Swasthya Adhikar Manch, Indore Convenor Chinmay Mishra vs. Union Of India Ministry Of Health And Family Welfare Secretary

ø3 ITEM NO.2 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 extension of time and office report) WITH W.P(C) NO. 79 of 2012 (With appln.(s) for directions, impleadment and office report) Date: 03/1/2013 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. Ms. Mamta Saxena,Adv. Mr. Bushra Parvesh,Adv. Mr. A.N. Singh, Adv. Mr. Pukhrambam Ramesh Kumar, Adv. WP 79/2012 Mr. Colin Gonsalves, Sr. Adv. Ms. Jayashree Satpute, Adv. Ms. Jyoti Mendiratta, Adv. For Respondent(s) Mr. Siddharth Luthra, A.S.G. Mr. S.P. Singh, Sr. Adv. Mr. Ashok K. Srivastava, Adv. Mr. R.K. Verma, Adv. Ms. Supriya Juneja, Adv. Mr. Arjun, Adv. for Ms. Sushma Suri, Adv. NCT of Delhi Ms. Asha G. Nair, Adv. for Mr. D.S.Mahra, Adv. ISCR Ms. Manisha Singh, Adv. Mr. Riku Sarma, Adv. Mr. Navnit Kumar , Adv. Ms. Aruna Gupta, Adv. Assam Mr. Avijit Roy, Adv. for M/s. Corporate Law Group Ms. Vibha Datta Makhija, Adv. Mr. Anil K. Jha, Adv. Ms. Priyanka, Adv. Ms. C.K. Sucharita, Adv. Ms. Vimla Sinha, Adv. for Mr. Gopal Singh, Adv. Mr. Khwairakpam Nobin Singh, Adv. Mr. Amit Kumar, Adv.

Mizoram Mr. Pragyan P. Sharma, Adv. Ms. mandakini Sharma, Adv. Mr. P.V. Yogeswaran, Adv. Ms. Sagarika Noitra, Adv. Tripura Mr. Gopal Singh,Adv. Mr. Ritu Raj Biswas, Adv. Chhattisgarh Mr. Atul Jha, Adv. Mr. Sandeep Jha, Adv. for Mr. Dharmendra Kumar Sinha, Adv. Karnataka Mr. V.N. Raghupathy, Adv. Puducherry Mr. V.G. Pragasam, Adv. Mr. S.J. Aristotle,Adv. Mr. Prabu Ramasubramanian, Adv. Meghalya Mr. Ranjan Mukherjee, Adv. Mr. S.C.Ghosh, Adv. Mr. S. Bhowmick, Adv. Mr. R.P. Yadav,Adv. R-31 Mr. Raktim Gogoi,Adv. Mr. Abhisth Kumar, Adv. Mr. Abhinav Mukerji, Adv. Ms. Pragati Neekhra, Adv. Mr. B. Balaji, Adv. Mr. Vijendra Kumar, Adv. Mr. Shaikh Chand Saheb, Adv. Ms. K. Enatoli Sema, Adv. Mr. Amit Kumar Singh, Adv. Mrs. Aruna Mathur, Adv. Mr. Yusuf Khan, Adv. Ms. Movita, Adv. WB Mr. Avijit Bhattacharjee, Adv. Mr. Chanchal Kr. Ganguli, Adv. Mr. Bikas Kargupta, Adv. Mrs. Sarbani Kar, Adv. Ms. Debjani Das Purkayastha, Adv.

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

In pursuance of our order dated October 8,2012, either the Secretary, Ministry of Health and Family Welfare, Government of India or Central Drugs Standard Control Organisation through 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 Deputy Drugs Controller (India) in the Central Drugs Standard Control Organisation. This affidavit is hardly in compliance of the order dated October 8, 2012 and deserves to be ignored. We order accordingly.

We now direct that an affidavit in compliance of the order dated October 8, 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 Director General of Health Services, Government of India. In the meanwhile, we direct the Chief Secretaries of the States other than States of Madhya Pradesh, Manipur, Union Territories of Dadar & Nagar Haveli and Daman & 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 the respondent No.1 - Union of India to inform the Chief Secretaries of the States/Union Territories of the above order without any delay.

In the meanwhile, we record and accept the statement of Mr. Siddharth 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 Drugs & Cosmetics Act, 1940 under the direct supervision of the Secretary, Ministry of Health & Family Welfare, Government of India.

List both the matters after four weeks.

I.A. Nos. 6 & 7 of 2012: Issue notice on I.A. Nos. 6 & 7 of 2012 returnable along with the main matter.

|(Pardeep Kumar) | |(Renu Diwan) |

|Court Master | |Court Master |