The "Guidelines on Similar Biologics" prepared by Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT) lay down the regulatory pathway for a similar biologic claiming to be similar...

G.S.R. 588(E) – whereas certain draft rules further to amend the Drugs & cosmetics Rules, 1945, were published, as required by sections 12 and 33 of the drugs & cosmetics act, 1940...

The requirement of local trial for a generic or similar biological (Bio- Similar) in other country like USA for its approval in the country, it has been decided that the drugs considered...

  By Jill Hartzler Warner, J.D.   The U.S. Congress and the Food and Drug Administration have long focused on bringing new therapies to patients with rare diseases, including children. Two years...

It has been decided by the Expert Committee constituted by the Ministry of Health & Family Welfare that waiver of Clinical trial in Indian population for approval of new drugs, which have...

As per the decision taken by the Expert Committee constituted by the Ministry of health & Family Welfare, all the Sponsors/ clinical trial applicants should ensure that the number of clinical trials...

NEW DELHI: Multinational pharmaceutical companies keen to conduct clinical trials for new drugs on Indians would have to ensure an early launch of those therapies in India if the trials result in...

It has been decided by the Expert Committee constituted by the Ministry of Health & family Welfare that all the sponsors/ manufacturers/ clinical trial applicants have to provide compensation to the trial...