Clarification and requirements related to Post approval changes as per CDSCO Guidance for Industry for Biological Products
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 all approved Biological Product on yearly basis having all changes compiled in Quality information.
Read MoreREQUIREMENT OF LOCAL TRIAL FOR A GENERIC OR BIO-SIMILAR IN OTHER COUNTRY LIKE USA FOR ITS APPROVAL IN THE COUNTRY
The drugs considered generics and similar biologics (biosimilars) in other countries like USA that have been marketed in such countries for more than four years and have a satisfactory report would be approved for marketing in India
Read MoreFBO must adhere to FSSAI guidelines, published on website of regulator
Health minister Dr Harsh Vardhan stated that food business operators (FBO) have to adhere to the advisories and guidelines issued by FSSAI since 2011, the year the Food Safety and Standards Regulations (FSSR) were implemented
Read MoreFSSAI extends food licensing, registration deadline to February 4, 2015
FSSAI has extended the deadline for obtaining licences and securing registration for FBOs under FSSR, 2011, by six months. The new deadline is February 4, 2015
Read MoreFIXED DOSE COMBINATION OF FLUPENTHINOL & MELITRACEN BANNED FOR HUMAN USE.
On basis of recommendations of the Drugs Technical Advisory Board (DTAB), the Central Government prohibits the manufacture for sale, sale and distribution of Fixed dose combination of Flupenthinol & Melitracen for human use with immediate effect.
Read MoreA Blueprint for Helping Children with Rare Diseases
The U.S. Congress and the Food and Drug Administration have long focused on bringing new therapies to patients with rare diseases, including children.
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Labeling of Cautionary Note under Rule of 97 of Drug & Cosmetic Act – (No. DCGI/MISC/572012)
Rule 97 of Drug & Cosmetics Act 1945, provides for printing caution/ Warning in respect of drugs covered under Schedule H, Schedule G and substance covered under the purview of Narcotic & Psychotropic drugs Act, 1985 for the information of patients, doctors pharmacists and others so that there is no misuse of these drugs.
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Govt forms panels to frame guidelines & SOPs for approval of new drugs, trials, banning drugs
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 (FDCs).
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Test licence for import of small quantity of drugs to be obtained from Zonal office, CDSCO
Transfer of certain functions and delegation of powers to the zonal offices of CDSCO under Rule 22 of the drugs and cosmetic rules 1945