Zydus, Intas under scanner for launching drug without permit

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 Organisation (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 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 November 6 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 panel recommended that the firm 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.