- Bookmark
- Share
- CaseIQ
Swasthya Adhikar Manch, Indore And Another v. Ministry Of Health And Family Welfare And Others
Factual and Procedural Background
The writ petitions allege widespread malpractices in clinical trials conducted by government, non-government, and independent investigators in India. Concerned about reported deaths, serious adverse events, and inadequate compensation to trial subjects, the petitioners sought judicial intervention. Between 8 October 2012 and 16 December 2013 the Supreme Court of India (Benches presided over by R.M. Lodha, J., with Anil R. Dave, J.; Madan B. Lokur, J.; and Shiva Kirti Singh, J. at various stages) passed a series of interim orders:
- Directed the Union Ministry of Health and Family Welfare or the Central Drugs Standard Control Organisation (CDSCO) to furnish data on all new clinical entities (NCEs) approved since 1 January 2005, including deaths, serious side-effects, and compensation paid (Order dated 8-10-2012).
- Issued notices to all State/Union Territory governments and required their affidavits on regulatory measures.
- Rejected a non-compliant affidavit from a Deputy Drugs Controller and demanded a compliant affidavit from the Secretary, Health or Director-General of Health Services (Order dated 3-1-2013).
- Recorded the Additional Solicitor General’s undertaking that, until further orders, all NCE trials would strictly follow Schedule Y of the Drugs and Cosmetics Rules, 1945 under the direct supervision of the Health Secretary.
- Took note of subsequent governmental steps—three amending notifications (GSR 53(E), 63(E), 72(E)) and a proposed Drugs and Cosmetics (Amendment) Bill, 2013—aimed at tightening trial regulation (Order dated 26-7-2013).
- Required nationwide consultations; the Health Secretary convened a meeting of State Chief/Health Secretaries on 13-8-2013 and filed an additional affidavit summarising State concerns and expert recommendations (Order dated 30-9-2013).
- Examined 162 clinical trials already approved by the Drug Controller General of India (DCGI) and ordered that 157 approvals granted before 3-1-2013 be re-evaluated by a Technical Committee and an Apex Committee; imposed an audio-visual informed-consent requirement for five post-3-1-2013 approvals (Order dated 21-10-2013).
- Allowed further time for the Union Government and petitioners to exchange additional affidavits (Order dated 16-12-2013).
Legal Issues Presented
- Whether the existing statutory and regulatory framework sufficiently safeguards trial subjects against death or serious adverse events and ensures adequate compensation.
- Whether approvals granted by the DCGI for clinical trials—especially those issued prior to the Court’s 3-1-2013 directions—require additional scrutiny by higher expert bodies.
- Whether nationwide, consultative, and transparent mechanisms must be instituted to monitor, record, and regulate clinical trials, including mandatory audio-visual recording of informed consent.
Arguments of the Parties
Union of India / Additional Solicitor General
- Filed affidavits detailing steps already taken: notifications GSR 53(E), 63(E), 72(E); introduction of the Drugs and Cosmetics (Amendment) Bill, 2013; constitution of New Drug Advisory Committees (NDACs), a Technical Committee, and an Apex Committee.
- Assured the Court that, pending further orders, all NCE trials would follow Schedule Y under direct ministerial supervision.
- Undertook to have the 157 pre-2013 approvals reviewed by the Technical and Apex Committees and to institute audio-visual recording of informed consent for the remaining five trials.
Petitioners
- Contended that post-3-1-2013 measures and proposed amendments do not fully address unresolved issues regarding monitoring of NCE trials, protection of participants, and transparency in compensation.
- Sought more comprehensive data and independent oversight mechanisms.
State Governments
- Several States, led by Madhya Pradesh, asserted that they had not been adequately consulted and emphasised the need for a robust national regulatory system rather than confining trials to government hospitals.
National Human Rights Commission
- Expressed willingness to offer specific suggestions to strengthen the regulatory framework.
Table of Precedents Cited
No precedents were cited in the provided opinion.
