Introduction

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.

1. Mistaken notions of ‘branded’ and ‘generic’ medicines in India

In India, confusion and misinformation about generic medicines abound. The confusion is spread across stakeholders including the public, prescribers, policymakers and pharmaceutical trading agencies.

In their 2012 addresses to the nation, the President and the Prime Minister emphasised the importance of access to generic medicines, and rightly so, because worldwide, generic medicines are being seen as an answer to soaring healthcare costs. For example, in the US, not only are six of every 10 prescriptions filled with generic medicines (14), but pharmacists are also allowed to replace branded medicines with generic ones. By contrast, in India, home of one-fifth of the world’s production of generic medicines, a consumer finds it difficult to access low-cost generics. We explain this paradox by clearing the misinformation about branded and generic medicines in India.

A generic drug is defined as a drug product that is comparable to brand/reference listed product in dosage form, strength, route of administration, quality and performance characteristics, and intended use (15). In countries where product patent laws are in effect, the originator firm holding the patent markets the medicines under a trademarked name with no competition for a period of up to 20 years. In these countries, generic medicines are low-cost versions of the innovator product, produced by a number of manufacturers after the patent on the medicine expires. Thus generic medicines are off-patent medicines made by companies other than the originator company, and may be marketed under a trade name (branded generic) or under the international nonproprietary name, or INN (unbranded generic). For example, Paracetamol is marketed as Crocin, Calpol, or Metacin (branded generic), or simply as Paracetamol (unbranded generic). Generic versions of the original patented drug, chemically identical to the originator product, are required by law to satisfy the same standards of quality, and are similar in safety, efficacy, risks, benefits, and intended use. Sceptics often raise the issue of bioequivalence and therapeutic equivalence of generic and brand/reference products. Actually, drug products are considered bioequivalent if there is no clinically significant difference in their bioavailability (as measured by extent and rate of absorption, and maximum blood concentration) (16). Generic drugs are identical and bioequivalent to an innovator brand (17). In the case of oral drugs, if the blood concentrations of two drugs are the same, then their concentration at the site of action and their effectiveness are also considered to be the same (16). There are few cases in which two drug products with the same active ingredient in the same dose may have different bioavailability (18). In all other circumstances, generic and brand name drugs can be considered interchangeable (19). A systematic review of 38 randomised controlled trials of generic and brand named cardiovascular drugs concluded that they were clinically equivalent (20).

The term generics is understood differently in India. In India, there was no patent protection for medicinal products before 2005 (only processes for manufacture of medicinal products could be patented); and the term generic medicines was used for those medicines which were marketed under the generic name (INN). A recent term for generic medicines used by the WHO is multi-source pharmaceutical products , which avoids the prevailing confusion between generic medicines (which can be marketed under a brand name), and the generic (non-proprietary) name of a medicine (21). In countries like the USA, prescriptions for unbranded generics predominate, while branded generics are a small part of the market — 58% of the dispensed prescriptions were for unbranded generics compared to only nine per cent for branded generics (14).

We use the term generic in line with its global usage to denote medicines which are off patent. The term used in this sense would represent virtually all the drugs in the Indian pharmaceutical market, since few enjoy patent protection. In India, the basic division is therefore not between medicines under patent and off-patent medicines, but between unbranded medicines (generic in the Indian sense) and branded medicines. Branded drugs in India are actually branded generics which are often misunderstood by patients, or even the media, as patented medicines (22), which they are not.

The brand scam

Drug makers and pharmaceutical trading agencies create an impression that branded generics are vastly superior to unbranded generics (which are often procured in the public health system and are available to patients free of cost). Even medical professionals consider unbranded generics to be substandard medicines. To add to the confusion, branded generics in India have been artificially divided by academicians and policymakers into two categories: branded products, which apparently refer to drugs made by reputed companies and promoted through doctors, and so-called branded generics , drugs apparently made by less reputed companies and promoted through retailers (23). Patients value quality, safety and cost-effectiveness of a medicine; it matters little to them whether the medicine is branded or unbranded and whether it is promoted through the retailer or the doctor. All drugs in India also have to meet the same requirements with regard to quality, irrespective of whether they are marketed under the INN or trade name, and regardless of the route of promotion.

