Minutes of discussion held with Dr.Rajeev Sadanandan IAS, Health Secretary, Government of Kerala by Mr.Gouridasan Nair, Chairman, Jananeethi Institute and Advocate George Pulikuthiyil, Executive Director, Jananeethi on 25th November 2011 at Health Department, Secretariat, Thiruvananthapuram.
Submission 1. We urge the Government of Kerala to introduce strict regulations in the area of clinical drug trials – i) in the constitution, composition and functioning of Ethical Committees, ii) selection of trial participants, iii) informed consent, iv) identification cards to the subjects of clinical drug trials, v) insurance coverage to trial participants, vi) ban or strict control of the Contract Research Organizations and vii) steps to ensure transparency and accountability in the process of clinical drug trials.
Response: A State Regulatory Board will be constituted to look into all issues raised. The Health secretary promised that positive steps will be initiated forthwith in all Government institutions. However, he honestly admitted that the state government has absolutely no control over the private hospitals and health institutions. Nevertheless, he said that he would take up these issues with the Chairperson of ICMR for necessary action.
Submission 2. Kindly take appropriate steps to introduce Best Practices and Ethical Standards in Clinical Drug Trials into the curriculum of Medical Education (including medical and para-medical education).
Response: An urgent meeting of concerned department heads is being held on 29th November 2011 at Secretariat consider the issues highlighted. The Health Secretary requested Jananeethi delegation to provide a list of potential consultants who can assist the Department in the process.
Submission 3. State Government has to declare a Policy on Patients’ Rights (Charter of Rights) and make every medical practitioner and health institution (hospitals, laboratories, research institutions etc.) liable to any violation/infringement of those rights.
Response: Accepted in principle. Jananeethi Institute has promised to submit a draft of Patients’ Rights at the earliest. Here again, the state government in the present context has limitations to impose strictures / liabilities on institutions in the private sector.
Submission 4. State Government must declare that every registered private hospital (of all denominations – allopathy, ayurveda, alternate medicines etc) comes under the purview of Right to Information Act.
Response: The Health Secretary was very positive with regard to government hospitals and other health institutions. However, he was helpless to make any promise with respect to private sector until specific legislation is made for that matter.
Submission 5. Hundreds of parents of students who are weak in studies and have fears of low marks in SSLC examination approach government medical college for certification of learning disability or being mentally challenged. If they produce a certificate, such students get considerable grace marks and get promoted to higher studies. Further, they are given financial help from Government. This certification is issued often without proper examination of the students. There are parents who threaten concerned staff in the hospital and get by coercive methods such certification. This has a great danger of stigmatization of normal students as deviants and it goes on records depriving their prospects in future.
Response: Instead of a single test and certification before SSLC examination, concerned students will be examined by a 3 member competent Board in concerned medical college consistently in standards VIIIth , IXth and Xth.