News Feature | September 4, 2014

India Considering Waiving Clinical Trials For Certain In-Demand Drugs

By Suzanne Hodsden

Currently, the Central Drugs Standard Control Organization (CDSCO) requires all drugs marketed in India to first undergo a local phase IV clinical trial, even if regulatory agencies from other countries have already approved the medication. However, recently, the New Drug Advisory Committee (NDAC) has proposed a waiver for two cancer drugs, Aflibercept and Trastuzumab, on the grounds that no alternative treatment currently exists to meet the demand.

Aflibercept is a treatment for metastatic colorectal cancer. The FDA and the EMA have approved the drug in patients who have already undergone an oxaliplatin treatment and experienced worsening symptoms. Trastuzumab is a monoclonal antibody used to treat Her2-positive breast cancer.

The NDAC argues that these diseases currently have no alternative treatment in India and should not be subject to the mandatory local clinical trial. A panel of experts met in early August and did discuss waivers for Aflibercept and Trastuzumab, but no final decision was made because no oncologist was present.

This newest proposal highlights the need for India to have a clear emergency/orphan drug policy. Under Indian law, the Drug Controller General of India (DCGI) can waive the trial requirement if it serves the ‘public interest,” but the law is not clear how these interests are defined.

So far, the CDSCO is proceeding with caution after a parliamentary panel discovered in 2012 that thirty-eight new drugs had been approved without the mandatory local trials and without adequate proof of emergency circumstances.

CM Gulhati, a drug regulatory expert, told the Economic Times, “The government’s hands should not be tied in situations of grave emergency, where it needs to bring to the country a drug already approved in a developed country and so needs to waive mandatory trials for the drug. Proper guidelines need to be drawn to demarcate what constitutes these emergencies.”

Ramesh Adige, pharma industry expert, stressed the need for clarity. He argued that not only were Indian patients in need of life-saving treatments, but the next public health epidemic might be just around the corner. “In such instances, there is no time to waste, if the drug or vaccine has gone through clinical trials in the U.S., Europe, or Japan.”