New Delhi : To expedite and regulate the testing of COVID-19 vaccine, the Central Drugs Standard Control Organisation (CDSCO) is in the process of putting a functioning mechanism in place.
The office is in the process of identifying two additional testing laboratories besides the National Institute of Biologicals, Noida (NIB Noida) and the Central Drugs Laboratory, Kasauli (CDL, Kasauli)
Dr Eswara Reddy, Joint Drugs Controller General of India said, “For the first time, a step is taken by the government to authorise vaccine manufacturers to produce the drug substance and drug product of the COVID-19 vaccine for commercialisation during the clinical trial development. However, they can release these batches in the market only after the grant of marketing authorisation by the CDSCO and manufacturing licenses issued by the state authority.”
The objective of this provision is to ensure that sufficient quantities of vaccines are available once the marketing authorisation is granted by the regulators.
“We are continuously interacting with the international regulatory agencies to understand the expectations and the various regulatory tools they are using for the decision making process. We are also in touch with the WHO to understand the current situation and decisions which should be taken on marketing authorisation,” informed Reddy.”
Touching on the challenges, Reddy informed, “We have granted permission to conduct a clinical trial on a healthy population, but the efficacy and immunogenicity of these vaccines in special populations like pregnant women, comorbid situation, children are a great challenge for the manufacturers as well as for the regulators.”
“The other challenge which we have identified and what we have already started addressing is batch releasing by the Central Drug Laboratory (CDL). Our CDL Kasauli is already engaged in the release of vaccines with a good number of batches for the approval process. We have made sure that whatever the batches are produced and sent to our laboratories are going to be tested well within a timeline. So that’s why we have sufficient capacities to test the COVID–19 vaccines by central drug laboratories. Fortunately, the two vaccines which are front runners, do not require any animal testing and their required testing time will be very less. The maximum required time for the stability test will be 14-16 days and then the batch can be released by our laboratories,” explained Reddy.
He further added, “We have also prepared for additional capacities and identified other laboratories for batch release. We are going to have at least two which are ready for testing and an additional two are in the pipeline. I understand from the industry that as on date we are expecting around 40 commercial batches to be released per month. However, both the laboratories i.e., NIB Noida, and the CDL Kasauli are able to test 300 batches of the COVID-19 vaccine per month. Overall, we are expecting around 70-80 batches in the next six to seven months, but at the CDSCO we are ready to test the batches and we are permitting parallel testing of COVID-19 vaccines manufactured at the CDL, thereby we can save at least 20 days’ time. We have also done skilling, training of our CDL laboratory staff and verification of methods used for testing of COVID-19 vaccines is also going on in our laboratories.”
Some of the other challenges identified by the CDSCO in developing COVID-19 vaccines are:
1) Follow up study to evaluate long term safety
2) Duration of immune response and risk of disease enhancement as antibody titers wane
3) clinical trials in special populations, pregnant women, comorbid situations, children etc.
4) Transmission of the virus from vaccinated people
5) Clinical Trial, adaptive design
6) Containers and closers syringes
7) Lead time for packaging, cold chain vehicle
8) Supply chain