Recent news reports indicate that the European Union (EU) has banned imports of Alphonso mangoes and four vegetables from India due to the presence of harmful pests and a lack of certification before export. The ban will be effective between May 1, 2014 and December 2015. It has been suggested that the ban could impact the export of nearly 16 million mangoes from India, the market for which is worth nearly £6 million a year in a country like the United Kingdom. In this context, it may be useful to examine the regulation of agricultural biosecurity in India, particularly with respect to imports and exports of such agricultural produce. Currently, two laws, the Destructive Insects and Pests Act, 1914 and the Livestock Importation Act, 1898, regulate the import and export of plants and animals with a view to control pests and diseases. Under the laws, the authorities ensure that infectious diseases and pests do not cause widespread damage to the environment, crops, agricultural produce and human beings, i.e. the agricultural biosecurity of a country. Common examples of pests and diseases have been the Banana bunchy top virus which stunts banana plants and stops production of fruit while another is the Avian Influenza, which caused extensive death of poultry and led to human deaths as well. Under the existing Acts, different government departments and government-approved bodies are responsible for regulating imports and certifying exports to ensure that there are no threats to agricultural biosecurity. The Department of Agriculture keeps a check on pests and diseases arising from plants and related produce, such as mangoes and vegetables, while the Department of Animal Husbandry monitors diseases relating to animals and meat products. The Agricultural and Processed Food Products Export Development Authority (APEDA) certifies exports of different commodities related to plants and animals. Various government committees have highlighted the ineffectiveness of the existing system due to its piecemeal approach and have recommended an integrated system to handle biosecurity issues. It has also been suggested that the existing laws have not kept up with developments in agriculture and are inadequate to deal with the emergence of trans-boundary diseases that pose threats to human, animal and plant safety. The Agricultural Biosecurity Bill, 2013, pending in Parliament seeks to replace these laws and establish a national authority, the Agricultural Biosecurity Authority of India (ABAI), to regulate biosecurity issues related to plants and animals. ABAI shall be responsible for: (i) regulating the import and export of plants, animals and related products, (ii) implementing quarantine measures in case of the existence of pests, (iii) regulating the inter-state spread of pests and diseases relating to plants and animals, and (iv) undertaking regular surveillance of pests and diseases. Under the Bill, exports of plants, animals and related products will only be allowed once ABAI has issued a sanitary or phytosanitary certificate in accordance with the destination country’s requirements. The penalty for exporting goods without adequate certification from ABAI is imprisonment upto two years and and a fine of Rs 2 lakh. The proposed ABAI will also meet India’s obligations to promote research and prevent pests and diseases under the International Plant Protection Convention and the Office International des Epizooties. A PRS analysis of various aspects of the Bill can be found here. The Bill will lapse with the dissolution of the 15th Lok Sabha. It remains to be seen how the incoming government in the 16th Lok Sabha will approach biosecurity issues to prevent incidents like the EU ban on imports of Indian fruits and vegetables in the future.
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:
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.
