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Archives for : clinical trials

India must enforce strict rules on clinical trials #healthcare

Putting patients first

NALINAKANTHI V

This year, on International Clinical Trials day, India has a reason to feel satisfied with the progress made in regulating the use of humans to test drugs. In August last year, the Supreme Court had batted for patient safety, coming down hard on the clinical research industry. But this is just the beginning. A vibrant environment needs to be created wherein adequate safeguards are available for trial patients while promoting novel research.

Though instances of unethical conduct of clinical trials in India dated back to 2005, the issue came under spotlight only in June 2011, after the Economic Offence Wing of Madhya Pradesh submitted its enquiry report. The report brought to light some gruesome facts about the conduct of trials in the state. Thousands of individuals, mostly children, were subjected to drugs and vaccines trials between 2006 and 2010, violating guidelines.

Even the mentally ill were not spared. Many such patients were subjected to trials for various drugs including the ones used to treat premature ejaculation. This was driven by perverse, profiteering motive pursued by a few clinical research organisations (CROs) that amassed millions of dollars at the expense of innocent patients. “The entire research community has been blamed for the mistakes of isolated people,” says Suneela Thatte, President of Indian Society of Clinical Research (ISCR).

A welcome rulingAfter series of unsuccessful debates in various forums including the Vidhan Sabha, a writ petition was filed in the Supreme Court in January 2012 by the NGO Swasthya Adhikar Manch and others. In October 2013, the court ordered halting of all the 157 clinical trials approved between January and August 2013. It sought a detailed report from the apex and technical committees, assessing the risk versus benefit for patients, before allowing trials in these 157drugs. The court also expressed concern over the non-existence of a strong framework to ensure safety of these patients.

This is a very positive move. Some changes have since been effected to the existing regulations such as mandating a video recording of the patient consent, registration of ethical committees and formulation of compensation for trial subjects who suffer adverse reaction, to name a few. But this will not suffice. Ensuring effective implementation of the set regulations is the most critical aspect.

Ensuring strict adherence to regulations will not only ensure protection of patients’ right but will also benefit the CROs who have been doing legitimate business. “We have always wanted robust regulatory framework governing clinical trials in India,” agrees Thatte.

The SC order is conducive to patients, but it has also made the clinical trial industry aware of its responsibilities towards patients. Today, on the occasion of International clinical trials day, the industry body ISCR plans to distribute a special patient handbook, which will serve as a guide for those who intend to participate in clinical trials. It is also conducting patient awareness programmes.

Safety and innovationThe industry’s efforts now seem to be directed towards re-building the confidence among the patient community, while also sending the signal to the government that they are willing to adopt the best practises in clinical trials.

As a developing country, India needs to encourage investment in innovative research. Hence, it is important to strike a balance between safety of trial subjects and the country’s healthcare needs, without compromising one for the other. “Patient is a very important stakeholder. Unless they come out and participate in trials, no innovative medicine will be available to patients” adds Thatte.

 

Read more here — http://www.thehindubusinessline.com/opinion/putting-patients-first/article6026059.ece

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EU – transparency of clinical trials data #healthcare

Europe backs more transparent, simpler clinical trial rules
April 2 Wed Apr 2, 2014 2:18pm EDT

(Reuters) – European Union lawmakers voted on Wednesday in favour of new rules that will ensure more open reporting of clinical trials results, even when they are negative, and also simplify the process for getting studies started.

The legislation approved by the European Parliament is expected to take effect in 2016 and will require results of all new clinical trials to be published within a year of the trial ending.

European Ombudsman Emily O’Reilly, whose office investigates complaints about maladministration in EU institutions, said the move was “a triumph for transparency” in European healthcare.

There has been a growing clamour for greater disclosure of detailed clinical trial results by pharmaceutical companies following a series of scandals over the safety of drugs such as Merck & Co’s now withdrawn painkiller Vioxx.

A number of senior doctors have argued that in too many cases the decision on how and when to prescribe drugs relies on selective evidence controlled by manufacturers.

The new rules mean it will in future be possible for independent researchers to verify whether medicines are as safe and effective as they are claimed to be.

Ben Goldacre, a British doctor and author of “Bad Pharma”, who has led a campaign called AllTrials urging study disclosure, welcomed the vote by parliamentarians as “an excellent small step forward”.

