Indian CRO ( Clinical Research Outsourcing ) Industry " Panel Requests Tighter Rules Against Clinical Trials"

I do not know how much impact the following will have and if anything will change... My opinion is that a lot of this is noise...but it certainly is something to keep in mind for those of you involved in Clinical Research Outsourcing to India. It is from Times of India:

"The committee has raised concerns over implementation of the good clinical practice guidelines (GCP) and ethical norms.

"Though the concerns regarding involvement of women in clinical trials have been specifically addressed in Indian GCP guidelines, the committee is doubtful whether these are being followed in letter and spirit," the report said.

Adding that most scandals about clinical trials revolved around issues like whether the patient knew about being part of the trial, whether informed consent to participate was taken or not and whether the patient was told about the possible side effects and risks.

The committee has asked the government to make the conditions for clinical trials more "stringent" and introduce clear guidelines on compensation. The committee, headed by Delhi MP Krishna Tirath, recommended an amendment to schedule Y making the trials easier.

The committee reviewed the family planning methods prevalent and opined that the entire contraception programme of the government had become women-centric and male sterilization had been put on the backburner. "

Source: http://timesofindia.indiatimes.com/rssarticleshow/3010486.cms

Comments

[kritika]

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