India’s apex drug regulatory agency, Central Drugs Standard Control Organisation has issued an alert to states and union territories confirming adulteration found in drug samples from Uttar Pradesh-based Marion Biotech. Issued by drug controller general of India Rajeev Singh Raghuvanshi, the alert states that the samples have failed quality tests.
The pharmaceutical firm is at the centre of a row over the death of children in Uzbekistan. In December last year, Uzbekistan’s health ministry had shared details of the issue with India’s health ministry.
Studies by Uzbekistan’s primary laboratory had shown the presence of ethylene glycol – a deadly chemical found to be responsible for deaths in Gambia – in Marion manufactured Dok-1 Max syrup.
The Central Drugs Standard Control Organisation (CDSCO), an arm under the ministry of health and family welfare, had conducted an investigation along with state drug regulatory officers. According to the alert, the probe found that the drug samples had failed quality tests. Out of 33 samples drawn, 24 are not-of-standard quality whereas 22 are adulterated or spurious.
“This is with reference to investigations conducted at Marion Biotech… In connection with the deaths of children in Samarkand, Uzbekistan,” stated the alert sent to licensing authorities of all states and UTs on Tuesday.
“During the course of the investigation, a total of 33 samples were drawn by drug inspectors of CDSCO NZ RTDL, Chandigarh has now forwarded the test reports of 30 drug samples, wherein 24 samples were declared as not of standard quality and out of these samples 22 samples fall under the category of adulterated/spurious under Section 17A and 17B of the Drugs and Cosmetics Act (sic),” said the alert as accessed by News18.
On January 13, News18 first reported details of the investigation report prepared by the food safety and drug administration in Lucknow. The report reflected “very poorly” on Marion, revealing multiple lapses in the manufacturing process.
The drug controller general of India (DCGI) has instructed officials to prevent the use of raw materials manufactured by Delhi-based drugmaker, Maya Chemtech, and issue directions to all manufacturers to stop procuring from the firm.
“It is further informed that Maya Chemtech was mainly the supplier of propylene glycol, which has been used in the impugned batches,” the alert said. “In view of the above, you are requested to issue directions to all manufacturers in your jurisdiction not to use propylene glycol supplied by Maya Chemtech.”
The DCGI further asked states and UTs to act in “public interest” by keeping a “strict vigil on the matter” and taking “stringent action against offenders”. He concludes the letter, stating that the matter is being referred for “strict implementation”.
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