Drug makers and pharmaceutical trading agencies aggressively promote their brand name drugs, often using dubious means (24). Each brand claims superiority over competing brands or unbranded medicines. The top 50 companies spent Rs 5,840 crore on drug promotion in a single year (25). This practice and cleverly created myths have made it difficult for patients to access low cost medicines in India. The argument that brand A is better than brand B does not hold for a number of reasons.

First, drug makers often market the same molecule under a variety of brand names and at widely differing prices. For example, Ranbaxy uses two brand names to market ciprofloxacin: Cifran (the best-selling brand) and Ciproace (the lesser-known brand). A tablet of Cifran (500 mg) costs Rs 9.90; that of Ciproace Rs 6.20 (26). Does it mean that Cifran kills bacteria faster than Ciproace does? How would Ranbaxy justify the difference in the prices of its two brand names?

Second, drug makers also market both so-called brands and branded generics. A recent study did not find any difference in quality between brands and so-called branded generics made by the same company (23), yet the difference in price is substantial.

Third, medical professionals often indicate that they trust drugs made by highly reputed companies. Their trust is misplaced because reputed companies in India often do not manufacture but only market medicines (which may range from vitamins to very expensive antibiotics). The medicines marketed by reputed companies are actually manufactured by so-called less reputed companies. For example, Glaxo Smith Kline (GSK) is well known for its brands such as Zevit (multivitamin with zinc), Augmentin (amoxicillin-clavulanate: an oral and parenteral antibiotic), and Esblanem (Meropenem: an antibiotic costing Rs 1,200 per gram). Little do the doctors and public know that GSK gets them manufactured by less well-known companies such as Remidex, Medreich and Hospira and merely markets these brands (information from product packages). This is true for hundreds of other companies as well.

Fourth, the companies argue that drugs promoted through chemists are cheaper than those promoted through doctors, because they do not have to offer the incentives and freebies that they routinely offer to doctors. This argument also does not hold because companies promote medicines to doctors as well as chemists (27).Wh ile doctors are offered gifts and even incentives (28), chemists are also offered bonuses on brands and hugely discounted prices on commonly used drugs (30). Recent studies have shown that trade margins in India for branded drugs can vary from 200% to over 1,000% (23, 30). Self-medication practices are widespread across the different socio-economic groups in India, as is the practice of over-the-counter drug dispensing. For minor ailments, consumers often do not see a doctor and prefer to medicate themselves. Blissfully unaware of the profit margins on simple antibiotics, cough syrups, painkillers or anti-histaminics, they end up paying exorbitant prices for the over-the-counter drugs they buy from local chemists (31). Abroad, generics are much cheaper than the originator product (32). Not so in India. The so-called branded generics have a printed maximum retail price which is sometimes even higher than that of so-called branded product (23).

Prescription malpractice

We wish to emphasise that the Indian pharmaceutical market is entirely a generics market, one in which a few branded generics, masquerading as innovator products, monopolise the market. There are thousands of brand name drugs in this market and patients have little access to low-cost branded or unbranded medicines. For patients to access low-cost generic drugs, it is important that drug companies reduce their profit margin, pharmacies stock and promote them and prescribers start writing them. Although the Medical Council of India’s code of ethics for doctors explicitly mentions that Every physician should, as far as possible, prescribe drugs with generic names (33), this practice is seldom followed.

We believe that doctors must write drugs by generic names in both public and private sectors. To begin with, public health facilities must enforce this practice because unbranded medicines are procured and dispensed in these institutions. The usual practice of patients seeking healthcare in the public health facilities being forced to buy brand name medicines from private chemists must be checked (22). The generic-name prescriptions in the private sector haven’t succeeded because private pharmacies either do not stock them or the pharmacists replace low-cost drugs with expensive branded ones. Therefore the government’s advice to all doctors to prescribe by generic name cannot be translated into practice. Also, when doctors prescribe fixed dose combinations (FDCs), they always choose brand name drugs. They argue that because FDCs have multiple ingredients, they find it difficult to prescribe them by their non-proprietary names. Prescribing by generic name in India will take root only when doctors prescribe unbranded single ingredient medicines, and take irrational FDCs off their prescriptions.

