Lack of access to essential drugs is a public health problem in India

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A poor girl sits with sack of waste, In India

Even as a scheme to provide health security to 10 crore people hangs fire for many months now, new research has revealed shocking lack of access to essential medicines in India, despite thousands being approved in an attempt to generate wider availability.

Researchers at Newcastle University, UK and in Mumbai, India publishing in the 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.

The report of the High Level Expert Group on Universal Health Coverage commissioned by the erstwhile Planning Commission had highlighted the importance of drugs in UHC. The report reads: “Ensuring effective and affordable access to medicines, vaccines and appropriate technologies is critical for promoting health security. In making our recommendations, we note that:

● Almost 74% of private out-of-pocket expenditures today are on drugs;

● Millions of Indian households have no access to medicines because they cannot afford them and do not receive them free-of- cost at government health facilities;

● Drug prices have risen sharply in recent decades;

● India’s dynamic domestic generic industry is at risk of takeover by multinational companies; and

● The market is flooded by irrational, nonessential, and even hazardous drugs that waste resources and compromise health.” A scheme to provide health cover to 10 crore families has been lying with the cabinet since November 2016.

The present study in JGH 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.

Lead author, Dr Colin Millard from Newcastle University’s Institute of Health and Society said: “What is worrying is that despite efforts to increase availability through market competition there remains inadequate access to essential medicines. 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.”

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.