Vidhi Aid

Submissions on the draft New Drugs and Clinical Trials Rules, 2018

 

Vidhi responded to a call for public comments on the Draft New Drugs and Clinical Trials Rules, 2018. We have recommended changes to these Rules to better protect the rights and safety of clinical trial volunteers, ensure harmonisation with international standards where needed, ensure the integrity of the drug regulatory process and improve enforcement.

Download the complete submissions on the draft New Drugs and Clinical Trials Rules, 2018

The Law isn't Straight: A Queer Person's Guide to Accessing Rights

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Despite progressive judgments of the Supreme Court in NALSA v Union of India (2014) and Puttaswamy v Union of India (2017), the overall legal regime for queer persons in India remains severely lacking. Recognising the slow nature of legal change and the need for alternate strategies in the meantime, this manual is an attempt to help queer persons navigate their daily lives under this flawed regime. The manual deals with identity documents, violence, education, health and personal finances. 

While this manual seeks to be a useful starting tool for LGBTQ+ persons in their attempt to access the legal system, it does not reflect the diverse experiences different persons have while trying to access their rights. We would be grateful for your feedback and hope to update the manual to make it as useful as possible.

Download the full manual titled The Law isn't Straight: A Queer Person's Guide to Accessing Rights

Audio guides on how to change your name and gender on your basic identity documents are available in Hindi, Malayalam, Kannada, Bengali and Marathi

UPDATE

1. The Supreme Court of India, in its landmark judgement, Navtej Johar vs. Union of India, has struck down section 377 to the extent that it criminalises sexual intercourse between consenting adults of the same gender. At present section 377 can be used in cases of rape and bestiality. 

2. The application form for PAN cards now has the option of “transgender” person.

Comments on the draft Uttar Pradesh Self-Financed Independent Schools (Regulation of Fees) Bill, 2017

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Vidhi responded to a call for public comments on the draft Uttar Pradesh Self-Financed Independent Schools (Regulation of Fees) Bill, 2017. Vidhi’s submissions critiqued the Bill based on inconsistency with existing legal frameworks and Supreme Court decisions, as well as pari materia legislations on fee regulation across different States. The submissions recommend several changes to the existing Bill based on the above analysis.

Download Vidhi’s submissions on the draft Uttar Pradesh Self-Financed Independent Schools (Regulation of Fees) Bill, 2017 here.

Submissions to the Standing Committee on the No Detention Policy

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The Department-Related Parliamentary Standing Committee on Human Resource Development recently invited comments on the Right of Children to Free and Compulsory Education (Second Amendment) Bill, 2017. An amendment is sought to be made to Section 16 of the Right of Children to Free and Compulsory Education Act, 2009, which prohibits schools from holding back or expelling any student till they have completed an elementary level of education i.e. grade 8. Through this amendment, this prohibition on holding back and expelling (popularly known as the No Detention Policy) will be partially done away with.

Currently, students up to grade 8 are evaluated through a system of ‘Continuous and Comprehensive Evaluation’ and cannot be made to repeat a grade. If this section is amended, schools will be required to conduct exams for students in grades 5 and 8. If they fail this exam, they will be given additional instruction and required to give a re-examination within two months of the results being declared. If they fail this re-examination, states must frame rules/guidelines to prescribe whether they will be held back in the same grade. However, they will still be prohibited from expelling students.

Based on a survey of available data on educational indicators (including drop-out rates, retention rates, transition rates and learning outcomes), we found that there is no clear evidence to show that the No Detention Policy has caused a deterioration in education outcomes. Any such deterioration may be attributed to a variety of factors, including high student-teacher ratios and insufficient school infrastructure. We therefore recommend that no amendment should be made to the provision unless rigorous evidence is available on the impact of the No Detention Policy. If such an amendment is to be made, it must be based on the research findings of the National and State Advisory Councils. Further, it must contain sufficient safeguards: a sunset clause, a prohibition on the use of terms such as ‘pass’ and ‘fail’, and must be accompanied by detailed detention regulations.

Download Submissions to The Parliamentary Standing Committee on Human Resource Development

Organ Transplant Law: Assessing compatibility with the right to health

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With instances of commercial dealings in human organs being discovered on a regular basis, it has become clear that there is a need to re-examine the law regulating organ transplants. In this report, we therefore analyse the Transplantation of Human Organs and Tissues Act, 1994, and the degree to which it has met its objectives. Using information obtained from different authorities under the Act, we assess its content and functioning against a set of 'right to health' indicators. 
Based on this, we recommend changes to the law, which include the harmonisation of the definition of 'brain death' across different laws and amending the Act to ensure that victims of human trafficking are not treated as offenders.

