ETHICAL AND LEGAL ISSUES RELATED TO CLINICAL TRIALS: A STUDY IN THE LIGHT OF COVID VACCINE MANDATE
Volume 4Issue II Year 2025
Dr. LEKSHMI G R
Assistant Professor, Government Law College, Ernakulam
lekshmiglc@gmail.com
Table of Contents
Dr. LEKSHMI G R
Assistant Professor, Government Law College, Ernakulam
lekshmiglc@gmail.com
Clinical Trial-World Health Organization-Helsinki-Covid Vaccine Mandate-Legal Framework and Judicial Response
1. (Feb.2,2025,8:00AM)
2. Variant B.1.1.7.
3. Variant B.1.351.
4. (Jan.22,2025,2:00PM),https://www.who.int/groups/technical-advisory-group-on-covid-19-vaccine-composition-(tag-co-vac).
5. (Jan.2,2025), http://www.who.int.Interim Statement during the spread of Omicron SARS CoV 2 Variant from the WHO Technical Advisory Group on Covid 19 Vaccine Composition TAG CO VAC.
6. (Feb.2,2025)
7. Helsinki Declaration on the Principle of Privacy and Confidentiality : 24. Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information.
8. Helsinki Declaration on Principle of Research Registration and Publication and Dissemination of Results: 36. Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. All parties should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results must be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest must be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.
9. (Feb.3,2025,5:00PM)
10. Ibid.
11. (Apr.23,2025)
12. See Second Schedule to Drugs and Cosmetics Rules, Schedule 11. The Subject Expert Committee is a statutory body, under the Central Drugs Standards Control Organisation under Rule 100 of the 2019 Rules, comprising group of experts with specialisation in relevant fields.
13. The Drugs and Cosmetics Act, 1940 is a central Act which regulates the import, manufacture and distribution of drugs in India ensuring quality standards.
14. As per r.2 (w) of Drugs and Cosmetics Rules,1945, new drug means,— (i) a drug, including active pharmaceutical ingredient or phytopharrmaceutical drug, which has not been used in the country to any significant extent, except in accordance with the provisions of the Act and the rules made thereunder, as per conditions specified in the labelling thereof and has not been approved as safe and efficacious by the Central Licencing Authority with respect to its claims; or (ii) a drug approved by the Central Licencing Authority for certain claims and proposed to be marketed with modified or new claims including indication, route of administration, dosage and dosage form; or (iii) a fixed dose combination of two or more drugs, approved separately for certain claims and proposed to be combined for the first time in a fixed ratio, or where the ratio of ingredients in an approved combination is proposed to be changed with certain claims including indication, route of administration, dosage and dosage form; or (iv) a modified or sustained release form of a drug or novel drug delivery system of any drug approved by the Central Licencing Authority; or (v) a vaccine, recombinant Deoxyribonucleic Acid (r-DNA) derived product, living modified organism, monoclonal anti-body, [cell or stem cell derived product], gene therapeutic product or xenografts, intended to be used as drug; Explanation : The drugs, other than drugs referred to in sub-clauses (iv) and (v), shall continue to be new drugs for a period of four years from the date of their permission granted by the Central Licensing Authority.
15. Data is maintained in the Clinical Trials Registry-India. Trial registration in the CTRI has been made mandatory by the Drugs Controller General (India) .
16. Pharmacovigilance refers to the monitoring systems that are put into place to oversee the safety of new pharmaceutical entities
17. Drugs and Cosmetics Act, 1940,No.23,Acts of Parliament,1940(India),Chapter IV from S.16 to S.33-A.
18. Ibid at S.26 B
19. Id. Chapter 111 and 1V
20. Drugs and Cosmetics Rules,1945.See Rules 122-A,122-B,122-D,122-DA,122-DAA and 122-E.Schedule Y deals with requirements and guidelines for permission to import and/or manufacture of new drugs for sale or to undertake clinical trials.