But he remains concerned that the new EU Clinical Trials Regulation only covers new clinical trials and does not address access to full study results carried out on older medicines already on the market.

In addition to forcing greater transparency, the new law will also reduce the red tape surrounding the approval process for studies on medicines, including simplifying rules for running multinational trials.

Taken together, the measures should save research institutions and companies conducting clinical trials in the EU some 800 million euros ($1.10 billion) a year in regulatory costs, EU Health Commissioner Tonio Borg said in a statement.

($1 = 0.7263 Euros) (Reporting by Ben Hirschler, editing by David Evans)
Over a dozen Ombudsman inquiries about the Medicines Agency

Activists will recollect that phramaceutical MNCs have steadfastly opposed the idea of disclosing clinical trial data under the Indian RTI Act. They claim that this information attracts the protection of Section 8(1)(d) of the RTI Act which exempts disclosure of information that is in the nature of commercial confidence or trade secret or intellectual property if such disclosure will harm their competitive position. I remember assisting an NGO SAMA to access clinical trial data about HPV vaccine under the RTI Act a few years ago when the DGHS refused to part with this information. Subsequently political parties took up the issue in Parliament. I have not followed up on this case since then. Perhaps readers may educate us in the regard about the latest developments in INdia.

Many companies in the pharma sector and their advocates in the legal fraternity in India have treated this category of information as confidential. They argue that disclosure will adversely affect their ability to innovate and provide effective medicines at competitive rates. Their main concern is about access of such kind of data by companies that manufacture generic equivalents of such drugs and supply them at cheaper rates to developing countries that cannot afford to buy their astronomically priced medicines.

The RTI jurisprudence on this issue is not well developed in India. I could find only a handful of cases on the website of the Central Information Commission (CIC). In 2011 the CIC accepted the arguments of the pharma MNCs that clinical trial data contains information in the nature of intellectual property and may not be disclosed (1st attachment). However in 2012 the CIC ordered disclosure of clinical trial data in another case (2nd attachment). The Supreme Court has been moved in a similar matter through a public interest litigation suit though not under the RTI Act. See news story at: http://www.biospectrumasia.com/biospectrum/analysis/155515/indian-apex-court-raps-govt-clinical-trial. I have not been able to find out if this case has been decided at all now.

The new law in the European Union should make the multi-national pharma companies reconsider their arguments to prevent disclosure of clinical trial data to the public. However as most major pharma MNCs have their base in the USA it would be interesting to watch their reaction to this new law. The European law requires even negative results of clinical trials to be made public. Come to think of it, do not pharma MNCs have a fiduciary duty of disclosure of the truth to the people in general and medical practitioners in particular? I hope Information Commission in India take note of this change in law in the European Union and deal with appeals relating to access to clinical trial data with greater alacrity even to the extent of erring on the side of transaprency.

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#India – Bhopal gas victims used as guinea pigs for drug trials #WTFnews

Bhopal memorial for those killed and disabled ...

Bhopal memorial for those killed and disabled by the 1984 toxic gas release. (Photo credit: Wikipedia)

 

TNN | Dec 17, 2013

 

 

NEW DELHI: Pharmaceutical companies Quintiles and Sanofi have failed to follow norms while conducting clinical trials of their new drugs on Bhopal gas leak survivors, the health ministry informed the Supreme Court.

During hearings on alleged flouting of norms by pharmaceutical majors in conducting clinical trials on humans, the court had ordered the health ministry not to proceed with the clinical trials of 157 new drugs/formulations till a stricter regime was put in place.

An application filed by two Bhopal-based NGOs in the pending petition by ” Swasthya Adikhar Manch” had alleged that survivors of the deadly poisonous gas leak from Union Carbide factory in Bhopal 30 years ago and being treated at Bhopal Memorial Hospital and Research Centre were being used as ‘guinea pigs’ for clinical trial of new drugs.

The health ministry listed three instances of norms being flouted:

* Inspection in 2010 on clinical trial of Telavancin by Quintiles Ltd: “Finding of the inspection of one clinical trial conducted at BMHRC showed some deficiencies like non-payment of compensation to the trial subjects for participation and non-reporting of serious adverse events within prescribed time limit.” The company was merely warned by Drug Controller General (DCG).

