India’s apex drugs regulator turns the screws on pharmaceutical-grade raw materials linked to syrup contamination risks

New Delhi: India’s drug regulator has told makers and suppliers of key cough syrup ingredients that no batch can leave the factory until it is registered and cleared online, according to two officials and a government document reviewed by Mint.

“…it shall be ensured that no batch of pharmaceutical grade of these solvents (propylene glycol, glycerine, sorbitol, etc.) should be distributed without uploading the required details sought on the DMS (digital monitoring system) and obtaining system-generated NOC (no objection certificate),” the directive said. State drug controllers have been told to make this a top priority, so every batch can be traced from the factory to the finished medicine.

The order from the Drugs Controller General of India (DCGI) covers propylene glycol, glycerine, maltitol and sorbitol. These ingredients are used in liquid medicines, and regulators treat them as high-risk for contamination.

Before shipping, a maker must now upload how much it produced, the lab test results for the batch and who bought it. The online system then issues a clearance, called a No Objection Certificate.

The move follows the deaths of at least 24 children in Madhya Pradesh and Rajasthan last year after they took cough syrups contaminated with toxic industrial chemicals, diethylene glycol and ethylene glycol. The chemicals damage the kidneys and can be fatal.

In 2022, the Gambia and Uzbekistan cough syrup incidents tragically caused the deaths of dozens of children due to DEG and EG contamination.

Queries emailed to the spokesperson of the ministry of health and family welfare, DCGI office, Sun Pharma, Cipla, Mankind on Sunday and Zydus Lifesciences on Monday remained unanswered till press time.

India’s pharmaceutical market is valued at $60 billion, ranking third globally by volume and eleventh by value, with annual exports at $30.5 billion. India also produces 20% of the world’s generic medicines by volume and supplies over 60% of global vaccine demand, according to government data.

What states have been told

“The CDSCO has established a Digital Monitoring System on the Online National Drug Licensing System (ONDLS) portal to ensure robust oversight of the supply chain integrity and quality parameters of high-risk pharmaceutical solvents and excipients such as propylene glycol, glycerine, sorbitol, etc,” DCGI Rajeev Singh Raghuvanshi said in a letter to state and Union Territory drug controllers on 27 October.

The regulator told state drug controllers to issue direct instructions across their jurisdictions:

“You are requested to direct all manufacturers and vendors/suppliers of pharmaceutical-grade high-risk solvents within your respective jurisdictions to ensure mandatory registration on the ONDLS portal immediately, upload batch-wise data, including total quantities manufactured, Certificates of Analysis (CoA), quantities supplied, vendor credentials, and complete onward distribution trails, etc. as per the information sought in the said portal,” the letter stated.

Drug makers backed the tighter tracking, though they fear delays in getting clearances. Nikkhil K. Masurkar, chief executive officer – ENTOD Pharmaceuticals based in Maharashtra, said that batch-level traceability of high-risk solvents is essential to prevent contamination and safeguard public trust in Indian medicines. The company specialises in ophthalmic drugs.

“The key challenge will now be to ensure seamless portal operations and timely NOC generation without disrupting manufacturing or raw material supplies,” Masurkar said.

“This measure will help prevent solvents that do not conform to pharmacopoeial grade from entering the pharmaceutical manufacturing supply chain,” said Viranchi Shah, national spokesperson at the Indian Drugs Manufacturers Association (IDMA) representing 1,200 companies.

Shah said the system will let makers trace every batch in a way that inspections and paperwork never could, and check that their ingredients come from verified suppliers.