21. Id. Chemical and pharmaceutical information is prescribed in Item 2 of Appendix 1,human clinical pharmacology data in Items 5,6 and 7 of Appendix 1 and as stated in Schedule Y 1.(iv).
22. Id.See Items 1 to 5 and 9 of Appendix 1.
23. See Appendix to Drugs and Cosmetics Act,1940.
24. Ibid.
25. See Drugs and Cosmetics Rules under Drugs and Cosmetics Act,1940 and the Drugs and Cosmetics Rules The trial shall be initiated only after permission has been granted by the Licensing Authority under r.21(b).
26. Schedule Y r.2(1).
27. Schedule Y r.2(4).
28. Appendix to Drugs and Cosmetics Act.
29. The Disaster Management Act,2005,No.53,Acts of Parliament,2005(India),S. 6(2)(i) allows the Union government to take measures to prevent disasters. National Disaster Management Authority has been constituted to oversee disaster management activities.
30. Order passed by the Government of NCT of Delhi on 08.10.2021 (ii) a directive issued by the Government of Madhya Pradesh on 08.11.2021 (iii) an order passed by the Government of Maharashtra dated 27.11.2021 (iv) an order issued by the Government of Tamil Nadu dated 18.11.2021 are some examples of executive restrictions on Covid.
31. Common Cause (A Registered Society) v. Union of India 2018(5) S.C.C.1(India); K.S. Puttaswamy v. Union of India(2017)10S.C.C.1(India).
32. It deals with procedure to be followed by the governing body in exercise of the powers and discharge of its function.
33. Abhilas,Kundavaram Paul Prabhakar etal., Impact of Prior Vaccination with CoviShieldTM and Covaxin on mortality among symptomatic Covid 19 patients during the second wave of the pandemic in South India during April and May 2021:A cohort study, 40 Vaccine, 2107-2113(2022).
34. Guidelines issued by Indian Council for Medical Research.
35. These two recourses have been rarely employed by the governing bodies.
36. The Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act 1940 is the authority responsible for enforcing Good Clinical Practices guidelines in India.
37. (Jan.23,2025)https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf . )
38. Further Rule 25 of the 2019 Rules, as per the Drugs and Cosmetics Act, 1940, provides that the clinical trial shall be performed in confirmity with set clinical trial protocol and as per Good Clinical Practices guidelines.
39. It provides that all research involving human subjects should be conducted in accordance with the ethical principles contained in the Declaration of Helsinki and should respect three basic principles, namely justice, respect for persons, beneficence and non-maleficence as defined by “Ethical Guidelines for Biomedical Research on Human Subjects” laid down by the Indian Council of Medical Research.
40. Functions of Ethics Committee as per Chapter 111,r.11, Drugs and Clinical Trial Rules 2019.
41. The Drugs and Clinical Trial Rules,2019. According to Rule 19 of the 2019 Rules, clinical trial of a new drug or investigational new drug shall be conducted in conformity with the permission granted by the Central Licensing Authority and after following the protocol agreed by the Ethics Committee for clinical trial, registered as per the provisions of Rule 8. Rule 19(2) of the 2019 Rules provides that the general principles and practices as specified in the First Schedule are to be followed.
42. National Guidelines for Ethics Committees Reviewing Bio Medical and Health Research Involving Human Participants issued in 2020. (Jan.3.2025)
43. ICMR National Ethical Guidelines 2017,S.12.
44. (Apr.6,2025).https://www.indiascienceandtechnology.gov.in/sites/default/files/file-uploads/guidelineregulations/1527507675_ICMR_Ethical_Guidelines_2017.pdf
45. Ibid.
46. These basic principles have been further expanded into 12 general principles such as: i. Principle of Essentiality ii. Principle of Professional Competence iii. Principle of Voluntariness iv. Principle of Maximization of Benefit v. Principle of Non-exploitation vi. Principle of Institutional Arrangements vii. Principle of Social Responsibility viii. Principle of Transparency & Accountability ix. Principle of Ensuring Privacy & Confidentiality x. Principle of Totality of Responsibility xi. Principle of Risk Minimization xii. Principle of Environmental Protection.
