ABSTRACT OF THE

WORKSHOP ON

GOOD MANUFACTURING PRACTICES

&

INSPECTION OF MEDICAL DEVICES

 ORGANISED BY

 THE CENTRAL DRUGS STANDARD CONTROL ORGANISATION

 New Delhi * September 19, 2002

Market Overview

• The ninth five-year Plan focuses on construction, expansion, upgrade of existing government hospitals, and increased investment from private sectors.

• Several states like Tamil-Nadu, Karnataka, Maharashtra, West Bengal, Bihar, and Andhra Pradesh are currently under various stages of funding from the World Bank, and the U.S. and European governments for development of Primary Healthcare Systems. This has shown consistent increase over the last five years.

Demand from Government Hospitals
Remains Vastly Unfulfilled

The central government outlay for the healthcare sector has been unable to bridge the demand and supply gap existing in public hospitals. The total expenditure (according to the ninth five-year plan) required for updating these hospitals (with the standards list of equipment) was estimated at $1933 million. However, the current spending is less than 40 percent of the same. The presents a big opportunity for device manufacturers to partner with the central and state governments to install cost-effective devices in these hospitals.

Market Overview

Minimal Formal Training and Investment, Faster Turnaround Time in Patient Examinations, and High Confidence Levels in Diagnosis Drives Market Revenues

Surgeons, gynecologists, urologists, and doctors are gradually adopting techniques, which were once a specialty of certain physicians (like radiologists) only. Increased simplicity of use has resulted in short-term training before commencement of operations. These simplistic techniques have opened avenues for them to increase revenues at a faster rate than through conventional business models.

Indigenous Technology to Provide Products at Lower Prices

Many local manufacturers have introduced sophisticated systems to march budgets of small hospitals and polyclinics. This has increased the market size, leading to an overall increase in revenues.

• Several manufacturing units producing a diverse range of medical equipment. Foreign firms such as Siemens , GE , Network Pickers, and Phillips Medical Systems have expanded their operations in the Indian market. Manufacturers of sophisticated systems such as multi parameters,ICCU,heart/lung machines,linear accelerators,Doppler ultrasound machines, MRI scanners and diagnostic and therapeutic equipment are showing good market potential.

• The largest market segment constituting 30 to 35 per cent of the total market is imaging systems including X-rays, CT scanners and MRI machines. This segment is dominated by GE, followed by Siemens , Phillips and Indchem ATL, Network-Pickers, Toshiba-STM and Toshniwal.

The second largest segment, equipment used in cardiology, has a large number of small and large players such as Hewlett Packard, Indchem, Larsen & Toubro, BPL , Hindtron, Toshbro and Torrent.

The mojor import of medical equipments include: specialized body scanners, ultrasound scanners, specialized portable and non-portable X-ray machines, implantable pacemakers, radiography and radiotherapy equipment.

The major promising sub-sectors include :

• Medical Imaging Equipment

• Cardiology Equipment

• Laboratory Instruments/Supplies

• Cancer Diagnostics & Treatment Equipment

Among the medical disposables, the important items manufactured in India include:

• I.V.Sets and Tubes

• I.V.Catheters or Canulaes

• Other Disposable Catheters

• Disposables Syringes and Needles

• Blood Bags

• Disposable Hand Gloves

• Disposable Non-Woven Fabric Products

There are about 125 manufacturers of medical disposables manufacturing units manufacturing the above products spread over India starting from Calcutta to Trivandrum.

I.V.Sets

There are about 100 firms in India including organized sector as well as small units manufacturing I.V.Sets, tubes etc.

The small scale Medical Disposables Manufacturing Units in Gujarat contribute approximately 60% of country’s production and requirements Medical Disposable Products like Intravenous Infusion (I.V.) Sets. With the origin of this Industry in

Gujarat about 25 years back, this Industry has grown many folds mostly in small-scale sector. The total production of I.V.Sets in India is understood to be around 300-350 million units per annum of which Gujarat contributes about 60%.

I.V.Cannulae

There are about 6 manufacturers of I.V.Cannulae in India today. While the information about the total production capacity is not available , a snap study carried out with the existing units indicate that the units are operating at 100% capacity and are in a position to export the products in a big way. Some of the existing units are having quality certification (CE Mark) required for the exports to Europe.Largely the production is located in and around New Delhi.

Blood Bags

Disposables Blood Bags are manufactured by 7 firms and most of them are medium scale or large-scale firms since Blood Bags manufacturing is relatively higher technology and investment project. The locations include : Trivandrum , Ahmedabad, New Delhi Kolkata etc. The total production capacity of these firms is about 25 million nos. per annum.

The production of surgical gloves and the non-woven fabric medical disposables is also concentrated in small-scale sector.

Other Products

The production of surgical gloves and the non-woven fabric medical disposables is also concentrated in small-scale sector.

Disposable Non-Woven Fabric Products

Non-woven fabrics have gained acceptance because of performance advantages such as added convenience of disposable diapers , the improvement in asceptic technique made possible by non-woven surgical packs and gowns also other hospital requirements such as hand-gloves , caps , masks , sheets, shoe-covers,etc.

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