A high-level Task Force on 'Development of Manufacturing Capabilities in each Medical Vertical in Pharmaceutical Production' has recommended to the government to create a vision document with short and long term plan for plasma industry in the country.
In its report on policy support to biopharma, prophylactics and OTC verticals, the task force asked the government to create a vision document with short and long term plan for plasma industry in the country, as this industry is very challenging, demanding and has a very long-term effect on return on investments. It also asked the government to frame a policy to encourage the voluntary collection of plasma “Source Plasma” in India for plasma fractionation.
Besides, the task force asked the government to create a mechanism to allow use of the expired blood samples/excess plasma by the fractionation centres. This will take care of about 30 per cent of the requirements. Further, it recommended to the government to develop harmonised regulatory guidelines/policy for stem cell research and clinical trials.
In its report on regulatory issues, the task force recommended to the government for regulatory approval for importing different categories of plasma/fractions/ intermediate and paste. It asked the government to create a facilitative regulatory landscape for plasma industry to grow and evolve, which would involve office of Drug Controller General of India (DCGI), National Institute of Biologicals (NIB), Department of AIDS Control (DAC), Indian Pharmacopoeia Commission (IPC) and National Pharmaceutical Pricing Authority (NPPA).
There should be a Fast Track mechanism for grant of licence for manufacturing of the vaccines, preferably a single window system, the task force recommended and further asked the government to reduce the present approval timelines for biopharmaceutical products in order to expedite commercial manufacturing. Validity of the import test license (form 11) and test license (form 29) should be increased from 1 year to 3 years, it said.
Earlier in December 2014, the department of pharmaceuticals (DoP) had constituted this task force under the chairmanship of secretary, DoP, to identify focus areas for development of manufacturing capabilities in the respective medical vertical keeping in mind the specificities of each medical discipline. The task force had submitted its report to the government in January this year.
The task force was asked to identify the gaps in domestic manufacturing in these verticals and suggesting ways to overcome them and also to identify the issues and support required from different government agencies and departments for achieving the manufacturing capabilities and filling the gap areas, if any, in each medical vertical.