Clinical Trials ( GCT ) in currently under evaluation and would be operational soon .
Launch of Pharmacovigilance programme in India for safety reporting of marketed drugs .
Safety reporting guidelines – CDSCO has issued guidelines for reporting SAEs in case of clinical trials . It includes the timelines for reporting of SAE and responsibilities of various stakeholders involved .
Compensation Guidelines – CDSCO has issued guidelines for providing medical management and compensation to the trial subjects in case of clinical trial related injury or death . They have also come up with a formula for calculating compensation .
All the above efforts have been undertaken to check the wrong doings and ensure greater patient safety . The number of clinical trial applications submitted to CDSCO has increased since 2013 . Industry has now again started to believe in the regulatory framework in India and have started to re-think to consider India as a potential participant for clinical trials .
Challenges and possible immediate measures
Due to uncertainty in regulations and hence approvals over the last 3-4 years , many multinational companies and smaller companies for drugs and devices halted their clinical research work in India . With improvements in regulations , the CROs are now once again highlighting the need to conduct trials in India . However , while many global companies resumed their clinical research work in India , further significant improvements needs
Restraining the maximum number of trials per investigator deteriorates the situation to select required number of sites particularly in oncology trials where there are limited numbers of veteran investigators available .
to be seen in this front . One of the ultimate challenges is to build confidence midst the global stakeholders in India ’ s new regulatory environment , which is “ now a more positive environment for clinical research in the country ”. Though the indigenous companies have started to again consider conducting clinical trials in India , there still exists hesitation in the mind of global investors which needs to be taken care of .
Limitation of maximum number of clinical trials per investigator to three is another major challenge . Restraining the maximum number of trials per investigator deteriorates the situation to select required number of sites particularly in oncology trials where there are limited numbers of veteran investigators available . The industry lost significant amount of skilled professionals to other areas of medical research . To attract skilled professionals back to clinical research industry is proving to be tough challenge .
While there have been improvements in approval timelines , any further reduction will be greatly welcomed by the industry . The government representatives should participate in various international conferences and other events dedicated to clinical research with the aim to advertise the fact that with the improved regulations , we have been become more conducive towards conducting clinical trials .
Timely policy interventions could make outlook bright
We are a nation of 1.3 billion people with many health challenges . Medical and clinical research is important not only for global clinical trials but also for local and academic trials so that the unmet and specific needs of Indian subjects are addressed . As long as we are able to systematize regulatory approvals in a timely manner , improve the quality of clinical research professionals , address the infrastructure issues , the industry is bound to improve significantly . Strict oversight by the Indian regulators is utmost essential for the growth of the Clinical Research Industry .
DR RENU RAZDAN
Dr Razdan is currently the Vice President Operations at JSS Medical Research India . With experience of over a decade and half , she has also served as COO at the Max Neeman International and at erstwhile Ranbaxy Laboratories as Senior Manager Business Development then Head of Exports . Dr Razdan holds a PhD in Biochemistry from German Cancer Research Centre ( DKFZ ), Heidelberg , Germany .
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