India taking baby steps to harmonize international regulatory standards for medical devices: DCGI

As per Dr V G Somani, Drugs Controller General of India, the medical device industry needs to look at quality, affordability, and access, and service delivery while developing products from a pricing and regulatory perspective

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New Delhi: “India medical device manufacturers have come a long way by showing their capacity and the capability to sustain through all the odds to deliver the services. At the same time, the government support through PLI Schemes is an indication about what it is exactly aiming at,” mentioned Dr. V G Somani, Drugs Controller General of India, CDSCO while speaking on Self Sufficiency (Atmanirbhar Bharat) in Medical Technology at Series I Webinar on Development of National Medical Technology Roadmap organized by PHD Chamber of Commerce and Industry on 22nd December 2020.
Dr V G Somani further said that the industry needs to look at quality, affordability, and access, and service delivery while developing medical products from a pricing and regulatory perspective. We need to keep on monitoring it so that it becomes a reliable solution for the consumer at large. If the regulatory and support mechanism matches with its expectation and the industry’s pace match, there is no reason that we as Indian manufacturers, cannot play a major global role.
Talking about the regulations, Dr Somani said, “Baby steps are to be taken for harmonizing the international regulatory standards for medical devices as the way forward. We need to consider that it doesn’t disrupt the actual manufacturing, market, and consumer cycle. We should have quality throughout the life cycle of the product as best as possible with the world.”
Dr Jitender Sharma, MD & CEO, AMTZ mentioned that there is a need to control the import and export HS codes; PLI Scheme for next 3 years; consolidation of R&D Funding on medical technologies; free fall of prices for social maximization and set minimum prices of products for leveraging the business.
Pradeep Multani, Sr. Vice President, PHDCCI in his presidential remarks deliberated about the importance and growth of Medical technology or Medtech that has intended to improve the overall quality of healthcare delivered through earlier diagnosis, less invasive treatment options, and reductions in hospital stays and rehabilitation times at a reduced cost. It has also responsible for increasing life expectancy in many disease areas, improving quality of life, and allowing people to remain integrated, economically productive, and socially active.
While giving an industry perspective, he talked about the increase in the market size share and domestic players which are operating in the consumables segment and catering to local consumption with limited exports. Large Multinational Corporations lead the high technology end of the Medical Devices market with extensive service networks.
Good quality, affordable, and comprehensive healthcare to all its citizens is the new age universal mantra, especially after many loopholes emerged globally during the Pandemic. While healthcare infrastructure and indigenous medical device manufacturing are the focus areas, the medical device sector in India needs focus, and policy interventions need to happen to achieve self-sufficiency.
Looking at the immense potential of the MedTech industry, India is looking to improve self-sufficiency as a part of the “Make in India” initiative. The rapidly expanding sector presents immense opportunities to global players. India is full of opportunities for medical device companies to explore and expand their business horizons in the Indian healthcare market, said Mr. Pradeep Multani.
Dr. N. Subramanian, Chair, Health Committee, PHDCCI while taking about the Medtech in the healthcare sector and the factors we need to grow ourselves in this sector are growing population, constant and frequent increase in the non-communicable diseases along with existing diseases and increase in access and affordability of treatment to the masses. He further said that the Government of India’s ‘Make in India’ initiative presents a platform for the sector to revisit the operating model, identify key imperatives for growth and explore possibilities for creating a step change in the medical devices sector. He also emphasized the value of technology in areas like telehealth, telemedicine, medical robots, digital platforms, cloud computing, wearable technologies, and others.
Mr. Rajiv Nath, Forum Coordinator, AiMED stated that Covid exposed India’s soft under belly of excessive import dependence of medical devices & the need for country to go into lock down to prepare ammunition to fight Covid and build manufacturing & healthcare delivery infrastructure on war footing with close coordinated unprecedented Inter Ministry support . The result was an unprecedented interest by garment exporters, auto makers, tourism & hospitality personnel to consider diversification to medical devices- we don’t wish to loose this impetus of creating an Atmanirbhar Bharat.
Mr. Bhargav Kotadia, MD, Sahajanand Medical Technologies mentioned that as healthcare providers continue to put colossal efforts in fighting against the pandemic, the reverberations of the current crises are being felt across the spectrum in the economy, especially in the Pharma and MedTech Industry. The ability to deal with these new and accentuated challenges and the Industry’s resilience will determine our success to adjust to the new normal and be prepared for a post-COVID world from now onwards.
Manish Sardana, President- India Business, Poly Medicure said that demand is scaling up with population and disease going up and meanwhile affordability and associability is also scaling up. He said that local demand is very important for make in India to succeed. He further said that a complete ecosystem require availability of raw material, availability of skilled labour and regulatory framework. Mr. Sardana said that demand push is very important and Government to have continued thrust on increasing patient affordability and accessibility. He also said that Incentive linked push to Innovate / Design in India should come in future and lastly he urged to correct the Inverted duty structure, means custom duty on importing raw material is more than importing the finished product.
Rajesh Patel, CEO IVD, Trivitron Healthcare said that Indian talents can develop all possible products and we need to train our local workers as their learning and adaptability is beyond compare. Mr. Patel further said that the Govt. must appreciate the efforts of the Industry and should not allow the free fall of price and must keep a cap on price fall. He further said that 70% of India is rural India and we need products for masses more than for classes. Mr. Patel also mentioned about climatic variance of more than 51 degree calculus where Quality, Affordability, flawless availability and post sales service are very important.
Vivek Tiwari, Founder & CEO, Medikabazaar appreciated the panel’s optimism in stating that the industry in on track to become Aatmanirbhar to a large extent in the next few years. Mr. Tiwari also mentioned resources as the critical element of the industry where India is lacking and urged the Government that there a need for skill development and to arrange good resources in the country for the development of this industry. Mr. Tiwari mentioned that we need to innovate and renovate to make the industry self reliant.
The webinar was moderated by Vivek Seigell, Assistant Secretary-General, PHD Chamber of Commerce and Industry, and was attended by many industry stalwarts pan-India.