Illegal clinical trials creating “havoc”:
 Supreme Court

The Hindu             04-01-2013

The Supreme Court on Thursday said uncontrolled clinical trial of drugs on humans by multinational companies was creating “havoc” in the country and slammed the Centre for failing to stop the “rackets” which has caused deaths.

Observing that the Government has slipped into “deep slumber” in addressing this “menace”, the court ordered that all drug trials will be done under the supervision of the Union Health Secretary.

The apex court said the government has failed to put in place proper mechanisms to stop “rackets” of multinational companies, which are conducting illegal clinical trials, and asked it handle the problem on an urgent basis.

“You have to protect health of citizens of the country. It is your obligation. Deaths must be arrested and illegal trials must be stayed,” the bench comprising R.M. Lodha and A.R. Dave said.

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Jananeethi's sharing of its findings of a study on

CLINICAL DRUG TRIAL & ETHICAL NORMS

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Clinical Drug Trial: Need for an Effective Regulation 

- A Consultation

27^th June 2012,   3.00 p.m., Hotel Ruby Arena, Thiruvananthapuram.

Report
The conduction of clinical drug trials in India poses many challenges. Many pharmaceutical companies outsource their drug trials to India because of lower cost, large population in combination with poverty and numerous diseases along with weak legal mechanism to curb the unethical trials. As the medical research world becomes increasingly globalised, there is a need to make research methodologically valid, and to observe the highest standard of ethics. An increasing number of pharmaceutical companies started outsourcing drug trials to Contract Research Organizations (CROs) in developing countries; these now make up a specialized global industry focusing on research on human participants. Currently the infrastructure for regulation, ethics review and monitoring is insufficient to regulate clinical trials in the country. While conducting the study on clinical drug trials in Kerala, Jananeethi Institute found that the mandatory norms and best practices in clinical drug trials were rampantly violated.  Several critical findings and observations emerged from this interventional study mandates for a strong campaign in order to combat unethical practices in the existing drug trial system. Recognizing the urgent need for furthering transparency in trials, protection of participant’s rights, and implementation of the good clinical practices, a State level Consultation was organized on 27^th June, 2012 at Hotel Ruby Arena near Medical College Thiruvanathapuram. 

The consultation began at 3.PM. Adv.George Pulikuthiyil; Executive Director of Jananeethi extended a warm welcome to the dignitaries and audience. He explained the core objective of the consultation. Eminent Jurist and Professor of Law, Padmashree Dr.N.R.Madhava Menon inaugurated the consultation. In his inaugural address he mooted for a state level mechanism to monitor the drug trials in order to ensure that the rights of the participants undergoing clinical drug trials are protected. It was followed by a short presentation by Adv. P.Sunilkumar of Jananeethi Institute sharing the key findings of the study. Dr.V.Mohanan Nair, formerly Deputy Director, Health and internationally acclaimed scholar on the Ethical Standards of clinical drug trials delivered the key note address. He explained the key features of the Indian regulatory framework on drug trials and insisted for its effective implementation sighting different ways of unethical practices happening during drug trials.  The consultation was attended by nearly thirty participants who mainly comprised of doctors, ethics committee members, legal experts, media persons and human right activists. There was active discussion from the floor and participants assured their cooperation and support for future initiatives. Consultation was presided and moderated by Dr V.Ramankutty, Professor, Achutha Menon Centre for Health Sciences, Medical College Thiruvanathapuram. He summarized the key points of the consultation and solicited support from the fraternity to bring significant changes in the drug trial system based on the findings of the consultation.

Jananeethi Stall on Thrissur Pooram Exhibition

Jananeethi Stall on Thrissur Pooram Exhibition ground
is a centre of attraction

  

Mr. P.M.Francis IAS, the District Collector of Thrissur formally opened the Jananeethi pavilion on Thrissur Pooram exhibition grounds at 6 pm on Monday the 9^th April 2012. The members of the Board and Executive Committee of Jananeethi, top officials of Pooram Exhibition Committee, representatives of civil society groups, law students of Thrissur Law College and Jananeeti staff attended the function.

This is the first time Jananeethi is putting up a stall in connection with the Thrissur Pooram. The exhibition will be open for 7 weeks, from 1^st  April to 21^st May  and is expected to attract not less than half a million people across the country. Thrissur Pooram, the most spectacular and colourful temple festival of South India, will be celebrated this year on the 1^st day of May 2012 with pomp and glory.

The stall has been given to Jananeethi by the Pooram Exhibition Committee free of cost at the intervention of the district collector. Jananeethi is the service provider of State Social Welfare Board for giving appropriate services to victims of domestic and gender based violence; and also protection to children, disabled and old age people. ...........   more details

With Health Secretary - 25-10-2011

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 25^th 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 29^th 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.