Today, the National Medical Commission Bill, 2019 was passed by Lok Sabha.  It seeks to regulate medical education and practice in India.  In 2017, a similar Bill had been introduced in Lok Sabha.  It was examined by the Standing Committee on Health and Family Welfare, which recommended several changes to the Bill.  However, the 2017 Bill lapsed with the dissolution of the 16th Lok Sabha.  In this post, we analyse the 2019 Bill.

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.  Experts have 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 MCI.

The 2019 Bill sets up the National Medical Commission (NMC) as an umbrella regulatory body with certain other bodies under it.  The NMC will subsume the MCI and will regulate medical education and practice in India.  Under the Bill, states will establish their respective State Medical Councils within three years.  These Councils will have a role similar to the NMC, at the state level.

Functions of the NMC include: (i) laying down policies for regulating medical institutions and medical professionals, (ii) assessing the requirements of human resources and infrastructure in healthcare, (iii) ensuring compliance by the State Medical Councils with the regulations made under the Bill, and (iv) framing guidelines for determination of fee for up to 50% of the seats in the private medical institutions.

Who will be a part of the NMC?

The Bill replaces the MCI with the NMC, whose members will be nominated.  The NMC will consist of 25 members, including: (i) Director Generals of the Directorate General of Health Services and the Indian Council of Medical Research, (ii) Director of any of the AIIMS, (iii) five members (part-time) to be elected by the registered medical practitioners, and (iv) six members appointed on rotational basis from amongst the nominees of the states in the Medical Advisory Council.

Of these 25 members, at least 15 (60%) are medical practitioners.  The MCI has been noted to be non-diverse and consists mostly of doctors who look out for their own self-interest over public interest.   In order to reduce the monopoly of doctors, it has been recommended by experts that the MCI should include diverse stakeholders such as public health experts, social scientists, and health economists.  For example, in the United Kingdom, the General Medical Council which is responsible for regulating medical education and practice consists of 12 medical practitioners and 12 lay members (such as community health members, administrators from local government).

What are the regulatory bodies being set up under the NMC?

The Bill sets up four autonomous boards under the supervision of the NMC.  Each board will consist of a President and four members (of which two members will be part-time), appointed by the central government (on the recommendation of a search committee).  These bodies are:

  • The Under-Graduate Medical Education Board (UGMEB) and the Post-Graduate Medical Education Board (PGMEB): These two bodies will be responsible for formulating standards, curriculum, guidelines for medical education, and granting recognition to medical qualifications at the under-graduate and post-graduate levels respectively.
  • The Medical Assessment and Rating Board: The Board will have the power to levy monetary penalties on institutions which fail to maintain the minimum standards as laid down by the UGMEB and the PGMEB.  It will also grant permissions for establishing new medical colleges, starting postgraduate courses, and increasing the number of seats in a medical college.
  • The Ethics and Medical Registration Board: This Board will maintain a National Register of all the licensed medical practitioners in the country, and also regulate professional and medical conduct.  Only those included in the Register will be allowed to practice as doctors.  The Board will also maintain a register of all licensed community health providers in the country.

How is the Bill changing the eligibility guidelines for doctors to practice medicine?

There will be a uniform National Eligibility-cum-Entrance Test for admission to under-graduate and post-graduate super-speciality medical education in all medical institutions regulated under the Bill.  Further, the Bill introduces a common final year undergraduate examination called the National Exit Test for students graduating from medical institutions to obtain the license for practice.  This test will also serve as the basis for admission into post-graduate courses at medical institutions under this Bill.  Foreign medical practitioners may be permitted temporary registration to practice in India.

However, the Bill does not specify the validity period of this license to practice.  In other countries such as the United Kingdom and Australia, a license to practice needs to be periodically renewed.  For example, in the UK the license has to be renewed every five years, and in Australia it has to renewed annually. 

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 medical practitioner.  If the medical practitioner is aggrieved of a decision of the State Medical Council, he may appeal to the Ethics and Medical Registration Board.  If the medical practitioner is aggrieved of the decision of the Board, he can approach the NMC to appeal against the decision.  It is unclear why the NMC is an appellate authority with regard to matters related to professional or ethical misconduct of medical practitioners. 

It may be argued that disputes related to ethics and misconduct in medical practice may require judicial expertise.  For example, in the UK, the regulator for medical education and practice – the General Medical Council (GMC) receives complaints with regard to ethical misconduct and is required to do an initial documentary investigation in the matter and then forwards the complaint to a Tribunal.  This Tribunal is a judicial body independent of the GMC.  The adjudication decision and final disciplinary action is decided by the Tribunal.

How does the Bill regulate community health providers?

As of January 2018, the doctor to population ratio in India was 1:1655 compared to the World Health Organisation standard of 1:1000.  To fill in the gaps of availability of medical professionals, the Bill provides for the NMC to grant limited license to certain mid-level practitioners called community health providers, connected with the modern medical profession to practice medicine.  These mid-level medical practitioners may prescribe specified medicines in primary and preventive healthcare.  However, in any other cases, these practitioners may only prescribe medicine under the supervision of a registered medical practitioner.

This is similar to 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.

On October 18, it was reportein the news that the central government has been given more time for framing rules under the Citizenship (Amendment) Act, 2019.  The President had given assent to this Act in December 2019 and the Act came into force in January 2020.   Similarly, about two years have passed since the new labour codes were passed by Parliament, and the final Rules are yet to be published.  This raises the question how long the government can take to frame Rules and what is the procedure guiding this.  In this blog, we discuss the same.

