WHO: India's Medtech Industry Underinvested, Too Import-Oriented

The World Health Organization (WHO) recently appointed India’s National Health Systems Resource Centre (NHSRC) as its fourth global WHO Collaborating Centre for Priority Medical Devices and Health Technology Policy. The move aims to help tighten and fine-tune regulations governing India’s medtech industry.

Despite the medtech industry in India being “underinvested” and “import-driven,” a WHO official recently expressed optimism that the market still holds great promise with the installation of a pro-business government led by new Prime Minister Narendra Modi, according to Business Standard.

Speaking during an event to announce the designation of the NHSRC as the First WHO Collaborating Centre in South East Asia Region, Dr. Nata Menabde, WHO representative to India, said that India’s medtech sector needs to improve as healthcare demand grows.   

“There is a need for appropriate and applicable health care technology in India,” she said in a recent statement issued by the Ministry of Health and Family Welfare. “Our medical devices industry is underinvested and heavily import driven at present, but with the current ‘Make in India’ campaign, there is a huge opportunity for growth and expansion of the medical device industry. This would highly improve the access of essential medical devices and healthcare technology to patients in India.”

“Prioritizing medical devices and health technology in the country is an important agenda item,” Shri B P Sharma, health secretary, Ministry of Health & Family Welfare, said in the statement. “It is critical to have the specifications in place for the medical devices and equipments that are already procured and used in the system. There is also need for dedicated medical devices testing laboratories to ensure the safety and efficacy of these devices.”

The NHSRC’s Division of Healthcare Technology & Innovation has been working in the areas of health technologies and related policy interface. According to the statement, this includes:

• Framing of technical specifications for technologies procured under National Health Mission
• Establishing best practices for technology life cycle management and maintenance
• Secretariat for assessment and uptake of innovations into public health systems
• Health technology systems research such as proposing roadmap for establishing testing laboratories
• Supporting the Health Ministry on issues related to free essential diagnostics and other technology intensive services
• Determining domestic manufacturing capacity, quality, and safety criteria for healthcare technologies
• Conducting health technology assessments.

In particular, the Division of Healthcare Technology & Innovation is extending technical support for a new initiative called the Materio Vigilance Programme of India (MVPI), according to the Times of India. The MVPI is designed to monitor medical device associated adverse events (MDAE) specific to India. Previously, the country has been dependent on data from developed countries to determine devices’ safety records. The nationwide program will be run by India’s regulatory body, the Central Drugs Standards Control Organization (CDSCO).

India’s government is strengthening the local medtech sector that has been criticized for being rife with irregular business practices proliferating under a murky regulatory environment. Tightening regulation may encourage device makers already established in the country to re-invigorate sales and entice new players looking to make an impact in this huge market.

The Health Ministry recently proposed amendments to local medical device and pharmaceutical laws that will be submitted to parliament for approval in 2015. CDSCO has also proposed several initiatives, including new accreditation standards for clinical trials and good manufacturing processes aligned with international standards.

India’s medical technology industry could generate as much as $50 billion in annual sales over the next decade, an increase of nearly 800 percent from the current estimate of $6.3 billion, according to estimates by the Confederation of Indian Industry (CII).