The row over Bt Brinjal, a genetically modified version of the plant, provoked the government into imposing a moratorium on the commercial cultivation of the plant in India.  The debate has revolved around issues of economic efficacy, human health, consumer choice and farmers’ rights. Jairam Ramesh, the Minister of State for Environment and Forests, made public his views on the subject, a gist of which is given below:

  • The Genetic Engineering Approvals Committee (GEAC) report recommended commercial cultivation of Bt Brinjal but qualified it by stating that since the issue has important policy implications at the national level, the government should take a final view on the matter.
  • Most of the state governments have expressed concern and have sought to ban the use of Bt Brinjal, or all GM crops.
  • Pesticides have harmful effect on human health and Bt technology is one way of reducing pesticide use.  However, other routes such as non-pesticide pest management can be explored.  For example, about 6 lakh farmers in Andhra Pradesh practice non-pesticide pest management over an area of about 20 lakh acres.
  • Safety is a concern since the kind of tests that have been done is not specific or stringent enough to detect toxins.  Also, tests have only been carried out by the developers of the product, Maharashtra Hybrid Seeds Company Ltd. (Mahyco).  (The results of the biosafety tests are available on the GEAC website).
  • There is no large-scale public funded biotechnology effort toward agriculture, which could compete with Mahyco.  Monsanto is the main producer of Bt Brinjal, and Mahyco is owned to the extent of 26% by Monsanto.
  • While two government owned agricultural universities -- University of Agricultural Sciences, Dharwad and Tamil Nadu Agricultural University (TNAU), Coimbatore – have produced Bt Brinjal along with Mahyco, doubts have been raised about how Bt related research in these universities have been funded.
  • There are apprehensions that there will be diversity loss in the variety of Brinjal if Bt Brinjal is introduced, and this fear cannot be glossed over.
  • While Bt Cotton and Bt Brinjal are not comparable, the introduction of Bt Cotton in India has made India the second largest grower of cotton in the world.  Over 90% of cotton farmers in India cultivate Bt Cotton.  Many farmers support Bt Cotton on economic grounds but some did express doubts.
  • The Central Institute of Cotton Research, Nagpur has developed a Bt cotton variety (Bikaneri Nerma) whose seeds can be kept by farmers for planting during the next season.  The Director of the Institute while expressing support for Bt Brinjal has mentioned that resistance development is a serious issue.  Therefore, more tests that are well-designed, widely-accepted and independently conducted are necessary.
  • The GEAC process has been questioned by  Dr P.M. Bhargava, the Supreme Court nominee on GEAC.  He opposed the recommendation on the ground that all necessary tests had not been carried out before coming to a decision.  The 2006 committee of the GEAC had asked for several tests to be conducted which were not taken into account by the second expert committee.  All GEAC reports (including additional tests) of tests conducted with regard to Bt Brinjal are in the public domain.
  • There is some evidence that the GEAC not followed global regulatory norms of which India is a party.  For example, the Cartagena Protocol on Biosafety, Rio Declaration on Environment and Development etc.
  • Some international scientists have raised doubts about Bt Brinjal and the way the tests were conducted.
  • Many Indian scientists have supported commercialization of Bt Brinjal such as Dr G. Padmanabhan of the Indian Institute of Science; Dr Deepak Pental, Vice Chancellor of Delhi University; and Dr Raj Bhatnagar of the International Centre for Genetic Engineering and Biotechnology, New Delhi.  However, even they have mentioned the need for a statutory body with regulatory powers and R&D capabilities to govern all aspects of GM crops.
  • The Indian Council of Agricultural research and a number of farmer’s groups have come out in support of the move to introduce Bt Brinjal.

In order to understand the process followed by GEAC before giving the green signal to Bt Brinjal, we have made a timeline in which the plant was approved and the bodies involved in the process.

2000-2005 Scientific tests carried out by Mahyco on Bt Brinjal
2006 Mahyco submits bio-safety data to GEAC (regulatory body under the Ministry of Environment and Forests). Seeks permission for large scale trials.
  Supreme Court stops ongoing field trials of GM crops due to a PIL filed by civil society representatives.
2007 The expert committee 1 set up by GEAC, submits its report.  Recommends seven more studies on bio-safety be repeated for reconfirmation of data generated during confined multi-location trials but approves large scale trials.
  Supreme Court lifts ban on GM crop field trials subject to conditions such as isolation distance etc.
  As per GEAC direction, Indian Institute of Vegetable Research (IIVR) takes up the responsibility of large scale trails of Mahyco's Bt Brinjal trials at 10 research institutions across the country in 2007 and 11 in 2008.
2009 Jan: IIVR submits the results of the large scale trails. Due to concerns raised by several stakeholders, GEAC constitutes another expert committee to look into adequacy of biosafety data generated as well as the concerns raised by all stakeholders.
  Oct 8: Expert-committee 2 submits its report. States benefits of Bt Brinjal far outweigh the perceived and projected risks.
  Oct 14: GEAC approves the environmental release of Bt Brinjal containing the event EE1 (with one dissent note from P.M. Bhargava).
  Oct 15: Jairam Ramesh announces a nationwide consultation in January and February of 2010 pending a final decision on this issue.
2010 Jan 13 to Feb 6: Public meetings were organized on the Bt Brinjal issue. The summary of the consultations is available on the Ministry’s website.
  Many states announce ban on commercial cultivation of Bt Brinjal including Uttarakhand, Himachal Pradesh and Karnataka.
  Feb 9: Jairam Ramesh decides to halt the commercialization of Bt Brinjal.

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.

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.