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SUPREME COURT OF INDIA
R.M. Lodha, Anil R. Dave, JJ.
Swasthya Adhikar Manch, Indore & Anr. - Petitioners
Versus
Ministry of Health and Family Welfare & Ors. - Respondents
Writ Petition (Civil) No. 33 of 2012
Decided On : 08-10-2012
Clinical Trials - Malpractices - The court directed the Government and non-Government entities to provide information on the number of approved clinical trials, deaths and serious side effects suffered by subjects, and details of compensation paid.
Fact of the Case:
The matter alleged malpractices in clinical trials by various entities. The court directed the Government and non-Government entities to provide specific information related to clinical trials.
Finding of the Court:
The court found it necessary to gather detailed information on approved clinical trials, deaths, serious side effects, and compensation paid to subjects. It directed the concerned authorities to provide this information within four weeks.
Issues: The issues revolved around the alleged malpractices in clinical trials and the need for transparency and accountability in providing information related to clinical trials.
Ratio Decidendi: The court's decision was influenced by the need for transparency and accountability in clinical trials, as well as the protection of subjects' rights and well-being.
Final Decision: The court directed the concerned authorities to provide specific information related to clinical trials within four weeks and issued notices to the Chief Secretaries of all states, except Madhya Pradesh.
ORDER :
Writ Petition (Civil) No. 33 of 2012
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 Director General of Health Services, Government of India, give information on the following points:-
(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.
5. Dasti, in addition to the ordinary process, is permitted.
6. It will be open to the petitioners to serve the various State Governments through their Standing Counsel as well.
7. Amended cause title shall be filed by the advocate on record of the petitioners within two weeks.
8. List the matter after eight weeks.
W.P(C) NO. 79 of 2012
List this Writ Petition along with Writ Petition (Civil) No. 33 of 2012.
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