DCGI Alerts States, UTs Against Raw Materials From Maya Chemtech, Supplier Of Marion Biotech
The Drug Controller General of India (DCGI), Rajeev Singh Raghuvanshi has issued a letter to the states and union territory licensing authorities against the usage of raw materials produced by Delhi based Maya Chemtech India that supplied the ingredients for the drugs at Marion Biotech which caused the death of 18 children in Uzbekistan
The Drug Controller General of India (DCGI), Rajeev Singh Raghuvanshi has issued a letter to the states and union territory licensing authorities against the usage of raw materials produced by Delhi based Maya Chemtech India that supplied the ingredients for the drugs at Marion Biotech which caused the death of 18 children in Uzbekistan. The investigation done by the Central Drugs Standard Control Organisation (CDSCO) recently concluded that the cough syrups produced by Marion Biotech indeed led to the children’s deaths.
In the alert issued the top Indian drug regulator has confirmed that from 33 samples that were tested by CDSCO, 24 samples were 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,” informed Raghuvanshi in the alert.
He has urged the licensing authorities to issue directions to all manufacturers against using propylene glycol supplied by Maya Chemtech, the DGCI in the letter said, “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."
On 09th January the license of Marion Biotech was suspended after the pharma company failed to reply to Uttar Pradesh’s drug regulator’s notice on violations of manufacturing procedures at the company’s manufacturing unit. Presently, Marion Biotech is set to lose its manufacturing license altogether as the UP’s drug regulator has begun the process to reprimand the company.
According to media reports the regulator is also preparing to file a case against the founders of the company for producing and selling adulterated drugs. An FIR has also been registered by the CDSCO’s drug inspector from Ghaziabad, Ashish Kondal in which it has been alleged by the inspector that the company disposed of materials and records related to drug manufacturing. Three arrests have already been made in the case, Tuhin Bhattacharya, head of operations, Atul Rawat, manufacturing chemist, and Mool Singh analytical chemist stand detained by the police.