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Abstract


Home > Archives

IJPASA-Volume 1 Issue 1 2012, APR-JUN

Pages: 26-34

COMPARATIVE STUDY OF TECHNICAL DOSSIER SUBMISSION IN SOUTH AFRICA AND INDIA FOR ANTIRETROVIRAL DRUGS

Author: Abha Anand*, Jagadish P.C, Syed sajjad Hussen, Sandeep G & N.Udupa

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Abstract

South African drug regulatory authority called MCC i.e. Medicine control council has given several guideline of drugs but not especially for antiretroviral drug for this reason only use of “off-label drugs” in South Africa has become an important part of mainstream, legitimate medical practice worldwide, especially common in oncology, obstetrics, paediatrics, infectious diseases (notably HIV) and rare diseases . Similarly in India CDSCO i.e. Central Drugs Standard Control Organization till the date has been not developed or implemented any specified rule or regulation for antiretroviral drugs in India. National AIDS Control organization provides different guideline for control use of anti retroviral drugs. But still there is lots of difference in technical dossier submission for approval of new drug or generic drug in South Africa. The comparative study of technical dossier submission of both of countries gives an idea to identify the areas where the regulations are aligned and recommend on the proposed framework for Indian market with respect to South African market for antiretroviral drugs.

Keywords: South African drug regulatory authority

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