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.