In the aftermath of the nuclear leaks in Japan, there have been concerns regarding the safety of nuclear power plants around the world. There are some proposals to change the regulatory framework in India to ensure the safety of these plants. We examine some of the issues in the current structure. Which body looks at safety issues regarding nuclear power plants in the country? The apex institution tasked to look at issues regarding nuclear safety is the Atomic Energy Regulatory Board. The AERB was set up in 1983 to carry out regulatory and safety functions regarding nuclear and radiation facilities. The agency has to give clearances for establishing nuclear power plants and facilities. It issues clearances for nuclear power projects in stages after safety reviews. The safety of setting up a nuclear plant in any given area is also assessed by the AERB. For example, it would have looked into the safety of setting up a nuclear power project in Jaitapur in Maharashtra. AERB also reviews the safety mechanisms within existing nuclear plants and facilities. To do this, it requires nuclear facilities to report their compliance with safety regulations, and also makes periodic inspections. Under the recently passed Civil Liability for Nuclear Damage Act, 2010 the AERB is also the authority responsible for notifying when a nuclear incident takes place. Mechanisms for assessing and claiming compensation by victims will be initiated only after the nuclear incident is notified. Why is the Atomic Energy Regulatory Board in the news? Prime Minister Manmohan Singh announced on March 29, 2011, "We will strengthen the Atomic Energy Regulatory Board and make it a truly autonomous and independent regulatory authority." This announcement came in the backdrop of the continuing crisis and high radiation levels at the Fukusima nuclear plant in Japan. News reports opined that the lack of proper autonomy of Japan's nuclear regulator curbed its effectiveness. Japan's ministry of economy, trade and industry regulates the nuclear power industry, and also promotes nuclear technology. These two aims work at cross-purposes. India's regulatory structure is similar to Japan in some respects. What measures has the AERB taken post the Fukushima nuclear incident in Japan? Following the nuclear incident in Japan, a high-level committee under the chairmanship of a former AERB chairman has been set up to review the safety of Indian nuclear power plants. The committee shall assess the capability of Indian nuclear power plants to withstand earthquakes, tsunamis, cyclones, floods, etc. The committee will review the adequacy of provisions for ensuring safety in case of such events. Is there any issue in the current regulatory structure? The AERB is a regulatory body, which derives administrative and financial support from the Department of Atomic Energy. It reports to the secreatry, DAE. The DAE is also involved in the promotion of nuclear energy, and is also responsible for the functioning of the Nuclear Power Corporation of India Limited, which operates most nuclear power plants in the country. The DAE is thus responsible both for nuclear safety (through the AERB), as well as the operation of nuclear power plants (through NPCIL). This could be seen as a conflict of interest. How does the system of independent regulators differ from this? The telecom sector provides an example of an independent regulator. The Telecom Regulatory Authority of India does not report to the Department of Telecommunications. The DoT is responsible for policy matters related to telecommunications, promoting private investment in telecom, and also has a stake in BSNL. Had TRAI reported to the DoT, there would have been a conflict of interest within the DoT. What will the proposed legislation change? Recent news reports have stated that a bill to create an independent regulatory body will be introduced in Parliament soon. Though there is no draft bill available publicly, news reports state that an independent Nuclear Regulatory Authority of India will be created by the bill, and the authority will subsume the AERB within it. This post first appeared as an article on rediff.com and can be accessed here.
The National Medical Commission (NMC) Bill, 2017 was introduced in Lok Sabha in December, 2017. It was examined by the Standing Committee on Health, which submitted its report during Budget Session 2018. The Bill seeks to regulate medical education and practice in India. In this post, we analyse the Bill in its current form.
How is medical education and practice regulated currently?
The Medical Council of India (MCI) is responsible for regulating medical education and practice. Over the years, there have been several issues with the functioning of the MCI with respect to its regulatory role, composition, allegations of corruption, and lack of accountability. For example, MCI is an elected body where its members are elected by medical practitioners themselves, i.e. the regulator is elected by the regulated. In light of such issues, experts recommended nomination based constitution of the MCI instead of election, and separating the regulation of medical education and medical practice. They suggested that legislative changes should be brought in to overhaul the functioning of the MCI.
To meet this objective, the Bill repeals the Indian Medical Council Act, 1956 and dissolves the current Medical Council of India (MCI) which regulates medical education and practice.
Who will be a part of the NMC?
The NMC will consist of 25 members, of which at least 17 (68%) will be medical practitioners. The Standing Committee has noted that the current MCI is non-diverse and consists mostly of doctors who look out for their own self-interest over larger public interest. In order to reduce the monopoly of doctors, it recommended that the MCI should include diverse stakeholders such as public health experts, social scientists, and health economists. In other countries, such as the United Kingdom, the General Medical Council (GMC) responsible for regulating medical education and practice consists of 12 medical practitioners and 12 lay members (such as community health members, and administrators from the local government).
