As per the new regulations under rule 122 DD, CDSCO has made it mandatory for all Ethics committee to get registered with CDSCO so as to get authority to review and accord...

File no. X11026/306/11-BD Dated 18 Jan 2013 In order to update the Quality information of already licensed products in a systemic approach it has been decided to submit the updated PPD of...

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...