|Year : 2013 | Volume
| Issue : 4 | Page : 197-202
Medical technology in India: Tracing policy approaches
UGC Fellow, Centre of Social Medicine and Community Health, Jawaharlal Nehru University, New Delhi, India
|Date of Web Publication||18-Dec-2013|
Center of Social Medicine and Community Health, JNU, Delhi
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Medical devices and equipment have become an indispensable part of modern medical practice. Yet these medical technologies receive scant attention in the Indian context, both at the health policy level and as an area of study. There has been little attempt to systematically address the issue of equipment based medical technologies and how to regulate their use. There is paucity of primary data on the kind of medical equipment and techniques being introduced, on their need and relative usefulness, reliability, patterns of utilization, on their production, procurement, distribution, costs, and accessibility. This article reviews some of the policy issues relating to equipment based medical technology in India, in light of the specific choices and policies made during and after the colonial period in favour of modern medicine and a technology-based public health system, attempts at self-sufficiency and the current international environment with respect to the medical equipment and health-care industry.
Keywords: Import of medical equipment, Manufacture of medical equipment, Medical equipment industry, Medical technology policy
|How to cite this article:|
Chakravarthi I. Medical technology in India: Tracing policy approaches. Indian J Public Health 2013;57:197-202
| Introduction|| |
Within the conventional definition of medical technology* vaccines, therapeutic drugs and pharmaceuticals receive a lot of attention, both positive and adverse. There is considerable literature on the emergence and activities of the pharmaceutical industry, research and development of new drugs, pricing mechanisms, political economy of drug manufacture and impact on health policies and regulations. Medical devices and equipment have also become an indispensable part of modern medical practice. Yet these medical technologies receive scant attention in the Indian context, both at the health policy level and as an area of study. There are only anecdotal references to these technologies in studies and discussions on privatization and specialization of medical care and in the context of "misuse" of technology. There has been little attempt to systematically address the issue of regulation of equipment based medical technologies. There is paucity of primary data on the kind of medical equipment and techniques being introduced, on their need and relative usefulness, reliability, patterns of utilization, production, procurement, distribution, costs and accessibility. This article reviews some of the policy issues relating to equipment based medical technology in India, in light of the specific choices and policies made during and after the colonial period and the current international environment related to the medical equipment and health-care industry.
| The Medical/Health-care System in India|| |
In India, the currently dominant forms of medical and health-care systems have their origins in the colonial period. The colonial rulers, provincial governments and medical professionals trained in modern medicine chose western medicine over indigenous systems. It also received support from private philanthropic organizations, like the Rockefeller Foundation. Although the hegemony of western medicine may have been initiated by the colonial State, it was retained and extended by influential sections of the nationalist leadership and the medical profession after 1947.
Exposure to English education in the colonial period gave rise to an educated, elite class of Indians trained in English language and modern sciences, including modern medicine. The adoption of western medicine by the Indian middle-classes and the training they received created an elite class of medical practitioners. Some of these medical practitioners had also been active in nationalist politics and this system got state patronage, as clearly enunciated by Bhore Committee, which favored the western medicine for both medical relief and public health activities. Since 1947 the state and the educated elites began modernizing the country through modern science, technology and medicine.  They reproduced those patterns of education and thinking, continued to maintain their professional links and all this was augmented in the post-1947 period.
| Policy and Planning for Medical Technology|| |
The nationalist movement had given rise to the notion of economic self-reliance, which shaped the planning process immediately after independence. Efforts were made to reduce dependency on developed countries and create domestic research potential. It was backed by import-substitution policies to protect home markets (such as patent regimes and tariff-barriers for import of technology) and promote a favorable environment for indigenous innovations and products. India was assisted in these efforts by international aid from various sources. In the phase of a planned economy adopted since 1951 and the industrial policy subsequently followed, a special role was accorded to small and medium enterprises (SMEs), established in almost all major sectors in the Indian Industry - such as in engineering, electrical and electronics; chemicals and pharmaceuticals, electro-medical equipment, plastic products etc. In spite of several limitations, SMEs made significant contribution toward domestic production, technology development and export. They were afforded protection until 1991, when the policies of liberalization and globalization were adopted.
