A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY
Our 17th Year of Publication
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Cover Story

Event Report

Conference On Indian Medical Devices and Plastics Disposables Industry 2010

Process of Commercialization of Medical Device Technology
Address by Mr C. Balagopal
  • There is an enormous scope for Indian Medical Device Industry to grow.

  • A lot of problems of Indian Medical Device Industry can be traced to inadequate & ineffective regulation.

  • The effort of govt. so far has been not to understand the special requirements of Medical Devices manufacturers but to attempt to somehow bring devices also under existing regulatory framework & the existing regulatory framework is related to the drug control regime which is very specifically targeted at pharmaceutical products.

  • One final appeal and recommendation I would make is that the various bodies sitting here, while in the individual capacity no doubt they are doing good work for their members, in order that they become more effective , they need to form a kind of apex organization which will bring all of them together . Because essentially, all of these are medical devices of the one kind or the other. so rather than remaining fragmented ,if they come together and form an apex organization, I am sure their voice will be heard much more since they will form more significant part of the economy in terms of turnover , employment and  economic impact and they should move for in getting the draft medical device regulation bill to become a reality.

Appreciating the efforts made by the organizers, Mr C. Balagopal mentioned that , “I remember the early days when Mr. Pandya was like alone crusader with very few followers, talking about things which were very important but which I think very few people understood. Now looking at the large participation & the number of companies, ( even govt. is taking an interest ) it looks like his mission is making a success.

Mr Balagopal focused his presentation on Regulations. The regulatory framework which is required for the growth of the healthy Medical Device Industry in India.

Coming back to the subject on “Process of Commercialization of Medical Device Technology”, he discussed about the early stages of the Medical Device Industry. He mentioned that , “From my experience, 25 years ago, when I was starting this process to manufacture blood transfusion bags of international quality, no Medical Device Industry worth the name was in India. Everything that we spoke about was unfamiliar to both the equipment manufacturers as well as material suppliers.”

“In the early stages, after commissioning the factory, we ran into those innovative technical problems, associated with scaling up a lab scale process to commercial scale. We inserted a small advertisement for suppliers of medical grade plastic materials”.

From the responses received indicating the expected prices, without knowing the expected quality, indicated that there was something wrong. One of the basic underlined causes I felt was the absence of the regulatory framework. When the factory was commissioned and they applied for the license to manufacture the blood bags, the regulatory authority couldn’t figure out where this product fitted ? When finally they discovered that the blood bag contains a small quantity of anticoagulants, the manufacturing license was given to us for making the anticoagulants and not blood bags. Less than 5% of the cost of the completed blood bag use accounted for by the anticoagulants. Though the container is the device , the first manufacturing license given to the blood bag manufacturers in India was to manufacture anticoagulants in a plastic container.

Even after 25 years, not much progress as well as growth is seen in the Medical Devices Manufacturing Sector. Today if we see the figures, the total use of Medical Devices in India and the proportion of that manufactured in India, we can see what the real problem is. For most of this devices which are being used in the country (you don’t need rocket science to make them), we do not have the entrepreneurs who either understand the market or the technical demands of the products . As a result, a very significant proportion of the total Medical Devices used in India is imported. As the health minister remarked in his opening address, there is an enormous scope for Indian Medical Device Industry to grow.

Talking further on Role of regulatory mechanism in promoting the Medical Device Sector , he said that, "most of us in India dread the word –Regulations. This is because with “Regulations", we imagine bureaucracy and all that follows which in our country , has been connected with hindrances for growth, corruption etc. But there is an undoubted role which regulatory framework plays for the growth of any sector. A lot of problems of Indian Medical Device Industry can be traced to inadequate & ineffective regulation. The effort of govt. so far has been not to understand the special requirements of Medical Devices  manufacturers but to attempt to somehow bring devices also under existing regulatory framework & the existing regulatory framework is related to the drug control regime which is very specifically targeted at pharmaceutical products. So this ended up (like I mentioned in the case of blood bags ) considering devices as deemed to be a drug for the purpose of regulations.

The most recent has been to revise the drug cosmetics art by an amendment in 2007 to expand the ambit of this act to also include some of the drugs. This operation has resulted in some problems which needs to be understood very well by the manufacturing sectors as well as by govt.

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