The crisis in access to essential medicines in India: key issues which call for action
Author: Anurag Bhargava, SP Kalantri | DOI: https://doi.org/10.20529/IJME.2013.028
The government is planning to introduce free generic and essential medicines in public health facilities. Most people in India buy healthcare from the private sector, a compulsion that accounts for a high proportion of healthcare-related expenditure. To reduce the burden of healthcare costs, the government must improve availability and affordability of generic and essential medicines in the market. It can do so because India’s large pharmaceutical industry is a major source of generic medicines worldwide.
In this article, we discuss three factors that have impeded access to generic and essential medicines: mistaken notions among policymakers, prescribers and patients about branded drugs and generic drugs in India; high prices of medicines due to the progressive dismantling of the system of regulation of medicine prices, and a drug approval and regulatory system that allows medicines (including fixed dose combinations) of doubtful efficacy, rationale, safety and public health relevance to dominate the market at the cost of access to affordable generic and essential medicines. The consequences of ill-health and wasted expenditure on drugs raise issues of public health ethics.
Improving access to essential medicines in India is an urgent public health and ethical imperative. This should include improved public provisioning, a system of regulation of drug prices, and an evidence-based drug approval process.
In India, a silent crisis in access to essential medicines confronts most patients who seek treatment of acute and chronic diseases. Close to 40% of Indians live on less than US $1 per day and most of them pay out of pocket for using healthcare. Out-of-pocket spending in India is over four times higher than public spending on healthcare. Unexpected illness can have a catastrophic effect on the family of the ill person: direct out-ofpocket payments could push 2.2%% of all healthcare users and one-fourth of all hospitalised patients, into poverty in a year (1, 2).
In addition, most Indians pay for medicines – a key factor that can contribute to the impoverishing effect of out-of-pocket payments for healthcare. According to the World Health Organization (WHO), an estimated 649 million people in India do not have regular access to essential medicines (3). Public provision of these medicines is poor; the median availability of 30 essential medicines in six states in India varied between 0% and 30 % (4). Patients are forced to buy medicines from the private market, a compulsion that often spells calamity for those who can ill afford the twin burdens of sickness and healthcare costs.
For example, India has the largest number of patients with diabetes in the world. A study has shown that patients belonging to the low income group in urban India were spending 27% of their annual income and those in rural India 34% of their annual income on diabetes care; most of this was spent on purchase of medicines (5). A recent study calculated the expenditure incurred on outpatient treatment of community-acquired pneumonia as a proportion of the mean per capita expenditure on food (6). Urban patients spent 17.6 % of their mean per capita expenditure on food (rural patients spent 23.4%) on the medicines prescribed for communityacquired pneumonia (6). Studies have also shown that of the rising out-of-pocket expenditures on healthcare, which push an estimated 32-39 million people below the poverty line annually (1, 7) more than 70% of expenditure was incurred on purchase of medicines (1, 7, 8).
The reality of healthcare in India is that the private sector now caters to 80% of outpatient and 60% of inpatient care (9). Patients are therefore forced to purchase medicines from the market, which functions (and is being allowed to function) in a manner antithetical to India’s public health needs. Not only do public health systems fail to provide essential drugs to patients, but the Indian pharmaceutical market is flooded with overpriced medicines that are inappropriate and irrelevant to the public health needs of the country.
The lack of access to essential medicines — 348 drugs are listed in the national list of essential medicines of India (10) — is the result of the inadequate budgetary provision for healthcare, the lack of a comprehensive policy on medicines in India, and a weak regulatory framework which allows medicines to be produced, promoted and prescribed without assurance of their rationality, quality or reasonableness of price. To reduce healthcare costs, it is important that people are able to access medicines of assured quality that are efficacious, safe and affordable. These essential medicines must satisfy the priority healthcare needs of a majority of the population and must be available as part of a basic healthcare system (11).
Government announcement on free generic and essential medicines
Some activities in 2012 suggest that this scenario might change. In February 2012, partly as a response to the persistent demands of civil society and the recommendations of the High Level Expert Group of the Planning Commission, the government announced plans to increase the outlay for health to 2.1% of the gross domestic product by the end of the 12th Five Year Plan (2012-17). The President’s speech in the budget session of 2012 referred to plans by the government to ensure universal access to free generic essential medicines in public health institutions in a time-bound and phased manner (12). This plan was also referred to by the Prime Minister in his 2012 Independence Day address (13). This was a welcome announcement (even if long overdue) articulated at the highest level of the government, although a year later the scheme has still not received adequate budgetary allocation to allow for its launch. If translated into reality by exercise of political will, good governance and allocation of adequate resources, it can revitalise the public health system in India.
