Top killers in India – diarrhea, TB, cardiovascular diseases and pulmonary diseases – rank abysmally low in the country’s clinical trial priorities that is heavily geared towards drug approvals in cancer, a new research study has revealed.
'Law in Numbers: Evidence Based Approach to Legal Reform,' authored by the Vidhi Centre for Legal Policy, says the top seven diseases in the country that accounted for almost half of all deaths in 2012 were associated with only 11.3% of all pharmaceutical clinical trials and 12.3% of all new marketing approvals. The disease that most clinical trials flocked to turned out to be Cancer, which doesn’t figure in the top ten causes of death in the country.
Pharma policy analysts that News18 spoke to said this could be due to the fact that Cancer has a massive market locally and globally unlike poor-man’s diseases such as TB or leprosy – whose numbers are slowly increasing – and kala azar.
Authors of the new report cautioned that regulators cannot be held responsible for this skewed priorities in clinical research. Dhvani Mehta, senior fellow at Vidhi, told News18 that the regulatory authorities could only grant approvals to the proposals that came to them. But most bodies involved in medical research are not focussing on India’s most pertinent needs.
This reflects in the data. There have been no drugs approved from 2009 to 2016 for TB, the second most lethal infectious disease in the country, that killed 480,000 people in 2015, and there are barely any clinical trials going on in this field. Neither has diarrhea, which ranks as the highest infectious killing condition in the country.
There was not nearly enough indigenous research to find new molecules for India’s disease burden, said Mehta. India’s TB burden has now also to contend with the growing multi-drug resistance threat, yet there is no innovation on that front.
India is a place where little research happens on issues relevant to the country, despite being a global clinical trial hub. It often ends up as one centre in a global multi-centric trial for drugs that are relevant to other countries’ markets.
Nivedita Saxena, co-author of the new report, felt this was a long-standing trend.
She referred to a paper in the British Medical Journal that examined trials in India from 2009 to 2010 and found that these trials often had market authorisation in the United States and the European Union but not in India.
The concept for this report, she said, came from a 2012 Parliamentary Standing Committee that had raised serious concerns over the drugs gaining approvals in India, largely without the mandatory Phase 3 trial, stating that none had relevance to India’s medical needs.
According to Vidhi's data, some of the large-scale trials in India from 2013 onwards were Fesoterodine in 2013, a drug to regulate overactive bladder syndrome, and duac gel in 2014 for acne. For cancer, some drugs that were approved were trastuzumab and rituximab.
Though research into cancer carries much significance, Saxena said that there was a tendency to approve trials for minor improvements to existing drugs and for types of cancers that affect very few people in India, as seen in the dactolisib clinical trial.
This mismatch stems from the way India’s pharmaceutical industry has grown, with very strong capabilities to reverse engineer patented drugs to create cheap drugs and next to none innovation, and in the fact that trials are still in the domain of private entities.
Bioethics and global health researcher Anant Bhan, who was involved in the process of drafting India’s National Ethical Guidelines for Biomedical and Health Research involving Human Participants, said that till the research was driven by profit margins such results were not surprising.
Like Mehta, he too stressed on the importance of encouraging indigenous research by supporting domestic scientific bodies and institutions.