Monitoring medical devices

The proposal to set up an Indian Medical Devices Regulatory Authority assumes importance in view of the necessity to stop the import of unreliable devices and for India to have a say in the international standardisation process.

AN 80-year-old patient goes to one of those high-tech private diagnostic centres that are mushrooming across the country for a Colour Doppler Echo Angiogram of an artery believed to have a high degree of blockage. The test result: "90 per cent blockage. Surgical intervention recommended." Surgery being a tricky proposition in such an advanced age, the patient goes to another centre on the advice of the physician for a repeat test in spite of having spent a couple of thousands of rupees on the first test. This time around, the result is: "70 per cent blockage. Consult physician." If the consulting physician is not skilled enough to interpret the test data properly, this could lead to all kinds of complications, besides mounting expenses. Even if the physician is good enough, there is the potential psychological impact on the patient. Given that nearly three-fourths of health care in the country is in private hands, this kind of situation is perhaps rampant with the proliferation of uncertified private clinics and diagnostic centres and the unregulated import of high-tech medical equipment under the garb of life-saving medical devices, whereas many of them may well be life threatening.

In the past couple of decades, for the right or wrong reasons, healthcare has become highly technology intensive. It is estimated that the medical devices market in India is worth $1.5 billion. Nearly 80 per cent of this industry is met by imports at very high costs - which no doubt is passed on to the patient - notwithstanding the impressive progress made in the field of biomedical technology in recent years with many indigenous devices trying to make a mark in the market. The government sector too spends a great deal on high-tech medical devices. According to reports, in 2000, an estimated one and a half million different medical devices, valued over $145 billion, were available in the world market and the figure is expected to exceed $260 billion by 2006.

Almost all countries that have a medical device industry have policies and regulatory processes or mechanisms in place. While the assurance of the quality of any marketed product is the responsibility of the manufacturer, the state also has the responsibility to protect the right of the consumer. In the case of medical devices, with potential health risks, the responsibility is even greater. In this scenario, it is indeed amazing that there is virtually no regulatory system in the country that ensures the reliability of these devices given that, like a drug or a vaccine, medical devices too, particularly those that are implanted in the human system, have attendant health risks. The more sophisticated is the underlying technology, the more complex becomes its calibration and operation and more serious are the potential errors due to malfunctioning and consequent harmful effects on a patient's clinical status. Therefore, like any drug, a medical device also requires to be evaluated for its quality, efficacy, reliability and safety before and after procedure for approval for its use in public health. If the device is implantable, it would also require systematic and rigorous pre-clinical and clinical studies, much like a drug.

India lacks any kind of regulatory framework for certification, quality assurance, safety evaluation and post-market surveillance of both imported and indigenous medical devices. Even the Drug Controller General of India (DGCI) does not have any mandate to regulate the medical devices market and the use of the devices in medicine. Apparently, the practice followed by the DGCI is to refer to matters relating to medical devices to the Indian Council of Medical Research (ICMR) on a case-to-case basis. Some low-technology devices like thermometers and weighing machines seek certification from the Bureau of Indian Standards (BIS) - for ISI marking - and that too is optional. Some imported high-tech devices, approved or cleared by their country of origin, as done by the United States' Federal Drug Administration (FDA), are apparently permitted to be marketed in India. It is not clear how the system operates and for which categories of devices this parent country approval is required.

In this context, it is pertinent to point out that not all devices permitted for export by other countries are allowed to be sold in the respective domestic markets. The export policy of the FDA says: "Although a device would not meet the requirements of the Federal Food, Drug and Cosmetics Act to be sold domestically, it may be exported legally and without FDA's permission." Provided that the device is: "In accordance with the specifications of the foreign purchaser; not in conflict with the laws of the country to which it is intended for export; labelled on the outside of the package that it is intended for export; and, not sold or offered for domestic commerce."