47. Supra n.42.
48. Less than Minimal Possibility of Risk or Harm, Minimal Risk Possibility, More than Minimal Risk Possibility or Harm.
49. New research directly related to COVID-19,Ongoing non-COVID research , New non-COVID researches.
50. (Feb.12,2025)
51. (Jan 20,2025)
52. COVAXIN, Indias indigenous vaccine and COVISHIELD, manufactured by Serum Institute of India in collaboration with AstraZeneca/Oxford University.
53. He was a member of the National Technical Advisory Group on Immunization.
54. Academy of Nutrition Improvement v Union of India (2011)8S.C.C. 211(India).
55. Academy of Nutrition Improvement v. Union of India (2011) 8S.C.C.274(India); Shri Sitaram Sugar Company Ltd. v. Union of India (1990) 3S.C.C. 223(India).See also Henning Jacobson v. Commonwealth of Massachusetts 197 US 11(1905), Zucht v. King 260 US 17(1922).
56. Distribution of Essential Supplies and Services During Pandemic, In re (2021)7S.C.C.772(India).
57. 1998(8) S.C.C. 296(India).
58. Association of Medical Super Speciality Aspirants and Residents v. Union of India 2019(8) S.C.C.607(India).
59. 2017(10) S.C.C. 1(India).
60. Second Schedule to the 2019 Rules under Drugs and Cosmetic Act,1940.
61. As regards COVAXIN, application for approval to manufacture the vaccine was made by Bharat Biotech on 23.04.2020.
62. Further, a similar feature of reporting of all Adverse Event Following Immunisation by the vaccinator was made available on the Co-WIN portal. District Immunisation Officers were given the facility to report Adverse Event Following Immunisation cases in alignment with the Pharmacovigilance Programme of India under Indian Pharmacopoeia Commission.
63. (Jan,2,2025)https://www.researchgate.net/figure/Rapid-development-of-COVID-19-vaccine-as-compared-to-traditional-vaccine-development_fig1_349873795
64. 2022 S.C.C OnLineS.C 533(India).
65.
References
1. (Feb.2,2025,8:00AM)
2. Variant B.1.1.7.
3. Variant B.1.351.
4. (Jan.22,2025,2:00PM),https://www.who.int/groups/technical-advisory-group-on-covid-19-vaccine-composition-(tag-co-vac).
5. (Jan.2,2025), http://www.who.int.Interim Statement during the spread of Omicron SARS CoV 2 Variant from the WHO Technical Advisory Group on Covid 19 Vaccine Composition TAG CO VAC.
6. (Feb.2,2025)
7. Helsinki Declaration on the Principle of Privacy and Confidentiality : 24. Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information.
8. Helsinki Declaration on Principle of Research Registration and Publication and Dissemination of Results: 36. Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. All parties should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results must be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest must be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.
9. (Feb.3,2025,5:00PM)
10. Ibid.
11. (Apr.23,2025)
12. See Second Schedule to Drugs and Cosmetics Rules, Schedule 11. The Subject Expert Committee is a statutory body, under the Central Drugs Standards Control Organisation under Rule 100 of the 2019 Rules, comprising group of experts with specialisation in relevant fields.
13. The Drugs and Cosmetics Act, 1940 is a central Act which regulates the import, manufacture and distribution of drugs in India ensuring quality standards.
