INDIAN MEDICAL DEVICES INDUSTRY

Medical devices play an important role in the delivery of medical care. In this large black cloud of Corona virus the only silver lining was the major boost provided to Make in India of Medical Devices which has been a neglected sector with import friendly policies in the past with negligible duties. Many businessmen in the auto sector, garments, hospitality and the tourism industry diversified into medical devices considering depressing times for their own businesses and saw an opportunity and growth in devices.

The Government of India through its flagship “Make in India” initiative relied heavily on Indian manufacturers to meet the rising demand of essential healthcare equipment for the country, pushing the Indian medical devices sector to become selfreliant.

The Association of Indian Medical Device Industry (AIMED) relentlessly worked at the forefront to combat the crisis. The COVID19 crisis has shown us that Indian medical devices sector can rise to the challenge. When imports got disrupted, specific devices detailed with quantified production shortages and a focused Interministry Group coordinating with domestic manufacturers via AIMED had addressed production bottlenecks and challenges so that not only capacity got utilized but also ramped up rapidly. Indian medical device manufacturing industry is at the cusp of a great opportunity. Manufacturing growth in China has been challenged by many countries resistance to buy Chinese medical devices.

Another opportunity is the current Indian Public Procurement policy. Due to geopolitical reasons global investors have begun to show renewed interest in India. Our government has also seized the initiative and in a series of measures has reformed the country’s foreign investment policy to allow higher levels of investment from abroad in diverse sectors. As a result India has become one of the most open economies in the world and rightly positioned to attract largescale foreign investments. The Indian Government with Invest India spear heading the initiative has already chalked out plans intending to remove all roadblocks and offer tailormade solutions to attract investment to make India a manufacturing hub for medical devices. Covid19 has changed the scenario of doing business. It has opened massive opportunities for healthcare sector in teleconsultation, Aibased diagnostics and remote healthcare management. India has shown its capability of rapid product development during the #COVID19 pandemic and with a strong hold in the IT domain, we can build sophisticated software products in the healthcare domain.

The govt. interventions helped the medical devices industry scaleup production during the pandemic. We enjoyed unprecedented teamwork and rapid proactive communication from NPPA who became a facilitator instead of a Regulator & Dept. of Pharma, DPIIT, Invest India and MSME Ministry as they set up help desks to address production bottlenecks of all Medical Devices especially, those related to COVID viz sanitizers, masks, ventilators, gloves & COVID IVD test kits.

We are waiting for a policy announcement on the following vital issues of the Indian medical devices industry to end the 85% import dependence forced upon us and an ever increasing import bill of over Rs 45,000 Crore: Consumer Protection:

• For ensuring ethical marketing is not disadvantageous, Trade Margin Rationalization is needed and will also protect consumers from exorbitant pricing. MRP labeling needs to be enforced on unit of sale of medical devices by customs. Also Govt. of India may introduce Trade Margin Cap Mechanism of maximum 75% trade margin between exfactory / import landed price and MRP in a phased manner but not from price to distributor as that would put India at a competitive disadvantage over imports.

• Regulate all medical devices under a Patients’ Safety Medical Devices law separate from drugs to protect patients and aid responsible manufacturing while decriminalization of minor offences.

• Restriction on import of preowned medical equipment

• While we thank the government for deploying 5% cess on some imported devices to encourage employment and Make in India of some medical devices, to address the 7090% import dependency, we seek this cess to be applied to other medical devices too. In addition, a predictive nominal tariff protection policy should also be implemented as done for mobile phones to ensure a vibrant domestic industry and competitiveness and price stability driven by competing domestic players.

• Incentivize domestic content in healthcare products in public healthcare procurements by preferential pricing for Q1 e.g. ICMED (QCI’S Indian Certification for Medical Devices) instead of L1 (lowest price) to ensure patients access acceptable quality made to global standards.