E-drug: Ethics of clinical trials (cont'd)
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Since the trials are to be conducted in India, all protocols need to be
approved by the Drugs Controller General, India (DCGI)in terms of
Schedule Y and Rule 122-E of the Drugs and Cosmetics Act. India
has its own ethical standards which are legally mandatory. DCGI will
accept trials only if these standards are met.
Trials for Phase I are not permitted unless the drug was discovered in
India. For drugs not discovered in India, trials are permitted only one
step below the studies conducted outside India. For example if a drug
has undergone trial at Phase III outside India, then Phase II are
allowed.
Approval by DCGI is subject to clearance by Hospital Ethics
Committee who have to follow Ethical Guidelines of the Indian
Council of Medical Research (ICMR). Studies in special groups, such
as pregnant women, are permitted only if the drug is meant for
pregnant women only.
All violations of drug laws are criminal in nature and are not
compoundable.
Dr. Chandra M. Gulhati
Editor, MIMS INDIA
(Monthly Index of Medical Specialities)
503 Mansarovar,
90 Nehru Place,
New Delhi 110019
India.
e-mail: seeemgee@yahoo.co.uk or mims@ndb.vsnl.net.in
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