Court's Reasoning and Analysis
The Court adopted a supervisory, incremental approach rather than issuing a single dispositive judgment:
- Information-gathering: Recognising the complexity and public-health impact, the Court first required comprehensive empirical data from the Union Government to understand the scale of deaths, adverse events, and compensation.
- Compliance enforcement: When the initial affidavit was found inadequate, the Court rejected it and insisted on compliance by top health officials, signalling the seriousness of the inquiry.
- Interim safeguards: To prevent ongoing harm, the Court mandated that all new NCE trials adhere strictly to Schedule Y and be overseen directly by the Health Secretary.
- Regulatory reform impetus: By taking note of newly issued notifications and proposed legislation, the Court encouraged systemic reform while retaining judicial oversight.
- Multi-tier review: Observing that 157 trial approvals lacked post-January-2013 scrutiny, the Court required evaluation by Technical and Apex Committees, focusing on risk-benefit analysis, therapeutic need, and patient safety.
- Informed consent integrity: The Court highlighted the necessity of audio-visual recording to document consent, balancing transparency with confidentiality.
- Stakeholder participation: Directions to consult State governments, NHRC, NGOs, and industry intervenors ensured that regulatory reforms would be comprehensive and participatory.
Holding and Implications
INTERIM DIRECTIONS ISSUED; MATTER ADJOURNED FOR FURTHER MONITORING
Direct effects:
- Union Government must file detailed, compliant affidavits and re-evaluate 157 previously approved trials through expert committees.
- Clinical trials of new chemical entities cannot proceed unless conducted under Schedule Y, supervised by the Health Secretary, and—where applicable—supported by audio-visual consent documentation.
- States and other stakeholders are engaged in the formulation of a strengthened regulatory framework.
Broader implications: While no final precedent was set, the Court’s continuing oversight has accelerated statutory amendments, prompted the creation of expert oversight bodies, and introduced transparency measures (e.g., mandatory AV recording of consent) that may influence future clinical-trial governance in India.
Order dated 8-10-2012
(Before R.M Lodha and Anil R. Dave, JJ.)
Writ Petition (Civil) No. 33 of 2012
1. This matter alleges malpractices in clinical trials by government and non-government as well as by independent investigators.
2. Having regard to the averments made in the writ petition and Interlocutory Application No. 4 of 2012, we are of the view that for proper consideration of the matter it shall be appropriate if the Secretary, Ministry of Health and Family Welfare, Government of India and/or Central Drugs Standard Control Organisation through the Director General of Health Services, Government of India, give information on the following points:
(i) The number of experimental new clinical entities (NCEs) approved for clinical trials by the Drug Controller General of India (DCGI) from 1-1-2005 to 30-6-2012,
(ii) whether deaths were suffered by subjects of clinical trials. If yes, the number of deaths,
(iii) whether serious side effects were suffered by the subjects of clinical trials. If yes, the number of such subjects and the nature of side effects, and
(iv) the details of compensation paid to the subjects who suffered side effects or paid to the family of the subjects who suffered death.
3. The above information shall be supplied within four weeks.
4. In addition to the above, we further direct that notice be issued to the Chief Secretaries of all the States, except the State of Madhya Pradesh which is already served and represented. Dasti, in addition to the ordinary process, is permitted.
5. It will be open to the petitioners to serve the various State Governments through their Standing Counsel as well. Amended cause-title shall be filed by the Advocate-on-Record of the petitioners within two weeks.
6. List the matter after eight weeks.
WP (C) No. 79 of 2012
7. List this writ petition along with Writ Petition (Civil) No. 33 of 2012.
Order dated 3-1-2013
(Before R.M Lodha and Anil R. Dave, JJ.)
8. In pursuance of our order dated 8-10-2012, either the Secretary, Ministry of Health and Family Welfare, Government of India or Central Drugs Standard Control Organisation through the Director General of Health Services, Government of India ought to have filed an affidavit on diverse aspects noted in that order. However, we find that an additional affidavit has been filed by the Deputy Drugs Controller (India) in the Central Drugs Standard Control Organisation. This affidavit is hardly in compliance with the order dated 8-10-2012 and deserves to be ignored. We order accordingly.
