India is still hugely dependent on importing medical devices, with imports accounting for roughly 80 percent of all medical equipment in the country. According to the Association of Indian Medical Device Industry (AiMeD), imports of medical devices increased by 24 percent in 2019, roughly standing at INR 39000 crore. A bulk of these imports come from the United States, China, Germany, and Singapore, for higher-end equipment in cancer diagnostics, medical imaging, ultrasonic scans, and PCR technologies.
In the wake of the COVID-19 pandemic, where countries around the world are scrambling to pull themselves out of ICU rooms, it has become more apparent that India needs to boost investment in manufacturing high-quality, indigenous medical equipment and reduce dependence on foreign imports. Measures have already been put in place towards this, with initiatives such as Startup India and the Make in India plan by the Niti Aayog.
While a handful of Indian devices are being developed by innovative start-ups, a future reality where medical equipment is largely Indian-owned or Indian-made has a long way to go. India needs to heavily invest in creating a robust healthcare infrastructure that allows for information sharing, research and development, innovation & technology management and quality & safety control, that can develop medical equipment and technologies to meet the existing needs of healthcare facilities while tackling indigenous challenges related to pricing, hospital workflows, and doctor-patient needs.
Price, quality and after-sales service support are major factors in medical equipment purchase decisions. Even though imported equipment can be more costly to purchase and maintain, medical facilities still overlook these costs, as they are assured of high quality that can in-turn translate to optimum patient care. In order for our dependence on foreign imports to reduce, we need to develop Indian-manufactured alternatives that can offer the same quality as that of its foreign counterparts, at a reduced price.
Until very recently, the Indian regulatory framework for medical equipment left a lot to be desired, with only 15 “notified” categories such as syringes, needles, stents, and orthopedic implants being regulated, and the rest of the market is largely unregulated. This was recently amended on February 11, 2020, by the Ministry of Health and Family Welfare, after consultation with the Drugs Technical Advisory Board, which widened the list of devices that need to be registered, before they can be sold in the country.
Medical equipment from the US and Europe, have FDA and CE certifications that give the procurement team at hospitals, assurance that the equipment will be of high quality. We hope that this move to regulate all medical devices will be an incentive for hospitals to consider Indian-manufactured medical equipment without having to compromise on quality.
By developing a robust regulatory body for medical devices, India can also lay the foundation to export medical equipment to other countries, like we are currently doing in the pharmaceutical industry (Indian exports of pharmaceuticals were valued at 20.1 billion USD in 2019, accounting for around 20 percent of the global generic drug exports)
Recently as part of the COVID-19 economic relief plan, the Government has decided to not allow foreign companies to participate in tenders up to Rs 200 crore. This move is a great incentive for medical companies to bolster their manufacturing process in India.
While several challenges lay ahead for India, with adequate support from the Indian Government and expert insights from key stakeholders in the healthcare industry, we have a great opportunity to drive local manufacturing of medical equipment, in accordance with global standards.