विधान

Are genetically modified crops safe enough?

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.

Bill to amend regulation of chemical weapons passed by Parliament

The Chemical Weapons Convention (Amendment) Bill, 2010 (the Bill) was recently passed by the Lok Sabha without any amendment.  The Chemical Weapons Convention Act, 2000 (the Act) was enacted to give effect to the United Nations Convention on the Prohibition of the Development, Production, Stockpiling and Use of Chemical Weapons and on their Destruction (the CWC).  The CWC aims to eliminate chemical weapons by prohibiting their development, acquisition, stockpiling, transfer or use by State Parties. The 188 State Parties of the CWC are required to take the steps necessary to prohibit these activities within their jurisdiction. India signed the Convention on January 14, 1993. The Bill was introduced in the Rajya Sabha on April 16, 2010 by the Minister of State in the Ministry of Chemicals and Fertilizers, Mr. Srikant Kumar Jena.  The Standing Committee submitted its report on August 3, 2010. This Bill was passed by the Rajya Sabha on May 3, 2012 with some amendments based on the recommendations of the Standing Committee.  The recommendations of the standing committee and the subsequent amendments made by the Rajya Sabha are as follows:

  • The Act disallows any person from transferring or receiving specified toxic chemicals from a citizen of a non-State Party.  The Bill changes this position by prohibiting transfer or receipt of the specified toxic chemicals from a non-State Party to the Convention.  The Committee recommended that the provision should clearly prohibit transfer or receipt from both non-State Parties and citizens of non-State Parties.  The Rajya Sabha has made the corresponding amendment to the Bill.
  • The Act mandates the registration of persons engaged in the production, transfer, or use of any toxic chemical.  The Bill makes registration mandatory, subject to certain threshold limits that are prescribed, for manufacturers of specified chemicals.  The Committee observed that this would make registration mandatory only for those manufacturers who cross the specified limit.  Thus, the Committee asked the government to consider a two-step process of compulsory registration of all manufacturers, followed by a declaration of those crossing the threshold limits.  This recommendation has not been accepted by the Rajya Sabha.  Hence, only those persons whose production of toxic chemicals exceeds the threshold would be required to register.
  •  The Act established a National Authority to implement the provisions of the Convention.  It empowers the central government to appoint officers of the National Authority as enforcement officers. The Bill broadens the central government’s power by allowing it to appoint any of its officers as enforcement officers.  The Committee recommended that eligibility criteria, such as technical qualifications and expertise, for these officers should be set under the rules.  The Committee also recommended that officers should be given suitable training before their appointment.  The Rajya Sabha has incorporated the suggestion of prescribing eligibility criteria under the Bill.

The Lok Sabha passed the Bill on August 30, 2012 without any amendments.  The standing committee report and its summary may be accessed here and here.

Implementation hiccups in the Food Safety and Standards Act, 2006

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.

Cabinet approves Bill to amend law on rape

According to a recent press release, the Cabinet has approved a proposal to introduce a Bill in Parliament to amend the Indian Penal Code, 1860 (IPC).  While the draft Bill is currently not available, its highlights are specified in the press release.  As per the press release, the Bill aims to make rape laws gender neutral.  The key features specified are:

  • Substituting the word “rape” with “sexual assault”;
  • Increasing the age of consent 16 to 18 years;
  • Excluding sexual intercourse between a married couple from the definition of rape, where the wife's consent has not been obtained and the wife is at least 16 years of age.

Present Law According to section 375 of the IPC, an allegation of rape has to satisfy the following criteria:

  • sexual intercourse between a man with a woman in the following circumstances: (a) against the will of the woman; (b) without her consent; (c) under duress; (d) consent obtained by fraud; (e) consent obtained by reason of unsoundness of mind or intoxication.
  • If the woman is below the age of 16 years, sexual intercourse is deemed to amount to rape.  Even if the woman has consented, it would be considered rape under the law.
  • There is however, an exception to this definition of rape.  Un-consented sexual intercourse between a man and his wife would not amount to rape if the wife is 16 years or older.

