India To Form Independent Medical Device Regulation Body
By Jof Enriquez,
Follow me on Twitter @jofenriq
India’s government has unveiled a draft proposal that will create the country's first agency dedicated to the regulation of medical devices. The plan is the latest in a series of measures instituted by Indian authorities to steer the country’s medical device industry away from imports and to build a stronger base for Indian companies.
The National Pharmaceutical Pricing Authority (NPPA) Department of Pharmaceuticals, which currently oversees medical device regulation in India, has issued the Draft National Medical Device Policy recommending formation of an autonomous National Medical Device Authority (NDMA). The NDMA would be tasked with promoting the local device sector, enforcing stricter safety standards, and installing price controls for devices, including surgical instruments, implants, and diagnostic equipment, Thomson Reuters reports.
The creation of an independent regulatory body also could stem alleged overcharging for imported devices. Over the last few months, Indian authorities have investigated numerous complaints from patients who claim to have been charged as much as three to four times the landed cost for certain devices like cardiac stents, according to the Times of India.
To institute price control, the draft proposes to include medical devices under India’s Essential Commodities Act and to create a separate pricing division dedicated to medical devices under the NPPA, according to Times of India. Moreover, authorities could announce a new medical devices control order that is separate from the Drug Prices Control Order, which presently covers both medical devices and pharmaceuticals.
"It (the draft) contains mostly very good content and is on the lines of our recommendations, but it does need some fine-tuning for ensuring more clarity of direction," said Rajiv Nath, a forum coordinator for the Association of Indian Medical Devices Industry (AIMED), to Times of India. The final draft proposal will be submitted for Cabinet approval following a six-week period for comments.
India's medical device industry is import-driven, with 70 to 80 percent of devices coming from overseas. The new policy would help reduce dependence on high-end device imports and strengthen the local sector, which currently is relegated to manufacturing disposables and low-end supplies.
The stated objective of the National Medical Device Policy is "strengthening the Make in India drive by reducing dependence on imports and setting up a strong base for medical devices, especially those with critical implications in terms of affordability and availability of patients."
In addition to the draft policy creating a dedicated regulatory agency, India’s government recently announced a series of measures to transform the country's device sector. In April, it announced plans to put up the country’s first industrial parks, in Gujarat and Chengalpattu, dedicated to medical device manufacturing. In May, the Central Drug Standard Control Organisation (CDSCO) — India's equivalent of the U.S. Food and Drug Administration (FDA) — unveiled a safety and surveillance program for medical devices, stricter accreditation standards for clinical trials, and enforcement of better quality control practices in local manufacturing.
Currently a relatively modest $4 billion market, India's share in the global medical device industry is set to increase significantly in the next decade.
“Appropriate regulatory framework, aided with proper government policies could help the industry grow to a USD $25 billion to $30 billion in the next ten years," said Sanjay Banerji, India Working Group chair of AdvaMed, in a Business Standard report.
India’s overall medtech industry could generate as much as $50 billion in annual sales over the next decade, an increase of nearly 800 percent from the current annual estimate of $6.3 billion, according to the Confederation of Indian Industry (CII).