Firm Under CDSCO Lens Over 'Unapproved' Drugs

Firm Under CDSCO Lens Over 'Unapproved' Drugs

HYDERABAD, 22 MARCH 2018: After conducting raids on the companies allegedly manufacturing “unapproved” drugs in Haridwar in Uttarakhand, the Central Drugs Standard Control Organisation (CDSCO) has decided to issue notices to the firms, including those located in Hyderabad, for marketing them.


Drug Controller General of India (DCGI) Dr S Eswar Reddy told TOI, “During recent searches in Haridwar, we found firms manufacturing drugs without prior approval from CDSCO. We found one of the companies, Mascot Health Series Private Ltd, manufacturing Napi-Bor and the same is marketed by Hyderabad-based Hetero Healthcare Ltd. We will be issuing notice to Hetero Healthcare for marketing this drug.”


He said during the searches in Haridwar they found 112 products and 73 new combinations are being manufactured and marketed by big companies. CDSCO is contemplating moves like cancellation of licences by the state drug authorities. CDSCO said fixed dose combination has not yet been approved under the Drugs and Cosmetics Act, 1940.


When contacted by TOI, Hetero Healthcare has denied the allegations made by DCGI. Namburi Bose, director (logistics) of Hetero Healthcare, said: “NapiBor is not a new drug. It is 8-10 year old. After four years, there is no need for DCGI approval. The drug is licensed by the Uttarakhand Drug Control Administration authorities and the licence is still valid.”


Bose further said: “Hetero Healthcare is not marketing any unapproved drug. We are not manufacturing any drug and we are a third party marketing company. We give purchase orders only for licensed drugs. We have been marketing this drug for the last six to nine months.”


Central drug officials say though the drugs are approved outside the country and not in India, phase III clinical trials and bioequivalence studies have to be taken up to test the safety and efficacy on the local Indian population.


Officials said state drug control authorities are granting licences without approval from DCGI and that there were no ‘safety trials’ conducted on these drugs. The drugs in question seized are anti-fungal medicines and creams and diabetes-controlling drugs.The Times Of India