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Maha FDA's XLN technology expedites disposal of applications related to mfg licences

Shardul Nautiyal, Mumbai Tuesday, January 6, 2015, 08:00 Hrs  [IST]

With the introduction of online Extended Licensing Node (XLN) system, Konkan division of Maharashtra Food and Drug Administration (FDA) has been able to dispose around 14, 000 applications till date since April 2014 in a time bound manner.

These applications are related to loan licenses, test licenses, certificates, additional products and renewals. Officials also admit that the time required for clearance of licenses have been reduced considerably after the introduction of online Extended Licensing Node (XLN) system.

The system was introduced last year as part of the state FDA's drive to speed up the issuance of licenses and certificates in the state online.

Konkan division accounts for the maximum number of 800 licensed manufacturing units out of the state's 1703 pharma manufacturing units. Apart from renewal of licenses and licenses for additional products, applications for licensees also include certificates required for exports and others like free sale certificate, no conviction certificate, capacity certificate, general GMP certificate, GLP certificate and market standing certificate.

The new XLN system has led to drastic improvement in terms of processing of renewal of licenses and granting of certificates with no bureaucratic hassles. Says an official associated with the development, "The system has been able to simplify the process of granting certificates and licenses by virtue of the fact that procedures now happen in a paperless and seamless manner which has considerably brought down the time taken to as minimum as 15 days."

Maharashtra FDA is implementing the online system across the state in order to accomplish timely disposal of renewal of licenses, testing licenses, licenses for additional products, performance certificate and free sale licenses among others.  

The XLN system, according to a senior FDA official is a boon for over 1700 existing manufacturing units across the state as the system will deliver online approvals for over 6 certificates required by pharma manufacturing units.

A senior FDA official informed, "Training programme under the technical guidance of National Informatics Centre (NIC) has also been conducted at Pune, Nashik, Aurangabad and Nagpur divisions to sensitise officials about the attributes of the new online system."

There are 1703 manufacturing units in the state out of which 240 units are WHO GMP certified. There are 883 allopathic units, 452 ayurvedic units, 31 homoeopathic units and 337 cosmetic product units across the state. Exports of medicines worth Rs.15,500 crore have been accounted from Maharashtra in the year 2013-14.

 
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