New Delhi: A joint working group (JWG) formed under the aegis of the Indian Council of Medical Research and Sun Pharmaceuticals Ltd, along with experts from International Centre For Genetic Engineering and Biotechnology and All India Institute of Medical Sciences, is planning to propose an overhaul for the drug regulatory system, vaccine development and clinical trials in the country.
The initial ideas mooted for updating the drug regulatory system include political support for the Drug Controller General of India’s regulatory framework, making public the decision for rejection or approval of a drug, maintaining timelines for regulatory approvals, regulatory control on data quality and appointment of specialized reviewers of drug process approval.
The meeting, conducted on Thursday, also involved founder of Sun Pharmaecuticals Dilip Shanghvi and ICMR chief Soumya Swaminathan. The body is expected to reach out to the Drug Controller General of India and other pharmaceutical companies to thrash out more details before making its representation to the government.
“The Sun Pharma, through the JWG, will seek consideration of government to initiate development of science-based regulatory systems and appropriate oversight of clinical trials. This is an important aspect of the JWG and would require participation of all stakeholders in academia, pharma industry and the government," said a statement from Sun Pharma.
The JWG is also likely to prioritize a list of diseases that a larger working group, comprising of representation from the drug regulator and other pharmaceutical companies, will focus on before the next JWG meeting which is scheduled not until another four months.
“The idea is to brainstorm and come up with ideas that streamline the drug regulatory process and make it easier for all parties involved. For example, we could look at introducing something like priority vouchers on the lines of the US FDA (Food and Drug Administration) for the Central Drug Standards Control Organization. A systematic process overhaul is something that will make the drug regulatory framework of the country consistent with global standards," said Altaf Lal, co-chair, JWG and senior advisor, Global Health, Sun Pharma.
The US FDA’s “priority vouchers" incentivize pharmaceutical are incentives to spur the development of new treatments for orhphan diseases–ones that generally do not attract interest due to the cost of development and the lack of market opportunities.
Other proposals discussed include capacity-building in clinical trial facilities in government hospitals, having better animal testing facilities and disease models.
“We are also looking at inviting the industry to partner with us–whether it is capacity building for clinical trials or revamping the drug regulatory system," said Swaminathan.