Aimed at bringing foreign investments in the country, Gujarat Food and Drug Control Administration (FDCA) has approved plant design of around 125 new manufacturing facilities through its plant approval committee in the past few months. This will also accelerate the Make in India campaign.
Gujarat government has also revised timelines for grant of manufacturing licenses and renewal of licenses to 60 days and that of grant and renewal of sale licenses to 30 days for speedy issuance of licenses. Earlier, the stipulated timelines for grant and renewal of licenses for sales was 45 days and 120 days respectively and for grant and renewal of manufacturing licenses was 120 days and 180 days respectively.
Over 4,000 manufacturing units are located across the state in four large clusters with 5 SEZ in an area of over 1,500 hectares, as per government of Gujarat data.
Gujarat FDCA has been able to make speedy disposal of applications related to issuing licenses to wholesalers and retailers online in a time bound manner since the introduction of online Extended Licensing Node (XLN) system set up in the state in 2007.
Following Gujarat online licensing model for sales licenses, 16 states replicated the model in the country. There are 37,000 retail and wholesale licensees in the state of Gujarat. At the time of introduction of the online system, there were 15,000 registered sale licensees in the state, which have also been digitised.
Gujarat today has 255 WHO certified manufacturing units with 23 MHRA certified, 24 TGA certified, 15 EU certified and 16 PICS certified units. Besides this, it boasts of 158 formulation units and 97 bulk drug units. It has 40 per cent of CROs and 40 per cent of CRAMS companies.
Gujarat is also coming up with a manufacturing park for medical devices at Sanand. Medical devices manufacturing requires certain high investment facilities which are too capital intensive for individual manufacturers to invest upon. A park with in-house high investment scientific facilities would help manufacturers reduce the cost of manufacturing by more than 40 per cent to 50 per cent.
National Institute of Pharmaceutical Education and Research (NIPER) Ahmedabad is also being developed as a National Centre for Medical Devices (NCMD) which will provide a conducive environment to nurture innovators and industry.