24 June 2013
As per Schcule Y of DRUGS AND COSMETICS (IIND AMENDMENT) RULES, 2005,"Clinical trial on a new drug shall be initiated only after the permission has been granted by the Licensing Authority under rule 21 (b), and the approval obtained from the respective ethics committee(s)."
Now our Company is required to submit fees of Rs.50,000/- and Rs.30,000/- to two Ethics Committees of two seperate hospitals to take the Approval of clinical trials.
Please guide the applicability of TDS provision on the same and why.
CAclubindia
