Union government is gearing up to develop India’s bio-manufacturing capability and its research initiatives. It is also monitoring the efforts in the area of reagents development for malaria, kala azhar and cholera vaccines, in addition to the development of affordable tests for diabetes. While the ministry of health and family welfare, which has a dedicated health research wing, is focusing on the development of vaccines for tropical diseases control, the Department of Biotechnology(DBT) is working on the draft of the bio-manufacturing policy.

India has proved that vaccine manufacture which is exported to over 110 countries has helped to control some of the dreaded diseases including polio, stated minister for health and family welfare Ghulam Nabi Azad.

The government is also working to strengthen the regulatory framework. It has directed the Drugs Control General of India (DCGI) to set up a Task Force to develop a regulatory framework for biological and biotech drugs. The policy for regulation can be approved by the Vision Group on biotechnology and the department of biotechnology.

“The pharma sector has a framework in place and now we needed a dedicated framework for the biotech industry to adhere to”, stated the union minister for health.

According to Dr. MK Bhan, secretary, department of biotechnology, “in order to increase our focus on the same, we will develop the draft of bio-manufacturing policy. For this we are working with the ABLE”.

Plans are also underway to come out with the setting up of 8 incubators across the country and one is in Bengaluru within the premises of the National Centre for Biological Sciences. He also stated that DBT would also commission an Academy for biotechnology in Bengaluru in a few weeks.

“We need to look at significant transformations for the sector. In order to witness development in the sector, we need to strengthen the regulatory issues. We are also looking bringing in the present Drugs Control infrastructure on similar lines of the US FDA. This is because the whole system of biotechnology is complex. There is also the need to set up a regulatory training school. We need solid support from researchers and scientists who are seeking drug approvals who require regulatory officials of the same wavelength to comprehend their efforts. These need to be mooted at a faster pace, to bring in outsourcing business from the bio-manufacturing space”, stated Dr. Bhan.

A combination of regulatory changes to setting up academia for access to trained workforce will help the growth of biotechnology industry, pointed out the DBT secretary.