In the 1940s and 1950s medical technology also received attention as a part of the planning for health services. The Bhore and Mudaliar Committees specifically made recommendations to estimate their requirements, to set up standards and to establish indigenous manufacturing capacity. The Bhore Committee recommended the appointment of a committee, largely technical, to examine the following matters: 
In the committee's view "it should be possible adequately to provide for these essential needs through a combination of private enterprise suitably assisted where necessary and production by the state where this is found to be in the public interest." It recommended setting up of a committee to set standards for medical institutions and equipment.
- What are the drugs and other medical requisites essential for general uses in this country?
- What practical steps should be taken to ensure their manufacture in this country in sufficient quantities and their sale at a price, which will make them available to all who need them?
- What should be the respective fields of the government and of private enterprise in the manufacture of these requirements?
- What aid and assistance should be given to private agencies in such cases and under what conditions?
- What machinery should be established to develop research regarding drugs and other medical requisites and their production in India and to ensure continuity and co-ordination of such research?
According to the Mudaliar Committee: "While some progress has been made by the pharmaceutical industry in many directions, the same is unfortunately not true in case of the indigenous manufacture of instruments, hospital appliances, laboratory equipment, etc. On the whole, the effort is sporadic and unorganized with no long-term plan and objectives. In spite of this the import restrictions have certainly given a great fillip to indigenous manufacture, which with suitable assistance and guidance is certainly capable of producing instruments and appliances of a quality equal to the best-imported articles".  The Mudaliar Committee emphasized the need for standards and specifications for medical equipment extending technical assistance to entrepreneurs. It also emphasized the need for self-reliance, "it will of course be necessary to restrict and finally stop imports altogether of the items included in the manufacturing program."
The base for a domestic medical equipment industry thus got laid with setting up of production facilities for routine electro-medical instruments, including X-rays, in the 1950s. Local manufacturing effort in medical electronic equipment began in the early seventies. Small consumables (syringes, intra-venous sets, gloves, blood-bags, catheters, etc.) and "low technology" equipment, such as conventional electrocardiography (ECGs), defibrillators, bedside monitors, diagnostic X-ray equipment and therapy equipment such as diathermy-ultrasound-electrotherapy, surgical diathermy, respiration monitors, ultrasound scanners, analytical equipment for pathological and biochemical analysis (spectrophotometers, colorimeters, blood cell counters, pH meters), incubators, pacemakers and other such instruments and equipment are manufactured in the country.
The 1970s was a period of questioning of modern science and technology and of movements for "appropriate technology" and intermediate technology. The hospital-centered biomedical model of healthcare services was questioned from many quarters. The concept of primary health-care (PHC) emerged from failures of the techno-centric vertical programs and innovations in community health. The Alma Ata Declaration of 1978 on PHC provided an opportunity to re-orient and put in place a system of basic health services, envisaged in the earlier planning period, based on local needs and capacities (self-reliance) and to shift from the use of highly sophisticated medical technology to less sophisticated or locally appropriate ones.  However, these proposals were not seriously implemented. Instead, the selective PHC advocated by international institutions was adopted, which re-inforced the vertical programs for rural areas, to be delivered through community health workers. On the other hand, medical education continued with its emphasis on specialization and urban orientation. Medical technology diffused into the country in a number of ways: through medical education, research and missions; multinational corporate transactions; technical assistance projects sponsored by the World Health Organization; and bilateral foreign aid programmes.  By the mid-1970s specialized technologies (ultrasonic fetal examination, fiber optic endoscopy, cardiac catheterization, renal dialysis, cobalt isotopes for radiotherapy, open heart surgery and laser beam therapy) had been introduced in government teaching institutions.  Much of this technology had been procured through the state and placed in public institutions and public health programs.