9. We now direct that an affidavit in compliance with the order dated 8-10-2012 shall be filed within four weeks from today either by the Secretary, Ministry of Health and Family Welfare, Government of India or Central Drugs Standard Control Organisation through the Director General of Health Services, Government of India. In the meanwhile, we direct the Chief Secretaries of the States other than the States of Madhya Pradesh, Manipur, Union Territories of Dadar and Nagar Haveli and Daman and Diu to file their written responses on affidavit within four weeks from today. It will be the responsibility of Ms Sushma Suri, Advocate-on-Record for Respondent 1 Union of India to inform the Chief Secretaries of the States/Union Territories of the above order without any delay.
10. In the meanwhile, we record and accept the statement of Mr Sidharth Luthra, learned Additional Solicitor General that until further order by this Court, clinical trials of new chemical entity shall be conducted strictly in accord with the procedure prescribed in Schedule Y of the Drugs and Cosmetics Rules, 1945 under the direct supervision of the Secretary, Ministry of Health and Family Welfare, Government of India.
11. List both the matters after four weeks.
IAs Nos. 6 and 7 of 2012
12. Issue notice on IAs Nos. 6 and 7 of 2012 returnable along with the main matter.
Order dated 26-7-2013
(Before R.M Lodha and Madan B. Lokur, JJ.)
13. Pursuant to the order dated 8-10-2012, an affidavit has been filed by the Secretary, Ministry of Health and Family Welfare, Government of India (for short “Secretary, Ministry of Health”).
14. Mr Sidharth Luthra, learned Additional Solicitor General submits that certain measures have been taken to strengthen the regulation of clinical trials that include amendment in GSR 53(E) dated 30-1-2013, GSR 63(E) dated 1-2-2013 and GSR 72(E) dated 8-2-2013. GSR 53(E) specifies procedure to analyse the reports of serious adverse events including deaths occurring during clinical trials and procedures for payment of compensation in case of trial related injury or death. GSR 63(E) specifies various conditions for conduct of clinical trials, authority for conducting clinical trial inspections and actions in case of non-compliance. GSR 72(E) provides for requirements and guidelines for registration of Ethics Committee. By amendment, it is proposed that no Ethics Committee can review and approve any clinical trial protocol unless it is registered with the Central Drugs Standard Control Organisation and that in case of non-compliance, the registration can be suspended/cancelled.
15. The learned Additional Solicitor General also informs us that the Drugs and Cosmetics (Amendment) Bill, 2013 has been approved by the Government. The Bill has a separate chapter containing strict penal provisions relating to payment of compensation, Ethics Committee, etc. Certain other measures, which have been taken to strengthen regulation of clinical trials, were also orally stated by the learned Additional Solicitor General.
16. However, Mr Sanjay Parikh, learned counsel for the petitioners submits that the measures, which have been taken after 3-1-2013 as noted above, and the proposed measures do not answer many issues particularly, with regard to the clinical trials in respect of new chemical entities and so also the controlling and monitoring measures.
17. Ms Shobha, learned counsel for the National Human Rights Commission (for short “the Commission”) submits that the Commission has specific suggestions to offer that may help strengthening regulation of clinical trials.
18. Ms Vibha Dutta Makhija, learned counsel for the State of Madhya Pradesh submits that no consultation with regard to the measures that are necessary for strengthening regulation of clinical trials has taken place with the State Government. The State Government is directly concerned with the matter. As a matter of fact, the stand of the State of Madhya Pradesh, as stated by Ms Vibha Dutta Makhija, is the stand of almost all the States/Union Territories.
19. Having regard to the above, the learned Additional Solicitor General submits that the Secretary, Ministry of Health shall convene the meeting of the Chief Secretaries/Health Secretaries of the State Governments and the Administrators of the Union Territories to discuss all the facets and aspects concerning the legal framework for strengthening the regulation of clinical trials and other incidental matters.