This definition of rape does not include use of other body parts or foreign objects by the offender upon the victim’s body.  Such offences are classified as “use of criminal force to outrage the modesty of a woman” (see here) and are punishable with two years imprisonment or fine or both.  Rape, on the other hand, is punishable with imprisonment for seven years to a life term. Proposals to amend the law on rape Through an order in 1999, the Supreme Court had directed the Law Commission to review the law on rape (Sakshi vs. Union of India).  The Law Commission had in its 172nd Report, dated March 25, 2000 made recommendations to amend the law to widen the definition of rape.  In its report, the Commission had recommended that rape be substituted by sexual assault as an offence.  Such assault included the use of any object for penetration.  It further recognised that there was an increase in the incidence of sexual assaults against boys.  The Report recommended the widening of the definition of rape to include circumstances where both men and women could be perpetrators and victims of sexual assault.[1]   Amendments to the law on the basis of these recommendations are still awaited. The High Court of Delhi has recognised the need to amend the laws on rape.  It observed that the law did not adequately safeguard victims against sexual assaults which were included by the Law Commission within the scope of rape.  It was observed that the definition should be widened to include instances of sexual assault which may not satisfy the penile-vaginal penetration required under the existing law. The 2010 draft Criminal Laws Amendment Bill, released by the Ministry of Home Affairs, attempted to redefine rape.  The draft provisions substitute the offence of rape with “sexual assault”.  Sexual assault is defined as penetration of the vagina, the anus or urethra or mouth of any woman, by a man, with (i) any part of his body; or (ii) any object manipulated by such man under the following circumstances: (a) against the will of the woman; (b) without her consent; (c) under duress; (d) consent obtained by fraud; (e) consent obtained by reason of unsoundness of mind or intoxication; and (f) when the woman is below the age of 18. Variation between proposals The existing legal provisions, the Law Commission Report, the 2010 Bill and the recent press release are similar in that they provide an exception to marital rape.  Under the law, un-consented sexual intercourse is not an offence if the wife is above a certain age.  (Under the existing law the wife has to be over 16 years’ of age and as per press release she has to be more than 18 years old.)  This is at variance with the proposal of the National Commission of Women (NCW).   An amendment to the IPC recommended by the NCW deleted the exemption granted to un-consented sex between a man and his wife if she was more than 16 years old.  It therefore criminalised marital rape. As per the press release, this exemption has been retained in the proposed Bill.  Furthermore, as per the release, while the age of consent for sexual intercourse will be increased to 18 years, for the purpose of marital sex, the age of consent would be 16 years.


[1] Review of Rape Laws, Law Commission of India, 172nd Report, paragraph 3.1.2,  "375.  Sexual Assault:  Sexual assault means - (a) penetrating  the  vagina (which term shall include the labia majora), the  anus  or  urethra  of  any person with - i)      any part of the body of another person or ii)   an object manipulated by another person except  where  such penetration is carried out for proper hygienic or medical purposes; (b) manipulating any  part  of  the  body  of  another person  so  as  to cause penetration of the vagina (which term shall include the labia  majora),  the anus or the urethra of the offender by any part of  the other person's body; (c) introducing any part of the penis of a person into the mouth of another person; (d)    engaging in cunnilingus or fellatio; or (e) continuing  sexual  assault  as defined in clauses (a) to (d) above in circumstances falling  under  any  of  the  six following descriptions: ... Exception:  Sexual intercourse by a man with his own wife, the wife not being under sixteen  years  of  age,  is  not sexual assault."

