The Gujarat Food and Drug Control Administration (FDCA) has approved the plant design of around 80 new manufacturing facilities through its plant approval committee in the past three months as part of ease of doing business in the country. This is aimed at bringing foreign investments in the country and accelerate the Make in India campaign.

This comes close on the heels of Gujarat government having 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 as part of Pharma Vision 2020 under the Right of Citizens to Services 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.

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.

Over 4000 manufacturing units are located across the state in four large clusters with 5 Special Economic Zones in an area of over 1500 hectares, as per government of Gujarat data.

The growth in pharma exports would also complement the first upcoming medical device testing lab of the country at Vadodara in Gujarat. A final proposal on the same has been sent to the Union health ministry for its implementation.

Recommended and promoted by the Union commerce ministry to help Indian manufacturers gain self-reliance in medical device testing in the country, an amount of Rs. 15 crore has also been earmarked for the country’s flagship project.

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.

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.

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.