* Inspection in 2011 on clinical trial of Tigecycline by Quintiles Research Pvt Ltd: Finding of the inspection showed deficiencies like non-payment of compensation to trial subjects and non-reporting of serious adverse events in time. Again, the pharmaceutical firm was only warned in March 2012.

* Inspection in 2011 on clinical trial of Fondaparinux by Sanofi-Synthelabo Ltd resulted in identical findings – non-payment of compensation to subjects and non-reporting of serious adverse events and the DCG had again issued only a warning in March 2012.

From these three instances, it was clear that the pharmaceutical firms were not paying the mandatory compensation due to Bhopal gas disaster survivors, who had volunteered to be subjects in the clinical trial of new drugs and formulations.

The health ministry said of the 157 new drugs/formulations by global pharmaceutical firms which were directed to be re-evaluated by the apex court, the technical committee (TC) had evaluated 50 cases.

“The TC considered the details of the data relating to the safety and efficacy of the study drugs, details of protocols containing the objective of the studies, inclusion and exclusion criteria for enrollment of patients, treatment, assessment of safety and efficacy parameters keeping in view risk versus benefits to the subjects, innovation versus existing therapy and unmet need of the Indian population,” the ministry said.

“After considering the details, the TC recommended the continuance of these 50 clinical trials as they met all the relevant aspects of safety and efficacy,” the ministry said. A bench of Justices RM Lodha and SK Singh posted the matter for further hearing in February.

 

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#India – Clinical trials: SC issues notices to Centre, PATH

Ball-and-stick model of the fialuridine molecu...

Ball-and-stick model of the fialuridine molecule, a drug that failed clinical trials due to unexpected toxicity. Colour code (click to show) : Black: Carbon, C : White: Hydrogen, H : Red: Oxygen, O : Blue: Nitrogen, N : Yellow-green: Fluorine, F : Purple: Iodine, I (Photo credit: Wikipedia)

New Delhi: TNN
The Supreme Court on Monday issued notice to PATH, an international NGO working in the health sector, on a PIL alleging that it indulged in unethical conduct of clinical trials in collaboration with ICMR between 2009-10 in Andhra Pradesh and Gujarat.
A bench of Chief Justice P Sathasivam and Justice Ranjan Gogoi also sought response from the Centre and state governments on the petition filed by an NGO Sama, which works in the field on feminist activism and health.
The bench tagged the case with other petitions on clinical trials being heard by a different bench.
The petitioner alleged that there were serious failures on the part of PATH (Programme for Appropriate Technology in Health) and Indian Council of Medical Research (ICMR) in complying with legal and ethical requirements to obtain written ‘informed’ consent and it caused serious adverse events.
“The Ethics Committees failed in their duty to protect the rights of trial participants by allowing the trial to be conducted in young girls from socio-economically backward families and where medical facilities were poor or non-existent,” the petition said.
It added, “The current ethical and legal framework to protect subjects of clinical trials is grossly inadequate and needs to be re-examined.”
Earlier, a bench headed by Justice R M Lodha, which was hearing a batch of PILs against clinical trials, had said that trials in the country must be held to help people here and must not be allowed for the benefits of multinational companies. AGENCIES

 

 

 

 

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PRESS RELEASE= #India – SC – No Clinical Trials of 157 NCEs till further order #Goodnews

SWASTHYA ADHIKAR MANCH

6, Bijasan Road, Opposite Mahavir Bagh, , INDORE, Madhya Pradesh

[email protected]. Ph No.09425311547/ 0993278855

pharma

“No Clinical Trials of 157 NCEs till further order & 5 NCEs after proper mechanisms put in place” – Supreme Court

October 21st, New Delhi : 8th hearing of the writ petition filed by Swasthya Adhikar Manch took place today before the bench of the Supreme Court consisting of Justice R.M Lodha and Justice S.K. Singh. The case was filed in February, 2012 and the last hearing was held on 30th September, 2013.

