FICCI asks govt to recast adverse rules of 2013-14 to revive clinical trial industry

The Federation of Indian Chamber of Commerce and Industry (FICCI) has asked the Union health ministry to recast the adverse regulations introduced in the year 2013-14 as there is an urgent need to revive the clinical trial sector in the country to address the burden of existing and new diseases. According to the FICCI, India has witnessed heightened activism and media sensationalism targeting clinical research resulting in a slew of new regulations. While these regulations have been well-intentioned, they have proved to be disastrous for clinical research in the country and the long-term future of pharmaceutical innovation in India.  “There is an urgent need to revive the sector to address the burden of existing and new diseases. This would include recasting of adverse regulations introduced in 2013-14”, the FICCI said in its wish-list submitted recently to the new Union health ministry Dr Harsh Vardhan. It further said that a framework of internal operating procedures should be put in place for the efficient functioning of the regulatory authority in order to maintain a high level of documentation, probity, and transparency. The functioning of the regulatory authority should be subject to regular audits. Summary audit data in appropriate format should also be available in the public domain.  The regulatory authority should function at a high measurable standard of customer service with regards to research applicants. This should include time-bound review and disposal of applications. Customer service metrics should be available in the public domain in a timely manner. Besides, the CDSCO should be strengthened through a comprehensive programme of up-gradation of qualifications, skills and experience of personnel dealing with the review of research applications within the regulatory authority. Several issues pertaining to BA-BE studies, compensation packages, long processing time due for approvals etc. needs to be streamlined for reviving clinical trials in the country. The FICCI also demanded to the government to create awareness amongst judiciary, media and civil societies in order to enable them to take informed decisions. Source:Pharmabiz