Drug Regulator Goes Paperless, Will Only Accept Soft Copies for Approvals and Licences from February 1
Pen drives, emails, and Google Drive — the government’s drug regulatory authority is no longer accepting documents written on paper to grant approvals and manufacturing permits for medicines or devices as well as vaccines News18 is reporting.
To promote “Digital India to promote ‘Digital India’, the Central Drugs Standard Control Organisation (CDSCO) has requested its branches all over India to take “only Soft copies”. The new rules will go into effect on the 1st of February.
The regulator the 25th of January “issued directions requesting that every zone, sub-zone ports offices, labs, and zones to convert from physical files to an electronic file to process all offline applications in order to facilitate smooth and effective operation of CDSCO’s e-office Domain”.
According to the latest announcement that was accessed through News18, “all applicants or interested parties are asked to submit their application forms, heavy dossiers, documents, and query answers, etc…in the form of soft copies …”
A lot of government departments at the national state and central levels are moving to digital procedures, to improve transparency and efficiency in day-to-day processes. The move is a result of issues including lost documents and the production of duplicate documents to address identical challenges.
In this case, for instance, the Comptroller and Auditor General of India (CAG) announced on April 1, 2013, that all audit and accounting operations in India were to be made digital platforms. The CAG eliminated the need to store physical documents across the 130 offices. The new system ensured a seamless recording without the hassle of coordinating massive quantities of physical files to preserve record-keeping and transparency for the duration of time.
ALL FUNCTIONS SHIFTED TO DIGITAL APPLICATIONS
The document explains how the rules apply to those that submit documents or applications in connection with WHO Good Manufacturing Practices (WHO-GMP) as well as private labs for testing licensing for manufacturing, blood banks and DNA forms, vaccines as well as veterinary products, and others miscellaneous requests – which cover most of the duties of the regulatory.
The new order clarifies that submissions must be made through pen drives as well as Google Drive. “The massive dossiers, documents queries, documents, etc. can also be sent via an e-mail with a scanned copy that is less than 20MB of pdf files,” it said.
The document read: “No hardcopy of the application will be considered at this office after January 1, 2024.”
“All producers or other stakeholders can assure a strict submission of applications in electronic format and without this, their applications are not accepted or further processed,” said the notice and added that “co-operation about the introduction of an electronic office to encourage digital India is greatly sought.”
