Telangana bats for Indian vaccine industry, wants Centre to clear bottlenecks

HYDERABAD: Telangana, which houses several vaccine manufacturers who account for a third of global vaccine production, has appealed to the union government to clear the bottlenecks being faced by the industry pertaining to clinical trials, manufacturing, funding, and policy on licensing and procurement of vaccines before the country loses its competitive advantage to other nations.
The Telangana industries minister KT Rama Rao in a letter to the union health minister Harsh Vardhan on Thursday appealed to constitute a high-level empowered committee with representation from the government and industry to formulate a strategic plan to expedite the development of the vaccine for Covid-19 to assert India’s position as the global vaccine hub.

This comes a couple of days after Rao interacted with the vaccine manufacturers in Hyderabad where the industry representatives had aired concerns over the absence of guidelines in India for vaccine making and immunisation, and funding commitment from the government.

Telangana has appealed to the Centre to formulate a robust procurement policy in consultation with the industry to ensure vaccine availability and its equitable distribution.

The Telangana minister sought the Centre to announce clear guidelines on the licensing of the COVID-19 vaccine, while pointing out that USFDA and WHO have already published the guidelines on the development and licensure of COVID-19 vaccine.

There is a need for similar guidelines in India to help facilitate the timely development of safe and effective vaccines for COVID-19. These guidelines shall also remove subjectivity and allow all manufacturers to adhere to common guidelines and standards,” said Rao.

Rao has sought the Centre to decentralise the central regulatory agencies for fast-tracking of testing and approvals for the vaccines by empowering the zonal Central Drugs Standard Control Organisation arms to avert the constraints of the industry in sending all the vaccine samples from across the country to the CDSCO headquarters.

“I am pleased to note that CDSCO has a zonal office along with a sophisticated drug-testing laboratory headed by Deputy DCGI (Drug Controller General of India) rank official in Hyderabad and we request you to kindly instruct CDSCO to delegate more powers and authority, with additional resources, to the zonal office in Hyderabad,” said the Telangana minister, adding that it helps the domestic vaccine industry with expeditious clearances to swiftly contribute to the Aatma Nirbhar Bharat.

Batting for the cause of the Indian vaccine industry, Rao urged the Centre to look at setting up a strict but simple and transparent regulatory regime to fast-track development of vaccines, while pointing that “India has one of the most complex regulatory systems in the world for vaccine approvals.”

India now has six different ministries at the central and state level that give approvals for vaccines including the union ministries of health, animal husbandry, science and technology, commerce, environment and forests, and state health ministries.

Referring to an allocation of Rs 100 crore from the PM CARES fund to provide funding support for indigenous vaccine development, Rao urged the Centre to “expedite the formulation of guidelines for the release of funds to indigenous vaccine manufacturers.”

Rao has also appealed to the Centre to set up another fund “to support manufacturing companies in advanced stages of clinical trials to help scale up their manufacturing capacities. This will help faster production of vaccines.”

Apart from seeking to expedite the approvals for clinical trials and manufacturing, the Telangana minister sought the Centre to allow the vaccine manufacturers “to maintain stockpiles of the vaccine being used for clinical trials so that the stockpile can be immediately released in the market on successful clinical trials. This will reduce the time to make the vaccine available as manufacturers enhance their manufacturing capacities to scale production.”