Third Amendment in Drugs & Cosmetics Rules, 2013
In the Drugs and Cosmetics rules 1945, after rule 122DC, the following rule shall be inserted
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 MoreGovernment bans sale and manufacture of pain killer Dextropropoxyphene
As per the notification, Government had suspended the manufacture, sale and distribution of Dextropropoxyphene and formulations containing Dextropropoxyphene for human use.
Read MoreNotification for Cosmetic Registration in India
The provision regarding registration of import of cosmetics into country has been implemented from 31st March 2013. Now, it is mandatory to get the registration done as per the new rules. We, at CliniExperts have a team to assist you for the registration process.
Read MoreNotification for the Submission of Safety and Efficacy of FDC permitted to manufacture but not approved by DCGI
In respect of FDC Falling under definition of “New Drug” licensed by state licensing Authorities before 1.10.12, without the permission of DCG (I), it has been decided that the DCG (I)
Read MoreClarification For Import Of Non-Notified Medical Devices
Non-Notified Medical Devices donot require Registration certificate and Import Licence for import into India
Read MoreRegulation/Guidelines
Import 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
Insight
CDSCO has drafted guidelines for determining Quantum of financial compensation to be paid in case of Clinical Trial related Injury or Death
The Good Clinical Practice (GCP) Guidelines for Clinical Trials of India under para 2.4.7 provides that the research subject who suffers physical injury as a result of their participation in clinical trials are entitled to financial or other assistance
Regulation/Guidelines
Second 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