- (1.) ON 26.7.2013, Mr. Siddharth Luthra, learned Additional Solicitor 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 adjourned and the Secretary, Ministry of Health was directed to file further affidavit.
(2.) 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.
(3.) 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 States also gave their view points. The views expressed by the States of Madhya Pradesh, Rajasthan, West Bengal, Punjab, Andhra Pradesh, Karnataka and Gujarat have been particularly noted in the additional affidavit. Based on the deliberations, the Secretary, Ministry of Health and Family Welfare summed up and made the following observations: A). Even though the concerns have been raised about the conduct of clinical trials in the country, clinical trials are necessary or the development of new drugs in the country. India has the capacity and knowhow for drug discovery research. However, there should be a robust system for conducting clinical trials in the country to ensure that trials are conducted in a scientific and ethical manner and in compliance to the regulatory provisions. B). Restricting clinical trials to Government Hospitals alone would not provide a solution. What is required is a robust system for regulating the conduct of clinical trials in the country. C). The amount of money paid by the sponsor/companies to the investigator for conduct of clinical trial may act as an inducement to the investigator for conducting clinical trials. Sometimes such inducement may lead to bias in enrollment of subjects in the trials. D). Regulatory provisions may be made so that information relating to the amount of money paid by the companies to investigators for conduct of clinical trials is in the knowledge of the regulatory authorities. E). There are some concerns on certain clauses of the amendment of Drugs & Cosmetics Rules made on 30.1.2013 regarding compensation in clinical trials. Some amendments in these clauses may be required. F). A Committee constituted under the chairmanship of Dr. Ranjit Roy Chaudhury for formulating guidelines on clinical trials and new drugs has submitted its report. The report will be helpful in further strengthening of the Regulation of clinical trials in the country. G). States' suggestions and views would be considered for further strengthening of the Regulation of clinical trial. The additional affidavit also states that suggestions have been received from (i) National Human Rights Commission; (ii) Mr. Sanjay Parikh, advocate for the Petitioners; (iii) SAMA Resource Group for Women and Health and Locost Standard Therapeutics and (iv) Indian Society for Clinical Research.;