14. As per r.2 (w) of Drugs and Cosmetics Rules,1945, new drug means,— (i) a drug, including active pharmaceutical ingredient or phytopharrmaceutical drug, which has not been used in the country to any significant extent, except in accordance with the provisions of the Act and the rules made thereunder, as per conditions specified in the labelling thereof and has not been approved as safe and efficacious by the Central Licencing Authority with respect to its claims; or (ii) a drug approved by the Central Licencing Authority for certain claims and proposed to be marketed with modified or new claims including indication, route of administration, dosage and dosage form; or (iii) a fixed dose combination of two or more drugs, approved separately for certain claims and proposed to be combined for the first time in a fixed ratio, or where the ratio of ingredients in an approved combination is proposed to be changed with certain claims including indication, route of administration, dosage and dosage form; or (iv) a modified or sustained release form of a drug or novel drug delivery system of any drug approved by the Central Licencing Authority; or (v) a vaccine, recombinant Deoxyribonucleic Acid (r-DNA) derived product, living modified organism, monoclonal anti-body, [cell or stem cell derived product], gene therapeutic product or xenografts, intended to be used as drug; Explanation : The drugs, other than drugs referred to in sub-clauses (iv) and (v), shall continue to be new drugs for a period of four years from the date of their permission granted by the Central Licensing Authority.
15. Data is maintained in the Clinical Trials Registry-India. Trial registration in the CTRI has been made mandatory by the Drugs Controller General (India) .
16. Pharmacovigilance refers to the monitoring systems that are put into place to oversee the safety of new pharmaceutical entities
17. Drugs and Cosmetics Act, 1940,No.23,Acts of Parliament,1940(India),Chapter IV from S.16 to S.33-A.
18. Ibid at S.26 B
19. Id. Chapter 111 and 1V
20. Drugs and Cosmetics Rules,1945.See Rules 122-A,122-B,122-D,122-DA,122-DAA and 122-E.Schedule Y deals with requirements and guidelines for permission to import and/or manufacture of new drugs for sale or to undertake clinical trials.
21. Id. Chemical and pharmaceutical information is prescribed in Item 2 of Appendix 1,human clinical pharmacology data in Items 5,6 and 7 of Appendix 1 and as stated in Schedule Y 1.(iv).
22. Id.See Items 1 to 5 and 9 of Appendix 1.
23. See Appendix to Drugs and Cosmetics Act,1940.
24. Ibid.
25. See Drugs and Cosmetics Rules under Drugs and Cosmetics Act,1940 and the Drugs and Cosmetics Rules The trial shall be initiated only after permission has been granted by the Licensing Authority under r.21(b).
26. Schedule Y r.2(1).
27. Schedule Y r.2(4).
28. Appendix to Drugs and Cosmetics Act.
29. The Disaster Management Act,2005,No.53,Acts of Parliament,2005(India),S. 6(2)(i) allows the Union government to take measures to prevent disasters. National Disaster Management Authority has been constituted to oversee disaster management activities.
30. Order passed by the Government of NCT of Delhi on 08.10.2021 (ii) a directive issued by the Government of Madhya Pradesh on 08.11.2021 (iii) an order passed by the Government of Maharashtra dated 27.11.2021 (iv) an order issued by the Government of Tamil Nadu dated 18.11.2021 are some examples of executive restrictions on Covid.
31. Common Cause (A Registered Society) v. Union of India 2018(5) S.C.C.1(India); K.S. Puttaswamy v. Union of India(2017)10S.C.C.1(India).
32. It deals with procedure to be followed by the governing body in exercise of the powers and discharge of its function.
33. Abhilas,Kundavaram Paul Prabhakar etal., Impact of Prior Vaccination with CoviShieldTM and Covaxin on mortality among symptomatic Covid 19 patients during the second wave of the pandemic in South India during April and May 2021:A cohort study, 40 Vaccine, 2107-2113(2022).
34. Guidelines issued by Indian Council for Medical Research.
35. These two recourses have been rarely employed by the governing bodies.
36. The Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act 1940 is the authority responsible for enforcing Good Clinical Practices guidelines in India.
37. (Jan.23,2025)https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf . )
38. Further Rule 25 of the 2019 Rules, as per the Drugs and Cosmetics Act, 1940, provides that the clinical trial shall be performed in confirmity with set clinical trial protocol and as per Good Clinical Practices guidelines.
