Currently, the COVID-19 outbreak is affecting the logistics and transportation of essential commodities, including vaccines and In-vitro Diagnostics(IVDs). Recently importers approached the Central Drug and Standards Control Organization (CDSCO) and shared with...

The Central Drugs Standard Control Organization (CDSCO) acknowledges the potential impact of COVID-19 pandemic on the healthcare system and broader society, and the impact it may have on clinical trials and subjects....

The SARS-CoV-2 virus started in December 2019 and then spread at an alarming rate, mainly to China, Italy, the USA, Iran, Japan, and South Korea and even India. There is no drug...

What are Biological Products? Biological products are used for diagnosis, prevention, treatment and cure of diseases and certain medical conditions and are regulated by the Food and Drug Administration of India. They...

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...

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...