Late last month the Indian regulator announced it would no longer accept “offline” requests to conduct clinical trials, marketing applications or other registration documents for vaccines.
The move is part of a wider “E-Governance” initiative designed to streamline regulatory processes for manufacturers and make best use of agency resources.
A representative told us "CDSCO as a part of the comprehensive e-Governance program has launched the portal in November, 2015. As a part of the strategy, various services are being launched in phases. More than 70% of our services are now online."
He said the portal has a number of advantages for vaccine firms.
"India is a large country and the manufacturers including those of vaccines are located across the country. [Previously] applications for clinical trials, MA, Import registration etc were accepted only at the CDSCO Hq at Delhi," adding that, "Sugam gives a convenience to file the application sitting at the applicant’s office."
The Department of Information technology under the Government of India manages the database and is responsible for ensuring its security according to the CDSCO representative.
“Even the CDSCO employees cannot download the data without authorisation. The data can only be viewed and cannot copied," he said.
Online
The Central Drugs Standard Control Organisation (CDSCO) launched the Sugam platform in November 2015.
Since then the regulator has gradually expanded the range of documents drug and cosmetic firms can submit through the portal.
In February last year, it announced medical device developers could file through the portal.
The following April, CDSCO established a database of drug manufacturing facilities within the system. The aim was to allow manufacturers to upload details of production sites for verification by state regulators.
Vaccine developers have been able to seek approval for trials, submit marketing authorization applications, register vaccines or seek import licenses for such products since January last year. However, until this month they were also asked to submit hard-copy requests.