What information to be given for pharmacological and toxicological aspects of the drug?
An executive summary is to be given mentioning the specific and general pharmacological actions of the drug. Information on toxicity studies, viz, reproductive toxicity, local toxicity and carcinogenic activity should be briefly mentioned. 19 What information should be given in respect of clinical documentation? Nothing specific is to be mentioned. A copy of new drug permission under Rule 122-A is to be enclosed. 20 What information is to be given in case of a special products. A product dossier is to be enclosed for information. 21 What are the specific issues involved for the domestic importers in the present Notification? a) Fees for Test Licence of a single drug has been increased from Rs 15 to Rs 100 and an additional fee of Rs 50 for each additional drug. b) Government Hospital and Autonomous Medical Institution can import new drugs for their own patients in small quantities with a fee of Rs 100 for single drug and a fee of Rs 500 for each additional drug. c) Fees for import lice
