(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