A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY
Our 18th Year of Publication
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Cover Story

8th Two Day National Conference on
Indian Medical Devices & Plastics Disposables Industry 2011

Event Report

Shri Jay Narayan Vyas
Hon. Minister of Health and
Family Welfare,
Government of Gujarat

  • Technology will invade and pervade every field of activity and pharmaceuticals, medical device industry, implants etc. cannot be different.

  • The business is 3 billion US$ per year in India by 2012, it is expected to swell roughly to 6- 8 billion US$.

  • Taking advantage of the skilled manpower and technological development, India has the capability to develop this industry and can be a supplier to the world.

  • Asia hardly accounts 1/5th of the medical devices that are manufactured in the world. And if Asia is to progress, India has to progress and so is for Gujarat.

  • Technology will invade and pervade every field of activity and pharmaceuticals, medical device industry, implants etc. cannot be different.

  • We are in a state (Gujarat) which is
    - No. 1 body donating states in the world.
    - No. 1 eye donating states in the world.
    - Where at a single location largest no. of kidney transplantations are taking place.
    - Which has a record for fastest and largest number of knee joint replacement operations being done,
    - Which is most advanced as far as dental implants are concerned.
    - Which has the best cancer treatment facilities in the country, state which is no.1 as far as per capita blood donation is concerned.

  • The business is 3 billion US$ per year in India by 2012, it is expected to swell roughly to 6 - 8 billion $.

  • There are two things that Indian manufactures should fill happy about :
    - The pharma to implant share is 15% compared to 28 % in the world, that means there is lot of opportunity to grow.
    - This is still an hi-tech import dependent country, that means there is lot of scope.

  • Taking advantage of the skilled manpower and technological developments, India has the capability to develop this industry and can be a supplier to the world.

  • Asia hardly accounts 1/5th of the medical devices that are manufactured in the world. And if Asia is to progress, India has to progress and so is for Gujarat.

Dr. A. Ramkishan
Asst. Drug Controller Of India
CDSCO, Subzonal office, Ahmedabad

  • Medical device companies in Gujarat are competent enough to take care of all critical aspects like biocompatibility, toxicological & stability testing, validation process as well as design and development.

  • Medical device companies in Gujarat are competent enough to take care of all critical aspects like biocompatibility, toxicological & stability testing, validation process as well as design and development.

  • There are eighty or more licensed manufacturers. The regulators in Gujarat very closely monitor infrastructure as well as quality control including microbiology.

  • As a result, not only the regulatory norms are satisfied, the safety and effectiveness of the products and the interest of public health are also taken care of.

Dr. Eswara Reddy Head, Medical Devices
Division & Assistant Drugs Controller of India
CDSCO, Ministry of Health and Family Welfare, Government of India

  • Medical devices are considered to be critical for the services offered in prevention, diagnosis, and rehabilitation of illness or diseases.

  • In India, there is demand for worth 15000 crores medical devices by value this year, and it is expected to be around 20000 crores in next year.

  • Hospitals : There are 0.9 beds per 1000 population in India against world average of 3.9 beds per 1000 population.

  • There is a need to regulate and assure the quality of medical devices marketed in the country because of the potential health risks.

  • The Gujarat FDCA has an excellent e-governance system in place.

Healthcare services : Pharma and Medical Device Industry in India

  • Hospitals and other areas occupy 72% of total healthcare market.

  • Pharma share is only 22 % of the total healthcare market.

  • Medical devices and equipment have only 6% but it has its own importance and place in the quality healthcare system in India.

  • Medical devices are considered to be critical for the services offered in prevention, diagnosis, and rehabilitation of illness or diseases.

  • In India, there is demand 15000 crores for worth medical devices by value this year, and it is expected to be around 20000 crores in next year.

  • 80% of our medical devices at present are imported from other countries; on other hand there is 60% of export of or indigenously produced medical devices, especially disposables medical devices and medical devices furniture to the rest of the world.

  • According to WHO, estimate after next 12 years. India is going to spend 10 lakh crores rupees in healthcare sector i.e. around 225 billion $. Need of Innovation in Medical Device Technology

  • To make our health services more freely available we need very good facilities at hospitals which includes medical devices also.

  • Hospitals. There are 0.9 beds per 1000 population, in India against world average of 3.9 bed per 1000 population.

  • To comply with these requirements there is need of innovation

  • With the convergence of many scientific and technological breakthroughs, the phase of medical invention is accelerating, inspiring a better clinical outcome with less invasive procedure and shorter recovery times.

  • Success in any medical technology innovation would be dependent on the financial incentives from the government. Capacity for quality research, supporting regulatory systems, demand and supply of the health services and supportive investment community. Need for stringent Medical Device Regulations in India

  • The medical technology sector in India comprise of three sub-sectors :
    - Medical Equipments
    - Medical Devices
    - Medical Disposables and Furniture

  • Medical equipment share is 55%, medical implants like cardiac stents, IOL , dental implants etc. has share of 25% and medical disposables like syringes , catheters have 20% of the share.

  • In India the medical devices are regulated as drugs. In true sense devices are different from the drugs. There are only 14 notified medical devices till now and there are more than 3000 medical devices categories available in India.

  • There is a need to regulate and assure quality medical devices marketed in the country because of the potential health risks.

  • The major amendments proposed in the Drugs and cosmetics acts include the definition of medical devices as per the GHTF definition, which is globally accepted.

  • At present the D & C act regulates only drugs and cosmetics, so the name is going to be renamed as Drugs, cosmetics and medical devices act.

  • This will include
    - The classification of medical devices
    - The standards for the medical devices
    - The role of notified bodies for the conformity assessment
    - Panel provisions for any violations of provisions of drugs
    - cosmetics and medical devices act
    - The audit procedures etc.

  • These are the major changes as proposed in the amendments of Drugs & Cosmetics act bill 2011.

Gujarat FDCA as “facilitator”

  • Gujarat is hub for the medical device industry. Out of 106 licences granted for medical devices almost 40 licensed manufacturing units are located only in Gujarat. This is a great credit that goes to Gujarat government.

  • The Gujarat FDCA is working as a facilitator instead of Inspectors. The Gujarat FDCA is a model for other FDCA authorities in India.

  • The Gujarat FDCA has an excellent e-government system in place. The e-government on the computer system, all the data is available on their finger tips.

  • Moreover, Gujarat FDCA is actively involved in our DCG meetings; there is a lot of contribution in the meetings, especially in the designing of our medical device regulation.

  • Gujarat drug testing laboratories are first laboratories in India having the NABL accreditation.

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