Right to Education: the story so far

In India, children between the age group of 6 and 14 years have the fundamental right to free and compulsory education.  This right is implemented through the Right of Children to Free and Compulsory Education Act, 2009 (RTE Act).  The Act is applicable to all categories of schools (government and private). According to recent media reports (see here and here), many schools (including government schools) are flouting norms laid down in the RTE Act.  Unaided schools have criticised state government over norms related to religious and linguistic status of minority schools (see here and here).  The government has also faced flak over unclear norms on neighbourhood schools and reimbursement of money to private schools (see here, here and here). Most Acts ‘delegate’ the power to make rules and regulations for operationalising the law to the executive (Ministry).   We provide an overview of the Rules notified by the state governments. The central government notified the RTE Rules 2010 on April 9, 2010, which are applicable to all schools under the central government, and in the five Union Territories without legislatures.  Most of the states have notified similar Rules with a few variations. The Rules define the limits of a neighbourhood and make it mandatory for the local authority to maintain list of children within its jurisdiction.  They also prescribe the composition of the School Management Committee to be formed in government schools.  Private schools shall reserve 25% of the seats for disadvantaged children.  These schools shall be reimbursed for either their tuition charge or the per-student expenditure in government schools, whichever is lower.  All private schools have to be recognised before they can start operation.  Recognition is contingent upon meeting the minimum standard laid down in the Act    Existing private schools have to meet the norms within three years of commencement of the Act.  If they are not compliant after three years, they shall cease to function.  Government schools under the central government have to meet only two conditions: the minimum qualification for teachers and the student-teacher ratio. For all state government schools and un-adided schools, the power to make rules is delegated to the state government.  The central government circulated Model Rules for the RTE Act to the states.  All state governments, except Goa, have notified the state RTE Rules.  Delhi and Puducherry have also notified them.  Most of the states have notified similar Rules with a few variations.  We list some of the variations. Andhra Pradesh: The break-up of the 25% quota among the various disadvantaged groups have been included in the Rules.  Scheduled Castes: 10%; Scheduled Tribes: 4%; Orphans, disabled and HIV affected: 5% and children with parents whose annual income is lower than Rs 60,000: 6%. Rajasthan: Private schools either have to be affiliated with a university or recognised by any officer authorised by the state government.     Karnataka: In addition to the minimum norms under RTE Act, private schools have to comply with the Karnataka Education Act, 1983. Gujarat: If an existing recognised school is unable to meet the infrastructure norms it may be given the option of demonstrating that it achieved certain learning outcomes, both in terms of absolute levels and as improvement from previous years. Uttar Pradesh: The government shall pay per child reimbursement to the school after it gives a list of children with their Unique Identity Number and other details. Kerala:  The local authority has to maintain a record of all the children (0-14 years) within its jurisdiction.  It shall also maintain the Unique Identity Number of every child, as and when issued by the competent authority, to monitor his enrolment, attendance and learning achievements. Haryana:  Defines textbooks, uniform and writing material.  It states that Hindi is to be the preferred medium of instruction in all schools. For using other language, permission of Director, Elementary Education Dept is required (to be given within 45 days or deemed to be granted). West Bengal: The Rules give detailed definition of the appropriate age for each class.  They require schools to be set up in a relatively noise-free and pollution-free area with adequate supply of drinking water and electricity.  Existing schools (which are already recognised or affiliated with a Board) may get the local municipal authorities to provide infrastructural support including relaxation of building rules to comply with the requirements of the Act. Additional sources

  1. PRS Brief on Right of Children to Free and Compulsory Education Bill, 2008.
  2. PRS Bill Summary on Right of Children to Free and Compulsory Education (Amendment) Bill, 2010.
  3. Accountability Initiative’s Policy Brief on 25% Reservation under the RTE.

Alternate proposal to the National Food Security Bill

According to news reports, the Prime Minister recently chaired a meeting with ministers to discuss an alternative plan (“Plan B”) for the National Food Security Bill, 2011 (hereinafter “Bill”).  The Bill is currently pending with the Standing Committee of Food, Consumer Affairs and Public Distribution.  It seeks to deliver food and nutritional security by providing specific entitlements to certain groups.  The alternative proposal aims to give greater flexibility to states and may bind the centre to a higher food subsidy burden than estimates provided in the Bill.  It suggests changes to the classification of beneficiaries and the percentage of the national population to be covered by the Bill, among others. Classification of beneficiaries The Bill classifies the population into three groups: priority, general and excluded.  Individuals in the priority and general groups would receive 7 kg and 3 kg of foodgrain per person per month respectively at subsidized prices. Plan B suggests doing away with the priority-general distinction.  It classifies the population on the basis of 2 categories: included and excluded.  Those entitled to benefits under the included category will receive a uniform entitlement of 5 kg per person per month. Coverage of population Experts have suggested that the Bill will extend entitlements to roughly 64% of the total population.  Under the Bill, the central government is responsible for determining the percentage of people in each state who will be entitled to benefits under priority and general groups. Plan B suggests extending benefits to 67% of the total population (33% excluded), up from 64% in the Bill.  The Ministry has outlined two options to figure out the number of people in each state that should be included within this 67%.  The first option envisages a uniform exclusion of 33% in each state irrespective of their poverty level.  The second option envisages exclusion of 33% of the national population, which would imply a different proportion excluded in each state depending on their level of prosperity. The Ministry has worked out a criterion to determine the proportion of the population to be included in each state.  The criterion is pegged to a monthly per capita expenditure of Rs 1,215 in rural areas and Rs 1,502 in urban areas based on the 2009-10 NSSO survey. Thus, persons spending less than Rs 40 in rural areas and Rs 50 in urban areas per day will be entitled to foodgrains under the alternative being considered now. Financial estimates Newspaper reports have indicated that the revised proposal will add Rs 7,000 to Rs 10,000 crore per year to the current food subsidy estimate of Rs 1.1 lakh crore.  According to some experts, the total cost of the Bill could range anywhere between Rs 2 lakh crore to Rs 3.5 lakh crore (see here and here).

