(a) the procedure being adopted for the permission of new drug alongwith the normal time taken for the grant of permission for the new drug; and

(b) the names of the new drugs for which permission has been granted during this year and what is the time taken in each case?

THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI A. RAJA)


(a): Evaluation of a new drug application for market authorization is a complex process. Requirements are prescribed under rules 122 A to E and Schedule `Y` of the Drugs and Cosmetics Rules, 1945. The modalities include inter-alia initial evaluation of chemical and physical characteristics, animal toxicity, pharmacokinetics and pharmacodynamics of the drug, by the office of the DCG (I) and experts. Approval of protocols for clinical trials as well as data generated by various clinical trials, result of testing of new drug by the Central Government lab etc. is further examined. Certain Categories of the drugs viz. Anti- cancer, anti- AIDS etc. are examined on a fast track mode.

The time taken for evaluation of new drug applications varies according to the nature of the molecule/drug and the application. It may normally take more that five years for approval of an Investigation New Drug ( A drug molecule not tested on human beings anywhere in the world), about 1-3 years for the first time approval of the drug already approved elsewhere and about 2-3 months for subsequent applications for already approved drugs. This is, however, subject to timely submission of all required data as per provision of Schedule `Y` of the Drugs and Cosmetics Rules.

(b): A list of New Drugs approved this year (1st January, 2001 to 30th June, 2001) is annexed.


ANNEXURE

NEW DRUGS APPROVED BY DRUG CONTROLLER GENERAL (INDIA) DURING THE PERIOD JANUARY-2001 TO 30TH JUNE 2001

S.No 	NAME OF THE DRUG	CATEGORY       	DATE OF     	DATE OF
						RECEIPT OF  	APPROVAL
						APPLICATION



1. 	Sildenafil        	Men Erectile   	2/6/1998    	8/1/2001
	Citrate           	dysfunction


2.++ 	Triflusalcaps 30  	Prevention of  	25/6/1996   	17/1/2001
	mg                	Thromboembolism


3.++ 	Thymosin Alfa 1   	Anti Hepa-B    	28/10/1994  	17/1/2001
	Inj.


4.+  	Vinorelbin        	Anti Cancer    	6/2/2000    	17/1/2001
	Tartrate Inj.


5.   	Clopidogrel       	Anti Platlet   	5/7/2000    	2/2/2001
				Aggregation
				Inhibitor
6.+  	Indinavir         	Anti Aids      	22/5/2000   	1/2/2001
	Sulphate


7   	Butenafine HCL    	Anti fungal    	11/8/2000   	14/2/2001
	cream 1%


8.   	Mitrazapine       	Anti           	10/4/2000   	14/2/2001
				depression


9.   	Doneprazal HCL    	For            	3/12/1998   	20/3/2001
				Alzheirmer`s
				D.
10.  	Mosapride         	Prokenetic     	29/3/2000   	13/3/2001
				agent
11.  	Bupropion SR      	Smoking        	12/7/2000   	10/4/2001
	Tab.150 mg.       	cessation
12.  	Reloxifen         	Menopausal     	13/10/1999  	4/5/2001
				osteoporosis
13.+ 	Efavirenz         	Anti HIV       	27/4/2000   	6/6/2001
	50/100/200mg
14.  	Moxifloxacin      	Anti           	March 1997  	26/6/2001
				bacterial
15.  	Misoprostol       	Anti ulcer     	3/4/1997    	21/6/2001
16.+ 	Nelfinavir        	Anti HIV       	22/12/2000 	29/6/2001







+    	Anti cancer/anti AIDS or immunosuppressive durgs.
++   	Drugs referred to ICMR and Experts