New Delhi, October 8: A health expert from the Standing National Committee on Saturday flagged several "missing links" in the World Health Organisation's (WHO) claim of over 66 deaths due to cold and cough syrup produced by Maiden Pharmaceuticals Ltd and sought a thorough probe.
"The first death was reported in July, but the WHO informed the regulator in India on September 29. The Indian government has not received a complete causality assessment. Out of the 23 samples tested, four were found to contain diethylene glycol/ethylene glycol. The missing links must be probed," Dr YK Gupta, vice-chairman, Standing National Committee.
He said any country that imported drugs should first get them tested as per the defined standards, which were missing in this case. "When the drug is exported, it is tested and a certificate of analysis is issued and the importing country also gets it tested as per the defined standards or their Pharmacopeia. It seems this was somehow missed," he said.
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"Medicines produced in India are now known for their quality in the international market and it would be wrong to question their quality because of just one incident. Our regulatory body is strong and we have zero tolerance for all this," Dr YK Gupta said.
"The new drugs are approved by a central authority- the Drugs Controller General of India (DCGI) or Central Drugs Standard Control Organisation (CDSCO). However, the drugs- which are already approved and are present in the market have a manufacturing license and a production license issued by the state drug controller. And hence, it falls into the purview of a state controller," he added.
Gupta further emphasised on public awareness regarding the license availability for the exported medicinal drugs. "Cough syrups sold in India don't have this possibility," Dr Gupta said.
Dr Gupta later stressed that without the completion of the investigation, casting a bad image of the entire drug manufacturer in India should be avoided.
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-PTC News with ANI inputs
