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CGD NOTES
One of the main drivers of the problem of antimicrobial resistance (AMR)—an impending crisis which already causes over 1.25 million annual deaths globally and nearly 300,000 annual deaths in India—is the overuse of antibiotics. While access to antibiotics is key to prevent mortality, insufficient controls on prescription and dispensing can lead to high levels of unnecessary use and thus worrying increases in resistance. Striking the right balance between access and stewardship is a policy challenge for all countries.
India, as one of the biggest antibiotic markets and with the worst drug resistance index, is an important market to understand. The market in India is impacted by different policies at the state and federal levels, and by the availability of antibiotics in both the public and private sectors. The retail pharmacy sector is highly fragmented, with around 800,000 pharmacies and drug shops, only 4 percent of which are chains. These pharmacies are incentivised to maximise profit by increasing sales or dispensing more expensive drugs—and enforcing stewardship regulations on all of them is a significant challenge.
When designing stewardship policies, it is important to understand the role of these private sector pharmacies and how they impact antibiotic consumption patterns. Therefore, we conducted a study—led by Shaffi Fazaludeen Koya—on antibiotic consumption and pricing patterns in India at the national level and in the state of Kerala from 2016–2019, using both private and public sector sales data. We found four key takeaways:
1. The vast majority of antibiotics consumed were oral—but injectables accounted for over one-third of costs.
At the national level, 95 percent of total antibiotics consumed in the private sector were oral. This is unsurprising since oral preparations are more accessible and easily consumable—they can be taken in the community without requiring healthcare professional input—and are the first choice of treatment for many infections. However, despite only accounting for 5 percent of sales by volume, injectable antibiotics accounted for 38.5 percent of sales by price at the national level. This is because they are significantly more expensive—over 10 times more expensive per dose.
2. Even in a state with a strong public healthcare system, the majority of antibiotics were purchased in the private sector.
Kerala has a relatively well-functioning public healthcare system compared to other Indian states. However, the public sector in Kerala only accounted for 40 percent of oral antibiotic consumption and 31 percent of injectable consumption. This is despite the fact that prices per dose across all antibiotic groups were found to be much higher in the private sector—and so only 8.3 percent of spending on antibiotics occurred in the public sector. The fact that patients are still seeking out more expensive drugs in the private sector implies that the public system is insufficient at providing timely access. Given Kerala’s relatively strong system, this implies that the situation may be much worse in other states.
Table 1. Annual share of doses[1] of oral and injectable antibiotics across the public and private sector in Kerala state, 2016–19.
Public Share of |
Private Share of |
Public Share of |
Private Share of Cost (%) |
|
---|---|---|---|---|
Oral |
39.8 |
60.2 |
9.3 |
90.7 |
Injectable |
31.4 |
68.6 |
6.3 |
93.7 |
Total |
39.5 |
60.5 |
8.3 |
91.7 |
3. Consumption patterns across antibiotic classes paint a worrying picture.
The WHO categorises antibiotics as “Access” (which should make up the vast majority of consumption), “Watch” (which are only indicated for a specific, limited number of infective syndromes), and “Reserve” (which should only be used in very rare instances as a last resort). However, among injectable antibiotics, we found that Watch group antibiotics were consumed in nearly double the quantity of Access antibiotics, with a total of 51 percent of privately dispensed injectables at the national level being Watch drugs. While the focus on injectable antibiotics does mean we would expect to see increased levels of Watch dispensing (since many Access drugs are oral), such a high level is concerning since Watch antibiotics are more prone to developing resistance and so should be “prioritised as targets of stewardship programs and monitoring.” Even more worrying is that, among injectable antibiotics consumed in the private sector at the national level, 21.9 percent of doses belonged to the Discouraged group of antibiotics. These are mainly antibiotic combinations which the WHO believe do not have any reasonable indications for treating disease and may negatively impact AMR control and/or patient safety, and thus should not be dispensed at all. On the other hand, Reserve group antibiotics were used in extremely low quantities, making up only 0.61% of sales. This may indicate a concern in the opposite direction—that people with a justified need for these drugs are unable to access them, and are instead being treated with other less effective options.
Table 2. National level consumption and cost of injectable antibiotics in private sector by AWaRe group, 2016–19.
|
Doses Share (%) (Total = 262.6mil) |
Cost share (%) (Total = 75.7bn INR) |
---|---|---|
Access |
26.5 |
15.4 |
Watch |
50.9 |
52.3 |
Reserve |
0.61 |
5.9 |
Discouraged |
21.9 |
26.3 |
Not Listed |
0.01 |
0.05 |
When comparing private and public sector patterns within Kerala, we found the private sector playing a worrying role: disproportionately over-dispensing Reserve and Discouraged drugs. For example, the private sector provided four-fifths of Discouraged doses; and the share of Discouraged doses was 42.5 percent higher in the private sector compared to the share of these doses in the public sector.
Table 3. Volume and share of injectables between private and public sector in Kerala state by AWaRe group, 2016–19.
Public |
Private |
Total Doses (Millions) |
|
---|---|---|---|
Access |
34.0 |
66.0 |
1.8 |
Watch |
33.3 |
66.7 |
4.9 |
Reserve |
25.8 |
74.2 |
0.09 |
Discouraged |
20.8 |
79.2 |
1.26 |
4. Price control alone is insufficient for stewardship.
Reserve group antibiotics are significantly more expensive per dose than Watch group antibiotics, (₹2800 and ₹300 Indian Rupees, respectively, per dose) which in turn are significantly more expensive than Access antibiotics (₹170 per dose). Despite this price difference, as mentioned above, Watch antibiotics are still consumed more than Access antibiotics. In both the public and private sector in Kerala, expensive, later-line antibiotics such as ceftriaxone were consumed in higher quantities than cheaper alternatives such as gentamicin (18.4 vs 10.5 percent of doses in the public sector and 31.4 percent vs 7.8 percent of doses in the private sector). This is even despite the fact that gentamicin is listed as the first choice for many indications in the AWaRe book. Clearly, the higher price is an insufficient form of stewardship—and may even act counter to stewardship goals by incentivising providers to preferentially dispense these drugs to increase revenue. Additional stewardship measures, such as restrictions on the sale of Reserve and/or Watch antibiotics, are required.
Overall, the data show a concerning picture of overuse of important later-line antibiotics, insufficient stewardship, and reliance on the private sector. The reliance on the private sector is concerning, both because it means people are having to pay high out-of-pocket costs—already a significant cause of poverty—and because stewardship was found to be especially poor in the private sector. The dependence of antibiotic consumers in the Indian market on private sector sources demonstrates that antibiotic stewardship initiatives cannot ignore private pharmacies and hospitals. Conducting similar studies in other countries will be important to understand how best to implement stewardship initiatives in different regions.
[1] We used Defined Daily Dose (DDD), which is the assumed average maintenance dose per day used for the main indication in adults.
Disclaimer
CGD blog posts reflect the views of the authors, drawing on prior research and experience in their areas of expertise. CGD is a nonpartisan, independent organization and does not take institutional positions.
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