The aim of this study is to assess the availability of six essential medicines in private retail outlets in Maharashtra state. The concept of essential medicines was developed to promote rational use, lower cost, and improve access. This study found that despite the multiple brands of selected medicines listed in professional and commercial databases only a small fraction was available in private pharmacies.

As Table 2 shows, of the six essential medicines surveyed in the 124 pharmacies only metformin had high availability, this was followed by rifampicin at 64.5%, the other medicines where available in less than half the pharmacies studied. Market competition has certainly led to the approval of a very large number of brands of the six study medicines. According to the data we gathered from the three professional databases, the six medicines are represented by 2186 approved products each with different brand names; the commercial database Pharmatrac included 1359 brands with 978 of them marketed in 2011-12. This has not led to high levels of availability in the study pharmacies. The results of this study confirm what the studies mentioned in the introduction found, that in India there remains inadequate access to essential medicines. The strength of this study is that to our knowledge it is the first study of essential medicines in India which compares data on availability in pharmacies with data on pharmaceutical products found in commercial and professional databases.

There are three categories of medicine on the market in India. The vast majority of medicines are generics; these are either “branded medicines” or “branded generics”. In India “branded medicines” are generic drugs manufactured by multinational companies or Indian companies and marketed under their original brand name; these are the most popular drugs in the market. “Branded generics” are bioequivalent to the original product but marketed under another brand name by the same company or any other company [32]. As can be seen from the results of this survey, generic drugs on the Indian market are available in single drug formulations (SDFs) and fixed dose combinations (FDCs). There is also a small number of patented specialised drugs on the market in India such as anti-cancer medicines which are imported from the US and Europe.

Medicine packages in India by law display both the non-proprietary scientific generic name, plus the brand name. However, as previously mentioned, in India medicines are generally marketed and prescribed by brand name, not the scientific generic name. For example, in India, metformin, which is the internationally recognised scientific generic name of the drug, is marketed in the form of different products each having specific brand names (74 of these are listed in Table 4 ). Each product is sold at the Maximum Retail Price which is written on the package; this price is applicable throughout India and varies only slightly according to state level taxation. Each product contains the same medicine, but there is a wide variation in prices between different products and thus cost-effectiveness is not assured.

The results of this survey found that only a few of the approved products listed in the databases were available in the study pharmacies. Furthermore, the frequency of the availability of brands in the study pharmacies showed that only a small number of products were dominating the market; most of the products reported in the survey had frequencies of 3 or less. The reason behind the market dominance of certain products is unknown and more work needs to be done to understand prescribing practices, drug promotional activities including kickbacks, pricing and consumer preferences. A limitation of this research was that as we did not collect data on prices we were not able to explore whether this was a factor in the decision to stock particular brands.

Sales figures show that a large proportion of the 2186 approved products of the six essential medicine are available on the Indian market, but there remain questions about whether this level of market competition leads to wider availability of appropriate medicines and their rational use. For instance a large number of the approved products have zero sales and the reason for this remains unexplained. Across the six medicines in their SDF and FDC forms, zero sales were recorded for 13% to 63% of the available brands in the single year examined (November 2011 to October 2012). There are also questions concerning the safety and effectiveness of the numerous available FDC formulations. 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 [33,34].

The results of the survey show that pharmacies stocked a limited number of brands with considerable variation within and between pharmacies in the brands stocked. There was very high availability of metformin (91.9%) in all study districts and in both urban and rural areas. The national disease control program for diabetes has not been rolled out in all Indian states. In Maharashtra the program is still in its early stages. Metformin is supposed to be available at primary health centres, but this was generally not the case during the period of our study; it was available only in a few public health facilities in Mumbai City District. Diabetes, as a lifelong chronic disorder, provides an assured market for pharmaceutical companies. The high levels of availability in the private retail pharmacies in the four study districts may be accounted for by the poor availability of metformin in public health facilities and the low level of development of the national disease control program in Maharashtra. It may also be the case that metformin has been strategically marketed in the area taking advantage of the low level of public provision.

There was high availability of rifampicin (64.5%) in all study districts with higher availability in urban compared to rural areas. Although the well-established national disease control program for tuberculosis has achieved significant progress over the last decade (RNTCP Status report 2009), studies have reported that 50%-80% of TB patients in India take treatment from private health care facilities [35,36]. Additionally the consumption of first line anti tuberculosis drugs in the private sector market is very high (65%) compared to the use in public health facilities [37].