Download full report- Organ Transplant Law: Assessing compatibility with the right to health

Environmental Clearances and Monitoring in India: Report Card for the Ministry of Environment, Forest and Climate Change

One of the biggest challenges facing environmental law in India today is a weak implementation framework. Although laws, rules and regulations abound, compliance and enforcement are poor, with grave consequences for the environment and the rule of law. This is exacerbated by a lack of transparency-information about violations is hard to come by, making it more difficult to hold authorities accountable. 

This Report Card for the Ministry of Environment, Forest and Climate Change (MoEFCC) is an attempt to make more information of this kind available. We have analysed over 550 environmental clearances granted by the MoEFCC to assess the performance of its duties under the Environment Impact Assessment Notification against three parameters-speed, quality of appraisal and post-clearance monitoring. Our findings demonstrate that although the time taken for granting environmental clearances has significantly reduced, there are still serious deficiencies in the quality of appraisal and a neglect of monitoring duties by the MoEFCC. 

Environmental Clearances and Monitoring in India: Download the Full Report

Regulation of Private Schools in India

The last decade has witnessed growth in both the number of private schools in India and the proportion of children enrolled in them. The proportion of private schools rose from 19.49% in 2007-08 to 22.74% in 2014-15.  Around the same period, the share of enrolment of children between the ages of 6-14 in private schools rose from 19.3% to 30.8%.

The regulation of private schools in India remains an understudied topic, with little literature on the theory and practice of regulation, or on comparisons of different regulatory policies. The Right to Education Act, 2009, lays down norms and standards for private schools, including infrastructure norms, minimum teacher qualifications, pupil-teacher ratios and curricular standards. However, some aspects of private school operations continue to be governed almost exclusively by State laws, such as fee fixation and inspection of schools. Others are now governed by a combination of the RTE Act and State laws, such as recognition, hiring of staff and curriculum.

In this report, Vidhi has examined the existing regulatory framework for private schools in India, with a view to identifying common challenges and areas in need of reform. We have studied regulations for private schools in five States and proposed a normative framework for evaluating them. Based on the conclusions drawn from the evaluation, as well as existing international, constitutional and national legal obligations on private schools, we propose a roadmap for drafting State-level model regulations for private schools.

Regulation of Private Schools in India- Download Full Report

Grievance Redressal Mechanisms in Public Healthcare Establishments

In India, the right to health is not a statutory right and the National Health Policy, 2017 does not endorse a rights-based approach. It states that policy reform in healthcare should be through incremental infrastructure development, and suggests the setting up of medical tribunals to address disputes on standards of care, price of services, negligence and unfair practices.  However, setting up yet another tribunal may not be the best solution.

In this report, Vidhi has done an empirical analysis of complaints filed against public healthcare establishments to get a sense of the kinds of complaints made, the forums utilised and the remedies granted. Further, we have also analysed the existing legal and policy framework applicable to public health establishments in relation to grievance redressal. Though multiple avenues like the Consumer Protection Act, the Clinical Establishments Act, NHRC and writs are available for complaining against health right violations, each has its own shortcomings.

A lesser developed and a lesser used avenue is the internal grievance redressal mechanism in public healthcare establishments, and the focus of this report is to revamp this mechanism, to ensure that all kinds of complaints are resolved effectively. This report is a step towards informing the debate on enforcement of the right to health in public health establishment through internal grievance redressal mechanisms.

Grievance Redressal Mechanisms in Public Healthcare Establishments-Download Full Report

Cleaning Delhi's Air: Implementation Action Plan

The Vidhi Centre for Legal Policy has recently published an Implementation Action Plan to tackle Delhi’s air pollution. Using the IIT Kanpur’s Comprehensive Study on Air Pollution and Green House Gases (GHGs) in Delhi as its basis, this Action Plan suggests measures to control pollution from five major sources of air pollution in Delhi—emissions from coal-fired power plants, vehicular emissions, burning of crop residue, emissions from ready-mix concrete batching plants and construction sites. Although the Central Pollution Control Board has already drawn up a Graded Response Action Plan (‘Graded Action Plan'), its main thrust remains the stringent enforcement of existing standards/rules/bans. In this Action Plan, we attempt to go beyond the routine recommendation to strengthen monitoring and compliance and identify a range of actions—legislative, executive, policy, financial—that are needed to give effect to the many solutions that have already been proposed to combat Delhi’s air quality crisis.