At the same time, for import into the U.S. a device must meet stringent controls of the FDA. It should be a device approved by its Centre for Devices and Radiological Health (CDRH) and should obtain a pre-market approval or equivalence to an existing device. This could involve some samples being tested by the FDA to ensure quality and other claims. As a result, India has become a dumping ground for obsolete or poor-quality Western devices that have been discarded abroad owing to their adverse effects. Usually such information is withheld and without an overseeing authority, there is no restraint on their imports.

Clearly, the situation in India is not a desirable one. Without a rigorous system of standards, criteria and regulatory mechanisms for market approval and post-market monitoring, health care in the country would become a victim of market influences and unscrupulous trade practices, putting consumers' lives at risk. The situation has an adverse impact on the fledgling domestic industry also. In the absence of a clear-cut government policy, there is a reluctance to invest in this capital-intensive industry, thus affecting research and development (R&D) in the field and the industry's growth, despite technological capabilities. With no domestic approval, it also affects the export potential of indigenous products. In the absence of a policy governing medical devices, some Indian manufacturers are making use of the agencies of international standards institutions like the International Organisation for Standardisation (ISO) to obtain ISO 9000/14000 certification for their processes and products and get the European CE (Essential Certificate) in order to gain entry into the European market. It also renders the indigenous devices vulnerable to medico-legal problems in case of an adverse effect of the device.

There is an international initiative known as "Global Harmonisation Task Force (GHTF)", which was conceived in 1992 in an effort to harmonise the medical device regulatory frameworks across nations. It comprises its five founding members, Australia, Canada, the European Union, Japan and the U.S. Each of them has an active medical-device industry and has a well-developed regulatory framework, representing three geographical areas (Europe, Asia-Pacific and North America).

In a bid to further the convergence in standards and regulatory practices, the GHTF publishes guidance documents for the harmonisation of basic regulatory practices. These documents, developed by four study groups, can be adopted/implemented by different national medical-device regulatory authorities. The technical committee members include representatives from national authorities as well as from the industry. In the emerging post-World Trade Organisation scenario of globalised trade - India will be fully part of this regime in 2005 - the absence of a policy or a regulatory framework will put India at a disadvantage in forums like the WTO and the consequent international trade practices. It is important that the Indian perspective on these issues is presented in any harmonisation initiative. South Korea, China and Brazil, which have put in place appropriate regulatory mechanisms, are participating in this initiative as observers.

What is even more interesting is that India does not even find a mention in the regional initiative, known as the Asian Harmonisation Working Party (AHWP), which is working with the GHTF and is involved in forging a common direction for the harmonisation of medical device regulation in Asia.

The AHWP aims to provide a forum for discussion and training, facilitate information exchange and initiate projects relating to the GHTF. It is important that India should seek to play a significant role at least in the regional set-up. Otherwise people would remain unaware of whatever benefits (avoidance of non-tariff barriers) or drawbacks of harmonisation there may be in the years to come.

Given this enormous lacuna in this area, the ICMR and the Society for Biomedical Technology (SBMT), an inter-ministerial organisation set up under the Defence Research and Development Establishment (DRDE) in 1993, have recently come out with a proposal for the creation of the Indian Medical Devices Regulatory Authority (IMDRA) as the apex body for the implementation of the country's regulatory system for biomedical devices. It is significant that the SBMT has taken this initiative because it constitutes the only organised effort in the country to coordinate the development and marketing of biomedical devices, albeit those which have come as spin-offs from defence technology.

Some time back, given the constraints faced by indigenous R&D efforts as well as manufacturers, Dr. T. Lazar Mathew, the then Director of the Defence Institute for Nuclear Medicine and Allied Sciences (INMAS) and Chief Executive of SBMT, conceptualised a regulatory framework for the Indian context. This document was circulated to the various government agencies as a concept paper in 2001. The ICMR hosted it on its web site and invited comments. Since there was a felt need for a short-term as well as a long-term policy framework - given the fast technological obsolescence (usually five years) of medical devices as against drugs whose pharmacopaeial specifications last for decades, and also the rapid proliferation of devices - the ICMR constituted a committee under the chairmanship of Dr. M.S. Valiathan, the eminent medical scientist and the present President of the Indian National Science Academy (INSA) to prepare a detailed proposal. This 13-member expert committee, in turn, constituted a four-member task force headed by Dr.Mathew. The task force has come out with a document that is likely to form the basis for a regulatory authority, called the IMDRA, in the country.

