New Delhi: In reaction to the recent deaths in Madhya Pradesh attributed to the contaminated cough syrup, the Central Drugs Standard Control Organisation (CDSCO), India’s top drug regulator has issued a new advisory. Dr Rajeev Singh Raghuvanshi, Drug Controller General of India (DCGI) in the advisory urged drug regulators of all states and Union Territories to strictly ensure testing of every batch of raw materials and finished formulations before it is forwarded for sale.
The advisory comes after the death of several infants in Rajasthan, Madhya Pradesh, Jammu and other states including in foreign countries like Gambia and Uzbekistan. The DCGI noted that several manufacturers are not testing every batch of excipients and APIs. It said after the inspections that there is a lack of compliance with required quality control standards. This, as per the CDSCO is a clear violation of the Drugs Rules, 1945.
Key instructions by DCGI to Drug regulators of States/UTs
- Intensify inspections of manufacturing units.
- Verify that testing is being carried out for every batch.
- Ensure no batch released without test reports.
- Monitor manufacturers’ internal quality-control systems.
- Take “necessary measures” to enforce testing, sampling, verification.
The DCGI also instructed that the manufacturers are allowed to test either in their own approved lab, or any licensed third-party laboratory approved by authority. The CDSCO also reminded the drug regulators of states and UTs to strictly comply with Drugs Rules, 1945. This is to avoid any incidence of contamination as observed in India and abroad.
cause of toxicity in cough syrups
The main cause of toxicity in cough syrups is its contamination with industrial-grade solvents which are highly toxic. The industrial-grade solvents like diethylene glycol (DEG) and ethylene glycol (EG) are used as cheaper substitutes for pharmaceutical grade glycerine or propylene glycol.
The industrial-grade solvents are considered highly toxic even in small doses and can severely affect the body including acute kidney injury, neurological damage, metabolic acidosis, and multi-organ failure, which can lead to death particularly in children.
These toxic solvents enter the syrup due to failure in testing the raw materials or excipients before it is used for production. The experts commented that proper batch testing could have prevented the deaths.