Sushrut Surgicals and its group company Adler Mediequip, are widely known for their colossal contribution and market leadership in orthopaedic implants and devices in India and abroad.

Ajay Pitre, Managing Director, Sushrut Surgicals & Adler Mediequip and Vice Chairman, CII Medical Equipment Division shares his thought with eHEALTH about the achievements of his company, vision for the future and his wish-list for the government to catalyse the growth of domestic medical device industry in India.

Q. Sushrut is known as a pioneer in ortho implants and surgical equipment tools, and a market leader in spine and reconstructive surgery segment. When and how did it embark on this journey? What had been the core competence and winning philosophy of the company?

A. Sushrut Surgicals began operations in 1973 and today it is recognised as one of India’s oldest and most trusted companies in the field of orthopaedic implants and instrumentation. The group company, Adler Mediequip, was set up in 1993 with the objective of building on Sushrut’s experience in orthopaedic device business and bringing world-class orthopaedic medical devices to India. At present, Adler Mediequip is the exclusive manufacturing arm for the group’s operations, with Sushrut Surgicals being the marketing arm.

Adler is the first Indian orthopaedic device manufacturer to secure ISO 9002:1994 (in ’99); the first to receive ISO 9001:2000 (in ’02); the first to obtain the coveted CE certification (in ’03) and also the first in this field to be certified ISO 13485:2003 compliant (in ’06).

Recently, Adler Mediequip achieved the unique distinction of being the first Indian company to receive the Drug Manufacturing Licence from the Office of Drug Controller General of India, for its complete range of orthopaedic implants.

Q. What is the current portfolio of medical products and devices that Sushrut is offering? Which among are most cutting-edge in terms of technology and innovation?

A. Our current portfolio of devices can be divided into three broad clinical areas viz. ‘traumatology’, ‘spinal surgery’ and ‘reconstructive orthopaedic surgery’. In each of these areas, the group has a comprehensive range of implantable devices and complementary instrumentation. The group offers a number of solutions that are innovative and represent cutting edge technologies in clinical care.

One of the most innovative is a mini external fixator system – ‘UMEX’, developed in cooperation with a group of leading orthopaedic surgeons from Mumbai. This system enabled a revolutionary simpler method of correcting deformities in children, such as, club foot and club hand and has also enabled pioneering applications in area of post-burns deformity correction.

In the area of spinal surgery, the ‘OneLock’ spine system, a system of spinal screws and other associated devices used for spinal fusion/stabilisation surgery, represents cutting edge technology in terms of device performance.

In the area of reconstructive orthopaedic surgery, the group is currently engaged in making a strong contribution to the field of limb salvage surgery with the development of the ‘ResTOR’ modular resection system in association with Tata Memorial Hospital in Mumbai. 

Q. What is your existing R&D capacity and manufacturing facility in India? What is your level of annual investment (in percentage of turnover) on R&D?

A. We realised quite early that our future lies in presenting ourselves with qualitative innovations that matter in a global scenario. Hence, we have been continuously reinvesting in development of solutions.

Although, the development effort started in an ad hoc manner, currently, we have a group dedicated to R&D. Their direct and continuous interaction with surgeons helps in creating and validating many of our research and development.  .

Q. What has been your marketing strategy in India? Kindly elaborate on your initiatives around surgeon education and CME programs?

A. Our marketing strategy in India has focused on building high quality relationships with Indian orthopaedic community at large and with senior professors and teachers in the field. We believe that these interactions continuously nurture ongoing improvement based on continuous feedback. This network of relationships also enabled the group to continuously evolve in terms of product design and portfolio that meets the need of Indian orthopaedic community.

Sushrut’s commitment to surgeon education has taken the form of a dedicated infrastructure in the form of the ‘Sushrut Learning Center’, located in Sushrut House, at Hinjewadi, Pune. This centre has been created with state-of-the-art learning infrastructure in form of a professionally designed auditorium, latest in multimedia and audio visual technologies, a dedicated hands-on workshop area and video conferencing facilities.

Q. What are the existing challenges for medical device and equipment industry in India? What will be your wish list from government authorities for boosting this industry?

A. I will split the answer in two sections – viz. regulations and its effects on domestic medical device industry and lack of understanding of the government about issues affecting this industry.

Till October 2005, medical device industry in India was totally unregulated. The poorly constituted Gazette Notification of October 2005 (as a knee-jerk reaction to a public interest litigation case in Mumbai) notified ten categories of implantable devices as ‘drugs’ and brought them under the purview of Drugs and Cosmetics Act and Rules. However, it was completely unsuitable due to differences in the manner in which drugs and devices are intended to perform in the human body, and thereby, different risks they present. Later on, interactions between industry bodies like CII and FICCI and the implementing regulatory office (Drugs Controller General of India) brought forth various issues involved in this and increased general understanding of the subject. 

However, the knowledge developed through such interactions has neither percolated to regional hierarchy of regulators nor to relatively less knowledgeable sections of the domestic industry. As opposed to importers who need to tackle issues only at the regulators head office (HQ of DGCI), the domestic industry needs to compulsorily have the first point of contact at the regional level, as per current procedures implementing the Drugs Act.  To tackle problems at the regional level, the domestic industry has to interact with the State Government as well as the Central Government representatives causing enormous hardships and substantial delays.

To put into perspective, there  are close to 600 import registration/licences granted till date, as against less than 50 domestic industry manufacturing licenses. Moreover, majority of domestic manufacturing licenses have gone to a handful of progressive companies with global ambitions.  Many domestic players have not even applied due to lack of clarity and their inappropriate understanding of regulations. 

As a case in point, our own orthopaedic device industry has been reverse discriminated against finished products, which are completely duty free importablable for nearly a decade. Vital implantable raw materials that can only be sourced internationally need to be imported paying the highest duty rates + CVD amounting to 25 to 30% (lowest in this decade). Since finished products are exempted from Excise, we are actually paying higher than peak duty and therefore are being penalised for manufacturing in India. 

Thus, it seems that Indian government has raised substantial tariff and non tariff barriers against domestic manufacturing Industry. We can only hope that the government will take corrective measures for ensuring equitable treatment. 

My specific recommendations for the government would be as follows:

1. Recognise medical device as an independent and important industry for meeting cost effective healthcare needs across demographics.
   
   
2. Correct inappropriate regulations and grant adequate transition time.
   
   
3. Strictly enforce regulation without compromise on quality.
   
   
4. Remove duty anomalies faced by domestic manufacturers. Exempt them from import duties on raw materials, components or capital goods (technology).
   
   
5. Create grants/subsidised funding for domestic manufacturers for modernisation and technology adoption.
   
   
6. Encourage and fund innovation to create cost effective solutions.

Q. What has been the overall growth of medical device industry in India (in CAGR terms) in recent times? What are the future expectations?

A. The overall medical device industry has been growing by 12 – 15% CAGR in certain segments. In segments where there are latent unmet needs, it is likely to grow even as high as 25% CAGR.  This growth rate will be largely driven by capacity and capability creation which can be considered as key drivers. Of course, economic progress as well as growth in health insurance coverage would be other factors responsible to expand the healthcare industry and hence add.

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