39. It provides that all research involving human subjects should be conducted in accordance with the ethical principles contained in the Declaration of Helsinki and should respect three basic principles, namely justice, respect for persons, beneficence and non-maleficence as defined by “Ethical Guidelines for Biomedical Research on Human Subjects” laid down by the Indian Council of Medical Research.
40. Functions of Ethics Committee as per Chapter 111,r.11, Drugs and Clinical Trial Rules 2019.
41. The Drugs and Clinical Trial Rules,2019. According to Rule 19 of the 2019 Rules, clinical trial of a new drug or investigational new drug shall be conducted in conformity with the permission granted by the Central Licensing Authority and after following the protocol agreed by the Ethics Committee for clinical trial, registered as per the provisions of Rule 8. Rule 19(2) of the 2019 Rules provides that the general principles and practices as specified in the First Schedule are to be followed.
42. National Guidelines for Ethics Committees Reviewing Bio Medical and Health Research Involving Human Participants issued in 2020. (Jan.3.2025)
43. ICMR National Ethical Guidelines 2017,S.12.
44. (Apr.6,2025).https://www.indiascienceandtechnology.gov.in/sites/default/files/file-uploads/guidelineregulations/1527507675_ICMR_Ethical_Guidelines_2017.pdf
45. Ibid.
46. These basic principles have been further expanded into 12 general principles such as: i. Principle of Essentiality ii. Principle of Professional Competence iii. Principle of Voluntariness iv. Principle of Maximization of Benefit v. Principle of Non-exploitation vi. Principle of Institutional Arrangements vii. Principle of Social Responsibility viii. Principle of Transparency & Accountability ix. Principle of Ensuring Privacy & Confidentiality x. Principle of Totality of Responsibility xi. Principle of Risk Minimization xii. Principle of Environmental Protection.
47. Supra n.42.
48. Less than Minimal Possibility of Risk or Harm, Minimal Risk Possibility, More than Minimal Risk Possibility or Harm.
49. New research directly related to COVID-19,Ongoing non-COVID research , New non-COVID researches.
50. (Feb.12,2025)
51. (Jan 20,2025)
52. COVAXIN, Indias indigenous vaccine and COVISHIELD, manufactured by Serum Institute of India in collaboration with AstraZeneca/Oxford University.
53. He was a member of the National Technical Advisory Group on Immunization.
54. Academy of Nutrition Improvement v Union of India (2011)8S.C.C. 211(India).
55. Academy of Nutrition Improvement v. Union of India (2011) 8S.C.C.274(India); Shri Sitaram Sugar Company Ltd. v. Union of India (1990) 3S.C.C. 223(India).See also Henning Jacobson v. Commonwealth of Massachusetts 197 US 11(1905), Zucht v. King 260 US 17(1922).
56. Distribution of Essential Supplies and Services During Pandemic, In re (2021)7S.C.C.772(India).
57. 1998(8) S.C.C. 296(India).
58. Association of Medical Super Speciality Aspirants and Residents v. Union of India 2019(8) S.C.C.607(India).
59. 2017(10) S.C.C. 1(India).
60. Second Schedule to the 2019 Rules under Drugs and Cosmetic Act,1940.
61. As regards COVAXIN, application for approval to manufacture the vaccine was made by Bharat Biotech on 23.04.2020.
62. Further, a similar feature of reporting of all Adverse Event Following Immunisation by the vaccinator was made available on the Co-WIN portal. District Immunisation Officers were given the facility to report Adverse Event Following Immunisation cases in alignment with the Pharmacovigilance Programme of India under Indian Pharmacopoeia Commission.
63. (Jan,2,2025)https://www.researchgate.net/figure/Rapid-development-of-COVID-19-vaccine-as-compared-to-traditional-vaccine-development_fig1_349873795
64. 2022 S.C.C OnLineS.C 533(India).
65.