Local Indian Committees to Conduct Annual Inspections of Trial Sites

By Zachary Brennan

- Last updated on GMT

Local Indian Committees to Conduct Annual Inspections of Trial Sites
Clinical trial sites in India will be inspected at least once a year under a new regulatory plan issued by the CDSCO.

Each of the zonal offices under India’s Central Drugs Standards Control Organization (CDSCO) will be required to create expert committees to conduct the inspections and maintain records of the names and qualification of trial investigators, according to a new order from CDSCO.

Chinu Srinivasan of the All India Drug Action Network told In-Pharmatechnologist.com that there was not much, if any, oversight of clinical trial sites from the zonal offices prior to this order. He added that other expected improvements to the trial industry include “committees set up for SOPs [standard operating procedures] on various aspects of clinical trial regulation​,” as well as other committees to deal with “illegal and irrational​” fixed-dose combinations.

Srinivasan noted that the reports on the committees will come out by June or July.

The creation of independent committees to help regulate the country’s drug industry has become more common in recent months. India’s Ministry of Health and Family Welfare in March announced​ the creation of two other independent committees to help CDSCO regulate the country’s drug and clinical trial industries.

Earlier last month, CDSCO also said that monitoring the clinical trials and the adverse events from the trials would both be top priorities.

But the prioritization of trials may not attract more attention to what is becoming a fledgling industry in India. The number of trials approved peaked in 2010, with 500 approved, though in 2012, only about 260 were approved, according to CDSCO statistics​. Recent media reports​ said that the backlog of trials awaiting approval this year also has fallen.

Clinical trial specialists from Sanofi recently told Outsourcing-Pharma.com that the outlook for conducting trials in the country remains bleak.

India’s Supreme Court

All of the recent action government action follows the Indian Supreme Court’s rejection of an initial government affidavit​ in January. The affidavit dealt with how CDSCO’s plans to overhaul its oversight of the country’s clinical trial industry in the wake of a parliamentary report criticizing the agency for trial approvals and patient deaths.

The top court was set to hold a hearing on the matter May 8 but the All India Drug Action Network’s Srinavasan said the hearing did not take place and the next hearing is slated for July.

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