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:
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:
The Transgender Persons (Protection of Rights) Bill, 2016 has been listed for passage during the ongoing Winter Session of Parliament. This Bill was introduced in the Monsoon Session last year and referred to the Standing Committee on Social Justice and Empowerment, which tabled its report earlier this year. The Bill seeks to recognise transgender persons, and confer anti-discriminatory rights and entitlements related to education, employment, health, and welfare measures. This post explains key provisions of the Bill and certain issues for consideration.
Self-identification and obtaining a Certificate of Identity
The Bill provides for ‘self-perceived gender identity’ i.e. persons can determine their gender on their own. This is in line with a Supreme Court judgement (2014) which held that the self determination of one’s gender is part of the fundamental right to dignity, freedom and personal autonomy guaranteed under the Constitution.[1]
Along with the provision on ‘self-perceived gender identity’, the Bill also provides for a screening process to obtain a Certificate of Identity. This Certificate will certify the person as ‘transgender’. An application for obtaining such a Certificate will be referred to a District Screening Committee which will comprise five members including a medical officer, psychologist or psychiatrist, and a representative of the transgender community.
The Bill therefore allows individuals to self-identify their gender, but at the same time they must also undergo the screening process to get certified, and as a result be identified as a ‘transgender’. In this context, it is unclear how these two provisions of self-perceived gender identity and an external screening process will reconcile with each other. The Standing Committee has also upheld both these processes of self-identification and the external screening process to get certified. In addition, the Committee recommended that the Bill should provide for a mechanism for appeal against the decisions of the District Screening Committee.
Since, the Bill provides certain entitlements to transgender persons for their inclusion and participation in society, it can be argued that there must be an objective criteria to verify the eligibility of these applicants for them to receive benefits targeted for transgender persons.
Status of transgender persons under existing laws
Currently, several criminal and civil laws recognise two categories of gender i.e. man and woman. These include laws such as Indian Penal Code (IPC), 1860, National Rural Employment Guarantee Act, 2005 (NREGA) and Hindu Succession Act, 1956. Now, the Bill seeks to recognise a third gender i.e. ‘transgender’. However, the Bill does not clarify how transgender persons will be treated under certain existing laws.
For example, under NREGA, priority is given to women workers (at least one-third of the beneficiaries are to be women) if they have registered and requested for work under the Act. Similarly, under the Hindu Adoptions and Maintenance Act, 1956, there are different eligibility criteria for males and females to adopt a girl child. In this context, the applicability of such laws to a ‘transgender’ person is not stated in the Bill. The Standing Committee has recommended recognising transgender persons’ right to marriage, partnership, divorce and adoption, as governed by their personal laws or other relevant legislation.
In addition, the penalties for similar offences may also vary because of the application of different laws based on gender identity. For example, under the IPC, sexual offences related to women attract a maximum penalty of life imprisonment, which is higher than that specified for sexual abuse against a transgender person under the Bill (up to two years).[2]
Who is a transgender person?
As per international standards, ‘transgender’ is an umbrella term that includes persons whose sense of gender does not match with the gender assigned to them at birth.[3], [4] For example, a person born as a man may identify with the opposite gender, i.e., as a woman.[5] In addition to this sense of mismatch, the definition provided under the Bill also lists further criteria to be defined as a transgender person. These additional criteria include being (i) ‘neither wholly male nor female’, or (ii) ‘a combination of male or female’, or (iii) ‘neither male nor female’.
The Supreme Court, the Expert Committee of the Ministry of Social Justice and Welfare, and the recent Standing Committee report all define ‘transgender persons’ based on the mismatch only.1,[5],[6] Therefore, the definition provided under the Bill does not clarify if simply proving a mismatch is enough (as is the norm internationally) or whether the additional listed criteria ought to be fulfilled as well.
Offences and penalties
The Bill specifies certain offences which include: (i) compelling transgender persons to beg or do forced or bonded labour, and (ii) physical, sexual, verbal, emotional or economic abuse. These offences will attract imprisonment between six months and two years, in addition to a fine.
The Standing Committee recommended graded punishment for different offences, and suggested that those involving physical and sexual assault should attract higher punishment. It further stated that the Bill must also specifically recognise and provide appropriate penalties for violence faced by transgender persons from officials in educational institutions, healthcare institutions, police stations, etc.
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[1]. National Legal Services Authority vs. Union of India [(2014) 5 SCC 438]; Article 21, Constitution of India.
[2]. Sections 354, 354A, 354B, 375, Indian Penal Code, 1860.
[3]. Guidelines related to Transgender persons, American Psychological Association, https://www.apa.org/practice/guidelines/transgender.pdf.
[4]. Standards of Care, 7th Version, The World Professional Association for Transgender Health, https://s3.amazonaws.com/amo_hub_content/Association140/files/Standards%20of%20Care%20V7%20-%202011%20WPATH%20(2)(1).pdf.
[5]. Report of the Expert Committee on the Issues relating to Transgender Persons, Ministry of Social Justice and Empowerment, January 27, 2014, http://socialjustice.nic.in/writereaddata/UploadFile/Binder2.pdf.
[6]. Report no.43, The Transgender Persons (Protection of Rights) Bill, 2016, Standing Committee on Social Justice and Empowerment, July 21, 2017, http://164.100.47.193/lsscommittee/Social%20Justice%20&%20Empowerment/16_Social_Justice_
