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

Ü' ITEM NO.7 COURT NO.2 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 UNION OF INDIA & ORS. Respondent(s) (With appln(s) for directions and intervention and extension of time and impleadment and office report) WITH W.P(C) NO. 79 of 2012 (With appln.(s) for directions, permission and impleadment and permission to file additional documents and office report) W.P(C) NO. 91 of 2004 Date: 10/03/2014 These Petitions were called on for hearing today. CORAM : HON'BLE MR. JUSTICE R.M. LODHA HON'BLE MR. JUSTICE KURIAN JOSEPH For Petitioner(s) WP 33/2012 Mr. Sanjay Parikh, Adv. Ms. Manita Saxena, Adv. Ms. Bushra Parvesh,Adv. Ms. N. Vidya, Adv. Mr. A.N. Singh, Adv. Mr. Sapam Biswajit Meitei, Adv. Mr. Pukhrambam Ramesh Kumar, Adv. WP 79/2012 Mr. Colin Gonsalves, Sr. Adv Ms. Reshma Jaffari, Adv. Ms. Jyoti Mendiratta, Adv. WP 91/2004 Mr. Ankur Saigal, Adv. Mr. Mahesh Agarwal, Adv. Mr. Rishi Agrawala, Adv. Mr. E.C. Agrawala, Adv. Ms. Parul Shukla, Adv. For Respondent(s) Mr. Siddharth Luthra, A.S.G. Mr. S.P. Singh, Sr. Adv. Dr. Ashok Dhamija, Adv. Mr. M.P. Gupta, Adv. Mr. Aditya Singhla, Adv. Ms. Sushma Suri, Adv. Ms. Supriya Juneja, Adv. Mr. A.K. Kaul, Adv. Ms. Supriya Jain, Adv. Ms. Manita Verma, Adv. Mr. S.N. Terdal, Adv. Ms. Asha G. Nair, Adv. Mr. D.S. Mahra, Adv.

NCT of Delhi Mr. Siddharth Luthra, ASG Ms. Asha G. Nair, Adv. Ms. Supriya Juneja, Adv. Ms. Anandana Nanda, Adv. Mr. A.K. Kaul, Adv. Mr. Shadman Ali, Adv. Mr. D.S. Mahra, Adv. Madhya Pradesh Mr. Arvind Verma, Sr. Adv. Mr. C.D. Singh, Adv. Ms. Aditi Kochhar, Adv. Ms. Damini Hajela, Adv. Gujarat Ms. Hemantika Wahi, Adv. Ms. Preeti Bhardwaj, Adv. Uttarakhand Mr. Ashutosh Kr. Sharma, Adv. Ms. Rachana Srivastava, Adv. Mr. Utkarsh Sharma, Adv. Ms. Pratisha Chaturvedi, Adv. Jharkhand Mr. Anil Kr. Jha, Adv. Arunachal Pradesh Mr. Anil Shrivastav, Adv. Mr. Ritu Raj Biswas, Adv. Assam Ms. Krishna Sarma, A.A.G. Mr. Avijit Roy, Adv. for M/s. Corporate Law Group Goa Mr. Pratap Venogopal, Adv. Ms. Meenakshi Chauhan, Adv. Mr. Gaurav Nair, Adv. for M/s. K.J. John & Co. Himachal Pradesh Mr. Suryanarayan Singh, A.A.G. Ms. Pragati Neekhra, Adv. Ms. Heena Singh, Adv. Andhra Pradesh Ms. C.K. Sucharita, Adv. Manipur Mr. Sapam Biswajit Meitei, Adv. Mr. Khwairakpam Nobin Singh, Adv. Punjab Mr. Kuldip Singh, Adv. Mizoram Mr. Pragyan Pradip Sharma, Adv. Mr. Heshu Kayina, Adv. Mr. P.V. Yogeswaran, Adv. Tripura Mr. Gopal Singh,Adv. Mr. Chandan Kumar, Adv. Mr. Ritu Raj Biswas, Adv. Chhattisgarh Mr. Apoorv Kurp, Adv. Mr. A.P. Mayee, Adv. Mr. Charudatta Mahindrakar, Adv. Puducherry Mr. V.G. Pragasam, Adv. Mr. S.J. Aristotle,Adv. Mr. Prabu Ramasubramanian, Adv. Meghalya Mr. Ranjan Mukherjee, Adv.

