Konkan division of Maharashtra Food and Drug Administration has cleared 50 percent of the 800 applications for manufacturing licenses in the stipulated 48 hours time after the introduction of online Extended Licensing Node (XLN) system. The system was introduced in the Division recently as a part of the state FDA's drive to speed up the issue of licences 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 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 renewals of licences 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 three stages as compared to the eight stages earlier which has considerably brought down the time taken due to bureaucratic hassles."
With system being currently implemented at Pune and Nashik, Maharashtra FDA is planning to introduce the online system across the state in order to accomplish timely disposal of renewal of licenses, testing licences, licences for additional products, performance certificate and free sale licences among others.
The XLN system, according to a senior FDA official would be a boon for over 1700 existing manufacturing units across the state as system will deliver online approvals for over 6 certificates required by pharma manufacturing units. The state FDA receives 8000 to 10,000 applications in a year for manufacturing licences.
A senior FDA official informed, "A training programme under the technical guidance of National Informatics Centre (NIC) will be held in Aurangabad and Nagpur divisions shortly to sensitise FDA officials about the attributes of the new online system."
The system will help considerable saving in time and manpower as it will be centralised and paperless. There are 1703 manufacturing units in the state out of which 247 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.