The Surrogacy (Regulation) Bill, 2016 was introduced in Lok Sabha on November 21, 2016 and is listed for passage this week.  The Bill regulates altruistic surrogacy and prohibits commercial surrogacy.  We present a brief overview of the Bill and some issues that may need to be considered:

How is surrogacy regulated under the Bill?

The Bill defines surrogacy as a practice where a woman gives birth to a child for an eligible couple and agrees to hand over the child after the birth to them.  The Bill allows altruistic surrogacy which involves a surrogacy arrangement where the monetary reward only involves medical expenses and insurance coverage for the surrogate mother.  Commercial surrogacy is prohibited under the Bill.  This type of surrogacy includes a monetary benefit or reward (in cash or kind) that exceeds basic medical expenses and insurance for the surrogate mother.

What is the eligibility criteria for couples intending to commission surrogacy?

In order to be eligible, the couple intending to commission a surrogacy arrangement must be a close relative of the surrogate mother.  In addition, the couple has to prove that they fulfil all of the following conditions:

  • They are Indian citizens who have been married for at least five years;
  • They are in the age group of 23-50 years (female partner) and 26-55 years (male partner);
  • A medical certificate stating that either or both partners are infertile;
  • They do not have any surviving child (whether biological, adopted or surrogate), except if the surviving child is mentally or physically challenged or suffers from a fatal illness;
  • A court order concerning the parentage and custody of the child to be born through surrogacy;
  • Insurance coverage for the surrogate mother.

Additional eligibility conditions that the intending couple need to meet may be specified by regulations. It could be argued that the qualifying conditions for surrogacy should be specified in the Bill and not be delegated to regulations.

Who is a close relative under the Bill?

The Bill does not define the term close relative.

Who is eligible to be a surrogate mother?

The surrogate mother, apart from proving that she is a close relative of the couple intending the surrogacy, also has to prove all the following conditions:

  • She was or is married and has a child of her own;
  • She is 25 to 35 years old;
  • She has not been a surrogate mother before;
  • She possesses a medical certificate of her fitness for surrogacy.

What will be the legal status of a surrogate child?

The Bill states that any child born out of a surrogacy procedure shall be the biological child of the intending couple and will be entitled to all rights and privileges that are available to a natural child.

What is the process for commissioning a surrogacy?

The intending couple and the surrogate mother can undergo a surrogacy procedure only at surrogacy clinics that are registered with the government.  To initiate the procedure, the couple and the surrogate mother need to possess certificates to prove that there are eligible.  These certificates will be granted by a government authority if the couple and the surrogate mother fulfill all the conditions mentioned above.  The Bill does not specify a time period within which the authority needs to grant the certificates.  Further, the Bill does not specify a review or appeal procedure in case the application for the certificates is rejected.

What is the penalty for engaging in commercial surrogacy under the Bill?

The Bill specifies that any person who takes the aid of a doctor or a surrogacy clinic in order to conduct commercial surrogacy will be punishable with imprisonment for a minimum term of five years and a fine that may extend to five lakh rupees.

Offences such as (i) undertaking or advertising commercial surrogacy; (ii) exploiting or abandoning the surrogate mother or child; and (iii) selling or importing human embryo or gametes for surrogacy will attract a minimum penalty of 10 years and a fine up to 10 lakh rupees.

[This post has been co – authored by Nivedita Rao]

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.