Two days before World Clinical Trials Day, India’s Ministry of Health and Family Welfare has allowed manufacturers to make and stock vaccines for COVID-19 which are currently undergoing clinical trials for marketing authorisation for sale or distribution. This move will expedite the availability of COVID-19 vaccines in the country as soon as they are approved post trials.

This move has been lauded by the industry. Dr Chirag Trivedi, President, ISCR said, “This is a welcome move by the Ministry of Health and Family Welfare during this time of the COVID-19 pandemic. This will allow vaccine manufacturers to start manufacturing vaccine batches concurrently while clinical trials are ongoing. If the vaccine trial outcome is successful, this will help save time for the vaccine to be made accessible to the public since the vaccine can be made available immediately after seeking the due regulatory permissions. Thus, this will help in the quick vaccination of the Indian public.”

Dr Rajeev Dhere, Executive Director, Serum Institute of India said, “This is a very good step initiated by the Central Government and certainly, it will expedite the availability of the product in the market subject to clearance of the clinical trial.”

“I feel if the manufacturers follow the given methodology, guidelines and all the regulatory requirements, then similar permissions should be given to other vaccines as well,” he further opined.

A senior research scientist from the industry also complimented the move and said, “This is a good move by the Indian regulatory authorities. It will take care of the early launch of the COVID-19 vaccine with a condition of conducting successful completion of clinical trials.

However, though certain rules have been deferred by the government in the public interest to meet the emergent situation that has arisen out of COVID-19, the permission is subject to a few conditions.

As per a notification issued by the Central Government, in case anyone intends to manufacture and stock a vaccine for COVID-19, which is under clinical trial for marketing authorisation for sale or distribution, then, they need to obtain permission through Form CT-06 to conduct clinical trials of that vaccine.

Then, they need to obtain permission for their vaccine (new drug) through Form Clinical Trial 23 (CT-23) from the Central Licensing Authority under the New Drugs and Clinical Trials Rules, 2019.

Post that, he/she will have to make an application under rule 75 or rule 75A of the Drugs and Cosmetics Rules, 1945, as the case may be, to the concerned licensing authority appointed by the State Government along with the permission obtained for conducting a clinical trial through Form CT-06 under the New Drugs and Clinical Trials Rules, 2019, for grant of license to manufacture and stock the vaccine for sale or distribution under the provisions of the Drugs and Cosmetics Act, 1940 (23 of 1940).

The notification also highlighted that in case of any inconsistency between this notification and any rule made under the Drugs and Cosmetics Act, 1940 (23 of 1940), the provisions of this notification, it shall prevail over such rule in the public interest to meet the emergency, which has arisen due to COVID-19 pandemic.

Commenting on these measures, the senior research scientist opined that despite some relaxations, there is a need to obtain manufacturing and storing permission from the Central licensing authority which can be avoided to save time. He further said, “A company can get the necessary permission to manufacture and store the vaccine from state licensing authority by showing the CT permission from the CDSCO, which they need to apply under Form 75 or 75 A as the case may be. However, the organisation has to complete the formalities later on for the manufacturing of the vaccine.”

The order has come into force on the date of publication in the Official Gazette i.e., May 18, 2020.