New Delhi: The Central Drug Standards Control Organization (CDSCO) has initiated an inquiry against the two domestic drug makers Zydus Cadila and Intas Pharma for allegedly launching a combination drug to treat hypertension without mandatory prior approval after receiving a complaint from Hetero Drugs Ltd.
Law of the land requires that prior to launching any product in the market, a drug maker needs to seek approval from the Drug Controller General of India (DCGI). However the same was not done in case of a certain hypertension drug alleged another pharma company Hetero in its complaint to CDSCO.Hetero alleged that the company had launched the drug without conducting mandatory trials.
Mint reports that the particular drug has received the nod for launch only in the United States and Canada till now. According to the clinical trials guidelines of the CDSCO, if the product is approved elsewhere and not in India, phase III clinical trials and bio-equivalence studies are required to establish its safety and efficacy on the Indian population.
Hetero drugs Ltd had applied for manufacturing and marketing approval for its hypertension drug in December 2015.
The recommendation of the drug advisory body led the company to conduct bio-equivalence and clinical trials in July 2017. It submitted its report to the DCGI in September this year.
During the trials, Hetero Drugs found out that the combination drug they were trying to launch, was already out there in the market.
Quoting the complaint Mint states that “We noticed that the above-mentioned combination was launched into the market by various companies without having DCGI approval (form 46). The product has been supplied from Uttarakhand, with the license from state FDA (Food and Drugs Administration).”
According to officials at the DCGI office, an inquiry has been initiated against the companies and questions raised against Uttarakhand state drug controllers.
One official in the DCGI office told Mint, “Letters have been sent to the state drug controller and the companies to come clean on the issue. The license of the companies can be canceled if the complaint is found to be true. The product cannot be launched without the approval of DCGI.”