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....

In order to strengthen the scientific review and approval of new drugs/devices, the ministry has appointed 12 New Drug Advisory Committee’s (NDAC), Subject Expert Committees (SEC) and 7 Medical Device Advisory Committee’s...

It is acknowledged within the pharmaceutical industry that clinical trials represent the single most expensive aspect of a drug, or treatment, development process. Specifically, clinical trials are enormously resource-intensive and involve repetitive,...

It has been decided by the Expert Committee constituted by the Ministry of Health & Family Welfare that there should be provision for providing ancillary care to patients suffering from any other...

The 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...

In the Drugs and Cosmetics Rules, 1945 (i) After rule 122DAA, the following rule shall be inserted, namely;- “122-DAB – Compensation in case of injury or death during clinical trial- 1) In...

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...