India seeks to lure medtech to growing market
With 1.3 billion people and a new regulatory regime aimed at luring industry, India's medical device market seems primed for growth.
Valued at $5.2 billion, the sector is growing at an annual compound growth rate of 15.8%, putting it on track to hit $50 billion by 2025, according to Make in India, a government-led initiative to attract investment in the nation.
The Medical Device Rules 2017 that took effect a year ago seek to bring the sector in line with global standards and practices. They include a risk-based classification scheme, stricter registration and certification requirements to ensure quality of products placed in the market, conformance with international standards and alignment with Global Harmonization Task Force guidelines.
The rules also tighten controls around clinical trials, including requiring approval of an ethics committee before either commencement or evaluation of a study begins. FDA-approved trials are exempt from those requirements. India hopes to attract more multinational companies to set up shop on the subcontinent, increasing access to high-quality diagnostic products and treatments for its population.
U.S. device makers have welcomed the new rules. Da Vinci surgical robot maker Intuitive Surgical told investors on a recent earnings call it would increase investments in coming quarters to expand operations in new markets including India.
"The feeling broadly across our membership and the industry is it's definitely a step in the right direction," says Abby Pratt, vice president of global strategy and analysis at AdvaMed.
Procedurally and from a registration standpoint, the process for medical devices in India has improved. But the fact that devices are still basically regulated as drugs — the new rules are an administrative and not a legal document — creates uncertainty for manufacturers.
At best, the 2017 rules are a stopgap measure. The government acknowledges the need to recognize the distinct features of medical devices, such as evolution of technologies, and has stepped up talks of creating a distinct legal framework for devices, possibly even with a separate regulator. When that time comes, "we're urging them not to reinvent the wheel and have a unique India system, as opposed to something that's globally harmonized," Pratt tells MedTech Dive.
What's in the rules
Currently, only about 400 of the roughly 5,000 medical devices in India are regulated. The current list of 23 notified products includes 15 devices and eight items that are categorized as drugs. Notified products include disposable hypodermic syringes and needles, cardiac stents, drug eluting stents, catheters, intraocular lenses, bone cements, heart valves, orthopedic implants and blood and blood products, among others. Four more devices are set to join the list on Jan. 1, 2020: nebulizers, blood pressure monitoring devices, digital thermometers and glucometers.
Earlier this month, eight new devices were notified as drugs, subjecting them to increased regulation. These include all implantable devices, CT and MRIs, defibrillators, dialysis machines, PET and X-ray machines and bone marrow cell separator, according to a Feb. 8 notification.
All notified products must be registered with the group that oversees drugs and devices, the Central Drugs Standard Control Organization.
The group issued a FAQ to address common questions about the new rules, including in-country clinical trial requirements and adding additional devices to an existing license.
The new rules have much to like for industry: a simplified registration process, conducted entirely online, and no need for periodic review or renewals. Licenses and registrations remain valid until suspended or cancelled. Changes to a registration certificate can be made via the portal's Post Approval Change section.
Medical devices imported from other countries that have been approved in the U.S., European Union, Canada, Australia or Japan and have been on that market for at least two years can be sold in India by obtaining a license and undergoing conformity assessment. Additional clinical trials are not required.
Foreign manufacturers must appoint a licensed importer inside the country, responsible for submitting the registration application and necessary documentation.
Bumps in the road
While widely welcomed, industry has faced challenges since the new rules took effect, starting with what was widely considered an unrealistic 11-month transition period.
"There should have been minimum three-year transition period given to understand and prepare for the implementation of new regulation by the Industry and by the Regulators," P. K. Sharma, head of quality assurance at Hindustan Syringes & Medical Devices and technical officer for the Association of Indian Medical Device Industry, wrote in an email.
A lack of clarity and knowledge about the new rules and implementation at the state level also remains, he said.
Companies have also had to work with an online portal with numerous deficiencies and that doesn't function consistently, making it difficult to submit documents and register devices.
Another problem has been a lack of accredited certifying bodies required to demonstrate compliance with the medical device rules. Sharma said only a few certifying bodies have been accredited for auditing Class A and Class B manufacturers, and there are insufficient numbers of qualified auditors as well, both of which affect timing and quality of audits.
Foreign device makers are also facing new constraints on materials used in their products. Under a 2017 public procurement order, medical devices must contain between 25% and 50% local content, depending on the type of device.
AdvaMed "strongly opposes" the order, which inherently favors domestic manufacturers over imported products, Pratt says. She also questions the Indian government's ability to comply with the order, given that India depends on imports for 70% to 80% of its medical devices. "It's almost unrealistic to expect that they're going to be able to get these devices wit that level of local content," she adds.
Bigger challenges remain
Taken all together, India still has a long way to go to meet potential as a global destination for medical device manufacturers. There is a clear need for more and innovative technologies to address unmet medical needs, but not the infrastructure, personnel and capacity to support market growth.
Healthcare costs are also a barrier. India spends just around 1% of its gross domestic product on healthcare, and more than 60% of medical bills were paid for out of pocket in 2014, according to the World Health Organization. Contrast that with China, where 90% of the population is covered by some form of health insurance.
With roughly the same population and disease profiles, China's medical device market is around $30 billion, compared with India's not quite $6 billion, Pratt notes. "It's really underperforming as a medical device market," she says.
The Confederation of Indian Industry, a business association, is aware of the lag and recently launched the National Medical Devices Promotion Council to bolster growth in the sector.
And last year, Indian Prime Minister Narendra Modi began rolling out a massive health insurance scheme to bring medical coverage to 100 million families — or an estimated 500 million people. Dubbed Modicare, the program will provide covered individuals with 500,000 rupees (about $7,000) for treatment of serious health conditions.
"We're still watching and waiting to see how this plays out and what it means in terms of is it an opportunity, what are going to be the challenges, how do we navigate it and how are medical devices going to be treated in this huge scheme," Pratt says.