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Indigenous Manufacturers Competing for Excellence

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Dr P Siva Kumar

Tech-driven medical devices have been playing a pivotal role in driving Indian healthcare to reach the last mile. Due to rising demand of quality diagnostic services coupled with latest innovations, the industry is growing by leaps and bounds, says Dr P Siva Kumar, CEO, Trivitron Healthcare Pvt Ltd and Member of Association of Indian Medical Device Industry (AiMeD) in conversation with Elets News Network (ENN).

Q How medical devices equipped with latest technology are playing an instrumental role in providing comprehensive healthcare delivery?

In the healthcare delivery system, medical devices play a significant role in identifying/diagnosing the disease which facilitate the medical fraternity to provide comprehensive solution to the patient to overcome the diseases. Apart from the individual getting best treatment, it also plays a crucial role in reducing the disease burden of a community, State or the country. In brief, the medical devices are used for the following purposes across the spectrum of healthcare delivery:

• Diagnosis, prevention, monitoring, treatment, or alleviation of disease;

• Investigation, replacement, or modification of the anatomy or of a physiological process;

• Control of conception; on the human body by pharmacological, immunological, or metabolic means.

Unfortunately, medical devices in India are still dominated by the multinational overseas players and we are hugely dependent on import.

Q Tell us about the market opportunity and scope of medical equipment segment which is considered a sunshine sector of healthcare ecosystem.

Medical devices industry is highly innovative and technology-driven and thus, constantly changes the face of healthcare in the areas of diagnosis, treatment and delivery. While in India the perception is that there is very low level of market share of indigenous manufacturers of the Rs 65,000-70,000 crore market of medical devices with 70-90 per cent import dependency. It is self-reliant in consumables and disposables and has more import dependency on medical equipment and electronics. There are some exceptions to the rule being challenged bravely by some entrepreneurs in the medical technology space.

It is indicative of the huge potential for the industry to Make in India and plays a larger role in Indian healthcare space.

medical equipment

We have Transasia as a successful Indian manufacturer and an Indian MNC in the IVD (In Vitro Diagnostics) and highly automated Analyser space, Trivitron as a successful diversified Medical electronics and equipment manufacturer in Diagnostics and Imaging, Allengers, Cura, Skanray and Allengers in imaging – X-Rays and Ultrasound, Allengers and Involution in Cath Labs, Robonik and Accurex in Lab Analysers, Perfint in medical electronics, Prognosys in Linear Accelerators and Imaging, Mitra in video endoscopy, Appasamy and Forus in Opthomology, Phoenix and Zeus in neonatal care who are challenging the market dominators – GE, Philips, Siemens, Olympus etc.

The world’s eyes are on India and the Government of India has woken up to the huge potential of growth offered by the medical equipment and the medical electronic sector. Ministry of Electronics and Information Technology (Meity) is now treating this as a focus sunrise sector and has been in consultation with AiMeD and other stakeholders to replicate the success of the Cellular Phone industry.

On realising the huge opportunities offered by medical devices sector, the Chief Minister of Andhra Pradesh, Dr Chandrababu Naidu, has initiated the rapid development of the Andhra Medtech Zone (AMTZ) at Vishakapatnam under the able leadership of Dr Jitendra Sharma who was serving as his healthcare advisor.

An interdependent ecosystem is being created in AMTZ focussing on medical electronics with common manufacturing facilities of an X-Ray Tube manufacturing plant, an Electromagnetic Radiation Test house, a rapid prototyping Centre and tool room, head display and supply chain of downstream manufacturing of Plastic Molded components, silicon rubber key pad components, SMT PCBs etc. Not to be left behind, the Chief Minister of Telangana, K Chandrashekhar Rao has initiated rapid development of a Med Tech Park at Hyderabad.

Q Shed some light over the challenges plaguing this medical equipment segment. What the Government should do to encourage domestic market of medical devices?

The Per capita spending on healthcare in India is significantly lower than in China or Russia.

The Indian healthcare system is inadequate, inefficient and unevenly distributed focusing mostly in the urban geographies. There are Zero patient safety regulations unlike US FDA or CE of Europe acting as a Non Tariff barrier. Only some radiation safety regulations by AERB. Non-alignment of regulatory systems with global standards and lack of quality product testing infrastructure are hindering the progress of this sector. Babies get burnt by low quality Chinese incubators but still only 23 categories of medical disposables and implants only are covered under CDSCO under the Drugs and Cosmetics Act which is a misfit for medical electronics and equipment as it’s designed for Pharmaceuticals.

The Sector’s under development is stunted by poor attention by policy makers to addressing complete lack of Tariff protection with custom duties at Zero to a maximum of 7.5%.

There are rampant imports of low cost preowned second equipment being permitted in name of affordable access.

Indian manufacturers are discriminated against and kept out of the tender bidding process by asking for compliance to mandatory qualifications requirements like US FDA regulatory approval.

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