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 […]
Read MoreImport of Cosmetics Tested On Animal Prohibited
The central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs and Cosmetics Rules, 1945
Read MoreSecond Amendment in Drugs & Cosmetics Rule, 2013
In the Drugs and Cosmetics Rules, 1945, in Part X-A, after 122Dab, the following rule shall be inserted, namely
Read MoreThird Amendment in Drugs & Cosmetics Rules, 2013
In the Drugs and Cosmetics rules 1945, after rule 122DC, the following rule shall be inserted
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First pill to prevent HIV is only for some patients
First pill to prevent HIV only for some patients to reduce new HIV cases.
Read MoreImport of small quantities of cosmetics
for Import of small quantities of cosmetics for R& D purposes like packaging trials, consumer studies, shelf life studies and transport studies, necessary permission will be issued by the concerned port offices of CDSCO on case to case basis
Read MoreRegulation/Guidelines
First amendment in Drugs & Cosmetics Rules 2013
In the Drugs and Cosmetics Rules, 1945, After rule 122DAA, the following rule shall be inserted, namely
Regulation/Guidelines
Guidelines on “Similar Biologics: Regulatory requirements for Market Authorization in India” will be implemented from 15th September 2012.
The “Guidelines on Similar Biologics” prepared by Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT) lay down the regulatory pathway for a similar biologic claiming to be similar to an already authorized reference biologic.
Regulation/Guidelines
Fourth Amendment in Drugs & Cosmetics Rules, 2013
Following are the rules to amend the Drugs & Cosmetics Rules, 1945, namely-These rules may be called the Drugs & cosmetics (Fourth Amendment) Rules, 2013