Drug Controller Okays 19 New Drugs
The approval has been granted during the period January-June 1996.
These products will be considered as new drugs for a period of four years from the dates of their first approval.
Once approved by the DCGI, who comes under the ministry of health, the department of chemicals and petrochemicals (DC&P), under the ministry of industry, extends to the `new drug' the status of a decontrolled item.
The company which introduce the drugs will be free to fix its price without reference to DC&P as it will be out of the Drug (Prices Control) Order.
DC&P allows a `new drug' to be kept out of DPCO for four years provided the DCG(I) declares it as a completely new molecule to be introduced in the Indian market.
Among the 19 new drugs being introduced by Nicholas Piramal, three are meant for eye treatment.
Polyvinyl alcohol with povidone and chlorbutanol eye drops is a cure for burning irritation and discomfort due to dryness of the eye.
Levobunolol HCL is meant for controlling intra-ocular pressure in chronic open angle glaucoma and ocular hypertension.
The third product on this line from Nicholas Piramal will be Dipivefrin HCL, which is prescribed for the control of intra-ocular pressure in chronic open angle glaucoma.
In treating various cases of cancer, three drugs have been allowed to be marketed.
Elii Llily in association with Ranbaxy will introduce Gemcitabine injection for management of non-small cell lung cancer. Fulford's Amifostine is a chemoprotective agent.