Cleaning Delhi's Air: Implementation Action Plan- Download Full Report

Analysis of the Medical Treatment of Terminally ill Patients Bill 2016

In a petition currently before the Supreme Court to determine the legality of advance directives, the government has assured the Court that it will pass a legislation regulating the withdrawal of life saving treatment from terminally ill patients. Following this, and based on the recommendations of the Law Commission of India, the government solicited comments from the public on a draft Medical Treatment of Terminally-Ill Patients (Protection of Patients and Medical Practitioners) Bill.

To help inform the debate on this issue, we will be publishing a series of reports on end-of-life medical care and decision making. In the first report in the series, we examine this Bill, assessing its provisions against a set of principles that ought to govern such situations. This includes the right to die with dignity, patient autonomy and the ability to exercise it, the primacy of the patients best interests, communication and consultation between the medical practitioner, the patient, and the patient’s kin as well as minimising judicial intervention in end-of-life decision making.

Based on our analysis, we suggest a way forward for current efforts at drafting an effective and rights-respecting legislation, that also takes into account the ability of doctors to make medically sound decisions in the best interests of the patient.

Download the full report on the MTTP Bill

Submissions to the Ministry of Health and Family Welfare on the Medical Devices Rules, 2016

As part of its larger efforts to overhaul the regulatory framework for drugs and medical devices in the country, comments were invited by the Ministry of Health and Family Welfare on the Medical Devices Rules, 2016. These Rules introduce a process and conditions for the grant of licenses to import, manufacture and sell medical devices. Medical devices have been categorised based on the severity of risk associated with their use. Based on this categorisation, authorities have been set up to ensure that medical devices are compliant with specified quality standards and to audit manufacturing sites. The Rules also specify labelling requirements, impose a duty on license holders to recall defective medical devices and introduce safeguards in the process of clinical investigation and performance evaluation of medical devices.

In these comments, we note that the executive lacks the power to introduce certain provisions in these Rules. These provisions, usually in the form of primary obligations, would require legislative backing. For the effective implementation of these Rules, we recommend that a regulator (similar to the Food Safety and Standards Authority of India) with greater powers of enforcement be introduced. Finally, we provide a clause-by-clause critique of the Rules and recommend changes for the removal of ambiguity with respect to the scope and applicability of these Rules, the harmonisation of provisions with respect to medical management and financial compensation with Schedule Y of the Drugs and Cosmetics Rules, 1945 as well as ensuring a smoother transition from the provisions currently applicable to medical devices to these comprehensive Rules.

Download the submissions on the Medical Devices Rules

Submissions to the Ministry of Human Resource Development on the New Education Policy

The Ministry of Human Resources Development recently released its inputs for the draft National Policy on Education, 2016 for public deliberation. The proposed policy is in itself significant considering the dramatic changes that the political economy of the Indian state has seen since the previous education policy of 1986.

As the National Policy on Education is almost a generational document, it ought to take note of the changing role of the state in providing public goods, including education. Private sector’s presence and influence in elementary education would only expand. The complexity of the sector requires greater decision-making at local level, involving stakeholders, communities and local governments. The state must continue to have an important role in laying down policy, a framework curriculum, and principles and values to hold institutions and personnel responsible. The delegation of power must be both democratic and efficient. 

In this light, it is recommended that:

  • The state undertakes decentralisation of educational decision-making in a planned and consistent manner with the view to encourage local and community initiatives and cultivate stakeholder participation.
  • The state adopts facilitative principle-based regulations instead of rule-based. It would make the regulatory ecosystem adaptable and responsive to changes, harnesses local initiatives and strike an appropriate balance between autonomy and accountability
  • For this, the state should set out a dedicated plan of action with capacity-building both at the level of institutions as well as personnel implementing the policy vision.

Download the submissions to the MHRD on the New Education Policy

Submissions on amending the Hazardous Chemicals Rules, 1989 and the Chemical Accidents Rules, 1996

The Ministry of Environment, Forest and Climate Change recently invited comments from the public on amending the Manufacture, Storage and Import of Hazardous Chemicals Rules, 1989 and the Chemical Accidents (Emergency Planning, Preparedness and Response) Rules, 1996.

Vidhi submitted a short set of comments focusing on the need to harmonise the Indian regulatory framework with the United Nations Globally Harmonised System of Classification and Labelling of Chemicals. The comments highlight the need for more specific criteria for classifying chemicals, more detailed labelling requirements and safety data sheets, differentiating responsibilities across different users' groups of chemicals, and conducting periodic reviews of the risks presented by hazardous substances. 

