The Central Drugs Standard Control Organisation (CDSCO) has written to the state drug regulators asking them to ensure that drug manufacturers duly test the raw materials as well as the finished products before each batch is released into the market.
The move follows reports of deaths of children in Madhya Pradesh after consuming cough syrup.
“… During the inspections carried out at the manufacturing facilities and in the investigation of the drugs declared not of standard quality, it was observed in the reports that the manufacturers are not carrying out testing of each batch of excipients, or inactive and active pharmaceutical ingredients, for verification of compliance with prescribed standards before using them,” a letter sent on Tuesday by the country’s apex drug regulator to its state counterparts said.
The letter from the CDSCO also urged the state regulators to ensure that all drug manufacturers have a “vendor qualification system” in place so that raw materials from only reliable companies are utilised for making drugs.
According to rules, all drug manufacturers are required by law to test each batch of raw materials as well as the finished products at their own end or at a state-approved laboratory, maintaining the records for inspections as and when needed. The drug inspectors, though, are not regularly required to check the tests for each batch of the medicines. Such inspections are usually carried out if a product is found to be not of standard quality or if there is any complaint against the manufacturer.
High levels of the toxic compound diethylene glycol (DEG) — which led to acute kidney failure in children from MP’s Chhindwara district — end up in syrups as contaminants in the permitted solvent propylene glycol, experts said. This solvent is usually available in the market in both industrial grade, which may contain higher levels of impurities, and pharmaceutical grade where the levels have to be maintained under 0.1%.
Manufactured by a Tamil Nadu-based firm, Coldrif, one of the cough syrups consumed by the affected children, was allegedly found to contain as high as 48.6% DEG. At least 14 children died after allegedly consuming cough syrups.
An expert on drug regulation, on condition of anonymity, said that with drug regulators not going through these test reports on a regular basis, many companies forgo the step. This is true particularly in the case of firms that do not have in-house facilities for advanced tests such as gas chromatography, which is required for the detection of the colourless, odourless contaminant, the expert added.