Anand Rai& Ors. vs. Madhya Pradesh And Ors. Public Health And Family Welfare Department Secretary

v# ITEM NO.8 COURT NO.6 SECTION PIL S U P R E M E C O U R T O F I N D I A RECORD OF PROCEEDINGS WRIT PETITION (CIVIL) NO(s). 33 OF 2012 SWASTHYA ADHIKAR MANCH, INDORE & ANR. Petitioner(s) VERSUS MIN.OF HEALTH & FAMILY WELF. & ORS. Respondent(s) (With appln(s) for directions and I.A. 4 - appln.(s) for directions and office report) WITH W.P(C) NO. 79 of 2012 (With appln.(s) for directions and office report) Date: 08/10/2012 These Petitions were called on for hearing today. CORAM : HON'BLE MR. JUSTICE R.M. LODHA HON'BLE MR. JUSTICE ANIL R. DAVE For Petitioner(s) Mr. Sanjay Parikh, Adv. Mr. Pukhrambam Ramesh Kumar,Adv. Mr. Bashra, Adv. Mr. Colin Gonsalves, Sr. Adv. Ms. Jayashree Satpute, Adv. Ms. Jyoti Mendiratta, Adv. For Respondent(s) Mr. Siddharth Luthra, A.S.G. Mr. Ashok K. Srivastava, Adv. Mr. R.K. Verma, Adv. Ms. Sushma Suri, Adv. Mr. D.S. Mahra ,Adv Mr. Uday U. Lalit, Sr. Adv. Ms. Manisha Singh, Adv. Mr. Riku Sarma, Adv. Mr. Navnit Kumar , Adv. Mr. Ranjit Chaddha, Adv. For M/S Corporate Law Group Mr. Dushyant Dave, Sr. Adv. Ms. Vibha Datta Makhija, Adv. Mr. Amit Kumar ,Adv Mr. Atul Kumar, Adv. Mr. Ashish Kumar, Adv. Ms. Avijit Mani Tripathy, Adv. UPON hearing counsel the Court made the following O R D E R 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. 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:-

• i) The number of experimental New Clinical Entities (NCEs) approved for clinical trials by the Drug Controller General of India (DCGI) from January 1, 2005 to June 30, 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.

The above information shall be supplied within four weeks.

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.

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.

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.

|(Rajesh Dham) | |(Renu Diwan) | |Court Master | |Court Master |