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TMI Blog2013 (12) TMI 1707X X X X Extracts X X X X X X X X Extracts X X X X ..... s 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 8-10-20121, either the Secretary, Ministry of Health and Family Welfare, Government of India or Central Drugs Standard Control Organisatio ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... cluding 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 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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 adjourned2 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 Stat ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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 c ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 1-10-2013 (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 30-9-20134, 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 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ases 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 pres ..... X X X X Extracts X X X X X X X X Extracts X X X X
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