Can India lead the way in neglected diseases innovation?

Expert Review of Anti-infective Therapy, 2005

PLOS Medicine, 2005

The Lancet Global Health, 2013

Background In 1975-99, only 1•1% of new therapeutic products had been developed for neglected diseases. Since then, several public and private initiatives have attempted to mitigate this imbalance. We analysed the research and development pipeline of drugs and vaccines for neglected diseases from 2000 to 2011. Methods We searched databases of drug regulatory authorities, WHO, and clinical trial registries for entries made between Jan 1, 2000, and Dec 31, 2011. We defi ned neglected diseases as malaria, tuberculosis, diarrhoeal diseases, neglected tropical diseases (NTDs; WHO defi nition), and other diseases of poverty according to common defi nitions. Findings Of the 850 new therapeutic products registered in 2000-11, 37 (4%) were indicated for neglected diseases, comprising 25 products with a new indication or formulation and eight vaccines or biological products. Only four new chemical entities were approved for neglected diseases (three for malaria, one for diarrhoeal disease), accounting for 1% of the 336 new chemical entities approved during the study period. Of 148 445 clinical trials registered in Dec 31, 2011, only 2016 (1%) were for neglected diseases. Interpretation Our fi ndings show a persistent insuffi ciency in drug and vaccine development for neglected diseases. Nevertheless, these and other data show a slight improvement during the past 12 years in new therapeutics development and registration. However, for many neglected diseases, new therapeutic products urgently need to be developed and delivered to improve control and potentially achieve elimination. Funding None.

Pharmaceutical and Biomedical Research

The global burden for infectious disease remains high in the developing and underdeveloped countries like Sub-Sahara Africa, South–East Asia and Latin America. Among them, the three major contributors of mortality and morbidity are HIV/AIDS, tuberculosis and malaria which along with neglected tropical diseases (NTDs) are collectively known as “infectious diseases of poverty” (IDoP). There is the strong pressing need for developing new drug molecules for eradication of these diseases. We did a cross-sectional study as per the STROBE guidelines to compare the disease burden and new drug approved for IDoP in India. The findings of this study show that new drugs approvals in India has restricted to the non-communicable diseases only. This mismatch becomes even more apparent for communicable diseases included under IDOP which had only 2.7% share among the total new drug approved during year 2000 to 2017 and only half of them were true innovator drugs. This shows the urgent need to alloca...

PLOS Medicine, 2009

2013

The purpose of this working paper is to explore the feasibility of compiling and synthesizing disease‐specific information to inform the deliberation and discourse on identifying priorities for research to improve health – with a specific focus on the dimensions of public health, implementation science and financing. This working paper is a companion to Working Paper 1, which focused on basic science and targeted product development, including diagnostics, drugs, vaccines, microbicides and vector control products [Working Paper 1: “Priority Research Areas for Basic Science and Product Development for Neglected Diseases” by Sue J. Goldie, Jennifer S. Edge, Christen Reardon, Cherie L. Ramirez].

Journal of Venomous Animals and Toxins including Tropical Diseases, 2011

American Journal of Tropical Medicine and Hygiene, 2012

Health Economics

Funding sources: The authors acknowledge financial support available from Fundação para a Ciência e a Tecnologia, Ministério para a Educação e Ciência (FCT), Governo da República Portuguesa, Doctoral Fellowship POPH-QREN-SFRH-BD-69131-2010. 2 Does global drug innovation correspond to burden of disease? The neglected diseases in developed and developing countries.