It has also been proposed that if the cough syrup is manufactured in a plant/section approved by the regulatory agencies of these countries for any product, such cough syrups may also be allowed to be exported to any country without testing.
According to a recent report of the Central Drugs Standard Control Organisation (CDSCO), cough syrup samples collected from more than 100 pharma units in the country had failed quality tests and had the same toxins that were found in the cough syrups that were linked to deaths of children in Gambia, Uzbekistan and Cameroon.
The sub-standard batches were declared as “not of standard quality” (NSQ) for parameters such as diethylene glycol (DEG) or ethylene glycol (EG), it said.
Earlier, the government had notified that cough syrups manufactured in India can be exported only if they pass quality tests conducted by approved laboratories and on production of certificate of analysis.”The Cough syrups were permitted to be exported only after the samples were declared as of standard quality by any of the above laboratories,” the CDSCO said.Several laboratories, including government-run and private labs across the country, have since been conducting tests in the aftermath of reports linking India-made cough syrups to 141 child fatalities globally.
In May last year, the Drug Controller General of India (DCGI) had asked state drug controllers “to give instructions to their state-owned NABL-accredited laboratories to analyse the samples received from the manufacturers of cough syrups for export purpose on top priority and issue the test report at the earliest”.
The Directorate General of Foreign Trade (DGFT), too, had issued a similar order.
To strengthen the checks, the CDSCO, with the help of state drug control departments, has been carrying out inspections of the cough syrup manufacturing units and distributors of propylene glycol to map the supply chain.
