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CDSCO makes application process for PAC in BA/BE study through online from Oct 8

Our Bureau, New Delhi
Friday, October 1, 2021, 08:00 Hrs  [IST]

In line with its efforts to digitise and streamline the regulatory submission procedures, the Central Drugs Standard Control Organisation (CDSCO) is switching the facility for Post Approval Changes (PAC) process from offline to online with effect from October 8, 2021.

The Drugs Controller General of India (DCGI), in a notice, said that in order to streamline the regulatory submission procedure, the submission of applications on Post Approval Changes in Bioavailability (BA)/Bioequivalence (BE) study permission and import license for export purpose is functional on online system of Sugam portal.

Applicants seeking for approval of such PACs may now apply through the online portal, it said.

“The facility of offline submission of applications in hard copy or through e-mail may not be available after October 8, 2021, for processing,” added the notice, issued to all stakeholders, State and Union Territory Licensing Authorities and others.

The Sugam e-governance portal has been designed as a single window system for all the stakeholders to access the services provided by the portal, by implementing role based access control and actions. It has consolidated the entire drug regulatory framework at centre and provides a centralised dashboard for monitoring various regulatory clearances all over the country.

The portal is well integrated with the e-Nivesh that is the National portal to provide the project proponent/entrepreneur with all requisite information under one umbrella, which will reduce delays in various regulatory processes. SUGAM enables ease of business by providing the integrated workflow right from making an application for grant of permission/license, online payment, online review process, query management and grant of permission/license online. SUGAM portal internally builds the database of drugs & manufacturers and their current regulatory status (approved/banned) in India, according to Centre for Development of Advanced Computing (C-DAC), which created the portal.

According to the SUGAM portal, the authority has received around 14,728 applications in the BA/BE division, of which 12 are new, 13,506 are approved and 620 applications are rejected. There are 175 applications in process, 415 applications in which queries have been raised, in the division, it says.


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