KTR pitches for localisation of vaccine approval

Hyderabad: IT Minister KT Rama Rao on Thursday urged the Union Health Ministry to decentralise the authority for fast-tracking testing and approvals for vaccines. The Minister on Thursday wrote a letter to the Union Health Minister Harshvardhan on vaccine development efforts in the State.

Rao said that presently all vaccines were sent to the 'Central Drug Laboratory' in Kasauli in Himachal Pradesh. This was set up during British times as the cold weather in Kasauli was conducive for vaccine testing and certification.

Due to Covid pandemic, companies have struggled with logistics and have not been able to send the sample batches of vaccines to CDL. He said that for India to be a more efficient and competitive destination, it will be critical to decentralise some of the clearances/approvals, which does not require very high-level scrutiny at the CDSCO headquarters.

Reminding that CDSCO had a zonal office along with a sophisticated drug-testing laboratory in Hyderabad, the Minister requested the Union Minister to instruct CDSCO to delegate more powers and authority, with additional resources, to the zonal office in Hyderabad. This will help industries with expeditious clearances and immensely contribute to the Aatma Nirbhar Bharat, said Rao.

The Minister said that three Hyderabad-based companies are working towards developing the vaccine for Covid-19. "I am proud to inform you that one of these companies is leading these efforts and should soon have its Covid vaccine available in the market," he said mentioning about the other companies involved in manufacturing drugs such as Hydroxychloroquine, Favipiravir, etc that were actively used to treat Covid patients. Rao said that the country had one of the most complex regulatory systems in the world for vaccine approvals.

There are six different ministries at the Central and State level that give approvals for vaccines - Ministry of health GOI, Ministry of Animal Husbandry GOI, Ministry of Science and Technology GOI, Ministry of Commerce GOI, Ministry of Environment and Forests GOI, and Ministry of Health State Governments. The Minister wanted decentralization of the authority for fast tracking of approval of medicine.