NEW DELHI: Multinational pharmaceutical companies keen to conduct clinical trials for new drugs on Indians would have to ensure an early launch of those therapies in India if the trials result in...

It has been decided by the Expert Committee constituted by the Ministry of Health & family Welfare that all the sponsors/ manufacturers/ clinical trial applicants have to provide compensation to the trial...

THE Union Health Ministry is working on a proposal to provide accreditation to clinical trial centres, investigators and ethics committees — all of which will kept be out of the purview of...

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...

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...

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...