Pharma manufacturing units in Maharashtra would soon get licenses within 48 hours as compared to a minimum of 15 days earlier with the help of a unique online system introduced for the first time in India. Maharashtra FDA is planning to introduce 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 online Extended Licensing Node (XLN) system is in the initial stages of implementation at Maharashtra Food and Drug Administration's Thane division. According to an FDA official, "The system will be launched across the state in coming two months time with the technical guidance of National Informatics Centre (NIC)."
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 15 licenses and over 7 certificates required by pharma manufacturing units. The state FDA receives over 8000 applications in a year for manufacturing licenses.
A senior FDA official informed, "A training programme has already been concluded at Pune division to sensitise manufacturers and FDA officials about the attributes of the new online system. We are planning to spread it across Maharashtra with forthcoming workshops in Aurangabad and Nagpur divisions."
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.
Maharashtra FDA with its head office in Mumbai has 43 licensing authority offices stationed in various districts. Some licensing authorities handle more than one district operations. Each licensing authority office is headed by an Assistant Commissioner with four to five drug inspectors or senior drug inspectors. It is also sales and manufacturing license issuing authority and its enforcement activities revolve around monitoring of quality of drugs manufactured or coming from other states.