The study found moderate levels of availability of oxytocin (42.7%) in the study pharmacies, slightly more in the rural areas than in the urban ones. There is a well-developed maternal child health program in India and through this oxytocin is widely available at primary public health facilities, but unqualified staff and poor management of stocks and inadequate storage conditions all contribute towards poor availability of oxytocin in public health facilities and this may account for its availability in the private pharmacies [38-42]. Additionally there is evidence that its availability in private pharmacies has contributed to its misuse to induce or speed labours [38-41].

The study found moderate availability of fluoxetine (41.1%) in the study pharmacies in urban areas and poor levels in rural areas. The national disease control programs for depression and other mental health disorders are not well developed in India. Fluoxetine is included in the Indian national EML but it has low levels of availability in public health facilities. In addition there is a general lack of qualified doctors for prescribing such medicines in primary health care facilities. The low levels of availability in the study pharmacies may also be accounted for by the fact that private sector health facilities for treating depression and other mental health disorders are concentrated at the district headquarters. Other new medicines in the selective serotonin reuptake inhibitors group are now also available in India; this could also be a factor contributing to the low availability of fluoxetine.

With the exception of the urban area of Nagpur, the study showed low availability of artemisinin (33.1%) in both urban and rural private outlets. The national disease control program for malaria is generally well developed in India. However, this was not the case in urban areas of Nagpur district, which would account for the relatively high levels of artemisinin found here in the study pharmacies.

Of all the tracer medicines, lamivudine had the lowest availability in the study pharmacies. The situation was worse in the rural areas where in both Sangli and Dhule only one of the 15 surveyed pharmacies stocked it, and in Nagpur it was not available. The national disease control program for HIV/AIDS in India is relatively new, but it is a high priority program with good levels of funding, and consequently a strong well-staffed infrastructure is now in place. This has improved the availability of anti-retroviral medicines in secondary and tertiary public health facilities in India [43]. Lamivudine is an expensive lifelong treatment and as such the first recourse for people with HIV/AIDS in India is to use free anti-retroviral medicines provided by the national disease control program. This would account for the low availability of lamivudine in the study pharmacies. However, stigma associated with HIV/AIDS remains a problem in India, and this is a major reason why some patients still opt for treatment in private health facilities.

In conclusion, this survey shows that the large number of brands of the six study medicines registered in India, as documented by professional and commercial databases, has not translated into sufficient availability of these medicines in the study pharmacies. A solution would be to strengthen the national disease control programs for conditions associated with the six selected medicines, as they are the major source of free medicines for the large section of the population with limited financial means. In a few instances, this can be attributed to well-functioning public health programs that are a major source of free medicines for the large section of the population with limited financial means. Further strengthening of the national disease control programs for conditions associated with the six selected medicines is necessary as the private sector provision does not sufficiently ensure availability and affordability of medicines.

The present market based system also leads to irrational medicine use. The widespread use of brand names for prescribing is a case in point. It is acknowledged by the Indian Medical Council that the common practice of prescribing medicines by brand names can lead to confusion. In January 2013 it therefore asked doctors to prescribe drugs by scientific generic names to ensure compliance to clause 1.5 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) 2002 Regulations, which contains the provision that every physician should, as far as possible, prescribe drugs with scientific generic names in order to achieve rational prescribing and use of drugs [44]. This would be in accordance with the WHO’s guidance on the use of international non-proprietary names for safe prescription and dispensing of medicines [45]. The issue of the irrational use of FDCs in India has been addressed by McGettigan et al. [33].

In India there is no central database of products approved for manufacture and marketing by State Licensing Authorities. Recently the union health ministry's expert panel has been constituted in a massive exercise to examine and regularise the thousands of FDCs products (over 5000) permitted to manufacture and sale in the country by states without due approval from the Drugs Controller General of India (Ramesh Shankar, June 2014). CDSCO needs to review the number of brands on the market, taking into consideration sales, availability, price and the grounds for approval. There is also an urgent need for a consumer friendly central database which will enable people to verify manufacturing approval, efficacy and compare prices.