The Indian government has brought about some major changes with regards to the rules and regulations governing the manufacturing to enhance the quality of products used in the healthcare industry. As India...

BIOLOGICS AND BIOSIMILARS Biologics are medicinal products which are mainly composed of living tissues or cells. Sometimes, they are living entity- derived products used for the treatment or prevention of a disease....

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...