source of pharmaceutical grade solvents. Many liquid medicines contain propylene glycol and glycerine. If these are contaminated or replaced with industrial grade chemicals this can cause serious safety issues.

It is important to ensure that ingredients are pharmaceutical grade. Manufacturers must ensure they are the correct ingredient, pure and of good quality.

Manufacturers and suppliers will be held accountable for ensuring accurate information about their batches. Quality control will improve.

Although many within the industry see the benefits of improved monitoring, there are concerns regarding the digital approval process. There will be a high volume of requests for registration and approval which could cause delays. This could affect the availability of pharmaceutical grade solvents.

This could affect smaller manufacturers and suppliers.

Industry representatives have suggested that whilst these requirements only directly impact the solvent manufacturers/suppliers, there may also be impacts on the formulation manufacturers (Business Standard).

Overall this will improve accountability. Batches can be easily identified as being out of compliance. This will give more confidence in the pharmaceutical raw materials

Rh/MF