A recent news report stated that the Planning Commission has advocated putting in place a “proper regulatory mechanism” before permitting the use of genetic modification in Indian crops.  A recent Standing Committee report on genetically modified (GM) crops found shortcomings in the regulatory framework for such crops.  The current framework is regulated primarily by two bodies: the Genetic Engineering Appraisal Committee (GEAC) and the Review Committee on Genetic Manipulation (RCGM).  Given the inadequacy of the regulatory framework, the Standing Committee recommended that all research and development activities on transgenic crops be carried out only in containment (in laboratories) and that ongoing field trials in all states be discontinued.  The blog provides a brief background on GM crops, their regulation in India and the key recommendations of the Standing Committee. What is GM technology? GM crops are usually developed through the insertion or deletion of genes from plant cells.  Bt technology is a type of genetic modification in crops.  It was introduced in India with Bt cotton.  The debate around GM crops has revolved around issues of economic efficacy, human health, consumer choice and farmers’ rights.  Some advantages of Bt technology are that it increases crop yield, decreases the use of pesticides, and improves quality of crops.  However, the technology has also been known to cause crop loss due to resistance developed by pests and destruction of local crop varieties, impacting biodiversity. Approval process for commercial release of GM crops

  1. Initially, the company developing the GM crop undertakes several biosafety assessments including, environmental, food, and feed safety assessments in containment.
  2. This is followed by Bio-safety Research Trials which require prior approval of the regulators, the GEAC and the RCGM.
  3. Approval for environmental release is accorded by the GEAC after considering the findings of bio-safety studies.
  4. Finally, commercial release is permitted only for those GM crops found to be safe for humans and the environment.

Committee’s recommendations for strengthening the regulatory process The Standing Committee report found several shortcomings in the regulatory framework, some of which are as follows:

  • State governments are not mandatorily consulted for conducting open field trials on GM crops.  Several states such as Kerala and Bihar have opposed field trials for GM crops.  The Committee recommended that mandatory consultation with state governments be built into the regulatory process.
  • The key regulators, the GEAC and the RCGM, suffer from poor organisational set-up and infrastructure.  The Committee recommended that the regulatory framework be given statutory backing so that there is no scope for ambiguity or complacency on the part of the authorities responsible for the oversight of GM organisms.  It urged the government to introduce the Biotechnology Regulatory Authority Bill.
  • There is evidence that the GEAC has not complied with international treaties.  These include the Cartagena Protocol on Biosafety and the Rio Declaration on Environment and Development.  It recommended that legislation relating to liability and redress for damage arising from living modified organisms be enacted.
  • Some international scientists have raised doubts about the safety of Bt Brinjal and the way tests were conducted.  To remedy this situation, the Committee recognised the need for an overarching legislation on biosafety to ensure that biotechnology is introduced without compromising the safety of biodiversity, human and livestock health, and environmental protection.

Note that over the last few sessions of Parliament, the government has listed the Biotechnology Regulatory Authority Bill for introduction; however the Bill has not been introduced yet.  The Bill sets up an independent authority for the regulation of GM crops. For a PRS summary of the report and access to the full report, see here and here.

So far, both Houses of Parliament have been witnessing disruptions.  At the beginning of the session, 23 Bills were listed for passage, and 20 were listed for introduction.  Two weeks in, one Bill has been passed by both Houses, and three others by Lok Sabha.  These include Bills dealing with the re-haul of consumer protection laws, regulation of surrogacy, and recognition of transgender persons.  Six Bills have been introduced.  These include three Bills which replace the Ordinances currently in force, and a Bill to regulate dam safety.  In this blog, we discuss the key features of some of these Bills. 

Enhancing rights of consumers

The Consumer Protection Bill, 2018 replaces the Consumer Protection Act, 1986.  It was introduced in view of the significant changes in the consumer market landscape since the 1986 Act.  It introduces several new provisions such as enabling consumers to make product liability claims for an injury or harm caused to them, nullifying unfair contracts which impact consumer interests (such as contracts which charge excessive security deposits), and imposing penalties for false and misleading advertisements on manufacturers, as well as on the endorsers of such advertisements. 

The Bill also sets up Consumer Dispute Redressal Commissions (or courts) at the district, state, and national level, to hear complaints on matters related to deficiencies in services or defects in goods.  While these Commissions are also present under the 1986 Act, the Bill increases their pecuniary jurisdiction: District Commissions will hear complaints with a value of up to one crore rupees; State Commissions between one and ten crore rupees; and National Commission above 10 crore rupees.  The Bill also sets up a regulatory body known as the Central Consumer Protection Authority.  This Authority can take certain actions to protect the rights of consumers as a class such as passing orders to recall defective goods from the market, and imposing penalties for false and misleading advertisements. 