Law prohibiting sexual offences against children sparks controversy over age of consent

The Protection of Children against Sexual Offences Act, 2012 was passed by both Houses of Parliament on May 22.  The legislation defines various types of sexual offences against children and provides penalties for such acts. According to a report commissioned by the Ministry of Women and Child Development in 2007, about 53% of the children interviewed reported some form of sexual abuse.  The law has been viewed as a welcome step by most activists since it is gender neutral (both male and female children are covered), it clearly defines the offences and includes some child friendly procedures for reporting, recording of evidence, investigation and trial of offences.  However, the issue of age of consent has generated some controversy.  Age of consent refers to the age at which a person is considered to be capable of legally giving informed consent to sexual acts with another person. Before this law was passed, the age of consent was considered to be 16 years (except if the woman was married to the accused, in which case it may be lower).  Section 375 of the Indian Penal Code, 1860 states that any sexual intercourse with a woman who is below the age of 16 years is considered to be “rape”.  The consent of the person is irrelevant. This post provides a snapshot of the key provisions of the Act, the debate surrounding the controversial provision and a comparison of the related law in other countries. Key provisions of the Act

  • The Act defines a child as any person below the age of 18 years and provides protection to all children from offences such as sexual assault, penetrative sexual assault and sexual harassment.  It also penalises a person for using a child for pornographic purposes.
  • The Act states that a person commits “sexual assault” if he touches the vagina, penis, anus or breast of a child with sexual intent without penetration.
  • The Act treats an offence as “aggravated” if it is committed by a person in a position of authority or trust such as a member of the security forces, a police officer or a public servant.
  • It specifies penalties for the offences and provides a mechanism for reporting and trial of such offences.

Debate over the age of consent After introduction, the Bill was referred to the Standing Committee on Human Resource Development.  The Committee submitted its report on December 21, 2011 (see here and here for PRS Bill Summary and  Standing Committee Summary, respectively).  Taking into account the recommendations of the Standing Committee, the Parliament decided to amend certain provisions of the Bill before passing it. The Bill stated that if a person is accused of “sexual assault” or “penetrative sexual assault” of a child between 16 and 18 years of age, it would be considered whether the consent of the child was taken by the accused.   This provision was deleted from the Bill that was passed. The Bill (as passed) states that any person below the age of 18 years shall be considered a child.  It prohibits a person from engaging in any type of sexual activity with a child.  However, the implication of this law is not clear in cases where both parties are below 18 years (see here and here for debate on the Bill in Rajya Sabha and Lok Sabha). The increase in the age of consent to 18 years sparked a debate among experts and activists. Proponents of increasing the age of consent argued that if a victim is between 16 and 18 years of age, the focus of a sexual assault case would be on proving whether he or she consented to the act or not.  The entire trial process including cross-examination of the victim would focus on the conduct of the victim rather than that of the accused (see here and here). Opponents of increasing the age of consent pointed out that since this Act criminalises any sexual activity with persons under the age of 18 years (even if consensual), the police may misuse it to harass young couples or parents may use this law to control older children’s sexual behaviour (see here and here).  International comparison In most countries, the age of consent varies between 13 and 18 years.  The table below lists the age of consent and the corresponding law in some selected countries. 

Countries

Age of consent

Law

US Varies from state to state between 16 and 18 years.  In some states, the difference in age between the two parties is taken into account.  This can vary between 2-4 years. Different state laws
UK 16 years Sexual Offences Act, 2003
Germany 14 years (16 years if the accused is a person responsible for the child’s upbringing, education or care). German Criminal Code
France 15 years French Criminal Code
Sweden 15 years (18 years if the child is the accused person’s offspring or he is responsible for upbringing of the child). Swedish Penal Code
Malaysia 16 years for both males and females. Malaysian Penal Code; Child Act 2001
China No information about consent.  Sex with a girl below 14 years is considered rape.  Sodomy of a child (male or female) below 14 years is an offence. Criminal Law of China, 1997
Canada 16 years Criminal Code of Canada
Brazil 14 years Brazilian Penal Code 2009
Australia Varies between 16 and 17 years among different states and territorial jurisdictions.  In two states, a person may engage in sexual activity with a minor if he is two years older than the child.  In such cases the child has to be at least 10 years old. Australian Criminal laws
India 18 years. Protection of Children Against Sexual Offences Act, 2012

