Abstract

DOSSIER PREPARATION FOR CLARITHROMYCIN TABLET AS PER GUIDELINES OF UGANDA AND ITS COMPARISION WITH GUIDELINES OF INDIA

Namrata S. Vani*, Ronak R. Dedania, Vineet C. Jain and Zarna R. Dedania

ABSTRACT

For the sake of satisfactory healthcare and safeguarding the appropriate use of drugs the NDA ensures availability of essential, efficacious and cost-effective drugs to the entire Uganda population. NDA not only guides manufactures about pre-manufacturing and preregistration and their marketing requirements, but also prepare guidelines for the preparation and submission of dossiers of medicinal product in Uganda to ensure their quality, safety and efficacy. The designated authority issues a certificate of registration for a registered product in Uganda and which is of-course for the limited period of time and later on subject to renewal. The prevalence and high risk of H-pylori infection to population of aged between 1 to 15 years Clarithromycin anti-biotic seems to be essential requirement of the large population group in Uganda. The dossiers are submitted in CTD format. The CTD is organized into five modules. For getting marketing authorization, this submission is required to be approved on the guidelines basis. When it comes to India, Clarithromycin often used to treat certain infections like Pneumonia, bronchitis and infections of the ears, sinuses, skin and throat. In India CDSCO suggests the manufacturer / sponsor to submit application on Form 44 for the permission of New Drugs Approval under provisions of D&C Act 1940 and Rules 1945. This Form 44 is essential to make an application for the grant of permission to import or manufacture a new drug or to undertake a clinical trial. The submission needs the suggested format has chemistry and pharmaceutical information in detail while non-clinical and clinical data as per schedule Y. The licencing authority DCGI grants the permission only if it found safe and efficacious in the public health interest on the basis of examinations. There also submission is made in CTD format which includes the 5 modules, having complete information of product and manufacturer.

Keywords: CTD, Uganda, India, Anti-Biotic.