Last Updated on January 21, 2024 by The Health Master
Gujarat FDCA
In a significant stride towards modernizing regulatory procedures, the Gujarat FDCA (Food and Drug Control Administration) is set to launch its pioneering m-governance program.
With the successful completion of all three phases of safety audits, this innovative initiative is poised to benefit a staggering 55,600 stakeholders across the state.
Notably, this includes 3,800 allopathic drug manufacturers as well as 50,000 drug medical stores and wholesalers.
Enhancing Accountability and Transparency Through Mobile Applications
The initiative by Gujarat FDCA is a user-friendly mobile application designed to cater to all stakeholders, from drug manufacturers to medical stores.
The program’s primary objectives encompass instilling accountability, ensuring transparency, promoting inclusivity, fostering uniformity, and facilitating timely actions.
Importantly, these goals are set to be achieved without any disruption to existing systems and protocols.
Streamlined Access to Regulatory Information
One of the key advantages of the m-governance model is its ability to merge various online platforms into a single, seamless interface.
This consolidation promises faster, real-time access to application statuses, making the process more efficient and user-friendly.
This initiative seeks to eliminate the need for stakeholders to navigate multiple platforms, offering a unified and streamlined experience.
Transition from E-Governance to M-Governance
Gujarat FDCA Commissioner, Dr. H G Koshia, highlights the shift from the traditional e-governance model to the innovative m-governance paradigm.
The new model brings all licensees under a single platform, simplifying access to crucial regulatory information, licensing procedures, protocols, and processes.
The result is the seamless issuance of licenses and swift redressal of issues and grievances. It’s noteworthy, however, that homeopathy licensees have not been included in the initial rollout.
Mobile-Centric Approach for Effective Oversight
Underpinning the m-governance framework is the transition to mobile applications for all operations.
This transition extends to mobile testing, enhancing the effectiveness of governance and vigilance at the grassroots level.
This mobile-centric approach empowers authorities with real-time connectivity, enabling seamless monitoring and governance.
Revolutionizing Licensing Procedures
Previously, all operations were carried out offline, necessitating applicants to physically visit the office for application submission, follow-ups, and license retrieval.
To streamline these processes, Gujarat FDCA, in collaboration with the National Informatics Centre (NIC) of the Government of India, developed the cosmla.gujarat.gov.in web portal.
This portal offers a user-friendly platform for the issuance of licenses, characterized by transparency and stringent regulatory oversight.
Decade-Long Evolution: From DMLA to Cosmetics Licensing
Gujarat FDCA’s journey towards digitization began in 2011 with the development of the online platform for drug manufacturing license applications (DMLA).
This software revolutionized the delivery of efficient paperless services, expediting the granting of product licenses for APIs and formulations in the allopathic segment.
The state also pioneered the online Extended Licensing Node (XLN) system in 2007, facilitating the online grant of medical stores and wholesale sales licenses.
Furthering their commitment to good governance, Gujarat Chief Minister Bhupendra Patel launched the cosmetic manufacturing license portal on December 1, 2022.
This platform aims to make the licensing process transparent, accountable, and less time-consuming.
Gujarat’s Thriving Pharmaceutical Landscape
Gujarat’s pharmaceutical landscape is characterized by its impressive numbers.
The state boasts over 3,700 allopathic manufacturing units, 830+ ayurvedic manufacturing units, 826 cosmetics manufacturing units, and 9 homoeopathy manufacturing units.
Beyond this, Gujarat proudly hosts 1,081 WHO-GMP units and an impressive 140 USFDA approved drug manufacturing units, firmly establishing its position in the pharmaceutical domain.
In conclusion, the Gujarat FDCA’s forward-thinking m-governance initiative is poised to revolutionize the regulatory landscape for drug manufacturers and medical stores alike.
By harnessing the power of mobile technology and streamlining processes, this initiative sets the stage for enhanced accountability, transparency, and efficiency in the pharmaceutical sector.
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
PIL for Generic Drug Prescription: Supreme Court notice to NMC
Glenmark fined $30 million to resolve drug price-fixing charges
USFDA gives ANDA approval for Tacrolimus Ointment 0.03%
USFDA gives nod for this cancer treatment generic injection
Drug recall: Alembic, Aurobindo recall these drugs for this reason
National Policy ready for R&D in Pharma-Medical Device Industry
USFDA gives approval for this drug to treat Rare Blood Disease
India launches Rs 5,000 Crore R&D Incentive Scheme for Pharma Industry
Major FDA audit findings about Equipment and Instruments
DCGI issued alert for falsified this diabetes management drugs
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:
