New Delhi: Two domestic drug makers are under the scanner of the pharmaceutical regulator for allegedly launching a combination drug to treat hypertension without mandatory prior approval.
The Central Drug Standards Control Organization (CDSCO) initiated an inquiry against Zydus Cadila and Intas Pharmaceuticals after receiving a complaint from another drug company conducting clinic trials for the launch of the same project, said a senior CDSCO official on condition of anonymity.
A drug maker needs approval from the Drug Controller General of India (DCGI) before launching any product.
The drug has so far been approved for launch only in the US and Canada. 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.
The complainant alleged that the product had been launched without mandatory trials being conducted.
Zydus Cadila and Intas Pharma did not respond to an email sent by Mint on 6 November and repeated text messages till the time of going to the press.
The complainant—Hyderabad-based Hetero Drugs Ltd—had in December 2015 applied for manufacturing and marketing approval.
The drug advisory committee, which consists of experts on the subject, recommended that the company conduct bio-equivalence and clinical trials in July 2017.
The company completed the bio-equivalence study and submitted its report to the DCGI in September 2017. The study is done to measure the rate and extent of absorption of drugs in the human body.
When the trials were still on, it was found that the combination drug is already available in the market.
“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 licence from state FDA (Food and Drugs Administration)," read the complaint, a copy of which was reviewed by Mint.
A fixed dose combination contains two or more drugs combined in a fixed ratio of doses, available in a single dosage form.
Hetero Drugs said in its complaint it had spent a lot of money on the trials and asked DCGI “if the clinical trials are required on Indian patients or should we apply to get final permission on priority".
According to officials at the DCGI office, an inquiry has been initiated against the companies and questions raised against Uttarakhand state drug controllers.
“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 cancelled if the complaint is found to be true. The product cannot be launched without the approval of DCGI," one official in the DCGI office said on condition of anonymity.