clinical trials

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Legal Regulation of clinical Trials in India:

Legal Regulation of clinical Trials in India

CLINICAL TRIALS-BASICS.:

CLINICAL TRIALS-BASICS.

The Reality:

The Reality

INDIA- PREFERRED SITE:

INDIA- PREFERRED SITE

INDIA-PREFERRED DESTINATION:

INDIA-PREFERRED DESTINATION

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III phase is most expensive. Conducted on 1,000-3,000 patients, it confirms the therapeutic benefits of a new drug. PhRMA , an association of drug companies in the US spent Rs 2,12,446 crore on R&D in 2008. In the third phase the drug companies spent a whopping Rs 69,022 crore .

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MDC non-traditional research areas. Countries of Latin America and Eastern Europe, besides India, China and Russia, have become the clinical trial hotspots.

LAW?:

LAW?

INTERNATIONAL GUIDELINES:

INTERNATIONAL GUIDELINES

INTERNATION HUMAN RIGHTS DOUCMENTS…….:

INTERNATION HUMAN RIGHTS DOUCMENTS…….

LAW- INDIA:

LAW- INDIA

Schedule Y of DRUGS AND COSMETICS RULES, 1945.:

Schedule Y of DRUGS AND COSMETICS RULES, 1945.

APPLICATION:

APPLICATION

PROTOCOL:

PROTOCOL

INFORMED CONSENT:

INFORMED CONSENT

floodgate of legislation :

floodgate of legislation Sec 14 and 15 of Indian Contract Act which define consent and free consent., Sec.87-92 which provide the element of consent, S.3 of Medical Termination of Pregnancy Act, 1971, Sec 5 of the Pre-Conception and Pre-Natal Diagnostic Techniques (prohibition of Sex Selection)act, 1994,Sec.12 Transplantation of Human Organs Act ,1994

INDIA- ETHICS ON TRIAL:

INDIA- ETHICS ON TRIAL The global clinical trial industry is worth Rs 1,56,870 crore . Clinical trials conducted in India in 2008 were worth Rs 1,345 crore , shows data collected by Ziven Consulting, a Gurgaon -based clinical trial consulting firm. The figure may seem small but is growing at a staggering 65 per cent every year

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The trial business is likely to reach Rs 8,951 crores by 2012. In the next five years, India may conduct about five per cent of the global clinical trials, the firm’s data shows.

WHAT IS WRONG WITH OUR LAW?:

WHAT IS WRONG WITH OUR LAW?

Ignorance of law….:

Ignorance of law…. Registration of trials became mandatory in June 2009, four years after the Act was amended. There is, therefore, no mechanism to track the trials which began before June 2009 and are still incomplete.

2005 amendment to Drugs and Cosmetics Act-Himalayan Blunder:

2005 amendment to Drugs and Cosmetics Act-Himalayan Blunder In India, the earliest big trials were conducted in 1995 by Eli Lilly and Pfizer. Sanofi -Aventis, Bayer, Novartis, Johnson & Johnson, GlaxoSmithKline and Merck followed in mid-2000.

For instance…:

For instance… Conducting trials in India became easy after the 2005 amendment to Drugs and Cosmetics Act, According to this, second and third phase trials of drugs discovered abroad can be conducted in India in the same phase and at the same time as in other parts of the world. Earlier, companies had to repeat the first phase in India . The amendment, which came due to industry pressure, opened the floodgates for companies to conduct trials here.

Absence of law..:

Absence of law.. But there is no law that makes the guidelines binding on those involved in conducting trials. The United States Food and Drug Administration recently said it will not require conformation to the Declaration of Helsinki for trials done outside the US.

PROCEDURE.:

PROCEDURE.

PROCEDURE …ctd:

PROCEDURE … ctd

Surveys and reports,:

Surveys and reports, 2003 the ICMR with WHO had conducted a survey. The ICMR conducted a survey of REC of institutions conducting clinical trials funded by the ICMR in 2006-2007 59 th Report of the Department Related Parliamentary Standing Committee on Health and Family Welfare, May 2012

59th Report of the Department Related Parliamentary Standing Committee on Health and Family Welfare, May 2012 :

59 th Report of the Department Related Parliamentary Standing Committee on Health and Family Welfare, May 2012 ……A mission statement of CDSCO be formulated forthwith to convey in very unambiguous terms that the organization is solely meant for public health…

2003 Survey of ICMR with WHO :

2003 Survey of ICMR with WHO

RTI ,2012:

RTI ,2012 Drugs Controller General of India (DCGI) has admitted to not paying compensation  for any of the deaths that have occurred so far except in 2010-2011. According to information provided by DCGI 288 persons died due to clinical drug trials in 2008, 637 in 2009, 668 in 2010and438in2011.

