The Central Drug Standards Control Organization (CDSCO) has started an inquiry against Two domestic drug makers for allegedly selling a combination drug to treat hypertension without any prior mandatory approvals. CDSCO official said that we received a complaint from another company regarding this illegal launch of the medicine.
No pharma manufacture can launch any medicine without the approval from the Drug Controller General of India (DCGI). Despite this medicine has been approved in The US and Canada. CDSCO guidelines stated that if the medicine got approval from other countries but not in India, the manufacturer can go to phase III clinical trials directly. To establish safety and efficacy on the Indian population, Bioequivalence studies are also required.
The complaint is clearly stated that the medicine is not gone through phase III clinical trials and launched illegally in India. Regarding this Mint has sent an email to Zydus Cadila and Intas Pharma, but they not responded and after repeated texts, the news has disclosed to Press Media.
Actually, Hetero Drugs Ltd applied for the manufacturing and marketing approval in December 2015 and after noticing about this medicine launch in India, Hetero Drugs filed a complaint against them.
In the complaint, the company mentioned that our company has conducted bio-equivalence and clinical trials in July 2017 for this medicine and completed the bio-equivalence study and submitted its report to the DCGI in September 2017. The trial is done to test the rate and extent of absorption of drugs in the human body. But the medicine is already in the market and sold by various companies without any approvals. The product that came into notice has been marketed from Uttarakhand, with state FDA (Food and Drugs Administration) license. The hetero company also said that they spent a lot of money for these mandatory trials and questioned DCGI “if the clinical trials are required on Indian patients or should we apply to get final permission on priority”.
DCGI has started inquiries and sent letters to the state drug controller and the companies to come clean on the issue.