The implementation of the Food Safety and Standards Act, 2006 has run into rough weather.  The Act consolidates eight laws[1] governing the food sector and establishes the Food Safety and Standards Authority (FSSA) as the regulator.  It requires all food business operators (including small businesses and street vendors) to obtain a licence or registration.  The Regulations under FSSA related to procedure for obtaining a licence or registration was notified on August 1, 2011.  According to the Regulations, all food business operators had to get a licence or registration within one year of the notification.  Due to opposition from several food business operators (see here and here), the FSSA has now extended the deadline for getting a licence or registration by another six months (till February 2013).  However, some of the key concerns regarding the law have not yet been addressed.

Key issues related to the Bill raised by PRS (for more details see Legislative Brief)

  • The organised as well as the unorganised food sectors are required to follow the same food law.  The unorganised sector, such as street vendors, might have difficulty in adhering to the law, for example, with regard to specifications on ingredients, traceability and recall procedures.
  • The Bill does not require any specific standards for potable water (which is usually provided by local authorities).  It is the responsibility of the person preparing or manufacturing food to ensure that he uses water of requisite quality even when tap water does not meet the required safety standards.
  • The Bill excludes plants prior to harvesting and animal feed from its purview.  Thus, it does not control the entry of pesticides and antibiotics into the food at its source.
  • The power to suspend the license of any food operator is given to a local level officer.  This offers scope for harassment and corruption.

Other issues referred to in the media

  • The Act requires a food business operator to get different licenses if articles of food are manufactured or sold at different premises.  Newspapers reported that this provision was challenged in the Madras High Court but a stay order on the Act and its Rules was refused.
  • According to media reports, two hotel associations in Karnataka had challenged certain sections of the Act and Rules in the Karnataka High Court related to requirement of technical person for supervision of production process and requirement of a laboratory on the premises of food operators.  The court stayed these provisions for three months (till October 2012).
  • News papers reported that the Supreme Court is examining the question whether liquor is a food.

[1].  (a) The Prevention of Food Adulteration Act, 1954.  (b) The Fruit Products Order, 1955.  (c) The Meat Food Products Order, 1973. (d)  The Vegetable Oil Products (Control) Order, 1947.  (e) The Edible Oils Packaging (Regulation) Order, 1998. (f) The Solvent Extracted Oil, De oiled Meal, and Edible Flour (Control) Order, 1967. (g) The Milk and Milk Products Order, 1992. (h) Any other order issued under the Essential Commodities Act, 1955, relating to food.

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.