A dual system of medical care developed due to such policies and improper implementation of the plan objectives - of preventive medicine for rural areas, which largely comprised some technical intervention only for specific vertical programs to be delivered through health workers, para-medicals and ill-equipped rural health centers. And another one of curative and high-tech care for the urban areas to be provided through highly trained medical professionals located largely in well-equipped urban hospitals. The government turned a blind eye to recommendations to re-orient the existing pattern of medical education, to make it less techno-centric and more community-based and to include the indigenous systems of medicine. As a result the country continues to produce thousands of highly trained doctors, who opt to work in the urban areas or to emigrate. The training and exposure of these doctors gives them access not only to the best technologies, but to research and training in western countries, to the corporate hospitals and international markets in health-care.
In the 1980s, the situation began to change world-wide with the end of the Cold War and the emergence of the mantra of "globalization" and the "global village" and emphasis on planning for economic growth. The erstwhile import-substitution models and indigenous technology based models went out of fashion. The new development paradigm was an "export-based" one, involving developing "novel" technological capabilities. Subsequent health planning and policy did not mention about medical equipment and their requirements, availability, etc.
Interestingly, the report of a working group on electronics industry for the 8 th 5-year plan period (1992-1997) gives an idea of the developments in the medical equipment sector in the previous decades . According to this report:
In 1992, a study by the Ministry of Science and Technology, of the status of manufacture of medical equipment/systems in the country, under its scheme "Programs aimed at Technological Self-reliance" revealed several important findings regarding manufacturing and imports of medical equipment,  similar to those of the working group on electronics. It pointed out that: "Capability existed in India for manufacture of several electro-medical equipment such as: Diagnostic and mobile X-ray equipment, fluoroscopy defibrillators, ultrasound scanners (including transducers); ECG machines and monitors; diathermy units; heart rate and respiration monitors; cardiac monitoring systems with central monitoring unit; external pacemakers, fetal monitors and whole body computed tomography scanners. However, indigenous manufacture was still to take off, and their production accounted for less than 1% of the total electronics production in the country". It re-iterated the need to 'review the fiscal and promotional measures and the import policy, to promote the local industry and check excessive imports and save precious foreign exchange' (p 2-3). According to the study, most of the technology intensive equipment was being freely imported and marketed in the country due to the existing liberalized import policy (p 4). The important findings of this study were as follows:
- There was a sufficiently strong indigenous base for meeting the general requirements of diagnostic and therapeutic equipment for a medium sized hospital. Although necessary expertise and a certain amount of infrastructure existed in the country, the local industry had not grown to the required extent.
- Overseas manufacturers, who operated at much higher volume of production, were able to offer comparatively attractive prices, local manufacturers having to operate at low volume of production. Therefore, there was "a strong case to review present fiscal and promotional measures so as to promote the local industry and check excessive imports without affecting the health-care program of the country."
- A large number of electronic equipment was lying unutilized in various health institutions due to lack of proper maintenance. Among the recommendations of the Group were: Establishment of a quality and safety certification mechanism to promote acceptability of indigenously manufactured equipment among the medical community; and evolving a forum for dialogue on various aspects of medical electronic equipment, such as local availability, problems of the local industry, fiscal measures and requirements of health-care professionals.
The working group on medical electronics for the 9 th 5-year plan period (1997-2002) made identical observations regarding the larger proportion of imports when compared to the inadequate production and that a substantial part of the requirements could be easily met by the indigenous industry, given proper incentives and growth climate. Yet another important observation was that while the developments in electronics and innovations in diagnostic, therapeutic and communications technologies had been widely utilized in the tertiary and secondary health-care, the needs of the PHC setup had not been addressed. For example: There was need for there was need for light, inexpensive, electronic weighing machines for adults for early detection of under-nutrition; of simple haemoglobinometers that could be used by the ANM to check for anaemia in pregnant women; of light, inexpensive electronic blood pressure monitoring apparatus; of communication links with the CHC/ district hospital. All these were inexpensive, but there was reluctance to manufacture them. 
- In absence of a strong manufacturing base, various sophisticated medical electronics equipment was being imported.
- The liberal import policy, combined with lack of controls over trading of electro-medical equipment had led to mushrooming of local agencies representing foreign manufacturers.
- The local agents were generally not equipped to meet the after-sales service requirements and to offer product support (except for the well-established ones).