The Hon’ble Supreme Court raised serious concerns over 162 clinical trials of Global Clinical Trial (GCT) including New Chemical Entities (NCEs) / New Molecule Entities (NMEs) out of which 157 were approved before 31st December 2012 and 5 between January to August 2013. In the Court it was admitted by Ministry of Health & Family Welfare (MOHFW) and representative of Drug controller General of India (DCGI) that 157 clinical trials were approved by DCGI on recommendations of New Drug Advisory Committee (NDAC) and without the approval of Apex and Technical Committee formed after order of Court dated 3rd January 2013. The Hon’ble Supreme Court have ordered GoI to reexamine 157 GCT including NCEs by Apex and Technical Committees. Therefore, now Apex and technical committee will have to evaluate these 157 clinical trials particularly in terms of – assessment of risk vs. benefits for patients, innovations to existing therapeutic options and benefits to medical needs of the country. It is only after the assessment of apex and technical committee that the question of commencement of 157 approval will be considered. In case of remaining 5 clinical trials which have been approved in 2013, the Hon’ble Supreme Court ordered MOHFW to conduct it only after ensuring proper mechanism & procedure to ensure safety of the patients along with audio-visual recording of participants maintaining principle of confidentially and preservation of documentation. The Hon’ble Supreme Court also raised its concern that there is no checks and balance in the frame work where investigators are paid by sponsors and ethics committees are part of hospital with absence of proper mechanism to ensure patients safety.

Mr. Sanjay Parikh Senior Counsel for Swasthya Adhikar Manch argued and highlighted the facts in relation to NCEs/NMEs and asked the government to come out with a position paper on how these NCEs/NMEs will be in public and national interest. The Hon’ble Supreme Court also then inquired that out of 162 trials, how many molecules are patented outside country and benefiting MNCs instead of development of new drug for which learned Additional Solicitor General was unable to respond. Mr. Parikh also pointed out contradictions in data given in affidavit filed by MOHFW dated 26th July 2013 wherein it was stated that only 26 GCT were approved while in current affidavit of 18th October 2013, it is stated that only 5 trials are approved after 3rd January 2013 by the apex and the technical committee.

The petitioner asked the MOHFW to provide details of 162 approved clinical trials- Name of molecule, indication, name of sponsor, protocol, sites, number of subjects, name of investigators and minutes of NDAC, apex and technical committee meetings. The petitioner also raised serious concerns about Ranjit Roy Chaudhry Expert Committee report on issues like conflict of interest etc. The Ranjit Roy Committee also was not able to explain benefits to India by allowing NCEs/NMEs testing within the country.

The petitioners have been raising the issue of how NCEs/NMEs are benefiting MNCs at the cost of human life in India. The next hearing is scheduled on 16th December 2013.

Amulya Nidhi (9425311547), Chinmay Mishra (9893278855) – SAM 

N.D. Jayaprakash (9968014630) ([email protected]) – BGPSSS, Abdul Jabbar  (9406511720) – BGPMUS

for details write to : [email protected] | Visit – www.unethicalclinicaltrial.org

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Press Release – No Clinical trial including New Chemical Entities without proper mechanism- SC

Space-filling model of the fialuridine molecul...

 

 

 

September 30th, New Delhi : The writ petition filed by Swasthya Adhikar Manch came up for hearing today before the bench of the Supreme Court consisting of Justice R.M Lodha and Justice Mr Singh…… This case was filed in February, 2012 and this is the seventh hearing of the case, last hearing was held on 26th July, 2013.  

 

In the last hearing, the Hon’ble Supreme Court had directed Secretary, Ministry of Health and Family Welfare to organise a meeting of all chief Secretaries / Secretary from all states to discuss all the facets and aspects concerning legal framework for strengthening the regulation of clinical trials and other incidental matters. They had also asked the Government to take opinion of Petitioners, National Human Rights Commission and NGOs.

 

Today Mr. Sanjay Parikh Senior Counsel for Swasthya Adhikar Manch argued and highlighted the facts contained in the two affidavit filed by the Ministry of health and family welfare. In the additional affidavit filed by the Ministry of Health and Family Affairs it was stated that out of 475 New Chemical Entities only 17 were approved for marketing which comes to less than 4%. But in these clinical trials 2,644 persons died out of which only 80 deaths were attributed to clinical trials. Similarly, out of 11,972 SAEs, 506 alone were attributed to clinical trials. He mentioned that total 259 applications regarding NCEs / NMEs have been recommended for approval between 3rd July 2013 to 31st August 2013 out of them 162 have been approved for clinical trials by Drug controller General of India.

