5 lakhs Product Permissions, 4,880 Mfg Licences issued: Gujarat FDCA

Besides this, Gujarat today boasts of over 700 plus WHO-GMP units and 130 US FDA approved drug manufacturing units in the country.

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FDA

The Gujarat Food and Drug Control Administration (FDCA) has been able to register a total of five lakh product licenses and 4,349 manufacturing licenses through its first-of -its kind online platform –drug manufacturing license application (DMLA) software in the country.

As per the data on manufacturing licenses, there are 3, 349 allopathic units, 867 ayurvedic units, 665 cosmetics units and 9 homeopathic units, the data of which is available online.

Besides this, Gujarat today boasts of over 700 plus WHO-GMP units and 130 US FDA approved drug manufacturing units in the country.

Gujarat also has the distinction of having 28 per cent of drug exports to developed markets including the US.


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The Gujarat pharmaceutical industry is also upbeat as around 900 out of 1,100 plants had started operations in the state despite lockdown. Most of these plants produce formulations.

DMLA enables regulators to deliver efficient paperless services on time for granting product licenses for APIs, single ingredients and formulations under the allopathic segment.

Medicine Factory
Picture: Pixabay

Under this online programme, all the manufacturers under the allopathic segment should apply for product license in the state through 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 fresh license, renewal of licenses and additional product permission.

It generates instant information on total number of product licenses granted on real time basis thereby offering easy access to the availability of medicines in stock along with all the details of the manufacturers.

Gujarat FDCA Commissioner Dr H G Koshia said, “Gujarat FDCA has also been able to register 41386 wholesale and retail licensees online till date in a time bound manner through online Extended Licensing Node (XLN) system set up in the state in 2007.”


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