ICMR-Sun Pharma group to moot drug regulatory, vaccine development overhaul
The
group is likely to prioritize a list of diseases that a larger working group,
comprising of representation from the drug regulator and pharmaceutical firms,
will focus on before the next meeting.
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.
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