The basic objective for the regulation that is set forth in the document is "ensuring the safety and efficacy of the medical devices placed on the Indian market". The document has recommended creating a two-tiered system, combined with a third-party conformity assessment through a number of notified bodies, analogous to the system in operation for the E.U. countries as against the capital- and manpower-intensive and more bureaucratic, monolithic establishment like the FDA. Since the U.S. was the first to set up a regulatory system for medical devices, the laws came into existence under the FDA in the 1970s essentially in the backdrop of pharmaceutical regulations, which relied heavily on an exhaustive pre-market review of manufacturers' research data and clinical trials followed by approval and licensing. This time-consuming process very often meant that a certain device lost its timeliness in the context of fast-changing technology. The European system, on the other hand, derived the advantage of evolving later in the 1980s. It avoided the drawbacks and pitfalls of the U.S. model. Essentially, in the European model, the safety and efficacy and the quality assurance of a product is the responsibility of the manufacturers themselves. For high-risk devices, a third-party certification may be required, and for this the manufacturer has the choice of different procedures and institutions (the so-called Notified Bodies).

From the point of view of the manufacturer, clearly the European system is more expensive than the U.S. approach, with the state sharing a large burden of evaluation costs in the latter. The European model evolved basically from the requirements of a single European market. In harmonising the requirements of different E.U. nations, the approach was to formulate the common European Commission (E.C.) Medical Device Directives, which contain the essential requirements that are general and mandatory for quality control, safety and reliability. Products that comply with the directives - at present it is a set of three - carry the European CE mark of conformity, have legal sanction and can be marketed throughout Europe. Competent authorities such as health ministries are responsible for implementing the directives.

It is the responsibility of the manufacturer to comply with the standards set out by voluntary standards organisations such as the European Committee for Standardisation, which are empowered to write standards for the E.U. by drawing upon international standards institutions. For quality control certification, the manufacturer can get the product tested by any of the Notified Bodies (government and private laboratories) under a contract or otherwise. Given the flexibility inherent in this system, many other countries, like Canada and Australia, are adopting the basic principles of the E.U. system. Learning from the European experience, even the U.S. has, of late, begun to shed some of the baggage at least for low-risk products.

In the Indian context, too, the Mathew Committee has recommended the European model for adoption because of cost considerations, lack of technical infrastructure like the FDA, need for flexibility, and minimal bureaucratic control. However, as the document points out, Indian manufacturers are generally not as technically competent as their European counterparts, and placing on them the bulk of the responsibility for quality assurance and safety could act as a damper for the medical device industry in the country. The chief advantage of the European model is its long-term stability. By the laws themselves not being tied down by evolving technical standards, whose specifications have been left to international standards organisations with which the devices have merely to demonstrate conformity, the laws will not call for frequent changes. At the same time, the legal framework in terms of enunciated directives alone affords a great deal of flexibility to the manufacturer and, most importantly, the essence of timeliness of devices is not lost.

The system will include a pre-market strategy and a post-market one. The former will require a manufacturer to determine the risk categorisation of the device as per the proposed four-tier classification and submit the associated technical data for review and approval. The latter will involve surveillance and periodic assessment of the production process as well as quality and safety. The IMDRA is proposed to be assisted by various Conformity Assessment Bodies (CABs) - equivalent to the Notified Bodies of the E.U. system - and Certified Testing Laboratories (CTLs). The manufacturer or the CAB will get the product tested by a CTL and submit the results of the audit. To begin with, the IMDRA has been proposed to be set up as a small autonomous body under the Ministry of Science and Technology and located anywhere in India. It will include the maximum number of technocrats and operate as an autonomous entity. For the interim period (three to five years), it will have one main regulatory body and two or three sub-regulatory bodies, whose work will be overseen by an inter-ministerial council. The document has also recommended that the IMDRA be provided with all statutory and constitutional provisions to enforce the basic policy framework envisaged.