Medical Devices: Prioritise Quality Checks & a Strong Ecosystem

To establish India as a dependable Manufacturer of high quality medical devices in Global supply chain & to vie for being the 2nd factory in world

The Covid-19 pandemic situation was initially dreadfully challenging in India with a huge population and high import dependent medical devices sector. The Government of India through its flagship “Make in India” initiative relied heavily on the Indian manufacturers to meet the rising demand of essential healthcare equipments for the country, pushing the Indian medical devices sector for an Atmanirbhar Bharat

To establish India as a dependable Manufacturer of high quality medical devices in Global supply chain & to vie for being the 2nd factory in world, India needs to bring in a quality culture to maintain global standards in quality of healthcare products and the Prime Minister should constitute a Quality Advisory Council and a dedicated Principal Quality Advisor to the PM to evaluate the quality & standard of Indian products e.g. medical devices, advice & guide the PM, like they have office of Principal Scientific advisor to PM.

It is still being noticed that most of the PPE & Medical Masks being sold in India during COVID-19 are not manufactured to comply with Basic Standards of PPE as recommended by WHO

During this covid pandemic India faces huge hurdles in identifying and weeding out low quality & sub standard healthcare products flooding the markets in the absence of an able Quality scientist with pandemic leadership. The various quality institutions available are reporting to different Ministries and act in silos and defend their turf rather than working in complementary roles assigned to them as a team. Teams need leaders who are capable of handling the unprecedented situations.

So if country needs labs and testing infrastructure to test PPE coverall or masks or ventilator who plans and decides? Not NABL as their job is only Accreditation of the lab after its set up, not BIS as they have too many products & not equipped not DGCI- CDSCO as they have no funds and no claim no mandate to regulate as yet, MSME Manufacturers (?) they can invest in some simple testing equipment but not complex ones. Indian Institute of Science or the IIT – well yes some have great infrastructure but industry is not clear who has what and whether access is possible for commercial 3rd party testing.

To have Make in India to thrive one needs a quality mindset of vertical product standards, horizontal process (and common product family) quality standards, specifications, voluntary standards setting and at times safer regulatory controls and demonstration of compliance to standards with the help of test labs. These labs are not only needed for tests but to benchmark evaluations as well as Research and Development studies.

It is still being noticed that most of the PPE & Medical Masks being sold in India during COVID-19 are not manufactured to comply with Basic Standards of PPE as recommended by WHO. Concerned with the falling Standards of Quality & Safety apart from the huge surge in prices during COVID 19, AiMED (Association of Indian Medical Device Industry) representing interest of over 700 medical device manufacturers has sought intervention of Govt., Drug Prices Regulator, NPPA, in capping prices, and ensuring quality, both with ramifications on consumers, health workers and industry but is challenged by lack of coordination.

The penal system in the Drugs Act is a disincentive for medtech investors. The Act is not appropriate for innovative engineering products like medical electronics. Consumers do need access to high-quality PPEs and ventilators. An appropriate legal framework envisaged by the NITI Aayog is awaited as a medical devices law that would decriminalise most oversight and regulatory lapses and will have risk-proportionate penalties. This will encourage new entrants to venture into medical devices—as being engineering products and not drugs.

Another concern area that the Indian Medical Devices industry has been requesting the Govt. to address is Artificial Inflation where labeled MRP instead of protecting consumers in case of Medical Devices has become a license to charge the full MRP which may lead to profiteering at retail/ hospital end

Amid Covid pandemic & growing Indo-China tensions, India has to address every issue linked to national security. Healthcare being the most critical, India has to evolve imaginative policies and usher in reforms that will accelerate its economic revival. Developing our own domestic medical industry is the best way forward.

The Department of Pharmaceuticals has recognised that indigenous manufacturers have a disability of 12-15% on account of:

1. Lack of adequate infrastructure, supply chain and logistics;
2. High cost of finance;
3. Inadequate availability and cost of quality power;
4. Limited design capabilities; and
5. Low focus on R&D and skill development.

There is no mechanism to address these disabilities in manufacturing of medical devices. The Department of Biotechnology (DBT), the Biotechnology Industry Research Assistance Council (BIRAC), the NITI Aayog and the Office of the Principal Scientific Adviser have been working to create an ecosystem for nurturing start-ups and incubators. But once they create a commercial product and graduate to MSME entrepreneurs, the real challenge comes for these start-ups to cope up with the above-mentioned 12-15% disabilities and marketing challenges.

The focus needs to shift from chasing investment value by foreign brands and onto creating an ecosystem for making in India. Consider nurturing Indian manufacturing champions who will lead other mid-size and small-size manufacturers to follow. The COVID-19 crisis has shown that Indian medical device manufacturers can scale up manufacturing to tackle spiked demands for ventilators and other life-saving medical supplies.

For manufacturers demand comes from local consumption or exports. Imports of Medical Devices are a negative demand as domestic purchasing power is diverted to foreign goods. Converting negative demand to positive demand is what the Govt. should try to achieve and boost economy as well as create jobs.

Another concern area that the Indian Medical Devices industry has been requesting the Govt. to address is Artificial Inflation where labeled MRP instead of protecting consumers in case of Medical Devices has become a license to charge the full MRP which may lead to profiteering at retail/ hospital end. By rationalizing trade margin over import landed price consumer can gain and not feel exploited post COVID. This will also help Make in India prove itself in stents and knee implant and favor Ethical Marketing by Overseas and Indian Manufacturers.

We recommend the following reforms to give encouragement & boost  Manufacturers producing in India :

• Preferential Pricing for Domestic Manufacturers based on World Bank norms.
• Preference for ICMED / ISO Certified Manufacturers to boost quality.
• Preference for Design India Certified Manufacturers to boost indigenous development.
• Timely payment against Govt. Supplies.
• Penal provision against Hospitals that keep exclusionary compliance Clause of USFDA Certification as 3rd Country Regulatory approval.

What’s meant by Preferential Pricing? How does World Bank support Indigenous manufacturers in a developing country? World Bank has a clause to support domestic manufacturers by adding 15% to import CIF price of imported goods for the sake of bid comparison and thereafter the lowest price is winner. So if Indian manufacturer wins he will supply at his bid price, not at a higher price

We are glad Govt. has begun taking various initiatives to end the 80-90% import dependence forced upon us and an ever increasing import bill of over Rs Rs.42000 Crore, expediting steps for patients’ protection, stronger quality & safety regulations, price controls to make medical devices and quality treatment accessible and affordable and ethical indigenous manufacturing to be viable.