20. We accept the statement of the learned Additional Solicitor General and expect that a meeting for the purposes, as noted above, shall be convened by the Secretary, Ministry of Health expeditiously and positively within four weeks from today. The petitioners, National Human Rights Commission, NGOs/bodies and proposed intervenors may also submit their suggestions to the Secretary, Ministry of Health in respect of regulation and monitoring of clinical trials within two weeks from today.
21. Further affidavit, in compliance with this order, shall be filed by the Secretary, Ministry of Health within six weeks from today. The copy of such affidavit shall be given to the counsel for the petitioners, counsel for the State Governments/Union Territories, the Commission and proposed intervenors.
22. For further consideration, list the matter on 24-9-2013. IAs Nos. 8 and 9 shall be considered on the next date.
Order dated 30-9-2013
(Before R.M Lodha and Shiva Kirti Singh, JJ.)
23. On 26-7-2013, Mr Sidharth Luthra, learned Additional Solicitor General submitted that the Secretary, Ministry of Health would convene the meeting of the Chief Secretaries/Health Secretaries of the State Governments and the Administrators of the Union Territories to discuss all the facets and aspects concerning the legal framework for strengthening the regulation of clinical trials and other incidental matters. In view of the above submission, the matter was adjourned and the Secretary, Ministry of Health was directed to file further affidavit.
24. In pursuance of the above order, the additional affidavit has been filed by Mr Arun Kumar Panda, Joint Secretary, Ministry of Health and Family Welfare, Government of India. It is stated in the said affidavit that the Secretary, Ministry of Health and Family Welfare was to file the affidavit but he had to travel overseas due to official work and was to resume work on 20-9-2013 and, therefore, he has filed the additional affidavit.
25. In the additional affidavit, it is stated that on 13-8-2013, the meeting of the Chief Secretaries/Health Secretaries of the State Governments and the Administrators of the Union Territories was convened. In that meeting, diverse issues were deliberated. The States also gave their viewpoints. The views expressed by the States of Madhya Pradesh, Rajasthan, West Bengal, Punjab, Andhra Pradesh, Karnataka and Gujarat have been particularly noted in the additional affidavit. Based on the deliberations, the Secretary, Ministry of Health and Family Welfare summed up and made the following observations:
(a) Even though the concerns have been raised about the conduct of clinical trials in the country, clinical trials are necessary for the development of new drugs in the country. India has the capacity and know-how for drug discovery research. However, there should be a robust system for conducting clinical trials in the country to ensure that trials are conducted in a scientific and ethical manner and in compliance with the regulatory provisions.
(b) Restricting clinical trials to government hospitals alone would not provide a solution. What is required is a robust system for regulating the conduct of clinical trials in the country.
(c) The amount of money paid by the sponsor/companies to the investigator for conduct of clinical trial may act as an inducement to the investigator for conducting clinical trials. Sometimes such inducement may lead to bias in enrolment of subjects in the trials.
(d) Regulatory provisions may be made so that information relating to the amount of money paid by the companies to investigators for conduct of clinical trials is in the knowledge of the regulatory authorities.
(e) There are some concerns on certain clauses of the amendment of the Drugs and Cosmetics Rules made on 30-1-2013 regarding compensation in clinical trials. Some amendments in these clauses may be required.
(f) A Committee constituted under the chairmanship of Dr Ranjit Roy Chaudhury for formulating guidelines on clinical trials and new drugs has submitted its report. The report will be helpful in further strengthening of the regulation of clinical trials in the country.
(g) States' suggestions and views would be considered for further strengthening of the regulation of clinical trial.
26. The additional affidavit also states that suggestions have been received from (i) National Human Rights Commission; (ii) Mr Sanjay Parikh, advocate for the petitioners; (iii) Sama Resource Group for Women and Health, and Locost Standard Therapeutics, and (iv) Indian Society for Clinical Research.
