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Updated: December 26, 2013 01:55 IST

Ruling on clinical trials is in national interest: Azad

Aarti Dhar
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Union Health Minister Ghulam Nabi Azad. Photo: V. Sudershan
The Hindu
Union Health Minister Ghulam Nabi Azad. Photo: V. Sudershan

But it is a setback as there is a 50% drop

Union Health Minister Ghulam Nabi Azad on Wednesday admitted that the recent Supreme Court ruling on, and stringent regulations for, clinical trials had set drugs research back in India. But he was hopeful that the sector would gather pace again.

“We received a setback because not many pharmaceutical companies are coming forward for clinical trials now. There has been a 50 per cent drop in clinical trials after stringent regulations were put in place, but we are hopeful that they will pick up in the coming days,” he told The Hindu.

The changes were meant to protect the national interest and to do justice to those who participated in the trials, he said.

The Ministry has laid down tough rules to make companies liable for the death of, or injury to, any drug trial subject. Even permission for such trials is given after a rigorous process. Simultaneously, the Supreme Court suspended 157 previously approved trials pending review by new committees. This slowed down new trials, especially those by foreign companies or those being lined up with foreign collaboration.

The Supreme Court’s order came in response to a public interest litigation petition by a health rights group, Swasthya Adhikar Manch, which said trials in India had exploited poor patients, who were not even aware that the drugs were still being tested.

India made sweeping changes to the rules of the Drugs and Cosmetics Act, 1940, which governs clinical trials, making it mandatory for the principal investigator of the pharmaceutical company to reveal the contract between the subject and the company to the Drugs Controller-General of India. “Earlier, the informed consent of the persons on which the trials had been conducted was often manipulated by the companies to the disadvantage of the subjects,” Mr. Azad said.

Videography of the process of informed consent, with the full knowledge of the participant, had been made mandatory, and any death during a trial would have to be reported to the DCGI within 24 hours, he said.

The Drug Testing Advisory Board was the only body for granting permission for trials.

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A committee should be formed to check, if there is a political motive
to move trials out of India.
Thousands of professionals have become jobless – Has Supreme Court
thought about this, before making a decision?
Message to ALL Media person’s and supreme court – clinical trials are
not just done in India, its done globally and if we don’t do this,
there will be millions of death as we will never know, if medicines
are working on Indian populations or not.
The standard of care in clinical trials is much higher than what we
have in Indian hospitals. Lakhs of patients die due medical negligence
is any NGO worried about this?
Thousands of patients die by taking herbal medicines, churan, baba ka
thulla etc- Is any one raising any concerns?
Lakhs of Indians die due to road accidents, are we waiting for NGO’s
to file PIL to take actions.
Kindly address the real issues and don’t take decisions, just to cover
to major issues in hand.

from:  Akash
Posted on: Dec 27, 2013 at 20:13 IST

The new regulations are acceptable as there will be ethical conduct of the trial. But earlier also there were ethical conduct of the trial. If Supreme Court provide its decision as soon as possible, then we may get more clinical trials in India thereby better molecules and drug will be exposed to the Indian Population.

from:  Monisha
Posted on: Dec 27, 2013 at 12:16 IST

I appreciate the supreme court getting involved and health ministry taking steps towards better research environment in India. We are talking about approximately 8000 deaths in clinical trials over a 5-6 year period. I believe in India more than 8000 die every day due to various factors that both government and supreme court might know whether it is due to diarrhoea, infections, malnutrition etc. What are they doing with respect to these? I hope highest body in India enforces every government to implement measures for the overall well-being of the people.

from:  Dr. Sreedhar
Posted on: Dec 26, 2013 at 18:15 IST

I appreciate Mr.Gulam Nabi Azad for his comments on clinical trial industry.strict regulations are necessary in india.people who are not aware of clinical research and GCP guidelines should be trained and then better results will come out.

from:  Aijaz malik
Posted on: Dec 26, 2013 at 15:27 IST

This is a good move by health ministry. I agree that pharmaceutical companies are not coming forward for clinical trials in India. but what about those company who are waiting for DCGI approval.

1200 applications are pending for DCGI approval. I request you to kindly give approval to all pending clinical trials. After that other pharma company will come forward for clinical trials.
from:  Dr Rajiv Yadav
Posted on: Dec 26, 2013 at 13:15 IST

Yes, this was good move to get, like all business clean-ups that even the clinical trial business needs to clean up.

Due to a couple of "black sheep" the whole industry has been put on hold! That is the sad part, when many oncology and other patients could have the edge by taking part in legitimate and approved clinical trials, we have stopped all and sundry!

It is sad that even the Supreme court and the ministry has such a small view, over a larger good that this industry was bringing in to patients who had no other help and options.

Though I have been in the industry for 25 years, it is sad that instead of talking to other world regulatory body leaders India is rediscovering the wheel. Slight modifications and stringent methods can be specified by the govt and they are well come so far as they are helping the overall drug development.

Did we not in the past and even now living on drugs tested by 'Foreign Guinea Pigs"?, is it not a shame that we do not want to contribute now?

from:  Gopal Pai
Posted on: Dec 26, 2013 at 12:05 IST

Such a stringent rules of supreme court.

from:  shraddha
Posted on: Dec 26, 2013 at 10:10 IST
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