Express News Service
NEW DELHI: The Drugs Controller General of India (DCGI) has issued an alert to licensing authorities in states and Union territories against the use of raw materials manufactured by Delhi-based Maya Chemtech India, which supplied ingredients for cough syrups, produced by Marion Biotech, that were linked to the death of 19 children in Uzbekistan.
The Central Drugs Standard Control Organisation (CDSCO) had earlier issued a notice to Marion Biotech asking it to stop the sale and distribution of two products, stating that the sample was found to be “not of standard quality”.
Maya Chemtech was the main supplier of propylene glycol, which was used in the impugned batches.Rajeev Singh Raghuvanshi, the new Drugs Controller General of India, has confirmed that out of 33 samples that were tested by CDSCO, 24 were found to be not of standard quality. “Out of these samples, 22 samples fall under the category of adulterated/spurious under Section 17A and 178 of the D&C (Drugs and Cosmetics) Act, 1940,” he said in his letter.
The samples were collected by a joint team of Uttar Pradesh state and central drug controllers after Uzbekistan claimed that 18 children died after consuming a syrup manufactured by Marion Biotech.“Accordingly, you are requested to instruct your enforcement officials to keep a strict vigil on the matter and take stringent action as per the provisions of the said Act and rules against the offenders in the public interest,” he said.
Marion Biotech, a registered business company in Uzbekistan since 2012, exported Ambronol syrup and Dok-1 Max cough syrups to Uzbekistan. The company’s licence was suspended on January 9 after it failed to reply to the state drug regulator’s notice on violations of manufacturing practices at its production unit.
NEW DELHI: The Drugs Controller General of India (DCGI) has issued an alert to licensing authorities in states and Union territories against the use of raw materials manufactured by Delhi-based Maya Chemtech India, which supplied ingredients for cough syrups, produced by Marion Biotech, that were linked to the death of 19 children in Uzbekistan.
The Central Drugs Standard Control Organisation (CDSCO) had earlier issued a notice to Marion Biotech asking it to stop the sale and distribution of two products, stating that the sample was found to be “not of standard quality”.
Maya Chemtech was the main supplier of propylene glycol, which was used in the impugned batches.
Rajeev Singh Raghuvanshi, the new Drugs Controller General of India, has confirmed that out of 33 samples that were tested by CDSCO, 24 were found to be not of standard quality. “Out of these samples, 22 samples fall under the category of adulterated/spurious under Section 17A and 178 of the D&C (Drugs and Cosmetics) Act, 1940,” he said in his letter.googletag.cmd.push(function() {googletag.display(‘div-gpt-ad-8052921-2’); });
The samples were collected by a joint team of Uttar Pradesh state and central drug controllers after Uzbekistan claimed that 18 children died after consuming a syrup manufactured by Marion Biotech.
“Accordingly, you are requested to instruct your enforcement officials to keep a strict vigil on the matter and take stringent action as per the provisions of the said Act and rules against the offenders in the public interest,” he said.
Marion Biotech, a registered business company in Uzbekistan since 2012, exported Ambronol syrup and Dok-1 Max cough syrups to Uzbekistan. The company’s licence was suspended on January 9 after it failed to reply to the state drug regulator’s notice on violations of manufacturing practices at its production unit.