Lapses in the process of drug approval in India

The Parliamentary Standing Committee on Health and Family Welfare tabled a Report in Parliament on May 8, 2012, on the functioning of the Central Drugs Standard Control Organization (CDSCO).  CDSCO is the agency mandated with the regulation of drugs and cosmetics in India.  The Report covers various aspects of drug regulation including organizational structure and strength of CDSCO, approval of new drugs, and banning of drugs, among others. Following the Report, the Minister of Health and Family Welfare has constituted a Committee to look into the procedure for drug regulation.  The Committee is expected to make its submissions within a period of two months. This post focuses on irregularities in the approval of new drugs by CDSCO.  It discusses the regulations relating to drug approval and the Standing Committee's observations on the working of CDSCO. Approval of new drugs Drugs are regulated by the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetic Rules, 1945 [Rules].  The CDSCO, under the Ministry of Health and Family Welfare, is the authority that approves new drugs for manufacture and import.  State Drug Authorities are the licensing authorities for marketing drugs. New Drugs are defined as:

  • drugs that have not been used in the country before,
  • drugs that have been approved by a Licensing Authority but are now being marketed for different purposes, and
  • fixed dose combinations of two or more drugs that have been individually approved before but are proposed to be combined in a fixed ratio that has not been approved.

The Rules require an applicant for a new drug to conduct clinical trials in India to determine the drug’s safety and efficacy.  These trials are necessary for both domestically manufactured and imported drugs.  However, the authority can exempt a drug from the requirement of local and clinical trials in the public interest based on data available in other countries. Observations and recommendations of the Committee The Committee found that a total of 31 new drugs were approved between January 2008 and October 2010 without conducting clinical trials on Indian patients.  The Report mentioned that drug manufacturers, CDSCO officials and medical experts colluded to approve drugs in violation of laws.  Following are some of the Report’s findings:

  • Under the Rules, the Drugs Controller General (India) (DCGI), the head of CDSCO, can clear sites of clinical trials after ensuring that major ethnic groups are enrolled in these trials to have a truly representative sample.  This rule was violated by the DCGI when sites for clinical trials were approved without ensuring diversity.  The Committee recommended that the DCGI approve sites for trials only if they cover patients from major ethnic backgrounds.
  •  The Report found that certain actions by experts were in violation of the Code of Ethics of the Medical Council of India.  A review of expert opinions revealed that several medical expert recommendations had been given as personal opinions rather than on the basis of scientific data.  Additionally, many expert opinions were written by what the Report calls ‘the invisible hands’ of drug manufacturers.  The Committee recommended that CDSCO formulate a clear set of written guidelines on the selection process of experts with emphasis on expertise in the area of drugs.
  •  The Rules ban the import and marketing of any drug whose use is prohibited in the country of origin.  CDSCO violated this rule by approving certain Fixed Dose Combination drugs for clinical trials without considering the drugs’ regulatory status in their respective country of origin.  Drugs such as Deanxit and Buclizine, which have been prohibited for sale and use in their countries of origin, Denmark and Belgium, respectively, were approved for clinical trials.  The Committee recommended an inquiry into the unlawful approval of these drugs.
  • The Rules require animal studies to be conducted for approval of a drug for use by women of reproductive age.  CDSCO violated this rule in approving Letrozole for treating female infertility.  Globally the drug has only been used as an anti-cancer drug for use among post-menopausal women.  The drug has not been permitted for use among women of reproductive age because of side effects.  The Committee recommended that responsibility be fixed for unlawfully approving Letrozole.
  •  Rules require Post-marketing Safety Update Reports (PSURs) on drugs to be submitted to CDSCO.  PSURs are used to collect information on adverse effects of drugs on Indian patients as a result of ethnic differences.  When asked by the Committee to furnish PSURs on 42 randomly selected new drugs, the Ministry was able to submit PSURs for only 8 drugs.  The Report contended that this action reflected a poor follow-up of side effects on Indian patients.  The Committee recommended that manufacturers of new drugs be warned about suspension of marketing approval unless they comply with mandatory rules on PSURs.

