FSSAI Draft Norms for E-Commerce FBO’s
To ensure safety FSSAI has come up with draft norms for e-commerce FBO's. It is now mandatory to obtain licenses for all online Food Businesses and supply chain
Read MoreSubject Expert Committee’s Updates
The 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. […]
Read MoreNDAC/MDAC/SEC
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 (MDAC) to advise the CDSCO in making their decisions on approval of new drugs and global clinical trials.
Read MoreCLINICAL TRIAL
It is acknowledged within the pharmaceutical industry that clinical trials represent the single most expensive aspect of a drug, or treatment, development process.
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Sugam Portal – CDSCO Sugam Registration for Online Application
Indian Government has chosen to join the foray and ride the digital wave through SUGAM, launched on 14 November, 2015
Read MoreSummary of New Drug, New FDC and SND as per Drug and Cosmetic Act
Definitions of New Drug, FDC, SND and associated form
Read MoreInsight
Draft Guidelines on Similar Biologics, 2016
Medicinal products which are mainly composed of living tissues or cells are called Biologics
Insight
Regulatory Guidelines for Proprietary Food in India
Food Safety and Standards Authority of India (FSSAI) is actively working in rendering safety and nutritiously balanced food to the people of the country. Recently, the new guidelines for proprietary food in India came into force from August 22, 2016.
Insight
Initiatives on Global Clinical Trials
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 infrastructure, […]