Recognising transgender persons and their rights

Last week, Lok Sabha also passed the Transgender Bill, 2018.  This Bill seeks to recognise transgender persons, confers certain rights and entitlements on them related to education, employment, and health, and carves out welfare measures for their benefit.  The Bill defines a transgender person as one whose gender does not match the gender assigned at birth.  It includes trans-men and trans-women, persons with intersex variations, gender-queers, and includes persons having such socio-cultural identities as kinnar, hijra, aravani, and jogta.  The Bill requires every establishment to designate one person as a complaint officer to act on complaints received under the Bill. 

The Bill provides that a transgender person will have the right to self-perceived gender identity.  Further, it also provides for a screening process to obtain a Certificate of Identity, certifying the person as ‘transgender’.  This implies that a transgender person may be allowed to self-identify as transgender individual, but at the same time they must also undergo the screening process to get certified as a transgender.  Therefore, it is unclear how these two provisions of self-identification and an external screening process will reconcile with each other. 

Regulating surrogacy and overhauling the Medical Council of India

The Surrogacy Bill, 2017 which regulates altruistic surrogacy and prohibits commercial surrogacy was also passed in Lok Sabha.  Surrogacy is a process where an intending couple commissions an eligible woman to carry their child.  In an altruistic surrogacy, the surrogate mother is not given any monetary benefit or reward, and the arrangement only covers her medical expenses and health insurance.  The Bill sets out certain conditions for both the intending couple and the surrogate mother to be eligible for surrogacy.  The intending couple must be Indian citizens, be married for at least five years, and at least one of them must be infertile.  The surrogate mother must be a close relative of the couple, must be married and must have had a child of her own.  Further, a surrogate mother cannot provide her own gametes for surrogacy.

The surrogate mother has been given certain rights with regard to the procedure of surrogacy.  These include requiring her written consent to abort the surrogate child, and allowing her to withdraw from the surrogacy at any time before the embryo is implanted in her womb. 

Another key Bill which was listed for passage in Lok Sabha this session but could not be taken up is the National Medical Commission Bill, 2017 (NMC Bill).  Several amendments to this Bill were introduced in Lok Sabha last week.  The NMC Bill seeks to replace the Medical Council of India, with a National Medical Commission.  It introduces a common final year undergraduate medical examination called the National Exit Test which will also grant the license to practice medicine.  Only medical students graduating from a medical institute which is an institute of national importance will be exempted from qualifying this National Exit Test.  The Bill also gives the NMC the power to frame guidelines to decide the fees of up to 50% of seats in private medical colleges and deemed universities.  The NMC may also grant limited license to certain mid-level practitioners connected with the medical profession to practice medicine.  The qualifying criteria for such mid-level practitioners will be determined through regulations, and they may prescribe specified medicines in primary and preventive healthcare. 

Regulating dam safety

The Dam Safety Bill, 2018 was introduced in Lok Sabha and applies to all specified dams across the country.  These are dams with: (i) height more than 15 metres, or (ii) height between 10 metres to 15 metres and subject to certain additional design and structural conditions.  It seeks to provide for the surveillance, inspection, operation and maintenance of specified dams for prevention of dam failure related disasters.  It creates authorities at the national and state level to formulate policies and regulations on dam safety and implement them.  It also puts certain obligations on dam owners by requiring them to provide a dam safety unit in each dam, among other things. 

When the Bill was being introduced, few opposition members raised objections on the grounds of Parliament’s legislative competence to make a law on dam safety which applies to all states.  They gave the example of the previous Dam Safety Bill, 2010, which applied only to the states of Andhra Pradesh and West Bengal who had adopted resolutions requiring Parliament to pass a law on dam safety.

So far the winter session has seen poor productivity with Lok Sabha working for 14% of its scheduled time, and Rajya Sabha for 5%.  This is one of the least productive sessions of the 16th Lok Sabha.  This is also the last major session before the dissolution of the 16th Lok Sabha.  Both Houses will meet tomorrow after the Christmas break.  With a packed legislative agenda, it is essential for Parliament to function in order to discuss and deliberate the Bills listed.  However, with a limited number of sitting days available in the ongoing session and continued disruptions, it remains to be seen if Parliament will be able to achieve its legislative agenda.

- This post is a modified version of an article published by The Wire on December 26, 2018.