Download the submissions on the Hazardous Chemicals Rules and Chemical Accidents Rules

Submissions to the Ministry of Home Affairs on the Geospatial Information Regulation Bill, 2016

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Vidhi recently submitted comments to the Ministry of Home Affairs on the Geospatial Information Regulation Bill 2016. The Bill places stringent restrictions on the acquisition, dissemination and publication of geospatial information. 

We contend that the Bill places serious obstructions in the path of independent environmental research and informed, effective public participation in environmental decision-making. Geographic information systems freely available on online portals as well as information collected by ground truthing are valuable tools for environmental researchers and activists. Under the Bill, the use of this kind of information will require a prior licence from a Security Vetting Authority proposed to be constituted. 

The right to access information and to participate in environmental decision-making are integral components of the right to environment upheld by the Supreme Court under Article 21 of the Indian Constitution, and also affirmed by the High Courts, the National Green Tribunal and the Central Information Commission. 

We also argue that the Bill places unreasonable restrictions on the right to freedom of speech and expression, protected under Article 19(1)(a) of the Indian Constitution. The provisions of the Bill are disproportionate to the objective they intend to serve i.e. the protection of India's security interests. These interests are adequately protected by existing government policies on the use of geospatial information, all of which adopt nuanced and collaborative approaches to the sharing of such information. 

We recommend that the Bill, in its current form, be withdrawn, or at the very least, that the use of geospatial information for the purposes of participation in environmental decision-making be exempted from its provisions. 

Download the full submissions to the Ministry of Home Affairs on the Geospatial Information Regulation Bill, 2016

Suggestions on Proposed Amendments to the Pre-Conception and Pre-Natal Diagnostic Techniques Act, 1994

The Public Health and Environmental Justice Initiative responded to a call for public comments by the Expert Committee constituted to examine the proposed amendments to the Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994. 

Vidhi's suggestions focus primarily on the legal inconsistencies and drafting errors in the proposed amendments, which mainly relate to the duties and powers of the authority under the act and the penalties for contravention of the act. Through our suggestions, we attempt to move a step closer to fine-tuning the proposed amendments.

Download the suggestions on Proposed Amendments to the PCPNDT Act

Right to Education and Minority Rights

Pursuant to its commitment to universalise elementary education, the Government of India enacted the 86th Amendment to the Constitution. With this, Article 21A was introduced, making free and compulsory elementary education a fundamental right for all children within the age group of 6-14 years. Following this, the Parliament in 2009 passed the Right of Children to Free and Compulsory Education Act (RTE Act), detailing the content and enforcement of this right. The RTE Act mandates unaided schools to reserve 25% of their seats for children from weaker sections and disadvantaged groups. It also prescribes regulations regarding minimum acceptable infrastructure, staff and facilities that all schools should compulsorily provide. The broad canvas that the RTE Act seeks to cover leads to the question: does the Act take away the autonomy of religious and linguistic minorities to establish and administer educational institutions of their choice that the Constitution safeguards under Article 30?

This paper answers this question in the negative. We argue that a key rationale for including the rights of religious and linguistic minorities in the Constitution is to ensure preservation of their culture and the creation of an educated minority citizenry in the country. The RTE Act is not only in alignment with this purpose, but also furthers it by making elementary education of minimum acceptable quality available to all children including those from minority communities. For this, we look at the Constituent Assembly Debates and judgments of the Supreme Court which interpret the meaning and scope of Article 30 and Article 21A. We believe that questions of ‘minority character’ of an educational institution as well as the ‘welfare of minorities’ should be answered keeping in mind the purpose of both these provisions.

We contend that this Act has nothing in it to suggest that it would ‘annihilate’ the minority character of these institutions and would thus be an impediment to the welfare of minorities. The case is fairly straightforward when we take into account provisions which are largely regulatory in nature and are meant to make schools conducive spaces for learning. At the same time, some minority schools are also aided by the state. This gives greater legitimacy for state regulation. This principle has been upheld by various judicial pronouncements. Unaided minority schools, however, should be considered distinctly from aided schools. They enjoy relatively higher autonomy in their administration and day to day functioning. Yet, considering that the purpose of constitutional provisions on minority rights and the right to education could be harmonised, this distinction is not critical to our argument. The entire RTE Act, including the 25% quota provided in it, we argue, should apply to all minority schools. This reservation is different from those argued about in cases of higher education as it cuts across religious, linguistic and other identity groups. It should not unsettle the current demography of minority schools to the extent that it endangers their minority character. On the contrary, provision of free and compulsory elementary education should be regarded as a minimum core obligation of the state that seeks to capitalise on its demographic dividend in an increasingly knowledge driven economy.

Download the full report Right to Education and Minority Rights