Last Updated on September 30, 2024 by The Health Master
Regulatory
The Central Drugs Standard Control Organization (CDSCO) has taken a significant step towards modernizing India’s pharmaceutical regulatory landscape.
A series of innovative digital initiatives, unveiled at the iPHEX 2024 event, aim to enhance transparency, efficiency, and safety within the industry.
These initiatives, spearheaded by the Drugs Controller General of India (DCGI) Dr Rajeev Singh Raghuvanshi, are poised to revolutionize how the pharmaceutical sector operates.
National Single Window System (NSWS): A Unified Platform
One of the key initiatives is the National Single Window System (NSWS).
This centralized platform aims to consolidate all regulatory approvals at the national level, eliminating the need for multiple interfaces.
By streamlining the process, the NSWS will significantly reduce the time and effort required for industry players to obtain necessary licenses and approvals.
While currently operational for medical devices and clinical trials, the system is set to be expanded to cover other regulatory aspects in a phased manner.
Online National Drug License System (ONDLS): A Digital Revolution
Another crucial initiative is the Online National Drug License System (ONDLS), also known as the “One Nation-One Drug Licensing System.”
his digital portal, managed by CDSCO, offers a standardized approach to drug licensing across all states and union territories.
By ensuring uniform requirements and interpretations, the ONDLS aims to eliminate inconsistencies and discrepancies in the licensing process.
The system also maintains a comprehensive database of licenses, enabling efficient verification and ensuring regulatory compliance.
Track and Trace System: Ensuring Product Traceability
To enhance product traceability and combat counterfeiting, CDSCO is introducing the Track and Trace System.
This system will utilize QR codes or barcodes to track the movement of active pharmaceutical ingredients (APIs) and top formulations.
Starting with the top 300 brands of formulations, the system will gradually be extended to cover all remaining formulations, vaccines, and narcotic drugs.
Streamlined Subject Expert Committee (SEC) Meetings: Faster Decision-Making
To expedite the decision-making process, CDSCO has implemented streamlined Subject Expert Committee (SEC) meetings.
These meetings will allow for more efficient applicant presentations and faster disposals.
Additionally, a two-tier appeal mechanism will be in place to address any grievances.
Doorstep Delivery: Convenience and Regulatory Oversight
CDSCO’s Doorstep Delivery initiative will enable the sale and delivery of prescription drugs directly to consumers’ homes.
This measure aims to enhance convenience for patients while maintaining strict regulatory oversight.
SUGAM Portal: A Comprehensive Digital Platform
The SUGAM portal serves as a one-stop-shop for all import-related processes, clinical trials, human and veterinary drugs, cosmetics, medical devices, and ethics committee approvals.
By integrating various regulatory functions, the SUGAM portal simplifies compliance and provides easy access to regulatory services.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
Key Notes on Revised Schedule M: Must read
Important short notes for Industry and Regulators
CDSCO Guidelines on Drug Recall
Quality Assurance Vs Quality Control in the Pharma Industry
Major FDA audit findings about Equipment and Instruments
Understanding GMP, cGMP, and WHO-GMP
Quality Assurance in the Pharmaceutical Industry
Duties and responsibilities of QA person in Pharma Industry
Difference: Disintegration and Dissolution test in pharma industry
Understanding DQ, IQ, PQ, and OQ in the Pharma Industry
Dissolution test: Importance in Pharma Industry
Strengthening Drug Regulatory System in India: A Comprehensive Analysis
USFDA approval granted for Brimonidine Tartrate Ophthalmic Solution: Lupin
Revamping the Indian Pharma Supply Chain: A Comprehensive Report
Supreme Court stays notification omitting Misleading Advertisement Rule
Drug recall: Aurobindo, Glenmark, FDC recall drugs due to Quality Issues
CDSCO must maintain a registry of all Brand Name of Drugs: Dr BR Jagashetty
Jan Aushadhi: A Lifeline for Affordable Healthcare in India
Pharma Industry seeks more time to implement Revised Schedule M
Govt notifies Delhi Drug Inspector Recruitment Rules
156 Drugs banned in India: Download list
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