27. It is stated in the additional affidavit that the Government of India had already issued three notifications, (i) GSR 53(E) specifying the procedures for payment of compensation to the subjects of the trial in cases of injury or death; (ii) GSR 63(E) specifying various conditions for conduct and inspection of clinical trials; and (iii) GSR 72(E) specifying the detailed guidelines for registration of Ethics Committee.
28. The Expert Committee under the chairmanship of Prof. Ranjit Roy Chaudhury to prepare guidelines for approval of clinical trials and new drugs in the country was appointed which has submitted its report on 8-8-2013. It is stated that the said report is under consideration.
29. It has been brought to the notice of this Court that the Drugs and Cosmetics (Amendment) Bill, 2013 (for short “the Bill”) has been introduced in Parliament on 29-8-2013. The Bill has a separate chapter containing penal provisions for violation and non-compliance with the provisions relating to the conduct of the clinical trials.
30. It is further stated in the additional affidavit that 577 clinical trial sites have been inspected and notices have been issued to the investigators/sponsors/ethics committees seeking clarifications in 235 cases.
31. In light of the order passed by this Court on 3-1-2013 that until further orders the clinical trials of new chemical entity shall be conducted strictly in accord with the procedure prescribed in Schedule Y of the Drugs and Cosmetics Rules, 1945 under the direct supervision of the Secretary, Ministry of Health and Family Welfare, Government of India, it is stated that a system of supervision of clinical trials of new chemical entities by constituting an Apex Committee and Technical Committee has been put in place.
32. Giving the factual details, it is stated that till 31-8-2013, 12 New Drugs Advisory Committees (NDACs) have met 78 times wherein a total number of 1122 applications for approval of clinical trials, new drugs and fixed dose combinations were evaluated. Out of these 1122 applications, 331 were related to approval of Global Clinical Trial (GCT) including clinical trials of new chemical entities. Of these 331 GCT applications, NDACs after deliberations have recommended for approval of 285 applications. For 46 applications, no recommendation has been made. Out of the above 285 applications so far, DCGI has given approval to conduct clinical trials in 162 cases.
33. With regard to the conduct of clinical trials in respect of 162 cases for which approval has been given by DCGI, we keep the matter for consideration after two weeks to enable the Additional Solicitor General to place on record the report of Prof. Ranjit Roy Chaudhury and also the details of the existing regime which ensures the safety to the subjects of clinical trials and avoid any serious adverse event by such clinical trials.
34. List the matter on 21-10-2013 for consideration of the limited aspect with regard to the conduct of clinical trials in 162 cases as noted above.
35. With regard to the suggestions received by the Central Government from various stakeholders, namely; (i) National Human Rights Commission; (ii) Mr Sanjay Parikh, Advocate for the petitioners; (iii) Sama Resource Group for Women and Health, and Locost Standard Therapeutics; and (iv) Indian Society for Clinical Research and the Central Government's views thereon shall be considered by this Court on 16-12-2013 along with the pending interlocutory applications.
36. For the time being, also issue notice on IAs Nos. 10-12 of 2013.
Order dated 21-10-2013
(Before R.M Lodha and Shiva Kirti Singh, JJ.)
37. This order is in respect of the 162 cases for which approval has been granted by the DCGI. The matter was kept today as on the last date i.e 30-9-2013, Mr Sidharth Luthra, learned Additional Solicitor General, prayed for time to place on record the report of Prof. Ranjit Roy Chaudhury and also the details of the existing regime which ensures the safety of the subjects of clinical trials and avoids any serious adverse event by such clinical trials.
38. In pursuance of the order dated 30-9-2013, an additional affidavit has been tendered by Mr Sidharth Luthra, learned Additional Solicitor General. The same is taken on record.
