In the healthcare industry, regulations and standards play a significant role in assuring consumers of the safety and efficacy of the medicines, equipment and healthcare services. The case highlights serious weaknesses in the regulations governing healthcare industries in general and the medical device industry in particular. Take, for instance, the failure to diagnose Paritosh’s fracture correctly: It resulted from the poor quality X-ray machine that did not report a fracture. Lack of effective regulation has led to the presence of such counterfeit products in the market.
The medical device industry forms an important pillar of healthcare supply industries. It plays a central role in patient care, starting with diagnosis, treatment, in the OT, at the bed side, post-surgery and, in some cases, even after discharge. The medical device industry in India stands neglected by policy-makers, regulators and industry associations. This has serious implications for the development of a safe and effective healthcare system for the people. The absence of regulation also delays the entry of authentic local manufacturers into the market, since norms, approvals and guidelines are all a blur. This regulatory vacuum has created a market that is dominated by MNCs on one end and some counterfeit manufacturers on the other. The latter sell cheap by using raw materials of sub-standard quality and circumventing safety norms. Hospitals driven by profits alone prefer the cheaper alternatives, which has serious implications for patients’ health, as seen from the three wrong surgeries carried out on the right arm of Sunetra Govil. In her case, the bone plates were fake, and incorrectly used. One may even question the awareness of attending doctors, since a fundamental bone density test was not carried out on the patient.
Some premier MNC and local companies have their products approved by overseas regulators thereby gaining a false halo of quality assurance. Using these approvals as a marketing tool, these companies have created mutually beneficial relationships with doctors. Doctors prefer to use or prescribe quality products from them and, in turn, companies charge high prices knowing the preference of doctors. This relationship has resulted in a monopoly for these firms in some segments of the Indian medical device market, leading to a situation where the consumer is struggling with affordability, while all other stakeholders are benefiting from the system for example, Plus Care hospital’s MRI decision in the case.
Medical devices around the world are classified based on their safety requirements and several criteria are considered to evaluate the potential risk: degree of invasiveness, duration of contact, affected body system and local versus systemic effects. In the early 1980s, the Indian government realised the need for medical device regulation. However, the problem was a clear lack of understanding of how medical devices worked, their mechanism of action and criteria of performance measurement. This, in turn, created challenges for implementation and enforcement of regulations and standards. In India, this is aggravated by a lack of coordination between various bodies in states and at the Centre involved in the enforcement of standards.
It is clear that to prevent incidents such as misdiagnosis of Paritosh’s fracture and use of fake implants in the case of Sunetra, or to break the nexus between doctors and companies, there is need for a ‘smart and appropriate regulation’. In 2013, India took small step towards that by introducing new amendments to the Drugs and Cosmetics Act, 2013 in the Upper House of Parliament. These amendments recognise medical devices as a distinct category and incorporate new regulations in line with standard international practices developed by the International Medical Device Regulators Forum (IMDRF). Sadly, it has been two years and the Bill is still awaiting Parliament approval.
It can be seen that health awareness is a mindset issue that grips not just the patient but also the Indian policy-maker. And Abhed’s thinking is right. It’s about systems, controls, measures, integrity... and, as the case study shows, a ‘smart and appropriate regulation’ that brings all these together is still the missing link in the Indian healthcare system.
Meanwhile, the patient bears the brunt, blaming Karma or God.
The author is Senior Lecturer in International Development and Innovation at The Open University Business School, UK Analysis
(This story was published in BW | Businessworld Issue Dated 26-01-2015)
