Gujarat has achieved a rare distinction of having the highest number of 150 licensed medical device units under Central Licensing Approval Authority (CLAA) scheme as against a total 284 medical device units in the entire country. The state earlier had 130 units and added another 20 units recently.

Other states following Gujarat however have less number of units with 26 in Haryana, 18 in Uttar Pradesh, 17 in Maharashtra, 15 in Tamil Nadu and 10 in Kerala out of the 19 states having medical device manufacturing units.

CLAA has been formed to oversee the regulatory activities related to grant of manufacturing license for hi- tech medical devices in India. It aims at ensuring that the medical devices being manufactured in India follow the standard requirements set by the government to ensure safety, efficacy and quality of the devices.  

The Central Drugs Standard Control Organization (CDSCO) released a guidance document on August 7, 2015 to file an application for grant of the license for manufacturing of medical devices in India.

The devices currently regulated under CLAA scheme include cardiac stents, drug eluting stents, catheters, intra ocular lenses, I.V. Cannula, bone cements, heart valves, scalp vein set, orthopaedic implants and internal prosthetic replacements.

Says Gujarat Food and Drug Control Administration (FDCA) commissioner Dr H G Koshia, “Gujarat had registered the highest number of over 135 licensed medical device companies as against 253 in the entire country, as per government report of February 2015. Gujarat FDCA has added another 20 licensed manufacturers under the CLAA scheme raising the bar of new hi-tech medical devices in the country.”

This comes at a time when land for the upcoming medical device park at Sanand near Ahmedabad has also been allocated.

The application for grant of the license is made in Form 27. Along with the duly filled Form 27, several documents need to be submitted in order to get license in Form 28 for manufacture of medical devices in India.

To help get trained manpower for its upcoming medical device park, Gujarat FDCA has also tied-up with National Institute of Pharmaceutical Education and Research (NIPER), Ahmedabad.
 
High quality and skilled manpower in the country is one of the critical requirements in the medical devices sector today as more than 70 per cent of devices are imported as of today which is impacting the development of the domestic industry.

Prime Minister Narendra Modi’s Make In India campaign has gained further impetus as government is planning to expand NIPERs across the country to nurture manpower and hence boost domestic manufacturing of medical devices in the country.

The Centre has been mulling for quite some time for setting up the medical devices park in Gujarat in a bid to make India self-reliant in the sector.

The creation of manufacturing park for medical devices will boost the segment of hi-tech medical devices as 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.

This will also help facilitate to create an ecosystem for manufacturing of high end medical device manufacturing aimed at import substitution and export opportunities and would be a major boost to SMEs.