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.
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.
Read MoreSummary of New Drug, New FDC and SND as per Drug and Cosmetic Act
Definitions of New Drug, FDC, SND and associated form
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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 […]
Read MoreInsecticide Registration
We help our clients in liaisoning process at Central Insecticides Board and Registration Committee
Read MoreRegulation/Guidelines
Coronary Stents are Now Included in the National List of Essential Medicines: Its Impact on Prices, Availability, and Healthcare
National List of Essential Medicines The National List of Essential Medicines (NLEM), 2011, has been reviewed and revised by the Core-Committee constituted by the Ministry of Health & Family Welfare (MOHFW), Government of India. The committee has formulated a new list as per the inclusion and exclusion criteria. The […]
Regulation/Guidelines
Faster Import of Human Biological Samples: No Prior Approval Required!
As per the Director General of Foreign Trade (DGFT) via. the notification on August 4, 2016, (Notification No. 19 /2015-2020), an amendment in the policy of the import and export of biologicals used for commercial purposes has been made. This notification stated that the human biological samples used for […]
Insight
Subject 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. […]