Presently there is no specific provision under Drugs and Cosmetics Rules for payment of compensation in case of clinical trial related injury or death of the subject. However, the Good Clinical Practice...

n the Drugs and Cosmetics Rules, 1945, in Part X-A, after 122Dab, the following rule shall be inserted, namely:- “122 DAC. (1) Permission to conduct clinical trial- The licensing Authority as defined...

In the Drugs and Cosmetics rules 1945, after rule 122DC, the following rule shall be inserted, namely:- 122 DD. Registration of Ethics Committee-(1) No Ethics committee shall review and accord its approval...

This is to inform all concerned vide file no. 112/CDSCO/cosmetic/changes/DDC (I)/2011 Dated 4th july 2013 that “for Import of small quantities of cosmetics for R& D purposes like packaging trials, consumer studies,...

As per notification vide GSR No.332 (E) Dated 23 May 2013 Government had suspended the manufacture, sale and distribution of Dextropropoxyphene and formulations containing Dextropropoxyphene for human use. Its sale already banned...

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,...

According to DCG (I) file No. 4-01/2013-DC (Misc 13-PSC) dated 15 Jan 2013, In respect of FDC Falling under definition of “New Drug” licensed by state licensing Authorities before 1.10.12, without the...

File No. 29/Misc/3/2012-DC (169) 8th Jan 2013 Medical devices which are notified under the provisions of Drugs and Cosmetics Act 1940 requires Registration certificate in Form 41 and Import Licence in Form...