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Supreme Court Shocked by the Number of Clinical Trial Deaths


NEW DELHI: The Supreme Court, on March 10, 2014, expressed shock over the “disturbing” figure of 3,458 deaths and 14,320 Serious Adverse Events (SAEs) documented among volunteers in clinical trials in India conducted by pharma companies between 2005 and 2012. However, additional solicitor-general, Siddharth Luthra, appearing for the Union health ministry, told the apex court that not all deaths and SAEs can be attributed to the clinical trials as only 89 cases of deaths and 506 SAEs were attributable to clinical trials. The rest of the 13,814 SAEs and 3,369 deaths were unrelated to clinical trials. Those deaths, Luthra said, were because of the natural progression of terminally ill diseases.


The apex court bench of Justices R.M. Lodha and Kurien Joseph apparently was not convinced with the stand of the government. In fact, the bench expressed concern over the issue saying that the government must take a balanced approach so that the development in the area of drug research is not hampered and at the same time people’s lives subjected to trial are also protected.


Deliberating in the matter, the bench said, “Look, it is not a question of one, two or three deaths. The figures say that there were 3,458 deaths. It is a very serious matter and disturbing. We want to know what is the mechanism that you have put in place to prevent it.” Justice Lodha further asked Luthra, “We also want to know whether you have paid compensation to the 14,320 persons who had SAEs, apart from the 3,458 persons who had died.” The court also observed that the compensation was granted only to kin of those who died during the trials and asked why compensation should not be paid to those who were severely affected but were alive. It also directed the Centre to file an affidavit on what steps it was taking for making provision of payment of compensation to people who are affected in clinical trials.


The Supreme court was hearing a public interest litigation (PIL) filed by a Non-Governmental Organization (NGO) named Swasthya Adhikar Manch which, through counsel Sanjay Parikh, had alleged that a large number of innocent patients in India were being used by pharma companies as guinea pigs for their clinical trials of new drugs and were seeking directions for regulation of clinical trials of new drugs and chemical entities. Parikh also informed the court that the health ministry has not disclosed important details such as why certain new drugs were required to be tested through clinical trials, and whether these drugs had been subjected to clinical trials outside India.


Currently, the apex court has put on hold all clinical trials in India till the Government comes up with an effective mechanism to streamline clinical trials so that innocent lives are not lost. Earlier the court had also directed the government to ensure audio-visual recording of consent of clinical trial subjects. The court also demanded from the government whether the directions for approval of clinical trials of drugs are granted on only three parameters, i.e. risk versus benefits, innovation and India’s medical need. The court had earlier restricted the government from proceeding with clinical trials of 157 new drugs but later considered the applications on the above three parameters.


The court has now granted four weeks to the Centre to file its affidavit on the points raised by the NGO. The court also observed that it will take additional steps if cases of adverse effects are not controlled.



Pranab Mukherjee Hails India for Polio-Free Certification


NEW DELHI: Hon’ble President of India, Pranab Mukherjee, described the successful polio eradication programme of the country as a landmark achievement and “congratulated India on the incredible success.” While inaugurating the Polio Free Conclave 2014, organized by Rotary International on March 29, 2014, at Vigyan Bhawan, New Delhi, he remarked, “Polio eradication has been a priority health objective of the Government and was made possible due to the collective efforts of all the people associated with the programme. In a country like India, where sheer numbers of population and access to remote regions is a unique challenge, the fact that the programme reached every corner of the country, speaks of the unparalleled dedication of all concerned and the relentless efforts put in by the workers, doctors, activists and various stakeholders including parents of children in achieving this day.”


India and South-East Asian Region (SEAR) were declared polio-free by the World Health Organization’s (WHO) Regional Certification Commission for polio eradication on March 27, 2014. Union Minister of Health and Family Welfare (MoHFW), Ghulam Nabi Azad, received the certificate on behalf of India. This achievement makes SEAR, the fourth WHO Region to be certified as polio-free, after Americas in 1994, the Western Pacific region in 2000 and the European region in 2002. According to the international guidelines, a country or region has to be polio-free atleast for three years to qualify to be declared polio-free. India touched this milestone on January 13, 2014.


The President further suggested that India should assist other countries such as Pakistan, Nigeria and Afghanistan in their fight against the disease by improving their health systems and infrastructure. However, he warned, “We must be vigilant. There is need for watchfulness and preparedness to see that there is no recurrence of this disease.” He also informed that the agencies such as Rotary International and Bill & Melinda Gates Foundation helped with material resources and best practices to wipe out this crippling disease. Initiatives were taken up at several levels to spread awareness, provide prompt medical attention and administer the polio vaccine.


Mukherjee also presented mementos of appreciation and recognition to the former Union MoHFW, Dr A. Ramadoss; and Ghulam Nabi Azad. In his address, Azad credited the achievement to the decision to introduce the new bivalent polio vaccine which was indigenously developed for the first time, aggressive immunization and micro-block level planning covering the most endemic areas. He said that strong political will at the highest levels that ensured flow of required financial resources and deployment of huge manpower, constant monitoring and maintaining supply chains were some of the other factors.


The two-day Conclave, from March 29-30, 2014, was organized with the objective of celebrating India’s trailblazing success and at the same time to build momentum for the global movement to end polio by 2018. The conclave deliberated upon the challenges existing, the lessons from India’s campaign and the way forward for the global campaign, particularly, in the three polio endemic countries – Pakistan, Afghanistan and Nigeria – to ending polio. The Conclave was attended by more than 1200 participants including Health Ministers and delegates from neighboring and SEAR countries, representatives of global organizations and Rotary members from across the world joined the event to celebrate & renew Rotary’s commitment to ending polio from the world.


Kerala Government to Formulate Clinical Trial Registry


THIRUVANANTHAPURAM: The Kerala State Government has decided to formulate a Clinical Trial Registry, under the Drugs Control Department, owing to the reports of several clinical trial centres in the state violating the principles of human research ethics. The State Drugs Controller has been assigned with the work of preparing guidelines for the Clinical Trial Registry on the basis of the government’s direction. The guidelines will hopefully be prepared in two months’ time.


The Clinical Trial registry would include details of the title of study, hospitals & clinicians involved, type of research and in-patient details. The government decided to opt for Clinical Trial Registry based on the recommendation of a committee under the chairmanship of V.N. Rajasekharan Pillai. There have been media reports speaking about illegal clinical trials being conducted in the state. It was also found that the organizations which were conducting clinical trials in the state were not following the conditions stipulated as per the rules. The committee also found that the patients on whom the studies were performed were often selected through medical camps organized in remote villages and mostly illiterate or people from low income groups were selected for these trials.



The Drugs Control Department will be monitoring the clinical trials, which will be done only by the doctors. From now, all the centres and hospitals which conduct clinical trials would have to get registered, satisfying the conditions for trials. The State Board of Medical Research will be giving periodic training to investigators of clinical trials.