REGULATORY REQUIREMENTS FOR MARKETING AUTHORIZATION OF GENERIC DRUG PRODUCT IN BOTSWANA

Mo. Nasiruddin I Pawar, *Darshil B Shah, Dr. Dilip G Maheshwari

ABSTRACT

Immediately after independence in 1966, the pharmaceutical sector became a priority for the Government, and for many years Botswana pioneered numerous areas of pharmaceutical policy, receiving international recognition for this work. The Botswana pharmaceutical market is growing rapidly. It is heavily driven by imports. The majority of pharmaceutical sales in the country are from prescription drugs. There are two procedure by which a marketing authorization in Botswana can be obtained, Registration of Medicine through General format (MH 2048) and Registration of Medicines through CTD & SADC format. These both procedure are applicable to innovator and generic medicines. Branded medicines play an important role in medications, but generic medicines are their cost effective alternatives. Generic Medicines are similar to branded drugs in terms of efficacy, purity and are perceived to be safer as compared to new drug molecules, as they likely to be older and time tested. This review article attempts an insight on the recent regulatory aspects and marketing authorization procedures in Botswana by giving a detailed overview of the both General format and CTD-SADC format for pharmaceutical applicants to make proper marketing applications and market or place their pharmaceutical generic products in the Botswana.

Keywords: Generic drug product in Botswana, CTD & SADC format, Marketing authorization.