India: Clinical trials continue to be a cause of concern due to ambiguity in guidelines & lack of regulation

Clinical _Trials_Photo_Credit_PTIDespite clinical trials coming under scrutiny in various courts, little has changed on the ground. On September 30 the Supreme Court of India passed a ruling which said that no new clinical trials should be allowed for new drugs till a mechanism is put in place to monitor them. The Supreme Court also sought assessment of risk vs benefits to the patients, innovation vis-a-vis existing therapeutic options and the unmet medical needs of the country. However, recent reports have again raised concerns on clinical trials in the country. Reports reveal that there have been at least 370 deaths as a result of adverse events during clinical trials since February 2013. However, not all of them all received compensation from the government. 

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Article
22 December 2014

Indian regulatory system needs to be strengthened to improve clinical trial industry in India: Neuland labs CFO

Author: A. Raju, www.pharmabiz.com

As the clinical trial industry is facing lot of resistance in India, Industry experts are of the view that the Indian regulatory system should undergo massive reforms to contain unethical practices in clinical trials and should pave way to open up at least 10 per cent of global clinical trials in the country...According to N S Viswanathan, chief financial officer, Neuland Laboratories limited, the Indian drug regulatory system is very weak when compared to the US FDA, particularly in the clinical trials segment, the rules and protocols should be amended and strengthened so that it should not give any chance for the unscrupulous and rouge elements to take advantage of any loopholes in the regulations.

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Article
17 December 2014

Patients suffer as new norms impede clinical trials in India

Author: Hindustan Times

In the last two years, just 25 Global Clinical Trials (GCT) were approved to be conducted in India...Doctors have said the decline in the number of clinical trials is a loss to patients, who are being deprived of cutting edge drugs that clinical trials can offer...The new guidelines have brought clinical research in India to a grinding halt. While the intention of the new guidelines may be well meaning, but at the same time, they are so irrational that all the stakeholders in a clinical research are wary of applying for clinical trials,” said Suneela Thatte, president ICSR.

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Article
14 December 2014

370 die in clinical trials in 2 years, kin of only 21 get compensation

Author: Sushmi Dey, Times of India

At least 370 deaths have been reported during clinical trials in India since February 2013, but compensation has been paid in only 21 cases, according to government data...Of the 370 deaths, 222 (60%) cases have been examined so far by a regulatory panel on clinical trials. Of these, only 21 were eligible for compensation as the the drug under trial was found to have caused the deaths...Medical experts, however, say there is lack of clarity on the norms on which eligibility for compensation is decided. It is largely subjective, they point out, and the basic data comes from the very investigators who are involved in conducting the trial. Hence, it is not only possible for them to influence or manipulate data, there is hardly any wherewithal with the regulatory agencies to check its authenticity.

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Article
14 December 2014

India computes new formula to compensate clinical trial deaths

Author: Soma Das, Economic Times

India has become the first country in the world to start giving out compensations to victims of clinical trials on the basis of a formula that computes the sum after considering the age and health risk of the deceased...This is part of the government's efforts to address concerns raised by health activists that pharmaceutical companies do not always adequately compensate volunteers of clinical trials who end up with injuries. The Supreme Court is currently hearing a public interest litigation on the matter. An expert committee set up by DCGI has set a range of Rs 4-74 lakh as payout, depending on age and health risks of volunteers at the time of enrolment. These figures are significantly higher than what some...

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Article
10 March 2014

Supreme Court asks details on deaths from Centre

Author: Press Trust of India

The Supreme Court directed the Centre to provide details on the number of deaths and severe adverse effects caused to people who were subjected to clinical trials...The court passed the order after it found that there were discrepancies in the numbers given by the petitioner NGO and the government...While the NGO claimed that in 2012 and 2013, there were around 4,000 cases of severe adverse effects of drugs trial, including deaths, the government claimed the figure stood at 506, with 89 cases of deaths...The court also said that compensation was granted only to kin of those who died during the trials and asked why it should not be paid to those who were severely effected but alive...The Supreme Court is hearing a PIL filed by Swastha Adhikar Manch seeking directions for regulation of clinical trials of new drugs and chemical entities.

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Article
30 January 2014

Video-recording of consent for clinical trials driving away subjects

Author: Dhananjay Mahapatra,Times News Network

The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions...The protocol has made it mandatory for companies intending to conduct human trials of drugs to video-record the free consent of patients to be part of the trial. It also mandates them to inform patients about the possible adverse health effects of the drug, which is under clinical trial. ..This is because most patients, taken as subjects for clinical trials in India, suffer from terminal diseases and they do not want to reveal it on camera, despite the protocol providing for complete secrecy of the video-recorded consent obtaining process.

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Article
11 October 2013

Supreme Court stands firm on clinical trial ban

Author: Health Site

The clinical trials of 162 new chemical entities will continue to be on the hold as Supreme Court on Monday said that the technical committee and the apex committee will examine the benefits of these trials for the country...Reviewing the clearance for clinical trials of 157 new chemical entities by the National Drugs Advisory Committee and the Drug Controller General of India, the court said the technical and apex committees would look into the assessment of risk vs benefits to the patients, innovation vis-a-vis existing therapeutic options and the unmet medical needs of the country.

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Article
29 September 2013

No more clinical trials till you can monitor them: Supreme Court to Centre

Author: Nirmalya Dutta, Health Site

The Supreme Court passed a ruling...which said that no new clinical trials should be allowed for new drugs till a mechanism is put in place to monitor them...It had directed the Centre to convene a meeting of Chief Secretaries or Health Secretaries of all the states to frame a law for regulation of clinical trials of drugs by multi-national pharma companies. Earlier, the apex court had said that uncontrolled clinical trial of drugs by multinational companies was creating ‘havoc’ and slammed the Centre for failing to stop the ‘rackets’ which caused deaths...In an affidavit, the Centre had admitted that 2,644 people died during clinical trials of 475 new drugs from 2005 to 2012. ‘Serious adverse events of deaths during the clinical trials during the said period were 2,644, out of which 80 deaths were found to be attributable to the clinical trials,’ the affidavit had said.

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