Healthcare sector in India, barring pharmaceutical industry, continues to remain outside the purview of any regulatory control of the government even after 60 years of independence. Country's large number of government and private hospitals, pathology labs, diagnostic equipments makers, medical devices industry, etc. are, thus, not yet governed by any rules. And those who are engaged in the manufacture of these medical products and services are indulging in all kinds of unethical practices at the cost of common man. Legislations for some of these segments have been under preparation for some years but are yet to be finalized. Manufacture and sale of medical devices is one such critical area where the critical care patients are badly exploited by those engaged in their sale and manufacture. In fact, some of these products like cardiac stents, drug eluting stents, catheters, intra ocular lenses, IV cannulae, bone cements, heart valves, scalp vein set, orthopaedic implants, and internal prosthetic replacements had been brought under the purview of Drugs & Cosmetics Act in 2005, making it mandatory to get licence for their manufacture, sale and distribution. But, a recent news report says that DCGI has found that several entrepreneurs are engaged in the manufacture and sale of medical devices without obtaining licences.
Medical devices are considered life saving products like drugs and many of them are implanted into the human body for critical care. And these highly expensive products can only be recommended by the medical practitioners and not always on ethical considerations. Take the case of cardiac stents and drug eluting stents. Implanting of a poor quality or defective stent can cost the very life of the patient. Therefore, the product has to be of certain minimum standards of quality. Currently the standards for these products are decided by the companies who produce them and there is no competent authority to ensure their quality and safety. It is true that DCGI had issued a directive in 2005 mandating that one should obtain a license for its manufacture and sale. But that is no guarantee for its quality and safety. The very purpose of drafting The Medical Devices and Regulation Bill in the same year by the Department of Science & Technology was with the purpose of ensuring certain specific standards for this class of products by establishing a regulatory authority. The proposed authority with adequate powers can ensure standards, efficacy, safety and availability of medical devices manufactured or marketed in the country. It was also expected to develop a system of classification of devices, notify standards and guidelines from time to time, provide a mechanism for conformity assessment using direct or third party notified bodies and stipulate the procedure and guidelines for testing laboratories. The proposal for the regulatory authority seems to be quite comprehensive enough to take care of the complexities involved in managing this critical sector. But the whole initiative is understood to be not moving forward on account of inter ministry tangles. It is high time the Centre intervened and sorted out the differences between the ministries and get started the project.