Study on ‘Access to Medicines for which clinical trials were conducted in India’

Sama undertook a research study from 2015- 2016 exploring accessibility and affordability of drugs for which trials were conducted in India from 2005- 2010. The study has emerged as a logical continuation of the work that Sama has been involved with on various ethical and regulatory issues associated with clinical trials.

Through the earlier research Sama explored the perspectives of clinical trials participants on various facets of clinical trials wherein issues of post trial accessibility and affordability to drugs emerged. Often the drug tested is not marketed in the country and even when marketed it is so highly priced that it becomes unaffordable to the majority of Indian population. Sometimes the drugs are even irrelevant in the Indian health context. These issues indicated towards the need for a study exploring the affordability and accessibility of such new medicines for the population at large.

The current study focuses on quantitative data from the clinical trial registries, marketing and sales of new pharmaceutical products, etc. The study involved collating and analysing data on clinical trials, approval and marketing of new medicines, patent status, and pricing and sales of these new medicines from multiple sources.

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