 

Changes recommended by the Standing Committee on Land Acquisition and Rehabilitation and Resettlement Bill, 2011

(Co-authored by Sana Gangwani and Pallavi Bedi) The Standing Committee Report on the Land Acquisition and R&R Bill, 2011 was tabled in the Lok Sabha on May 17, 2012. The major changes to the Bill recommended by the Committee include:

  • Land may not be acquired for use by private companies and PPPs.
  • The role of the local governments should be expanded and made more participatory in the acquisition and R&R process. The role of Gram Sabhas should not be limited to consultation, but their consent should be obtained at different stages.
  • The Clause giving wide discretion to the government in notifying any project as infrastructure project should be deleted.
  • Threshold for R&R provisions should be fixed by the states and not the central government since sale and purchase of land is a state subject in the Constitution (Item 18, State List).
  • There should be a restriction on the acquisition of agricultural land.  The limit on the acquisition of such land should be fixed by the state governments.

For a detailed comparison of the Bill with the recommendations of the Standing Committee see here.

General Anti Avoidance Rule (GAAR)

The issue of the General Anti Avoidance Rule (GAAR) has dominated the news recently and there are fears that GAAR will discourage foreign investment in India.  However, tax avoidance can hinder public finance objectives and it is in this context GAAR was introduced in this year’s Budget.  Last week, the Finance Minister pushed back the implementation of GAAR by a year. What is GAAR? GAAR was first introduced in the Direct Taxes Code Bill 2010.  The original proposal gave the Commissioner of Income Tax the authority to declare any arrangement or transaction by a taxpayer as ‘impermissible’ if he believed the main purpose of the arrangement was to obtain a tax benefit.  The 2012-13 Finance Bill (Bill), that was passed by Parliament yesterday, defines ‘impermissible avoidance arrangements’ as an arrangement that satisfies one of four tests.  Under these tests, an agreement would be an ‘impermissible avoidance arrangement’ if it  (i) creates rights and obligations not normally created between parties dealing at arm’s length, (ii) results in misuse or abuse of provisions of tax laws, (iii) is carried out in a way not normally employed for bona fide purpose or (iv) lacks commercial substance.

As per the Bill, arrangements which lack commercial substance could involve round trip financing, an accommodating party and elements that have the effect of offsetting or cancelling each other.  A transaction that disguises the value, location, source, ownership or control of funds would also be deemed to lack commercial substance. The Bill as introduced also presumed that obtaining a tax benefit was the main purpose of an arrangement unless the taxpayer could prove otherwise. Why? GAAR was introduced to address tax avoidance and ensure that those in different tax brackets are taxed the correct amount.  In many instances of tax avoidance, arrangements may take place with the sole intention of gaining a tax advantage while complying with the law.  This is when the doctrine of ‘substance over form’ may apply.  ‘Substance over form’ is where real intention of parties and the purpose of an arrangement is taken into account rather than just the nomenclature of the arrangement.  Many countries, like Canada and South Africa, have codified the doctrine of ‘substance over form’ through a GAAR – type ruling. Issues with GAARcommon criticism of GAAR is that it provides discretion and authority to the tax administration which can be misused.  The Standing Committee responded to GAAR in their report on the Direct Taxes Code Bill in March, 2012. They suggested that the provisions should ensure that taxpayers entering genuinely valid arrangements are not harassed.  They recommended that the onus should be on tax authorities, not the taxpayer, to prove tax avoidance.  In addition, the committee suggested an independent body to act as the approving panel to ensure impartiality.  They also recommended that the assessing officer be designated in the code to reduce harassment and unwarranted litigation. GAAR Amendments On May 8, 2012 the Finance Minister amended the GAAR provisions following the Standing Committee’s recommendations.  The main change was to delay the implementation of GAAR by a year to “provide more time to both taxpayers and the tax administration to address all related issues”.  GAAR will now apply on income earned in 2013-14 and thereafter.  In addition, the Finance Minister removed the burden upon the taxpayer to prove that the main purpose of an alleged impermissible arrangement was not to obtain tax benefit.  These amendments were approved with the passing of the Bill. In his speech, the Finance Minister stated that a Committee had also been formed under the Chairmanship of the Director General of Income Tax.  The Committee will suggest rules, guidelines and safeguards for implementation of GAAR.  The Committee is expected to submit its recommendations by May 31, 2012 after holding discussions with various stakeholders in the debate.