39. In the additional affidavit filed by Mr Keshav Desiraju, working as Secretary, Ministry of Health and Family Welfare, Government of India, it is, inter alia, stated that since 2011 when the New Drug Advisory Committees (NDACs) were constituted, 78 meetings of these committees have taken place. During these 78 meetings held by NDACs so far, 1122 applications came to be evaluated by these committees. Of 1122 applications, 331 applications were related to approval of Global Clinical Trials (GCT), including clinical trials of new chemical entities (NCEs). Of these 331 GCT applications, NDACs have recommended approval of 285 applications and have not recommended approval for the remaining 46 applications. These 285 applications which have been recommended for approval by NDACs include clinical trials for investigational products relating to Anti-AIDS, Oncology, Cardiology, Neurology, Psychiatry, Metabolism, Endocrinology, etc. NDACs have evaluated carefully pharmacological, toxicological data, clinical data and protocol for the clinical trials including the objective of the study, eligibility criteria of the subjects, treatment, safety and efficacy assessments, etc. Of these 285 applications, the DCGI has given approval to conduct clinical trials in 162 cases till 31-8-2013. Out of 162 approvals, 157 approvals were given by the DCGI before 31-12-2012 which were prior to directions of this Court on 3-1-2013. The DCGI has given the approval to conduct clinical trials in the remaining 5 cases from 1-1-2013 till 31-8-2013 after the approval of the Apex Committee assisted by the Technical Committee.
40. The above facts show that insofar as 5 cases out of 162 cases which were given approval by the DCGI are concerned, these 5 cases had undergone the three-tier screening. First by NDACs, then by the Technical Committee and the Apex Committee and thereafter the approval has been given by the DCGI.
41. However, as regards 157 approvals which were given by the DCGI before 3-1-2013, the learned Additional Solicitor General fairly submits that these cases have not been evaluated by the Technical Committee and the Apex Committee. He submits that the Central Government is agreeable that these 157 cases may be evaluated by the Technical Committee and the Apex Committee as well, as has been done for the 5 cases for which approval was given after 3-1-2013.
42. We accept the statement of the learned Additional Solicitor General. We, however, observe that the Technical Committee and the Apex Committee while evaluating the above 157 cases shall keep in view all relevant aspects of safety and efficacy particularly in terms of assessment of risk versus benefit to the patients, innovation vis-à-vis existing therapeutic option and unmet medical need in the country.
43. In the light of the above, it is not possible to pass any order today with regard to 157 cases and the same will be considered after the reports of the Technical Committee and the Apex Committee in respect of 157 cases are submitted before this Court.
44. As regards 5 cases for which approval has been given by the DCGI after 3-1-2013, we record and accept the statement of Mr Sidharth Luthra, learned Additional Solicitor General that before the clinical trials are conducted, appropriate provision shall be made or administrative direction shall be issued which ensures that audio-visual recording of the informed process concerned of the participants is done and the documentation preserved, adhering to the principles of confidentiality. In other words, the clinical trials in respect of five cases shall commence after proper framework is in place concerning audio-visual recording of the informed process concerned and the preservation of documents while adhering to the principles of confidentiality.
45. List these matters on the date already fixed i.e 16-12-2013.
Interlocutory Application No. 8 of 2013 in Writ Petition (Civil) No. 33 of 2012
46. Interlocutory Application No. 8 of 2013 is allowed. Indian Pharmaceutical Alliance is permitted to intervene in the present case. They will be shown as intervenor in the cause-title. Amended cause-title shall be filed within two weeks.
Order dated 16-12-2013
(Before R.M Lodha and Shiva Kirti Singh, JJ.)
47. Pursuant to the order dated 21-10-2013, additional affidavit has been filed by the Ministry of Health and Family Welfare. Mr Sidharth Luthra, learned Additional Solicitor General submits that further additional affidavit needs to be filed by the Government of India to clarify certain position. Same may be done within three weeks.
48. Mr Sanjay Parikh, learned counsel for the petitioners also prays for time as he would like to respond to the additional affidavit filed by the Government of India on 12-12-2013. Moreover, he submits that certain information is needed from the Government of India for which he submits that an appropriate request will be made to them.
49. In view of the above, we permit the petitioners to file response to the additional affidavit of the Government of India within two weeks therefrom. List both matters on 31-1-2014.
Court Masters
Alert