STORY BEHIND THE COMPENSATION.:

STORY BEHIND THE COMPENSATION. A committee chaired by Maneka Gandhi, probed the compensation matter last year. The committee found that around 438 patients had died due to clinical trials in 2010. However, compensation was paid only to 22 patients because pharmaceutical companies claimed that out of 438, only 22 patients had died because of clinical trials and that the other deaths were unrelated and could have occurred due to various other reasons during clinical trials, such as the patients being already terminally ill or suffering side-effects of unrelated cause. A total of Rs 52,33,000 was paid to the 22 trial victims.

Loopholes in law:

Loopholes in law There is no check on the functioning of ethics committees. This has led to mushrooming of independent committees. Ethics committee shopping has become a norm . When the mandatory approval for trials is refused by one, pharmaceutical companies go to another. Ethics committees are not legally bound to make their decision public.

For instance…:

For instance… The ethics committee of Public Health Foundation of India (PHFI) refused PATH, a US-based non-profit working in collaboration with the Indian government, the permission to conduct a clinical trial for HPV vaccine for cervical cancer in Andhra Pradesh and Gujarat. PATH then approached an independent committee in Vadodara which gave its approval. Seven girls died during the trial.

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Lack of monitoring of ethics committees has resulted in exploitation of the vulnerable section The vulnerable become subjects as that is the only way they can get treatment. In most cases subjects are referred by their personal physician.

For instance.. Victims of Bhopal gas tragedy :

For instance.. Victims of Bhopal gas tragedy Victims of Bhopal gas tragedy were made subjects of clinical trials without their informed consent. The trials were conducted in 2004 at the government-funded Bhopal Memorial Hospital and Research Centre (BMHRC) set up to treat them. They were tested to study the effects of the antibiotic televancin ; tigecycline , which minimises antibiotic resistance; prasugrel , a drug for cardiovascular disorders; fondaparinux , which prevents blood clots; and a combination of the antibiotic cefoperazone and sulbactum , a chemical salt. Cefoperazone is no longer marketed anywhere. Fixed dose combination of cefoperazone with sulbactum was never approved in the US, home base of Pfizer which manufactured it, says Gulhati .

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Except for fondaparinux , none of the medicines were approved for human use, Can any hospital in the US dare to conduct trials on victims of disasters like Bhopal gas tragedy ?

guinea pigs:

guinea pigs Swasthya Adhikar Manch , Indore and Anr . V Ministry of Health And Family Welfare and Others SC has expressed concern over the alleged illegal clinical trial of drugs in the country urging that it is unfortunate that humans were treated as guinea pigs . WP (civil)No, 33 of 2012.

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Clinical trial participants should be respected and hailed as heroes. Taking an experimental drug is like going to war. They are working in the larger public interest

post-trial access to the drug-myth:

post-trial access to the drug-myth The participant is the loser as far as post-trial access to a new drug is concerned. In most cases, the subject is denied the medicine after the trial is complete even if he benefits from it. The medicine takes a long time to reach the market, and when it does it is too expensive. This forces the participant to return to the previous mode of treatment.

Multiple trials:

Multiple trials The ICMR guidelines prohibit more than one trial on a subject unless there is a time gap of at least three months.

Lucrative profession:

Lucrative profession Another RTI reply gives details of amounts received by doctors for conducting trials between 2006 and 2010 at MGM Medical College and M Y Hospital in Indore. Hemant Jain of the paediatrics department made Rs 75 lakh , Anil Bharani of the cardiology department Rs 65 lakh , Ashok Bajpai of medicine Rs 37 lakh and Salil Bhargava of chest and TB Rs 64 lakh . “A doctor’s salary at MGM Medical College is between Rs 60,000 and Rs 75,000 per month.

For instance..:

For instance.. Pushpa Varma , professor at the ophthalmology department of MGM Medical College, reached an agreement with CRO Quintiles Research India Private Ltd to test moxifloxacin , a solution for conjunctivitis. The trial was sponsored by Alcon Research limited, a firm based in Switzerland. The payment was sent to her residential address—61, Juni Karsera Bakhal , Indore. She was paid Rs 26,000 per subject. The trials were done on 35 subjects.

Contract Research Organization and law:

Contract Research Organization and law Regulatory authorities have no control over CROs. They are not mentioned in Drugs and Cosmetics Act and are not required to get registered. Anyone who is trained in clinical research and has good contacts in hospital and laboratories can set up a CRO . Many CROs compromise on ethics. They are called data producing shops. At times they do not report adverse events as it delays completion of the trial, They complete trials at least 30 per cent faster than pharmaceutical companies

Participant safety.:

Participant safety. particulars US INDIA legislations

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