How will the issues of medical misconduct be addressed?
The State Medical Council will receive complaints relating to professional or ethical misconduct against a registered doctor. If the doctor is aggrieved by the decision of the State Medical Council, he may appeal to the Ethics and Medical Registration Board, and further before the NMC. Appeals against the decision of the NMC will lie before the central government. It is unclear why the central government is an appellate authority with regard to such matters.
It may be argued that disputes related to ethics and misconduct in medical practice may require judicial expertise. For example, in the UK, the GMC receives complaints with regard to ethical misconduct and is required to do an initial documentary investigation. It then forwards the complaint to a Tribunal, which is a judicial body independent of the GMC. The adjudication and final disciplinary action is decided by the Tribunal.
What will the NMC’s role be in fee regulation of private medical colleges?
In India, the Supreme Court has held that private providers of education have to operate as charitable and not for profit institutions. Despite this, many private education institutions continue to charge exorbitant fees which makes medical education unaffordable and inaccessible to meritorious students. Currently, for private unaided medical colleges, the fee structure is decided by a committee set up by state governments under the chairmanship of a retired High Court judge. The Bill allows the NMC to frame guidelines for determination of fees for up to 40% of seats in private medical colleges and deemed universities. The question is whether the NMC as a regulator should regulate fees charged by private medical colleges.
A NITI Aayog Committee (2016) was of the opinion that a fee cap would discourage the entry of private colleges, therefore, limiting the expansion of medical education. It also observed that it is difficult to enforce such a fee cap and could lead medical colleges to continue charging high fees under other pretexts.
Note that the Parliamentary Standing Committee (2018) which examined the Bill has recommended continuing the current system of fee structures being decided by the Committee under the chairmanship of a retired High Court judge. However, for those private medical colleges and deemed universities, unregulated under the existing mechanism, fee must be regulated for at least 50% of the seats. The Union Cabinet has approved an Amendment to increase the regulation of fees to 50% of seats.
How will doctors become eligible to practice?
The Bill introduces a National Licentiate Examination for students graduating from medical institutions in order to obtain a licence to practice as a medical professional.
However, the NMC may permit a medical practitioner to perform surgery or practice medicine without qualifying the National Licentiate Examination, in such circumstances and for such period as may be specified by regulations. The Ministry of Health and Family Welfare has clarified that this exemption is not meant to allow doctors failing the National Licentiate Examination to practice but is intended to allow medical professionals like nurse practitioners and dentists to practice. It is unclear from the Bill that the term ‘medical practitioner’ includes medical professionals (like nurses) other than MBBS doctors.
Further, the Bill does not specify the validity period of this licence to practice. In other countries such as the United Kingdom and Australia, a licence to practice needs to be periodically renewed. For example, in the UK the licence has to be renewed every five years, and in Australia it has to renewed annually.
What are the issues around the bridge course for AYUSH practitioners to prescribe modern medicine?
The debate around AYUSH practitioners prescribing modern medicine
There is a provision in the Bill which states that there may be a bridge course which AYUSH practitioners (practicing Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy) can undertake in order to prescribe certain kinds of modern medicine. There are differing views on whether AYUSH practitioners should prescribe modern medicines.
Over the years, various committees have recommended a functional integration among various systems of medicine i.e. Ayurveda, modern medicine, and others. On the other hand, experts state that the bridge course may promote the positioning of AYUSH practitioners as stand-ins for allopathic doctors owing to the shortage of doctors across the country. This in turn may affect the development of AYUSH systems of medicine as independent systems of medicine.
Moreover, AYUSH doctors do not have to go through any licentiate examination to be registered by the NMC, unlike the other doctors. Recently, the Union Cabinet has approved an Amendment to remove the provision of the bridge course.
Status of other kinds of medical personnel
As of January 2018, the doctor to population ratio in India was 1:1655 compared to the World Health Organisation standard of 1:1000. The Ministry of Health and Family Welfare stated that the introduction of the bridge course for AYUSH practitioners under the Bill will help fill in the gaps of availability of medical professionals.
If the purpose of the bridge course is to address shortage of medical professionals, it is unclear why the option to take the bridge course does not apply to other cadres of allopathic medical professionals such as nurses, and dentists. There are other countries where medical professionals other than doctors are allowed to prescribe allopathic medicine. For example, Nurse Practitioners in the USA provide a full range of primary, acute, and specialty health care services, including ordering and performing diagnostic tests, and prescribing medications. For this purpose, Nurse Practitioners must complete a master’s or doctoral degree program, advanced clinical training, and obtain a national certification.
