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Aimed & Regulatory Update

Indian Embassy In Moscow Bats For Tapping Potential Of Indo-Russian Medical Device Industry Through Collaborative Efforts

• AiMeD and DRISP have joined hands to give a boost to bilateral medical device trade
• Future roadmap and emerging opportunities discussed in webinar
• MoU was signed between AiMeD and DRISP in November 2023

New Delhi, April 22, 2024: Given the enormous opportunities in the medical device industry for multifaceted bilateral engagements, experts from India and Russia have vouched for faster efforts to give a boost to collaborations to make the most of emerging opportunities in the areas of manufacturing and marketing lifesaving medical equipment and devices. AiMeD and DRISP had signed an MoU last year and are now moving ahead towards strengthening the bilateral relations through their collaborative efforts.

“The support extended by Indian Embassy in Moscow in our collective efforts to mutually cash in on emerging opportunities in medical device industry will go a long way in giving a further fillip to bilateral trade ties between two nations,” said Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD).

Nath informed that experts from India and Russia at a recently held webinar rightly stressed the need for a dynamic and multifaceted economic engagement, guided by shared interests and a commitment to further deepen bilateral cooperation and the two organisations will contribute in their own humble manner in line with that objective.

The online event was attended by over 70 Indian manufacturers and exporters alongside some key Russian investors.

“There is a huge scope for partnerships between Indian stakeholders and their Russian counterparts in the field of medical device industry. Centre for the Development of Russia India Strategic Partnership (DRISP) and AiMeD have joined hands to accelerate the pace of bilateral engagements, he said.

Ved Prakash, First Secretary, Embassy of India in Moscow, in his opening remarks, expressed gratitude for the organisation of the meeting on medical devices. Rohit Neema, Second Secretary, Indian Embassy in Moscow, promised his support for facilitating trade and cooperation in the medical device sector between India and Russia, recognising the sector's potential for economic growth and job creation.

Nath through his presentation of a comprehensive analytical document titled ‘Medical Devices –The next big thing after IT and Pharma’ showcased the latest trends and the year-on-year growth in exports and also introduced the audience to the domestic champions from various segments who have achieved great heights under the guidance of policies enacted by the Indian government.

Prasun Prakash, Founder, DRISP, alongside moderating the discussion, pointed out the right timing for the exchange of technology, critical data, knowledge base, human resource and expertise in the sector considering the latest geopolitical trends and the growing interest inside Russia towards establishing
strategic partnerships with Indian manufacturers.

Denis Stepanov, General Director of CES Spine Medics, Russia, highlighted the potential for Indian medical device manufacturers entering Russia. He said that there are opportunities in the market, such as the interest from manufacturers and the need for high-tech and high-quality medical products. He also addressed the challenges, including the registration process, competition from Chinese and Turkish manufacturers, and the need for international collaboration.

Ashish Rangra from Invest India made a detailed presentation on the Indian medical devices sector, covering its current valuation, projected growth, key segments, import dependency, and the government’s initiatives and incentives. He also discussed the upcoming manufacturing infrastructure, including the introduction of four new parks and success stories of companies investing in India.

About AiMeD

.AiMeD is an Umbrella Association of Indian Manufacturers of Medical Devices covering all types of Medical Devices including Consumables, Disposables, Equipments, Instruments, Electronics, Diagnostics and Implants. With a Primary Membership of over 300 Manufacturers and additionally of over 200 Associate Members representing the interest of over 1200 Manufacturers of Medical Devices to address the manufacturer’s problems.

The aim behind forming AiMeD is to allow the Indian Government to access a single point of contact and provide various services to the manufacturers like Advocacy on policy issues, Information services, Regulations for Medical Devices, Education and Training, services, Testing Assistance and guidance for Quality Certification (ISO, CE, GMP), advocacy and much more.

Ref : Website: https://www.aimedindia.com/


AiMeD Demands Separate Pricing Mechanism For Medical Devices Industry

The medical devices industry has reiterated that it needs a separate pricing mechanism and a separate regulatory framework from how drugs are regulated in the country, in the wake of the Department of Pharmaceuticals (DoP) constituting a committee to prepare a draft price control order for both drugs and medical devices.

"The domestic medical devices industry wants a separate regulatory framework and a separate pricing mechanism distinct from how drugs are regulated in the country," said Rajiv Nath, forum coordinator of Association of Indian Medical Devices Industry (AiMeD), the umbrella association of Indian manufacturers of medical devices covering all types of medical devices.

"Instead of price control, we have proposed price regulation based on trade margin monitoring and then a graded step by step non disruptive regulatory rationalisation at the first point of entry of goods into the supply chain where GST is initially charged on overseas and Indian manufactured medical devices," he added.

This could be applicable for imports and also ex factory prices. Indian manufacturers don't want to be equated with importers for foreign medical devices, we wish a level playing field with overseas manufacturers as importers are also distributors of overseas manufacturers, said Nath.

The DoP has constituted a Committee to reform the pricing framework for drugs and medical devices in the country and to prepare a draft Drugs and Medical Devices (Control) Order. The committee has to submit its report in three months.

The Committee will have three core members headed by Arunish Chawla, secretary, Department of Pharmaceuticals (DoP), with Kamlesh Kumar Pant, chairman of National Pharmaceutical Pricing Authority (NPPA) and Awadhesh Kumar Choudhary, senior economic advisor, DoP as members.

It will have two special invitees from the industry, one each from the Indian Pharmaceutical Alliance (IP Alliance) and Indian Drugs Manufacturers' Association (IDMA). The Committee will be free to invite anyone for seeking technical inputs or placing its views before the Committee.

The committee shall look into various aspects including the institutional reforms required for the NPPA, how to balance price and availability of essential medicines, while providing incentives to the industry to sustain growth and exports, how to design a price moderation framework for medical devices, while providing incentives to the industry to sustain growth and minimise imports, and how to design a price moderation framework for emerging and precision therapies to facilitate their timely reach to the needy patients.

The Committee is expected to come out with a draft Drugs and Medical Devices (Control) Order to achieve these objectives.

Recently the Department-related Parliamentary Standing Committee on Chemicals and Fertilisers has recommended the Department to take up the matter of price control for medical devices with the NPPA, for inclusion of medium and high-end medical devices which are used for critical care of patients,observing that the devices which are required for critical care to the patients should be listed under the National List of Essential Medicines (NLEM).

https://www.pharmabiz.com/NewsDetails.aspx?aid=166948&sid=1, March 14, 2024

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