K.T. Rama Rao, the Information Technology, Electronics and Communications Minister of Telangana, updated the Central Government regarding the process.
Mr. Rao, on the 7th of August, urged the Central Government to decentralize authority for fast track the long process of testing and approvals of vaccines of the Novel Coronavirus or COVID-19.
Mr. Rao, wrote to Harsh Vardhan, the Union Health Minister regarding the same.
In the letter, KTR updated Dr. Harsh Vardhan about the ongoing vaccine development efforts in the State.
Mr. Rama Rao urged the former to initiate steps for speedy approval of clinical trials, fast-track procedures for development and licensure of COVID-19 vaccine, manufacturing and procurement policy, and funding support for vaccine development.
KTR wrote, “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 to have fast vaccine approval it is 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.
KTR said, “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.”
Considering the difficult process of approval in India, Mr. Rao said, “Hence, it is suggested that India needs to have a regulatory framework that can hold good for global competition and ensure quality with speed.” He added, “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.”
Hyderabad’s Biotech International Private Limited with the Indian Council Medical Research (ICMR) developed a potential candidate vaccine for the Novel Coronavirus.
The clinical trials for the potential vaccine is undergoing.
Stay tuned for further updates.