Last Updated on January 5, 2024 by The Health Master
The Gujarat Food and Drug Control Administration (FDCA) has issued a license to set up 784 new manufacturing units in the past year in the state.
As of today, Gujarat has a total of 6.9 lakh product licenses and has issued 5,203 manufacturing licenses.
Today, Gujarat has:
- 3,533 allopathic manufacturing units,
- 835 ayurvedic manufacturing units,
- 826 cosmetic manufacturing units,
- 9 homeopathic manufacturing units.
- As per the data on manufacturing licenses issued last year:
The state drug regulator issued 4,349 manufacturing licenses last year. Detail:
- 3,349 allopathic units,
- 867 ayurvedic units,
- 665 cosmetic units,
- 9 homeopathic units.
Also read: USFDA-Gujarat FDCA to meet to discuss GMP compliance, capacity building
Besides this, Gujarat today boasts over 1,081 WHO-GMP units and 140 US FDA-approved drug manufacturing units in the country.
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.
Since its development in 2011, the DMLA online platform has been effectively utilized by the Gujarat FDCA in the country.
Following Gujarat’s online licensing model for sales licenses, over 16 states in the country replicated the model.
With the implementation of the online system, the process is now paperless and less time-consuming.
The Gujarat government has also revised the timelines for the grant of manufacturing licenses and renewal of licenses to 60 days and for the grant and renewal of sale licenses to 30 days under the Right of Citizens to Services for speedy issuance of licenses.
Under this online platform, all the manufacturers in the allopathic segment should apply for product licenses in the state online only.
Gujarat FDCA‘s DMLA also approves technical person’s details, company profile, certificate issue, inspection, sampling report, and fresh firm registration, apart from issuing the fresh license, renewal of licenses, and additional product permission.
It generates instant information on the total number of product licenses granted on a real-time basis thereby offering easy access to the availability of medicines in stock along with all the details of the manufacturers.
“Gujarat FDCA has also been able to register 48809 wholesale and retail licensees online to date in a time-bound manner through the online Extended Licensing Node (XLN) system set up in the state in 2007,” informed Gujarat FDCA Commissioner Dr. HG Koshia.
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