KTR asks Centre for vaccine plan

Industries minister K.T. Rama Rao on Thursday requested Union health minister Dr Harsh Vardhan to constitute a high-level empowered committee comprising officials from the Centre, key state governments and industry to formulate a strategic plan to expedite the development of a vaccine for Covid-19.

Reminding that the PM-Cares fund had allocated `100 crore for indigenous vaccine development, Rama Rao requested the minister to expedite the formulation of guidelines for the release of funds to indigenous vaccine manufacturers. Rama Rao said Hyderabad-based companies were working towards developing the vaccine for Covid19. “I am proud to inform you that one of these companies is leading these efforts and should soon have its Covid-19 vaccine available in the market,” he added.

Stressing the need to decentralise some of the clearances and approvals which do not require very high-level scrutiny at the CDSCO (Central Drugs Standard Control

Organisation). He noted that CDSCO had a zonal office along with a sophisticated drug-testing laboratory headed by a Deputy DCGI rank official in Hyderabad. “We request you to kindly instruct CDSCO to delegate more powers and authority, with additional resources, to the zonal office in Hyderabad,” Rama Rao said.

Stating that India has one of the most complex regulatory systems in the world for vaccine approvals, Rama Rao suggested that the Centre set up a strict but simple and transparent regulatory regime to fast-track development of vaccines, and help the biotech industry in general. He stressed on the requirement for clear guidelines on the licensing of the Covid19 vaccine in the country on the lines of FDA and WHO guidelines.

He said, “while two companies lead the vaccine development efforts, there are several other companies joining the race. These efforts need to be expedited while still maintaining regulatory rigour. It is requested that a framework for parallel approvals for clinical trials be developed at the earliest.”