In this article, we discuss three factors that have impeded access to affordable generic and essential medicines in India: (1) mistaken notions among policymakers, prescribers and patients about branded drugs and generic drugs, (2) high prices of medicines due to progressive dismantling of the system of regulation of medicine prices, and (3) a drug approval and regulatory system that allows medicines (and fixed dose combinations) of doubtful efficacy, rationale, safety and public health relevance to dominate the market at the cost of access to affordable generic and essential medicines.
- Mistaken notions of ‘branded’ and ‘generic’ medicines in India
- Overpricing of medicines in India: the imperative for price regulation
- The need for evidence-based drug approval and improved access to essential medicines
Lessons from successful initiatives in improving access to essential medicines
As the government endeavours to improve the availability of medicines in public health facilities, it would be beneficial for it to incorporate lessons from some successful initiatives in improving availability of essential medicines. Beginning October 2, 2011, Rajasthan state has started supplying free medicines at public health facilities. Since 1994, Tamil Nadu Medical Services Corporation has ensured ready availability of all essential drugs and medicines in the government medical institutions throughout Tamil Nadu by adopting a streamlined and transparent procedure for their procurement, storage and distribution. This quality-assured process of pooled public procurement has several features worthy of replication at the national level (63). A similar initiative has been implemented in Delhi state (64).
These initiatives have succeeded in procurement of unbranded essential medicines at very low prices, eliminating irrational medicines and unscientific fixed dose combinations. They have shown that given political and administrative will, it is not difficult to gather support from healthcare professionals for improving access to healthcare and decreasing the burden of expenses for patients, while achieving substantial savings in cost for the public exchequer.
The common people who purchase medicines at nearly half a million chemist shops in India, every day, await a similar exercise of political and administrative will of the government to improve access to low-cost drugs in the public health facilities. As this article goes to press, the quantum of funds for the free generic medicines scheme is not known as it did not appear in any line item in the budget for 2013-2014.The Working Group on Food and Drugs Regulations for the 12th Plan has estimated that an allocation of just Rs 5,000 crore per year would suffice to fulfil the central government’s share (85%) of the cost of the ‘free medicines for all’ scheme (65).
Direct out-of-pocket payments push one out of 45 healthcare users into poverty in a year; this number would fall to just one of 200 if healthcare users do not have to pay out-of-pocket for purchase of medicines (2). Reduction of this out-of-pocket spending on medicines which is impoverishing people by the millions is an ethical imperative for public health in India.
In conclusion, the plan to improve access to essential medicines through improved provisioning in public health facilities is a welcome initiative. However, given the current realities of the healthcare system in India and the catastrophic effects of outof- pocket payment on purchase of medicines being borne by the poor, making essential and rational medicines affordable in India is also an urgent imperative.
The government must correct the present distortions around the concept of generic medicines in India by providing quality assurance of medicines, emphasising the equivalence of different branded or unbranded medicines, and allowing the emergence of a true generics market, where different products can compete on price rather than on brand image. Prescription by generic name in all public health facilities should be mandated. The market should be made to move towards single ingredient, unbranded medicines.
To address the anarchy of drug prices which is impoverishing people, we need a comprehensive cost-based system, and not the market-based system of price regulation. The drug approval system in India needs to be overhauled on the lines suggested by the recent parliamentary committee which looked into the functioning of the CDSCO (58). The process of drug approval needs to be rigourous, evidence-based, transparent, and in line with the interests of public health in India. The government should address the lack of single-ingredient essential medicines in India for priority health conditions. All FDCs which lack a pharmacological rationale, contain ineffective or hazardous combinations, or are illegally approved by state drug controllers need to be removed from the market. The present predicament, of poverty of access to medicines amidst a plenty of overpriced, non-essential medicines which worsen poverty, should not be allowed to continue to imperil the lives and health of Indians.
Disclaimer: Anurag Bhargava contributed to this article in his personal capacity. The views expressed are his own and do not necessarily represent the views of the Himalayan Institute of Medical Sciences or HIHT University.
