(a) the details of the new Drug applications received by the DCGI during the years 2003 & 2004;
(b) the names of the Drugs and the companies approved during the year 2004 along with the dates of receipt of applications and approval; and
(c) the new FDC combinations permitted for marketing during the year 2004?
THE MINISTER OF STATE IN THE MINISTRY OF HEALTH & FAMILY WELFARE ( SMT. PANABAKA LAKSHMI)
(a) During the year 2003 & 2004 (upto 17.12.2004) the
office of DCGI has received 1057 and 1136 New Drug
applications respectively of various categories of New
Drugs, which includes investigational New Drugs, New Drug
molecules, subsequent approval, new fixed dose combination,
New dosage form, New indication etc.
(b) The evaluation of new drug applications is a complex
process as per Schedule - Y under Drugs & Cosmetics Rules
and varies according to the nature of molecule/drug,
published data and information furnished by the applicants.
Therefore, depending upon the nature of the application, it
may take on an average 3 to 5 years for an applicant to
complete all phase of trials required for approval of
investigational New Drug (i.e. a drug molecule not tested on
human being anywhere in the world); about 1-3 years for the
first time approval of the drug already approved elsewhere
but requiring confirmatory clinical trial, and about 2-3
months for subsequent applications for already approved
drugs. This is however, subject to submission of all
required data as per provisions of Schedule - Y of Drug &
Cosmetics Rules and opinion from experts.
Names of the New Drug molecules approved during the
year 2004 alongwith the name of companies, date of receipt
of application and approval is annexed herewith (annexure-1).
(c) The new fixed dose combination (FDC) permitted for
marketing during the year 2004 is annexed herewith (annexure-2).
ANNEXURE - I
NEW DRUGS (FIRST TIME APPROVAL) APPROVED DURING CURRENT
YEAR, 2004 ALONGWITH NAME OF COMPANIES & DATE OF RECEIPT AND
APPROVAL
Sl. Name of Name of Date of Date of No. Drugs Companies receipt approval
1 Dutasteride M/s. Dr. Reddy`s 26.09.2002 16.02.2004 Lab 2 Gefitinib M/s. Astrazeneca 02.01.2004 17.02.2004 3 Imidapril M/s. Elder 03.04.2001 23.02.2004 Pharma 4 Adefovir M/s. Cipla 16.04.2003 04.03.2004 5 Etoricoxib M/s. Cadila Cadila 05.03.2004 Healthcare, -24.04.2003 Glenmark, Hetero Glenmark 30.05.2003 Hetero 13.05.2003 6 Diacerin M/s. Elder 12.09.1997 12.03.2004 Pharma 7 Nitazoxanide Ms. Ind. Swift 27.12.2002 17.03.2004 Ltd. 8 Trolamine M/s. FDC Ltd. 01.03.1999 20.03.2004 9 Neotame M/s. Nutra Sweet 04.01.2003 22.04.2004 Co. (India) 10 Alfuzosin M/s. Ranbaxy 09.06.2003 14.05.2004 Labs. Ltd. 11 Tiagabine HCI M/s. Sun Pharma 03.03.2003 14.05.2004 12 Ibandronic Acid M/s. Roche 23.12.2003 18.05.2004 Scientific Co. (India) Pvt. Ltd. 13 Memantine HCI M/s. Sun pharma 25.06.2003 19.07.2004 14 Pimecrolimus M/s. Novarits 27.08.2002 23.07.2004 India ltd. 15 Rebamipide M/s. Macleods Ltd. 22.04.2003 28.07.2004 16 Migilitol M/s. Glenmark 27.06.2003 18.08.2004 17 Citicholine M/s. Sun Pharma Elder 20.08.2004 & M/s.Elder -23.12.1997 Pharma Sub - 02.12.2002 18 Everolimus M/s. Novartis 19.02.2004 30.08.2004 India Ltd. 19 Voriconazole M/s. Pharmacia 07.06.2004 09.09.2004 20 Orlistat M/s Intas Pharma 10.10.2003 27.10.2004 21 Deflazacor M/s. Macleods 28.10.2002 02.11.2004 22 Duloxetinet M/s. Torrent 19.05.2003 02.11.2004 Pharma 23 Atomoxetine M/s. Torrent 23.08.2003 09.11.2004 Pharma
ANNEXURE - II
NEW FIXED DOSE COMBINATIONS APPROVED DURING 2004
1 Nateglinide + Metformin 2 Desloratadine + Pseudoephedrine 3 Levocetirizine + Pseudoephedirne 4 S-Atenolol + Hyudrochlorthiazide 5 S-amlodipine + Atorvastatin 6 Amlodipine + Atorvastatin 7 Tamsulosin + Finasteride 8 S-amlodipine + Hydrochlorthiazide 9 Tiotropium + Formoterol Rotacaps/Inhaler 10 Lamivudine(ER) + Zidovudine(ER)+Nevirapine(ER) 11 Gatifloxacin +Dexamethasone Phos. Eye Drops 12 Esomeprazole + Domperidone SR 13 Aceclofenac + Paracetamol 14 Rabeprazole + Mosapride SR 15 Atorvastatin + Ezetimibe 16 Buprenorphine + Naloxone 17 Sucralfate + metronidozole + Lignocain Cream 18 Glibenclamide + Metformin SR 19 Escitalopram + Clonazepam 20 Dorzolamide + Timolol Eye Drops 21 Nebivolol + S(-) Amlodipine 22 Valdecoxib + Paracetomol 23 Amlodipine + Ramipril 24 Rebeprazole + Domperidone SR