Our 21st Year of Publication
Page  2 of 3

Cover Story

Global Medical Device Business And
India's Changing Role :
Trends and Challenges

In California, the leaderships and R & D manpower of the Medical Device Companies comprise of Indian Talent in a big way. People of Indian Origin are rare resource and creators of Intellectual Property (IP) for their Companies and Employers. Companies holding such IP can multiply revenues 5 to 10 folds.

The work is companies like GE or Siemens in India is owned by Companies in Germany or Netherlands or US but the people of Indian Origin work whether, it is in India or those Countries. Why in next 10 years, some similar work not be performed by Indian engineers working for of that work can not be the property of Indian Companies ?

Some of the Indian Clients are already doing similar work . One such western medical device Company has already completed designing with the help of Indian Engineers and Scientists for a Medical Product to be launched in China market, which is roughly 10 times the size for that particular product category than that of the Indian Market. The Market. The Company would not have been successful if they had done the work in the West. The Company cannot do this work in China because of apprehension of protection of IP.

Another leading US Company is working for Health related product for Latin American market. They do not find it economical to do so in US and hence they are hiring Indian Engineers to do the Innovations for Brazil, Argentina and other Latin American Markets.

There are many such examples of world class work is happening right here in this country.

Based on the capability of India for Innovations and ability to create value for the day-to-day requirements ,requirements, there is a need in India for instant T.B. Diagnostics possibility where one can take blood from the patient and decide within seconds whether the patient has T.B. or not. It’s India’s need unlike America.

Similarly, Lots of diabetics are present in India. We need to have a way to test the blood sugar that costs pennies, not the kind of solutions that you see from the west that you give away Glucometer but the patient needs so much money on the strips.

It is possible to find such solutions right in India and for this market is not limited to India. And beyond serving India, India, these products could be sold in
Africa, Africa, Latin America, America, Middle East though may not be in regions with rich people like North America, Japan etc.

Such Innovations can far more effectively be served by Indian Engineers than those working in the West. It also provides opportunities to Indian Companies.

Such opportunities are far bigger and far more immediate and hence it is better for Indian Companies to look at them rather than waiting for Government of India to change this rule or that rule.

We need to work with Global minds. We need to have more “Tata Nano”s coming out from the Medical Device Business.

We see success coming only from Innovative Companies, focused on manufacturing . When this happens in big way, you will see far bigger achievement than what we saw with IT business where it is “TCS” and “Wipro” leads. In Medical Device Business, there is much greater opportunity.

Like “Taiwan” and “Korea” has done in Electronics , Indian Companies can do for medical device market globally Global market and create far more value and far more market capitalization than what we have seen till today.

Another example is of “mobile “ phone business with an example of a California based Company, “QUALCOMM” which has built its entire business employing tens of thousands of people basically around Patents. They do not manufacture products without their own IP. Yet each of us has probably a device where in “QUALCOMM” is being paid because you buy that handset.

There is tremendous value in creating Intellectual Property which in the long run would serve India very well.


Indian Institute Of Science And National Centre For Biological Sciences Collaborates With Industries For The Early R&D Of Combination Products Like Pre-Filled Drug Delivery Devices

Indian medical devices companies have upheld US Food and Drug Administration (FDA) regulation on the current good manufacturing practice (cGMP) requirements applicable to combination products that would be enforced from July 22, 2013.

Indian Institute of Science and National Centre for Biological Sciences have collaborated with industries for the early R&D of combination products like pre-filled drug delivery devices.

As per US FDA, in a combination product the constituent parts retain their regulatory status as a drug or device, after they are combined. Hence the cGMP requirements that apply to each of constituent parts continue to become relevant even when they are combined to make combination products.

The FDA published a proposed rule in the Federal Register of September 23, 2009 (74 FR 48423) on current good manufacturing practices for combination products. The proposed rule merely provided that all such constituent parts must be manufactured in accordance with cGMP requirements that would apply to them if they were not part of a combination product, said the Regulatory authority.

The compliance with either the cGMP regulations for drugs at parts 21 CFR parts 210 and 211 or the quality system (QS) regulation for devices at part 820 which are 21 CFR part 820 will satisfy many, though not all, of the cGMP requirements applicable to both drug and device constituent parts, said the regulatory authority.

Ref: http://pharmabiz.com/NewsDetails.aspx?aid=73404&sid=1

Nipro Sets Up India's First Dialyser Manufacturing Facility

Nipro Corporation, a Japan based maker of life saving medical devices, consumables, pharmaceutical glass products has set up a facility at Shirwal near Pune which will manufacture the first made-in-India artificial kidney (dialyser).

The company has made investment of Rs 700 crore for this facility and it has been given mega project status by the State Government.

Also, the project has been accorded approval by the Atomic Energy Regulatory Board of the Bhaba Atomic Research Centre to introduce in-house Gamma technology for sterilising devices for the first time in the country.

Nipro has been operating in India since 1995, and notches an annual turnover of Rs 500 crore.

Commenting on this development, Milind Pappu, managing director, Nipro India Corporation said, "NIPRO India Corporation expects to achieve Rs 350 crore turnover in 2013.

The Pune Factory currently provides employment opportunity to 800 people and expects to double it by end of 2013. Nipro India’s Facility for manufacturing Artificial kidneys from synthetic fibers is the country’s most ambitious project in the Medical Device Industry.

The growing importance of Indian Healthcare market gives this country a central position in Nipro Corporation’s global strategy. We entered the Indian Market in 1995 and started our trading activity in the country."

According to Pappu, Nipro products will bring down the cost of dialysis and increase the reach. Currently, In India, only 10 per cent of patients can afford dialysis treatment. Initially, it will make six million dialysers per annum, which can be ramped-up and it plans to export 90 per cent of its production in the beginning.

Page  1  :  2  :  3

Back | Back to Top | Previous | Next