Published On
02 September 2024
Tags
healthcare, drugapproval, CDSCO, DCGI, pharmaceuticals, digitalregulation, pharmatech, India
Authors
Namrata Sinha (Partner), Mahir Shaparia (Associate) and Isha Akat (Associate)
The Central Drugs Standard Control Organisation (CDSCO) showcased its digital initiatives at iPHEX 2024, a major pharmaceutical industry event held in Greater Noida from 28 - 30 August 2024.
These initiatives aim to enhance transparency, improve efficiency, and ensure high safety and quality standards in the pharmaceutical sector.
Key Initiatives:
a) National Single Window System: A unified platform for all national-level regulatory approvals, currently partially implemented for medical devices and clinical trials.
b) Online National Drug License System: A digital portal for uniform drug licensing across India, standardizing requirements and maintaining a comprehensive license database.
c) Track and Trace System: Introduces traceability for active pharmaceutical ingredients and top formulations using QR codes or barcodes.
d) Streamlined Subject Expert Committee meetings: Allows for more inclusive and efficient applicant presentations, with a two-tier appeal mechanism.
e) Doorstep Delivery initiative: Enables direct sale and delivery of prescription drugs to consumers' homes using registered emails.
These initiatives are part of the Indian government's "Digital India" mission, aiming to empower stakeholders with efficient and transparent regulatory systems.
The CDSCO aims to reinforce India's position as a global leader in pharmaceuticals while maintaining a focus on quality and safety. (Source)
This material is for general information only and is not intended to provide legal advice. This material is distributed with the understanding that the authors are not rendering legal, accounting, or other professional advice or opinions on specific facts or matters and, accordingly, assume no liability whatsoever in connection with its use.