Only emails, pen drives or Google Drive — the country’s apex drug regulatory agency will stop accepting paper-based documentation for granting approvals and manufacturing licences for drugs, devices and vaccines, News18 has learnt.
To promote ‘Digital India’, the Central Drugs Standard Control Organisation (CDSCO) has asked its offices across India to accept “only soft copies”. The new rule will come into effect from February 1.
The regulatory agency, on January 25, “issued instructions requesting all zones, sub-zones, port offices, laboratories to switch over from physical files to e-file for processing of all offline applications for the smooth and efficient functioning of CDSCO’s e-office domain”.
According to the latest notice, accessed by News18, “all applicants or stakeholders are requested to submit their applications, bulky dossiers, documents, query replies etc…in the form of soft copy…”
Many government offices at both the state and central levels are transitioning to digital processes, aiming to enhance transparency in their day-to-day operations. This shift comes in response to challenges such as misplaced files and the creation of duplicate documents for the same issues.
For example, the Comptroller and Auditor General of India (CAG) declared on April 1 last year that all audit operations throughout India would transition to digital platforms. It eliminated the need for physical files across its 130 offices. This development ensured seamless record-keeping without the burden of managing vast quantities of physical documents while maintaining transparency and records for eternity.
All Functions Shifted to Digital Applications
The notice explains that the rule applies to stakeholders submitting applications or documents related to WHO Good Manufacturing Practices (WHO-GMP), private testing labs, manufacturing licenses, blood banks, vaccines, DNA forms, veterinary products and other miscellaneous applications – covering the majority of functions of the regulator.
The order clarifies that new submissions should be via pen drive or Google Drive. “The bulky dossiers, documents, query replies etc. may also be forwarded through e-mail in the scanned copy, preferably less than 20 MB in pdf format,” it said.
The order said: “No hardcopy of the application will be accepted by this office from 01 February 2024.”
“All manufacturers or stakeholders may ensure strict application submission in electronic mode, without which their applications cannot be accepted or processed further,” said the notice while adding that “co-operation in the matter in the implementation of e-office to promote digital India is highly solicited.”
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