Maharashtra Food and Drug Administration (FDA) has witnessed a considerable reduction in time required for clearance of sale and manufacturing licences after the introduction of online Extended Licensing Node (XLN) system in the state in April last year.
Konkan division of Maharashtra FDA alone has been able to dispose of around 14,000 applications until recently since April 2014 in a time bound manner. Konkan division accounts for the maximum number of 800 licenced manufacturing units out of the state's 1703 pharma manufacturing units.
These applications are related to loan licences, test licences, certificates, additional products and renewals. The system was introduced last year as part of the state FDA's drive to speed up the issuance of licences and certificates in the state online.
Apart from renewal of licences and licences 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 licences and granting of certificates with less bureaucratic hassles. Says an official associated with the development, "The system has been able to simplify the process of granting certificates and licences. 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 licences, testing licences, licences for additional products, performance certificate and free sale licences 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, "Online system has been set up after conducting training programme under the guidance of National Informatics Centre (NIC) in all the 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.