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Gujarat FDCA’s m-governance programme to be rolled out soon as all three phases of safety audit conclude
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Shardul Nautiyal, Mumbai
August 23 , 2023
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The Gujarat Food and Drug Control Administration (FDCA)’s flagship m-governance programme will soon see the light of the day as all three phases of safety audit have been concluded to benefit 55,600 stakeholders in the state including the 3,800 allopathic drug manufacturers and 50,000 drug retailers and wholesalers.
A mobile application for all the stakeholders including the manufacturers and retailers is aimed at bringing in accountability, transparency, inclusivity, uniformity and timeliness without disrupting the existing systems and protocols. The m-governance will merge all the online platforms at one place for faster, real time access towards getting status of the application in a seamless manner.
“Gujarat FDCA’s transition from its e-governance model to m-governance model will help all the licensees under one single platform to facilitate easy access to regulatory information, licensing rules, procedures, protocols and processes towards seamless issuance of licenses and timely redressal of issues and grievances. The m-governance system will have an oversight from a senior FDA official of the Assistant Commissioner rank. However, homeopathy licensees have not been included currently,” informed Gujarat FDCA commissioner Dr H G Koshia.
All the applications will be on mobile as per the m-governance model which will also include mobile testing to bring in effectiveness of governance/vigilance at grassroots level. Effective utilization of capacity and instruments and real-time connectivity for monitoring and governance are the other advantages of the m-governance model.
Earlier, all operations were done offline for which the applicant had to come in person to apply in the office, follow up the application and get the license. To do all the above operations online, the officials of Gujarat FDCA and National Informatics Centre (NIC), Government of India (GoI) then created a web portal cosmla.gujarat.gov.in to ease the issuance of licenses with transparency and stringent regulatory oversight.
Since its development in 2011, the Gujarat FDCA online platform drug manufacturing license application (DMLA) software has enabled regulators to deliver efficient paperless services on time for granting product licenses for APIs and formulations under the allopathic segment. Gujarat also launched an online Extended Licensing Node (XLN) system in 2007 for online grant of retail/wholesale sales licenses. Gujarat Chief Minister Bhupendra Patel on December 1, 2022 had launched the cosmetic manufacturing license portal to make the licensing process transparent, accountable and less time consuming as part of Gujarat government’s good governance initiative.
Currently, Gujarat has over 3,700 allopathic manufacturing units, 830 plus ayurvedic manufacturing units, 826 cosmetics manufacturing units and 9 homoeopathy manufacturing units. Besides this, Gujarat today boasts of over 1,081 WHO-GMP units and 140 US FDA approved drug manufacturing units in the country.
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