|Table 1: Look alike and sound alike brands in India|
|LONA||Low sodium salt||Dabur||For use in hypertension, heart failure|
|Lona||Clonazepam||Triton Healthcare||In epilepsy|
|AZ||Albendazole||Cure Quick Pharma||Worm infestation|
|AZA||Vitamin C, Lycopene, Vitamin A, Zinc, Selenium||Moraceae||Vitamin and mineral supplement|
Source: CIMS July 2012, company websites
|Table 2: Overpricing in medicines in India|
|Name of drug||Use||Unit||Lower priced generic||Highest priced generic||MGIMS Sevagram Price (2012)|
|Risperidone 1 mg tablets||Psychosis||10 tablets||Sizomax (RPG) Rs 14||Risperdal [J&J (Ethnor)] Rs 135||Rs 135Riz (Alkem Lab) Rs 13.90|
|Amlodipine 5 mg tablets||Hypertension||10 tablets||Amlibon (Novartis) Rs 15||Amlogard (Pfizer) Rs 79||Biodepine (Biochem Pharma) Rs 4.40|
|Enalapril 5 mg tablets||Hypertension||10 tablets||Myoace (Merck) Rs 16.75||Envas (Cadila) Rs 46.07||Encardil (Medley) Rs 24.75|
|Atenolol 50 mg tablets||Hypertension||14 tablets||Ziblok (FDC) Rs 8||Tenormin (Nicholas) Rs 43.96||Ziblok (FDC) Rs 7.70|
|Ramipril 2.5 mg tablets||Cardiac failure||10 tablets||Sclerace (Novartis) Rs 29||Cardace (Sanofi Aventis) Rs 73||Odopril (Blue Cross) Rs 20.70|
|Tamoxifen 10 mg tablets||Breast cancer||10 tablets||Oncomox (Sun) Rs 15.50||Nolvadex(Astra Zeneca) Rs 186||Cytotam (Cipla) Rs 11.40|
|Letrozole 2.5 mg tablets||Breast cancer||10 tablets||Oncolet (Biochem) Rs 99||Femara (Novartis) Rs 1,815||Letrofil (Fortus) Rs 320.45|
|Atorvastatin 10 mg tablets||High cholesterol||10 tablets||GenXvast (Hetero) Rs 10||Atorva (Zydus) Rs 104||Stator (Abbott) Rs 8.80|
|Ciprofloxacin 500 mg tablets||Antibiotic||10 tablets||Zoxan (FDC) Rs 49||Cifran (Ranbaxy) Rs 99||Swiflox (Indswift) Rs 18.40|
|Glimepiride 2 mg tablets||Antidiabetic||10 tablets||K-Glim (KAPL) Rs 15||Amaryl (Sanofi Aventis) Rs 117.40||K-Glim (KAPL) Rs 14.70|
|Ceftriaxone 1 g Inj.||Antidiabetic||vial||Eracef (Brawn) Rs 42.50||Nosocef (Merind) Rs 179||C-One (Abbott) Rs 19.22|
|PiperacillinTazobactum 4.5 g Inj.||Antidiabetic||vial||Pirotaz (Samarth) Rs 280||Zosyn (Wyeth) Rs 967||Tazira (Piramal Heathcare) Rs 138|
|Streptokinase 1.5 million units Inj.||Cardiac||vial||Indikinase (Bharat Biotech) Rs 1,500||Streptonase (United Biotech) Rs 3,450||Glanikinase (GlandPharma) Rs 756|
|Enoxaparin 60 mg Inj.||Cardiac||vial||Enclex (Cipla) Rs 238||Clexane (Sanofi Aventis) Rs 615||Troynoxa (Troikaa) Rs 153|
|Cisplatin 50 mg Inj.||Anti-cancer||vial||Plationco injection Chandra Bhagat) Rs 31||Blastolem (Elder) Rs 511.98||Oncoplatin (Sun Pharma) Rs 47.88|
Source: CIMS India, April-July 2012, www.medlineindia.com. Mahatma Gandhi Institute of Medical Sciences pharmacy rate list (December 2012)
|Table 3: Fixed dose combinations approved by DCGI, to be ‘made only in India’|
|Fixed dose combination||Indication for use|
|Amoxicillin 250 mg + Cloxacillin 250 mg + Lactobacillus spores||Infections|
|Cefixime 100mg + Cloxacillin (as Sodium) 500mg + Lactobacillus (45 million spore) tab||Antibiotic|
|Metformin + Alpha lipoic acid||Diabetic polyneuropathy|
|Enalapril + Hydrochlorthiazide + Paracetamol||Hypertension|
|Ceftazidime 500 mg + Tobramycin 60 mg injection||Infections with Pseudomonas aeruginosa|
|Cefixime 100/200 mg + Cloxacillin250 mg||Upper and lower respiratory infections|
|Alpha Lipoic Acid USP 100mg + Methylcobalamin 1500mcg + Vitamin B6 IP 3mg + Folic Acid IP 1.5mg + Benfotiamine 50mg + Biotin USP 5mg + Chromium Picolinate USP Eq. to Chromium 200mcg Capsule||Treatment of diabetic polyneuropathy|
|Cefixime (SR) 400mg + Moxifloxacin (SR) 400 mg Tablets||For the treatment of lower respiratory tract infections in adults only|
|Nitazoxanide + Ofloxacin||Urogenital infection|
|Vitamin C 500 mcg + Zinc citrate 2.2 mg + Selenium 60 mcg||For Vitamin C deficiency|
Source: http://cdsco.nic.in/ for list of approved drugs for 2006-2011. [cited 2013 Feb 3]
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