Mr. S. Sanyal, Av. Jammu & Kashmir Mr. Ashok Mathur, Adv. Haryana Mr. Manjit Singh, A.A.G. Ms. Nupur Chaudhary, Adv. Mr. Tarjit Singh, Adv. Mr. Kamal Mohan Gupta, Adv. Bihar Mr. Abhinav Mukerji, Adv. Ms. Bihu sharma, Adv. Ms. Purnima Krishna, Adv. Uttar Pradesh Mr. Irshad Ahmad, A.A.G. Mr. Abhisth Kumar, Adv. Mr. Vaibhav Yadav, Adv. Rajasthan Mr. S.S. Shamshery, A.A.G. Mr. Sandeep Singh, Adv. Ms. Ruchi Kohli, Adv. Tamil Nadu Mr. R. Rakesh Sharma, Adv. Mr. B. Balaji, Adv. Mr. Selvinraja, Adv. Kerala Mr. M.T. George, Adv. Nagaland Ms. K. Enatoli Sema, Adv. Mr. Amit Kumar Singh, Adv. Sikkim Mr. A. Mariarputham, Adv. Gen. Mrs. Aruna Mathur, Adv. Mr. Yusuf Khan, Adv. for M/s Arputham, Aruna & Co. West Bengal Mr. Anip Sachthey, Adv. Mr. Soumya Chakraborty, Adv. Maharashtra Mr. Aniruddha P. Mayee, Adv. Ms. Rajshri Dubey, Adv. UT-Chandigarh Mr. Gopal Singh, Adv. Ms. Vimla Sinha, Adv. UT-Andaman & Nicobar Mr. Balasubramaniam, Adv. Administration Mr. K.V. Jagdishvaran, Adv. Ms. G. Indira, Adv. Odisha Ms. Shalini Chandra, Adv. Ms. Swati Chandra, Adv. Mr. Sudhanshu Saran, Adv. Ms. Ayusha Kumar, Adv. Ms. Madhu Sikri, Adv. Ms. Anitha Shenoy, Adv. Mr. Jagjit Singh Chhabra, Adv. NHRC Ms. Shobha, Adv. Ms. Jyoti Rana, Adv. MCI Mr. Gaurav Sharma, Adv.

Mr. Sumeet Bhatia, Adv

UPON hearing counsel the Court made the following O R D E R

From the rejoinder affidavit filed on 06.03.2014 by the petitioners in Writ Petition (Civil) No. 33 of 2012, inter alia, as regards approval of 475 trials including New Clinical Entities (NCEs) from January 2005 to June 2012 the following situation emerges :

506 subjects had serious adverse effects arising from clinical trials that occurred from January 2005 to June 2012.

It transpires that for these subjects neither any compensation has been provided nor paid.

Mr. Siddharth Luthra, learned Additional Solicitor General for the Union of India, prays for time to seek instructions in this regard and to state on affidavit about the quantum of compensation and the time within which such compensation shall be paid to these subjects.

The table at page 28 of the rejoinder affidavit indicates the total number of deaths and so also the total number of subjects who had serious adverse effects in the clinical trials. The table refers to approval of 475 New Clinical Entities (NCEs) from January 2005 to June 2012. As to whether or not the new regime has been successful in reducing deaths and serious adverse effects in clinical trials needs to be evaluated. We, accordingly, direct the Union of India to give information with regard to deaths and the number of subjects who received serious adverse effects in clinical trials due to approval of NCEs for the period from 1st of July 2012 to 31st of December, 2012 and from 1st of January, 2013 to 31st of December, 2013. The necessary information shall be furnished by Union of India on affidavit within four weeks.

Mr. Sanjay Parekh, learned counsel for the petitioners in Writ Petition (Civil) No. 33 of 2012 has raised the grievance that three parameters, namely, (i) assessment of risk versus benefit to the patients, (ii) innovation vis-a-vis existing therapeutic option and (iii) unmet medical need in the country, indicated by this Court in the order dated 21.10.2013, have not been followed in letter and spirit in granting approval to 157 NCEs.

Mr. Siddharth Luthra, learned Additional Solicitor General, submits that in the affidavit which is to be filed by the Union of India, this aspect too shall be responded.

List the matters on April 21, 2014.

Interlocutory Application No. 13 of 2014 in Writ Petition (Civil) No. 33 of 2012

Issue notice returnable on April 21, 2014. Union of India may respond to the application in the meanwhile.

Interlocutory Application Nos. 11-12 of 2013 in Writ Petition (Civil) No. 33 of 2012

We record and accept the statements of Mr. Siddharth Luthra, learned Additional Solicitor General for the Union of India and learned counsel for the I.C.M.R. that reply to these applications shall be filed within four weeks.

List these interlocutory applications along with the main matter.

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