 

The Petitioners pointed that in their affidavit Ministry of Health and Family Welfare had mentioned that due to Clinical trials of New Chemical Entities/ New Molecular Entities (NCEs/NMEs) 164 deaths had occurred in the year 2010, out of which 125 alone had died on account of clinical trial of Rivoroxaben by Bayer. However, as per the Ministry of Health and Family Welfare office memorandum dated 26.04.2011 to the Lok Sabha Secretariat a total 671 cases of death occurred in the Year 2010 out of which 89 deaths were related to clinical trial.

 

The above data is contradictory to Ministry of health and family welfare in which they are claiming that only 80 deaths due to clinical trials occured from year 2005 to 2012. The list of drug companies that conducted the trials included several pharmaceutical companies such Bayer, Eli Lilly, Pfizer, Sanofi Intas, Merck, Boahringer, Astrazeneca, Novartis, etc.

 

Counsel for Swasthya Adhikar Manch- Mr. Sanjay Parikh mentioned that the reason for so many deaths is because NCEs/ NMEs are being tested on Indian citizens without following the regulations and taking necessary precautions taking advantage of poverty and tardy implementation including corruption. It was also urged by the Counsel that the clinical trial of NCEs/ NMEs is not at all beneficial to the Country and therefore, should not be allowed.

 

As per the letter dated 26.04.2011 written by the Ministry to Lok Sabha Secretariat, from the year, 2005 to 2010 alone 1243 global clinical trials has been permitted.

 

In the other letter dated 06.06.2011 by DCGI it has been mentioned that out of 645 cases of death response has been received only in 300 cases and out of 300 in only 2 cases compensation and treatment expenses have been paid.

 

The Court has given 10 weeks time to the MOHFW to come out with the actual implementation of the suggestions given by State Government, NHRC, Petitioner and NGOs to strengthen the regulatory framework of clinical trials in the country.

 

Mr. Sanjay Parikh also represented the Bhopal Gas Peedith Mahila Udyog Sangathan (BGPMUS) and the Bhopal Gas Peedith Sangarsh Sahayog Samiti (BGPSSS) who are interveners in this case.

 

The Supreme Court also issued notice on an intervening application filed by Swasthya Adhikar Manch based on the 72nd Parliamentary standing Committee on Health and Family welfare report dated 30th August 2013 where in it has been recommended that action should be taken against PATH, State Government of Andhra Pradesh, Gujarat, ICMR, and other Government officials including Drug controller General of India. In the said case HPV vaccine was given to 14,091 girls in Khammam district of Andhra Pradesh and 10,686 girls in Vadodra, Gujarat. These girls were between age group of 10-14, of which 7 girls died due to these illegal vaccine trials.

 

The Court appreciated Mr. Sanjay Parikh, Senior Counsel and Swasthya Adhikar Manch for bringing to notice the fact that Indian citizens are being exploited by multinational drug companies and without proper regulatory framework clinical trials are happening in the country. The next hearing is scheduled after two weeks.

 

Amulya Nidhi (9425311547), Chinmay Mishra (9893278855) – SAM N.D. Jayaprakash (9968014630) – BGPSSS, Abdul Jabbar  (9406511720) – BGPMUS

 

[email protected]) Visit – www.unethicalclinicaltrial.org

 

 

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For Pharma MNCs, India is Heaven for Clinical Trials but Hell for the Country-” Supreme Court

The writ petition filed by Swasthya Adhikar Manch came up for hearing on Junly 26th before the bench of the Supreme Court consisting of Justice R.M Lodha and Justice Madan B. Lokur. This case was filed in February, 2012 and this is the sixth hearing of the case, last hearing was held on 3rd January, 2013.

In the last hearing, the Hon’ble Supreme Court had directed the Director General, Health Services or the Secretary Ministry of Health to file an affidavit on different aspects concerning the Clinical trials of New Chemical Entities, in particular the deaths and adverse impacts that have taken place from 2005 to June, 2012. The Court had also issued notices to all States and UT’s for filing status report on the ongoing clinical trials. Accordingly, reply from 16 States/UTs were filed. All the States/UTs stated that they have no role to play in the clinical trials or their approvals. The additional affidavit was filed by the Secretary, Ministry of Health and Family Welfare on the four issues raised by the Hon’ble court in its order dated 8th October, 2013.

