India taking further steps to reform clinical trial industry
Most recently, CDSCO (Central Drugs Standard Control Organization) released a draft bill that would make a few changes around patient compensation, which comes in addition to moves by the Supreme Court to engage regulators around trial ethics. Some of the preliminary moves seemed to cause a slight rebound in the number of trials being run in India last year, though current numbers of trials have not been disclosed by CDSCO.
Harish Kuppam, business intelligence analyst at Quintiles India, told Outsourcing-Pharma.com that in “response to all the chaos [that] happened due to regulatory fluctuations in the Indian clinical trial industry,” governing bodies are now taking some major steps to reform their ways.
For instance, the Ministry of Health is working to provide accreditation to clinical trial centers, investigators and ethics committees, Kuppam told us, noting that “any misuse or violations in the future would make them lose their accreditation.”
In addition, an expert committee headed by Prof. Ranjit Roy Chaudhury has formulated policies, guidelines and SOPs (standard operating procedures) for new drugs and clinical trials. “These are boasted to be one of its kind for the complete transparent, foolproof and streamlined protocols for clinical trials,” Harish said.
Prof. Chaudhury's committee “has already started scrutinizing the new drug approval documents submitted by pharma companies.” Chaudhury’s Technical Review Committee deliberates and decides whether a trial should be approved, and he noted that only protocols for which there is a definitive need in the country should be approved. He also said investigators should not conduct more than three trials at a time.
Severe punishments, such as “five year terminations,” will apply for new drug approvals and were imposed on the applicants whose documents were found to be fabricated or falsified, Kuppam said.
He also cautioned that a significant amount of time is needed to implement these developing policies and guidelines so the current pace of adding new clinical trials in India is expected to remain slow.
“However, the newly formed government in India seems to be actively supporting industries that can potentially increase the country's economy and provide new job opportunities,” he added. The moves in clinical trials come as India is also working to control widely spreading diseases like H1N1 and Ebola.