- The foreign companies are not obliged to provide training nor ensure that necessary infrastructure is available for repair (p 5).
- There was no obligation on the part of the trade or the industry to meet safety or quality certification. Indian standards were available only for some categories of electro-medical equipment. All this had resulted in continual drain on the foreign exchange reserves of the country and accumulation of sub-standard, un-repaired and uninstalled equipment worth crores of rupees (p 109).
- Purchase of expensive equipment and their partial utilization due to gap in information among physicians regarding availability of appropriate equipment abroad and within the country.
- The agents/dealers of the indigenous small-scale manufacturers, where applicable, were unequipped to provide after-sales service, nor did they have the requisite exposure to the specificities of bio-medical applications.
- The reliability of the indigenous equipment, particularly those manufactured in the small-scale sector needed improvement since the investment levels were very low in terms of quality control, assembly and test equipment.
- There was also lack of skilled manpower for manufacture, operation, repair and maintenance in the medical electronics industry. The role of biomedical engineers in hospitals was yet to be recognized.
For the first time in 1996 the planning commission set up a working group to review the requirements for supportive and diagnostic services at primary, secondary and tertiary level health services.  According to this group:
This working group proposed the setting up a medical equipment management unit in the ministry of health, to deal with ascertaining equipment needs, selection, procurement, installation, training, maintenance, etc., which would be also responsible for maintaining equipment in all government hospitals. It also made recommendations regarding diagnostics equipment and technologies appropriate for each level of care and supportive services including requirements of staff and space and resource allocations, to be implemented in the IX plan period (1997-2002).
- Medical equipment management and maintenance were important.
- While capital costs were rising, yet medical equipment was a widely mismanaged resource in the government healthcare facilities.
- An estimated 30% of the total health-care budget was spent on equipment of which 5-10% was on high-tech medical engineering systems, such as imaging systems, laboratory analyzers and linear accelerators.
- Nearly 40-60% equipment was non-operational due to inadequate maintenance. 80-85% of the faults were simple and could be handled with trained personnel. (The study of the medical electronic equipment industry referred to earlier pointed out that due to lack of adequate funds government hospitals refrained from annual service contracts beyond warranty period. This resulted in dependence on non-specialized, ad hoc service arrangements, made as and when some equipment became non-functional). Such a situation contributed directly to breakdown and reduction in operating life of equipment.
- There was no policy on requirements of bio-medical engineers in the overall health manpower strategy.
Since the 1990s, with structural adjustment and dominance of the neo-liberal ideology, provision of medical care has become a business largely for profits and is being organized along business lines. The importance attached to economic growth, the services sector, foreign exchange, etc., is being exploited by the "health-care industry" to expand and grow into a profitable "healthcare market." This `healthcare market' is now being treated by all segments of business, including the medical equipment industry, as an opportunity to expand, grow and make profits. 
| Conclusion|| |
One finds that the initial policies emphasizing self-sufficiency laid foundations for domestic equipment manufacturing capacity. Medical technology was considered a component of health planning, and several working groups have re-iterated the need to standardize requirements of medical equipment. However, much of these have been ignored. The health ministry itself has not given attention to medical technologies, to assessing their requirements, production, standardization, utilization and regulation. Although the provision of public health, medical care and education was undertaken by the state as part of planning for a health system, supply and use of medical technologies did not form part of this planning. Manufacture of medical technology was left to private parties, both domestic and foreign, and was affected by economic considerations and prevailing industrial policies. Yet, the recommendations to curb excessive imports in order to support the indigenous capacities have been ignored. Since the 1980s policies explicitly began to encourage and utilize in various ways the presence of the private sector in medical care. Incentives were given for private investments by offering concessions for import of high-tech equipment and to non-resident Indians to invest in industry and in the welfare sector. Over the last two decades the private sector, especially the corporate sector and economic considerations of growth, profits, market efficiency, have become significant forces in the health system and are significant contributors in shaping the priorities and use of technology.
| Acknowledgment|| |
The author would like to thank Dr. Ritu Priya for reading initial drafts and making valuable suggestions.
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