In the additional affidavit filed by the Ministry of Health and Family Affairs it was stated that out of 475 New Chemical Entities only 17 were approved for marketing which comes to less than 4%. But in these clinical trials 2644 persons died out of which only 80 deaths were attributed to clinical trials. Similarly, out of 11972 SAEs, 506 alone were attributed to clinical trials. In the earlier affidavit filed by the Additional DGC(I) it was admitted that the data has been provided by the private firms.

Today, the Additional Solicitor General appearing for the Ministry admitted that the said data was provided by the Companies and that DGC(I) has no data of its own. Therefore, it cannot be said that how many out of 2644 died because of clinical trial and out of 19772 how many suffered SAEs because out of clinical trials. Therefore, it is obvious that the companies have fudged the data to escape the liability. More shocking fact related to the table given by the Ministry regarding deaths attributable to clinical trials and the compensation paid from 2008 to upto June, 2012.

The Petitioners in their rejoinder affidavit pointed out that though the Ministry of Health and Family Welfare had mentioned 164 deaths in the year 2012, out of which 125 died on account of clinical trial of Rivoroxaben by Bayer, in the letter which was written by Ministry of Health and Family Welfare dated 26.04.2011 to the Lok Sabha Secretariat as many as 671 cases of death in the Year,2010 alone were reported. According, to the list provided in Annexure B to the said letter, in case of deaths which had taken place due to trial of Rivoraxaban the reason mentioned was cardiac arrest and the said reason was said to be not related to clinical trial. Out of 125 deaths which had taken place due to Rivoraxaban, Bayer paid compensation to only 5. From the said annexure B it also came out that other companies also participated in clinical trials of new chemical entities but their names have not been mentioned by the Ministry in the additional affidavit. The drug company- Sanofi did clinical trials because of which 135 persons died whereas in the additional affidavit only 5 deaths have been mentioned in the additional affidavit. As per Annexure B, 89 deaths took place in 2010 alone due to clinical trials as against 80 which Ministry of Health and Family Welfare claimed from year 2005 to 2012. The list of drug companies that conducted the trials included several pharmaceutical companies such Bayer, Eli Lilly, Pfizer, Sanofi Intas, Merck, Boahringer, Astrazeneca etc. The name of one of the pharmaceutical company- Novartis was missing from the list.

Counsel for Swasthya Adhikar Manch- Mr. Sanjay Parikh mentioned that the reason for so many deaths is because NCEs are being tested on Indian citizens without following the regulations and taking necessary precautions. It was also urged by the Counsel that the clinical trial of NCEs is not at all beneficial to the Country and therefore, should not be allowed.

The Hon’ble Court while passing the order noted the contention that one of the problematic areas is that the NCEs and its regulation and other one is proper monitoring. The Petitioner had also pointed out that during the entire process of clinical trial there is no check by the Drug Authorities and the entire process of clinical trial is given in hands of Sponsor, Investigator appointed by Sponsor, Expert Committee appointed by Sponsor, therefore, no independent person gets any information about causes of death and causes of SAEs. Because of this serious lacuna, manipulation of data takes place. After the deaths/SAEs are caused the Drug Company without paying any compensation goes away with the data. Therefore, neither the country nor the citizens are benefitted. Even if the medicine is ultimately approved, citizens have to pay at the same cost as others have to pay in any other country in Asia.

Advocate Shri Sanjay Parikh also drew attention of the Court to the fact that Jan,2013 onwards i.e. last six months there has been no improvement as regards clinical trial of NCEs/NMEs and protection of patients. The Rules have not resulted in any enhanced benefit to patients. It was also stated that in Cases of death where no investigation/ inquiry has been conducted, post mortem are not being done by the Authorities, even when the existing rules provide that.

As per the letter dated 26.04.2011 written by the Ministry to Lok Sabha Secretariat, from the year,2005 to 2010 alone 1243 global clinical trials have been permitted. In the year, 2006 alone 671 death have occurred. The list annexed with the letter accepts that 89 deaths were related to clinical trials in the year,2011. Out of 26 cases entitled for compensation details of only 19 persons were given. Out of the 19 persons only three have peen paid compensation.

