Registration of Pharmaceutical drug product in Emerging Market is most demanding task. Regulatory requirements are harmonized in regulated countries by Common technical document (CTD) filing, while there is diversity of requirements in emerging markets. International conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has brought regulatory authorities and pharmaceutical industries of US, Japan and Europe together for various aspects of drug registration but there are is no such harmonized guideline for emerging market except Association of Southeast Asian Nations (ASEAN) and Gulf Co-operation Council (GCC) where harmonization exist in clusters with their mutual concern. The optimization and harmonization requirements has become mandatory and can be examined by the incidence of higher cost involved in availability of drugs, quality requirement of premise and research and development, regional registration requirements. Quality, Safety and Efficacy data has significance importance in dossier registration. Pharmaceutical Industries has to comply with regulatory requirement in Emerging market and for betterment of public Health and safety. The review also explains a brief about different regulatory requirement for Registration of drug product in Emerging market and comparative data for registration of dossier application in Emerging market.

Introduction: Tuberculosis (TB) is one of the top 10 causes of deaths worldwide. India is still a highest TB burden country. There is scarcity of data on TB knowledge from Rajasthan state of India. Materials & Methods: Cross-sectional community based study was carried out at Model Rural Health Research Unit, Jaipur, an unit of Department of Health Research, Ministry of Health & Family Welfare, Government of India. Results: Study reports the result from 1993 adult participants from 10 villages of 2 sub-districts of district Jaipur. About 88.9% of studied participants knew that TB is an infectious disease and it spreads from TB patient to healthy person in close contact. Only 22.3% of participants knew ‘DOTS is the name of treatment for TB’. While, only 58.9% knew ‘sputum is used for diagnosis of TB’ at health centres. Scheduled castes, scheduled tribes and backward classes social groups knew less than the mainstream ‘General’ social group. The observed difference was statistically significant (p<0.05). Logistic regression analysis estimated the relative contribution in knowledge status. Discussion: The knowledge of study participants on transmission of tuberculosis was similar to the knowledge of population in country wide study. They poorly knew that sputum is used for diagnosing the tuberculosis disease; socio-demographic inequity exists in this knowledge too. People from older age groups, underprivileged social groups and minority need extra educational activities.

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