Hospitals and medical research organisations that conduct clinical trials on humans may soon face surprise inspections from the regulatory authorities.
The hospitals, the sponsor pharma companies and the institutional ethics committees that oversee these trials will all come under the regulator’s scanner.
“The inspections have been planned to create confidence among various stakeholders on ethical and scientific standards followed by Indian clinical research organisations while testing new medicines on humans,” said Surinder Singh, Drugs Controller General of India (DCGI).
The office of the DCGI, under the health ministry, has started training officials for this. Full-fledged inspection teams will be in place by December 2009.
According to Singh, the core inspection team will comprise a drug inspector, a pharmacologist and a clinician. While the drug inspector will oversee the compliance with regulatory requirements, the pharmacologist will scrutinise the management of clinical data. The clinician or the doctor will look into the safety aspects.
The office of the DCGI, in collaboration with the United States drug regulator, the USFDA (United States Food and Drugs Administration), has just concluded an initial training session for a 25-member core team drawn from the regulator’s office and various research institutions.
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The members of this group will be in charge of zone-wise training for inspection squads. Singh said the national core group would be split into four to train the inspection teams. Live audits in hospitals will be a part of the training.
The controller’s office is also in the process of framing inspection guidelines for its teams. “We will frame the guidelines, validate them and implement them uniformly across the country. There are about 500 ongoing clinical trials in the country and we need to have a proper system to track these”, Singh said.
The health ministry will soon set up an expert committee of clinical trial experts, industry representatives and regulators to prepare the draft guidelines. The committee will submit its recommendations within six weeks. “We intend to finalise the guidelines by the year-end,” Singh said.
According to a recent KPMG study, Indian clinical research market is projected to reach $600 million by 2010.