In the other letter dated 06.06.2011 mentions that out of 645 cases of death response has been received only in 300 cases and out of 300 in only 2 cases compensation and treatment expenses have been paid.

NHRC also intervened in the case and stated that the NHRC has also formulated some suggestions regarding strengthening regulations for the conduct of Clinical trials in the interest of patients and wishes to submit its report.

Hon’ble Supreme Court hence reiterated that India is becoming heaven for MNCs pharma industries to conduct clinical trials but are proving hell to the Country. The Court then directed the Ministry of Health and Family Welfare to organize a meeting of all Chief Secretaries/ Secretaries of Department of Health of all States/UTs within 4 weeks to discuss the present legal framework related to clinical trials .The Court also stated that the Ministry may consider the suggestions from NGOs, NHRC & other bodies in this regard.

The Court directed the Ministry to file affidavit after the meeting is convened and regulation is put in place.

The Hon’ble Supreme Court also acknowledged and appreciated that because of the efforts made by the Petitioner Swasthya Adhikar Manch , the regulatory framework and changes in conduct of clinical trials has taken place.

Mr. Sanjay Parikh also represented the Bhopal Gas Peedith Mahila Udyog Sangathan (BGPMUS) and the Bhopal Gas Peedith Sangarsh Sahayog Samiti (BGPSSS) who are interveners in this case.
Swasthya Adhikar Manch has regularly brought to notice the fact that Indian citizens are being exploited by multinational drug companies using the loopholes and lacunae in law and regulatory framework.
The next hearing scheduled for 24th Sep 2013.
AmulyaNidhi (9425311547) ChinmayMishra (9893278855) – SAM
N.D.Jayaprakash (9968014630)-BGPSSS, AbdulJabbar (9406511720)-BGPMUS
[email protected])
Visit – www.unethicalclinicaltrial.org

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US agency confirms suspension of India clinical trials

The NIH, an arm of the US health department, has cancelled approximately 40 ongoing clinical trials in the country. Photo: Mint

 

NIH says recent clinical trial regulations in India have affected some its studies
Vidya Krishnan , livemint.com
 
New Delhi: The National Institutes of Health (NIH), the state-owned medical research agency of the US, has finally confirmed that it has put on hold all clinical trials in India, following the health ministry’s efforts to tighten related laws.
“Recent clinical trial regulations in India have affected some NIH studies,” the NIH said in a 19 July statement. “Some trials have stopped enrolment and some others have been postponed.”
The NIH, an arm of the US health department, has cancelled approximately 40 ongoing clinical trials in the country, Mint reported on 11 July. NIH had declined comment at that time.
The health ministry relaxed some of the new rules it put in place, after realizing that these could effectively kill India’s growing clinical trials industry, according to a note posted on its website on 10 July. These tighter laws were instituted following the Supreme Court’s intervention.
The clinical trials business in India is estimated to be worth around $500 million (Rs.2,970 crore), according to researcher Frost and Sullivan, which projects that it will grow to $1 billion by 2016. Industry experts estimate a loss of $150-200 million in the past six months on account of regulatory changes.
After industry lobbying, the ministry has already relaxed norms—one concerning compensation and another that said the tests could have only the desired or intended effects, and no other.
India approved 475 clinical trials for “new chemical entities” not used as drugs elsewhere in the world, according to documents submitted by the Drugs Controller General of India in the Supreme Court, between January 2005 and June 2012.
The documents said that 11,972 adverse effects, excluding deaths, were reported in the period, with 506 of these being directly attributable to the trials. They put deaths from trials at 2,644 in the past five years.
In a 3 January ruling, the apex court revoked the powers of the Indian drug regulator to approve trials for new chemical entities, placing the responsibility on the health secretary, who was asked to personally vet all approvals. Since then, only six trials had been approved until this month, when the ministry cleared 50 trials at one go.
“We believe the protection of research participants involved in clinical trials is an ethical imperative and we commend the substantial efforts being made to review the oversight of clinical trials in India,” the NIH said in its statement. “We are following developments surrounding the amendments to the Drugs and Cosmetics Rules, and are hopeful that additional information and guidance surrounding their implementation will pave the way for our continued joint endeavours.”

 

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