Under the Constitution, the Legislature has the power to make laws and the Executive is responsible for implementing them.  Often, the Legislature enacts a law covering the general principles and policies, and delegates the power to the Executive for specifying certain details for the implementation of a law.  For example, the Citizenship Amendment Act provides who will be eligible for citizenship.  The certificate of registration or naturalization to a person will be issued, subject to conditions, restrictions, and manner as may be prescribed by the central government through Rules.  Delay in framing Rules results in delay in implementing the law, since the necessary details are not available.  For example, new labour codes provide a social security scheme for gig economy workers such as Swiggy and Zomato delivery persons and Uber and Ola drivers.  These benefits as per these Codes are yet to be rolled out as the Rules are yet to be notified.

Timelines and checks and balances for adherence

Each House of Parliament has a Committee of Members to examine Rules, Regulations, and government orders in detail called the Committee on Subordinate Legislation.  Over the years, the recommendations of these Committees have shaped the evolution of the procedure and timelines for framing subordinate legislation.  These are reflected in the Manual of Parliamentary Procedures issued by the Ministry of Parliamentary Affairs, which provides detailed guidelines.

Ordinarily, Rules, Regulations, and bye-laws are to be framed within six months from the date on which the concerned Act came into force.   Post that, the concerned Ministry is required to seek an extension from the Parliamentary Committees on Subordinate Legislation.  The reason for the extension needs to be stated.   Such extensions may be granted for a maximum period of three months at a time.  For example, in case of Rules under the Citizenship Amendment Act, 2019, at an earlier instance, an extension was granted on account of the onset of the COVID-19 pandemic.

Activity

Timeline

  • Publication of Rules, Regulations, and Bye-Laws, where public consultation is required under the Act
  • A minimum of 30 days for public feedback
  • Consequently, for publication,
  • Three months, if the number of suggestions is small
  • Six months, if the number of suggestions is large
  • Publication of Rules, Regulations, and Bye-Laws, not requiring public consultation
  • Six months from the date on which the concerned Act came into force
  • Any extension for publication
  • A maximum of three months at a time

To ensure monitoring, every Ministry is required to prepare a quarterly report on the status of subordinate legislation not framed and share it with the Ministry of Law and Justice.  These reports are not available in the public domain.

Recommendations to address delays

Over the years, the Subordinate Legislation Committees in both Houses have observed multiple instances of non-adherence to the above timelines by various Ministries.  To address this, they have made the following key recommendations:

  • Statement on reasons for the delay: In 2011, Rajya Sabha Committee recommended that while laying Rules/Regulations before Parliament, the Ministry should also lay a statement explaining the reasons for the delay, if any.
  • Scrutiny of delays by the Cabinet Secretary:  In 2016, the Rajya Sabha Committee recommended that the Cabinet Secretary should continue the practice of calling the Secretaries of concerned Ministries/Departments, to explain the reasons for the delay in framing the subordinate legislation.  Each Ministry should send a quarterly status report to the Cabinet Secretariat.
  • Revisiting guidelines: In 2011, Lok Sabha Committee recommended that the 1986 guidelines should be revisited and all major recommendations of the Committee should be incorporated.  However, as per the Action Taken Report, the government observed that the ministries consider the extant guidelines adequate and these guidelines were re-iterated in 2012.

Are all Rules under an Act required to be framed?

Usually, the expressions used in an Act are “The Central Government may, by notification, make rules for carrying out the provisions of this Act.”, or “as may be prescribed”.  Hence, it may appear that the laws aim to enable rule-making instead of mandate rule-making.  However, certain provisions of an Act cannot be brought into force if the required details have not been prescribed under the Rules.  This makes the implementation of the Act consequent to the publication of respective Rules.  For example, the Criminal Procedure (Identification) Act, 2022 enables the police and certain other persons to collect identity-related information about certain persons.  It provides that the manner of collection of such information may be specified by the central government.  Unless the manner is prescribed, such collection cannot take place.

That said, some other rule-making powers may be enabling in nature and subject to discretion by the concerned Ministry.  In 2016, Rajya Sabha Committee on Subordinate Legislation examined the status of Rules and Regulations to be framed under the Energy Conservation Act, 2001.  It observed that the Ministry of Power had held that two Rules and three Regulations under this Act were not necessary.   The Ministry of Law and Justice had opined that those deemed not necessary were enabling provisions meant for unforeseen circumstances.  The Rajya Sabha Committee (2016) had recommended that where the Ministry does not feel the need for framing subordinate legislation, the Minister should table a statement in Parliament, stating reasons for such a conclusion.

Some key issues related to subordinate legislation

The Legislature delegates the power to specify details for the implementation of a law to the Executive through powers for framing subordinate legislation.  Hence, it is important to ensure these are well-scrutinised so that they are within the limits envisaged in the law.

  • Capacity of Committees on Subordinate Legislation:  Parliamentary Committees on Subordinate Legislation have the responsibility to examine Rules in detail.  In past, they have examined some key rules, regulations, and notifications regarding e-commerceliability of internet-based services, and demonetisation.  However, usually, they are able to examine only a fraction of subordinate legislation in detail.  For more details, please see the PRS discussion paper here.
  • Uniformity of standards:  Countries such as UKUSAAustralia, and Canada have overarching legislation for regulating the framing of subordinate legislation.  These laws provide for the manner of public consultation, timelines, drafting standards, and a common register.  India does not have any similar law.  In India, the detail whether public consultation for subordinate legislation is required or not, is specified in respective Acts.  The General Clauses Act, 1897 also governs certain aspects of the framing of subordinate legislation.  In addition, the Pre-Legislative Consultation Policy, 2014 guides the pre-legislative consultation on subordinate legislation.

See here for our recently published analysis of the Criminal Procedure (Identification) Rules, 2022, notified in September 2022.  Also, check out PRS analysis of: