Vaatsalya Clinical is an independent auditing and consulting firm based in Bangalore, INDIA.

We provide full range of GCP, GLP, quality assurance audits on a global basis and have a wide and varied range of clients, both domestic and international clients who are conducting trials or are planning to conduct trials in INDIA

Our team provides a comprehensive range of quality assurance services, including auditing, consulting, validation and training to pharmaceutical, biotechnology, medical devices, and healthcare industries for.

BANGALORE: In a significant move aimed at making clinical trials on human beings more ethical and transparent, the Drugs Controller of India has ruled for the first time that all clinical trials taking place across the country in all areas of health – new drugs, treatments, therapies, surgical procedures and new medical devices – must be compulsorily registered. The rule will come into effect on Monday 15 June 2009.

Simply put, clinical trials and research conducted on human beings can now be accessed by the general public too. Hitherto, research institutions and companies obtained permission from the regulatory authorities and registration of the trials was voluntary.

Now, the Drugs Controller General of India (DCGI) has asked the Indian Council of Medical Research to ensure that while granting permission for clinical trials, the applicants are advised to get the trial registered before initiation of the study. The new rule mandates that trials should be registered before the enrolment of the first patient. Not just fresh human trials but even ongoing trials must be registered, the DCGI has said.

Source :  TOI

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