India has been an attractive destination for clinical trials because of its large population and varied demographics. Despite having tremendous potential, only 1–2% of global clinical trials are being conducted in India. To utilize its full potential with respect to the trained GCP professionals, trained investigators as well as […]
Read MoreThe Union health ministry has constituted two expert committees to formulate policy guidelines and standard operating procedures (SOPs) for approval of new drugs, clinical trials, banning of drugs and Fixed Dose Combinations (FDCs).
Read MoreIn the Drugs and Cosmetics Rules, 1945, After rule 122DAA, the following rule shall be inserted, namely
Read MoreAs 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 its approval to clinical trial protocol.
Read MoreFollowing are the rules to amend the Drugs & Cosmetics Rules, 1945, namely-These rules may be called the Drugs & cosmetics (Fourth Amendment) Rules, 2013
Read MoreThe drugs considered generics and similar biologics (biosimilars) in other countries like USA that have been marketed in such countries for more than four years and have a satisfactory report would be approved for marketing in India
Read MoreThe Central Drugs Standard Control Organization (CDSCO) plays an important role in safeguarding and enhancing public health by ensuring the quality, safety, and efficacy of drugs, cosmetics, and medical devices. It is the Central Drug Authority for fulfilling functions allocated to the Central Government under the Drugs and Cosmetics Act. […]
It is acknowledged within the pharmaceutical industry that clinical trials represent the single most expensive aspect of a drug, or treatment, development process.
Decided by the Expert Committee that there should be provision for providing ancillary care to patients suffering from any other illness during the trial.
