A shocking revelation of the lack of access to essential medicines in India, despite the approval of thousands in an attempt to generate wider availability has been reported by research teams at Newcastle University, UK and in Mumbai, India. The study published in Journal of Global Health found that policy to open up the market has generated a large number of brands of medicines, but there are still not enough available in the pharmacies.
This study assessed the rational use - those drugs shown to be safe and effective with good evidence - and availability of six essential medicines in 124 private pharmacies in Maharashtra State, India.
In theory, competition within India's vast market for generic drugs should ensure that essential medicines are available in private retail outlets at a price people can afford. However, the study found that despite there being multiple approved products listed in India databases, few were available in private pharmacies at a price people could afford.
"We found that multiple brands of selected medicines are listed in professional and commercial databases -running into thousands - yet only a small fraction were available in private pharmacies."
Thousands of medicines approved, yet few available
The researchers examined the drugs available for six common health needs: artemisinin (malaria), lamivudine (HIV/AIDS), rifampicin (TB control), oxytocin (reproductive health), fluoxetine (mental health) and metformin (diabetes). The study found that for each of the medicines there were multiple approved products listed in Indian databases, 2186 in total.
They found that only metformin was easily available- in 91% of the pharmacies studied- followed by rifampicin which was present in just above half the pharmacies (64.5%). The other four medicines were available in less than half.
In addition, the medicines were also available in fixed dose combinations (FDCs), where two or more drugs are combined in a set ratio in a single dose form, usually a tablet or capsule. There are concerns in India over the safety and effectiveness of these products. In 2007, the Indian regulatory body the Central Drugs Standard Control Organization (CDSCO) banned 294 FDCs which had been approved by state authorities but had never received central authorisation; in 2012 a further 45 FDCs were withdrawn.
Dr Millard adds: "The high level of approved products available on the Indian market also raises questions about rational medicine use, that is are they being used in unsafe combinations?"
The authors call for a review of available brands, taking into consideration levels of sale and grounds for approval, and the setting up of a centralised database of registered pharmaceutical products.