Open Letter to Niti Aayog _ Medical Device Regulation_2019

From,
Sandeep Naik,
Director,
Naik Meditechs & Devices Pvt. Ltd.,
31/2129-D, Karollil Road,
Thammanam PO,
Ernakulam- 682032

To,
The CEO, NITI Aayog,
5th Floor - CEO’s Chamber,
Sansad Marg, Sansad Marg Area,
New Delhi, Delhi 110001

Dear Sir,

I would like to introduce myself as the Director of Naik Meditechs & Devices Pvt. Ltd, a medical device import and distribution company based out of Ernakulam, Kerala.

Since our inception in 2003, and privatization in 2009, we have had the opportunity to introduce several cutting edge medical technologies & therapies in India having represented companies like India Medtronic, Olympus, J&J Cordis, Roche and many other multinational companies as their channel partner in Kerala as well as companies like Rudolf Riester, Seca, Gossen Metrawatt, IMT Analytics, Flaem & Visiomed as importers & channel partners in South India.

Our clients include govt. hospitals, research institutions and small, medium & large private hospitals / clinics who have benefited from technology, durability and accuracy of our products.

We would like to congratulate you and thank you for the new legislation where you have proposed to have a separate regulator for medical devices. We are glad that the fact that validation and testing of medical devices required specialized skills has been finally given due recognition. We are also enthused about creation of National Register of Medical Devices and the move to allocation unique identification number to every medical device that has been approved by the authority. This will go a long way in curbing the menace of unapproved and unproven devices that are rampant in the market today.

The reform is a much needed one and will go a long way in making health care diagnosis, monitoring & delivery much safer and reliable.

However, as an SMB player in the industry, we do have our reservations with regards to how the regulatory and approval framework has been designed as well as with the quality and capacity of existing infrastructure which has to deal with the validation and approval of Medical Devices.

Medical Device Industry in India is pegged at $5–10Bn where an estimated 80–90% of items are imported. Thousands of SMB’s are engaged in import and marketing of medical devices and provide employment to lakhs of skilled and semi-skilled workforce in India. While bigger corporations and Indian manufacturers have been able to influence and shape the upcoming regulatory framework, concerns of a vast majority of SMBs who form a vital cog in medical device industry have been largely unaddressed and unanswered.

Having represented some of the leading international companies in field of medical testing & calibration and trained numerous biomedical departments, MedTech OEMs and biomedical engineers in the subject over last 8 years, we would like to bring to your notice certain action points, which if addressed, would make transition to new regime painless and effective for all stake holders.

Develop Expertise & Manpower in Testing & Validation of Medical Devices

We must bring to your notice the dearth of qualified manpower to address the deluge of registrations that will pile up as soon as this legislation is in place.

This will not only delay approval process, will also make it superficial and completely paper based. The resulting red-tapism would end up defeating the spirit behind this regulation.

Organizations like AMTZ / KIHT Vizag are playing a stellar role in up-skilling the existing and upcoming pool of biomedical engineers. However much needs to be done in terms of framing a curriculum in this domain as well as rapidly improving lab infrastructure so that skilled manpower in this segment is created and made available for industry to absorb.

Integration of the Testing, Calibration and Validation procedures and protocols into the engineering curriculum will also help in providing additional avenues of employment to our engineers on their graduation.

We would urge you to ensure that there is no dearth of qualified biomedical engineers deployed across various accredited laboratories so that approvals are not stalled or delayed.

Create Internationally Accredited Laboratories and Adopt Internationally accepted Testing Protocols.

Capacity enhancement of Internationally accredited validation, testing and calibration infrastructure across the country must be done on a war footing.

We do have laboratories like ERTL, STQC, HLL and AMTZ which have already made huge investments in testing equipment and trained workforce. However, we must have these laboratories invest in international accreditation.

We must also adopt internationally accepted testing procedures and norms which will not only open up international markets to Made-In-India products that have been locally approved but also make this a hub for testing & validation services as devices approved in Indian laboratories are per internationally accepted standards would also accepted internationally. This can help create a vast pool of skilled jobs.

Standardization of Medical Device Approval Framework

We are updating BIS Standards to accommodate diverse range of medical devices. We must also create stringent testing procedures & norms working together with international bodies that have decades of experience in framing norms and approving medical devices in their regions. The Current BIS standards being created are a starting point. However, we need to work together with IEC / NIST / VDE to create standardization and abide by international standards.

This will reduce burdens on the Small & Medium med-tech companies (Indian & International) who bring in real innovation in the industry but are forced to duplicate efforts and also spend exorbitant amounts in registration& validation costs across geographies.

An International Certification Gateway for Medical Devices so that devices validated in India can be accepted globally without any regulatory hurdles and vice-versa would help bring down device costs and make high end technology equally accessible to all.

Review Exorbitant Registration Costs for Imported products in India

While we are a $10Bn industry, we are but only a fraction of international device industry (2% of $550 Bn Medical Device Industry globally). Even at a CAGR of 15%, building walls around our market will do more harm than good and keep us away from the path breaking innovations in this field.

Legislation must provide for easier registration norms for devices already approved under FDA, CE and other certification which are internationally accepted.

This would help in reducing registration cost burden for importers who are now forced to spend any where between $1000–$2000 per product in addition to $5000 per manufacturing location. The annual volumes handled by the SMB importers are usually between $50K — $500K.

Lack of proper norming, guidelines, testing protocols, testing capacity and documentation has resulted in rogue private consulting firms charging ridiculous amount of consultancy fees (INR 3.5 Lakh to INR 10 Lakhs per Product ). These firms are forcing small and medium international Med-Tech companies who depend on SMB importers to hand over master distribution licenses in their name taking advantage of the lack of clarity in the regulatory framework.

These registration costs are extremely prohibitive for International small and medium Med-tech companies (which already have FDA / CE and other international approvals) to absorb, leaving the importer to absorb a significant potion of registration cost.

Differentiate between Import License and Product Registration

The current legislation does not differentiate between product registration and import permits.

For current notified devices by the CDSCO, many importers are being forced into filing separate registrations for the same device at exorbitant costs.

International companies are being told that each importer must file separate product registrations for the same device resulting in a cost multiplier which is forcing many international companies to re-think their distribution policies or even re-consider selling their products in the Indian market.

Multiple importers must be allowed to import devices against a single approval.

Internationally accepted classification of devices

There has been an upward migration with regards to classification of medical device categories that has created a unnecessary regulatory burden and cost escalation.

Devices like Blood Pressure monitors which have been internationally accepted as Class A (Low Risk) have been migrated to Class B (Low Moderate Risk). Similarly Nebulizers and Suction apparatus internationally classified as Class B (Low Moderate Risk) have been migrated to Class C (Moderate High Risk). This migration is unfair and seeks to provide undue advantage to domestic firms which have a huge cost advantage when it comes to registration and validation fees.

Single window of approvals for devices for import / manufacture and trading

A single window system for submission of documentation and devices for testing along with processes that would help companies and their channel partners comply with the regulation without any third-party assistance would help overcome red-tapism in proposed regulatory framework.

We do hope that your team would consider the above mentioned points during the drafting of the legislation.

Thanking you,

Yours Sincerely,

Sandeep Naik,

Director, Naik Meditechs & Devices Pvt. Ltd. (www.naikmeditechs.com)

Co-founder, Doctor’s Bazaar (www.doctorsbazaar.com)