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Fast-track vaccine process: KTR to Centre

IT and Industries Minister K T Rama Rao has sought decentralization of authority for fast-tracking the long drawn process of testing and approvals of vaccines.

In a letter to Union Minister for Health and Family Welfare Harsh Vardhan on Thursday about the ongoing vaccine development efforts in the State, Rama Rao urged the former to initiate steps for speedy approval of clinical trials, fast-track procedures for development and licensure of Covid vaccine, manufacturing and procurement policy, and funding support for vaccine development.

“Presently all vaccines are sent to the Central Drug Laboratory (CDL) in Kasauli, Himachal Pradesh. Due to Covid-19, companies are unable to send the sample batches of vaccines to CDL. The Drug Controller General of India (DGCI) took note of these logistic challenges faced by the vaccine manufacturers and asked them to forward only the summary of each batch and lot to CDL through email along with necessary undertakings. I appreciate the relief offered by DCGI to vaccine manufacturers in the interim,” he said.

He pointed out that for India to be a more efficient and competitive destination, it was critical to decentralize some of the clearances and approvals which do not require very high-level scrutiny at the CDSCO (Central Drugs Standard Control Organization) headquarters. “The CDSCO has a zonal office along with a sophisticated drug-testing laboratory here and we request you to kindly instruct CDSCO to delegate more powers and authority,” Rama Rao said.

Stating that the country has one of the most complex regulatory systems in the world for vaccine approvals, the Minister pointed out that there are six different ministries at the Central and State level that give approvals for vaccines. “Hence, it is suggested that India needs to have a regulatory framework that can hold good for global competition and ensure quality with speed,” Rama Rao said, adding that there was a requirement for clear guidelines on the licensing of Covid-19 vaccine.

While two companies lead the vaccine development efforts, there are several other companies that have joined the race towards potential Covid-19 vaccines, he said, and urged the Union government to allow vaccine manufacturers to maintain stockpiles of the vaccine to be used for clinical trials so that it can be immediately released in the market on successful completion of clinical trials. “This will reduce the time to make the vaccine available as manufacturers enhance their manufacturing capacities to scale production,” he said.

“As we wait for the first vaccine to get approved, it is requested that a robust procurement policy should be formulated in consultation with the industry to ensure vaccine availability and its equitable distribution,” he said, and suggested speedy formulation of guidelines for release of funding from PM-Cares. “Another fund may be set up to support manufacturing companies in advanced stages of clinical trials to help scale up their manufacturing capacities. This will help faster production of vaccines,” Rama Rao said.

Suggesting constitution of a high-level empowered committee to formulate strategic plans to expedite the development of vaccine in India for Covid-19, he said that it was needed to assert our position as the global vaccine hub.

The Minister pointed out that Hyderabad had come to be known as the “Vaccine Capital of the World,” manufacturing 5 billion doses every year which is also one-third of the global vaccine output. He mentioned that three Hyderabad-based companies were 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 added.

The Minister also mentioned about other companies involved in manufacturing drugs such as hydroxychloroquine, favipiravir, among others, that are actively used to treat Covid patients.

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