'Lack of specific laws hurting orthopaedic implant sector'

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SME Times News Bureau | 07 Sep, 2011
Delay by the government in introducing specific regulations for the medical device industry has started to affect the orthopaedic implant sector, said Rajeev Chhabra (Ace Ortho Care Pvt. Ltd.) in an exclusive interview to SME Times.

Excerpts of the interview...

Please brief our reader more about the conference on medical devices regulations for orthopaedic industry, which was held on September 10 in New Delhi?
Rajeev Chhabra: The conference was organized on the Upcoming Medical Device Regulations with specific focus on Orthopaedic Implant Industry and effect of regulations on the Orthopaedic Implant Industry.

What is the size of Indian medical device manufacturing industry sector?
Rajeev Chhabra: In North India, here are around 15-20 Organized Manufacturers and More than 50 Unorganized (subcontractors) Manufacturers who are part of this Northern Orthopaedic Association.

What are the challenges the sector is facing now-a-days? And how will you address these challenges in the conference?
Rajeev Chhabra: We can segregate the challenges into following points:
1.Cost to Compliance: Low affordability of subcontractors
2.Exports not being allowed to manufacturers without having manufacturing Drug License
3.Less Availability of Resources (Technical Persons-specific for orthopaedic implant industry-the guidance document needs consideration of engineering background for competent persons
4.Fear of losing business as a result of increased manufacturing and material input costs.

Due to lack of separate regulation, the medical device industry is facing problems. What is your view on this?
Rajeev Chhabra: It cannot be said that due to lack of regulation Medical device industry is facing problem, in fact this regulation will help improve the overall product and GMP regulations are definitely helpful in organizing the manufacturing activities. The problems mentioned in third point cannot be linked to the problems due to lack of regulation. Every regulation is meant for improvement.

Do you agree the inordinate delay in legislation to regulate the medical device industry is hurting both business interests as well as consumers' rights to safe medical devices. What is your take on this?
Rajeev Chhabra: What we are manufacturing today, was being manufactured with same manufacturing process and quality control as well as using same grade of implantable stainless steel and titanium raw materials. The devices were safe before the gazette notification of 6 and 7 October 2005 and today as well. We manufacture implants and understand that it is going to remain in body for long duration and sometimes upto the lifetime of the patients, so we always take care of using good quality raw materials safe for the patients. Delay in regulation was not that much anticipated but we understand that there are protocols to be followed for any bill to be passed. It has not affected in the past that much but now it is affecting due to denial by the hospitals and clinics to accept these implants without having drug license.

Have you had words with the government regarding the same? What is government's move on this?
Rajeev Chhabra: We are communicating with FDA, DCGI Office on a regular basis and we have always received favourable response.

According to media reports, the medical devices, diagnostics and equipment industry is only a fraction of the USD 35-billion domestic healthcare sector. How you see its potential here in India?
Rajeev Chhabra: We are growing and world is looking at us as a manufacturing hub for various kind of medical devices including Orthopaedic Implants and such regulations will help improve our international presence as well.

Last but not least, please tell our readers more about your association (Northern Orthopaedic Association). And what are your mediums for promotion for the benefit of your clients?
Rajeev Chhabra: We are at the nascent stage of inception and not more than 1 year of active operations. This is the first such event being organized and we hope to increase it in the future.