Coronavirus pandemic: DCGI to expedite approvals of COVID-19 drugs, vaccines

News date: 27 March 2020Source:

The drug regulator said in case of emergency, they are would granting import license without registration certificate subject to approval of government.

In an effort to provide quick access to vaccines and drugs to treat COVID-19, the Drug Controller General of India (DCGI) has announced several measures including expediting reviews and approvals for drugs and vaccines already approved in other countries. The Indian drug regulator will also grant speedy permissions for clinical trials, waiver of data requirement for animal studies and approval of manufacturing licenses within seven days.

The drug regulator said, in case of emergency, it is granting import license without registration certificate subject to approval of the government.

At least three Indian vaccine Serum Institute of India, Zydus Cadila and Bharat Biotech are developing vaccine for COVID-19, other drug companies like Cipla are working on developing antiviral drugs that are considered to work against COVID-19. Many public research laboratories and pharma companies are developing vaccines, antibody therapies and repurposing existing drugs for COVID-19.

"Any firm or research institute having protocol for repurposing of existing drugs/vaccines for treatment of COVID-19 will also be given priority for review and approval," VG Somani, Drug Controller General of India (DCGI) said in a notification.

Applications for clinical trial permission and application to import or manufacture drug or vaccine for sales and distribution would be processed on priority through expedited review and accelerated approval, the notification said.

"Any firm having a drug or vaccine already approved for COVID-19 in any other country can directly approach DCGI for expedited review and accelerated approval," DCGI said.

Data requirement for animal toxicity study, clinical study, stability study etc. may be abbreviated, deferred or waived on case to case basis depending upon the type of vaccine, nature of drug, plant from which the drug is extracted and its experience in case of phyto-pharmaceuticals, the notification added.

Application to manufacture or import drugs or vaccines for test, analysis or clinical trial may be processed within seven days.