The Drug Controller General of India (DCGI) has approved 12 new drugs during the period January to June 2000. In a recent official communique to all local Drug Control Authorities, the Central body has informed about the approval of the new drugs.
The drugs that have been granted permission in the country during this period will be treated as new drugs for the next four years and thereby, the authority to clear applications for manufacturing or marketing licenses of these drugs will be vested with the DCGI only for four years from the date of the initial drug approval.
The new drugs approved by the Central Drug Authority are Oxiconazole, Temozolamide, Olanzapine, Fluvoxamine Maleate, Celecoxib, Nevirapine, Repaglinide, Ganciclovir, Trapidil, Rofecoxib, Rosiglitazone Maleate and Irbesartan.
Among the new drugs approved by the DCGI, Repaglinide and Rosiglitazone Maleate are under the category of anti-diabetic and Celecoxib and Rofecoxib are NSAIDs. The other drugs - Oxiconazole, Temozolamide, Olanzapine, Fluvoxamine Maleate and Nevirapine are catogorised as anti-fungal, anti-cancer, anti-psychotic, anti-depressant and anti-HIV respectively. The new drugs such as Ganciclovir and Irbesartan are suggested for the treatment of viral attack and Hypertension respectively and Trapidil is an adjunct in Angioplasty.
The dates of approval of these drugs are as follows:
Name of the Drug
Date of Approval
Oxiconazole
17.01.2000
Temozolamide
17.01.2000
Olanzapine
27.01.2000
Fluvoxamine Maleate
21.02.2000
Celecoxib
22.02.2000
Nevirapine
06.03.2000
Repaglinide
23.03.2000
Ganciclovir
05.04.2000
Trapidil
11.05.2000
Rofecoxib
26.06.2000
Rosiglitazone Maleate
28.06.2000
Irbesartan
26.06.2000.