challenge 4 Indian Clinical Research outsourcing, R&D plans because of a new discovery that Indians are genetically not single large population
“Drug companies engaged in clinical trails could be worried as our research shows that many groups in modern India descend from a small number of founding individuals. A common drug may not be the answer, considering the genetic variation in the Indian population. For instance, medicines tested on the Western population may not be effective on the Indian population,” said Lalji Singh, former director of the Centre for Cellular and Molecular and Biology (CCMB) who has co-authored the research findings on Reconstructing the Indian Population History, said on Thursday.
The work, published in the latest issue of Nature, has medical implications for people of Indian descent. More than three-fourths of India’s over one billion people are burdened with genetic disorders. The study shows that Indians have been genetically different from other groups and this could be a major cause of recessive diseases. The incidence of genetic diseases among Indians is, therefore, different from the rest of the world.
That could spell bad news for Clinical Research Outsorucing to India and Indian CRO companies, FDA can request for Pharmacogenomics supplementary data to prove that, Results of clinical trial are applicable to American populations.
“Drug trials should take into account diseases that are specific to the population,” said Lalji. A senior official of a top Indian drug-maker who did not wish to be identified said that pharma companies, the world over, are alive to the issue as the success of clinical trails and the efficacy of a drug hinges on the gene pool.
Ofcourse they knew about it all the time, Indian Ayruvedic medicine was aware that all humans canot be treated for the sames diseases with same treatment, more than 1000 years ago.
The article is available at Nature Magazine