Date: 20-Feb-2020

Rajasthan rolls out red carpet for drug cos by reducing timeline for issuing licenses

The drug manufacturers intending to set up manufacturing plants in Rajasthan will now onward get manufacturing licence within 21 days time as against two months earlier. Likewise, the Certificates of Pharmaceutical Products (CoPP) required for export will be issued within 15 days from the 45 days earlier. With the reduction in timelines for issuance of various licences, the Rajasthan government has intended to build conducive eco-system for new and existing drug companies in the state to boost drug manufacturing and export from the state. As per a notification issued by the state government on February 11, 2020, the timeline has been fixed for issuance of various licences. The aim of the initiative is to facilitate ease of doing business in pharma sector and make Rajasthan as the most preferred destination for pharmaceutical industry in the country. The timeline fixed for various procedures before grant of manufacturing licence for drug includes plant inspection by state drugs control office in 10 days, followed by shortcoming rectification and verification in a week, screening of products in three days and processing and granting of licence in a day. Besides this, approval of product permission will be done in three days. Test licence will be issued in three days. WHO GMP certificate will be issued in just 15 days. The state drugs control office will send recommendation for grant/renewal of licences to central licensing authority with respect to vaccines/sera, large volume parental/notified medical devices in a month. The changes will be effected in existing manufacturing licences in 15 days. Besides this, licence validity certificate, neutral code certificate, quality and capacity certificate and performance certificate will be issued in a week. Free sale certificate, market standing certificate, GMP/GLP certificate, non conviction certificate and production capacity certificate will be issued in just 5 days. The drugs control office will grant permission for blood storage centre in 15 days. Blood bank licence will be renewed in 15 days. Said additional health secretary Rohit Kumar Singh if documents will not be cleared within a stipulated timeline, the concerned licensing authority will be held responsible for it. The aim of the initiative is to instill confidence into drug makers. With the ease of doing business, the government has intended to attract pharmaceutical units to establish their footprints in the state to provide employment opportunities. As of now the state has 150 drug units including APIs units and formulation units. It is learned that the government is coming up with medical device park in Jodhpur. It is in process of identifying plot in Udaipur and other areas to set up API park. The promotion of ease of doing business is part of Rajasthan Industrial Development Policy, 2019. The policy envisages to set up 'One Stop Shop' for pharma related clearance. As per the policy, fiscal incentive shall be provided to manufacturers of APIs, formulations and medical devices to promote domestic manufacturing of drugs and services. Preference in government procurement as well as price advantage shall be given to local manufacturers. Infrastructure such as warehouses/temperature controlled facilities shall be strengthened for storing pharmaceutical equipments, products etc, says policy document. Welcoming the government's initiative to promote ease of doing business in pharmaceutical sector in the state, Rajasthan Pharmaceutical Manufacturers Association (RPMA) president Vinod Kalani said “The government is trying to develop Rajasthan as a hub for API, formulation, cosmetics production. The timeline fixed by the state government for grant of various licences is much faster than the neighbouring states. It will promote ease of doing business in pharmaceutical sector and instill confidence into drug manufacturers.”