Regulatory negligence

The drug regulatory agencies in developed countries like the US, Canada, the UK and Australia promote the use of generics and highlight their therapeutic equivalence to brand name originator products. In India, most prescribers do not know there is no difference, in pharmaceutical terms, between unbranded and branded medicines, or between brands, and the drug regulatory authorities make no effort to educate them. Both doctors and patients prefer brand name drugs over generic drugs because the latter, in their eyes, are low quality and substandard — if not counterfeit — drugs. Patients prefer to spend on brands they can trust, and consider a company’s visibility and corporate image as a proxy for authenticity and quality control.

If the government were to provide quality assurance of all medicines available in the market, then a truly competitive market for generics competing on the basis of price could emerge in India which would immensely benefit the consumer. There would be increased prescriber support for unbranded generics in India and a better performance of schemes like the Jan Aushadhi stores which aim at providing good quality low-priced, unbranded medicines from five public sector companies (34, 35). Our own experience of running pharmacies at secondary and tertiary care institutions, based on low cost, unbranded as well as branded, generics sourced from carefully chosen drug companies, has been very positive in terms of savings in cost to patient and patient outcomes.

Brand name medicines in India cause the cost of treatment to spiral and are also a frequent but under-reported cause of medication errors. More than 60,000 brands exist in the Indian market but there is no registry of these drugs. As a result, brand names of medicines with dissimilar therapeutic effects (lookalike or sound-alike drugs; Table 1), result in serious medication errors (36). In our clinical practice, almost every day we see dozens of patients who are unable to find the drugs their doctors have prescribed, because the brand name drugs in the prescription they carry are available at only a few select shops close to their doctor’s clinic.

2. Overpricing of medicines in India: the imperative for price regulation

Price regulation has been a key element of India’s pharmaceutical policy since 1970. Prices of medicines have however been rising over the past few decades due to progressive dismantling of the system of price regulation. The Drug Prices Control Order (DPCO) initially placed price limits on 348 medicines deemed essential in India, a number that shrank to just 74 drugs by 1995 (37). Most drugs required to treat diseases of public health importance were either underrepresented in this list or were not represented at all (38). The list did not include vaccines, oral rehydration salts, drugs for cancer or coronary artery disease, and included very few drugs for respiratory diseases, hypertension, and diabetes (38).

Market failure

The government tried to justify its lax control over regulation of drug prices by arguing that competition alone was enough to control their prices, an expectation belied by subsequent developments. Drugs not listed in the DPCO started getting costlier, and the rise in drug prices consistently outstripped the prices of all other commodities (37). For 17 years — 1995 to 2012 — the number of drugs under price control did not change.

A public interest litigation filed in the Supreme Court of India is seeking to re-introduce price regulation of all the medicines in the National List of Essential Medicines (NLEM). At the behest of the court, the NLEM was recently revised (10) and a revised National Pharmaceuticals Pricing Policy is on the anvil (39).

The government, however, intends to switch to a marketbased pricing formula which, if implemented, will either only marginally reduce drug prices, or may actually increase them (40, 41). Several publications have pointed out that the new policy may adversely impact public health in India (42, 43, 44). An analysis of the top-selling 300 brands suggested that 62% of them contained medicines outside the NLEM, and of the 115 FDCs only 20% could be considered rational (45). These medicines and such combinations would be outside the purview of price control, and this would reduce the efficacy of price control as an intervention to reduce healthcare-related costs.

Are price differentials ethical?

Medicines are overpriced in India. In India, the pharmaceutical sector shows three types of price differentials which reflect this overpricing. The first differential is the greater than 10-fold difference in the maximum retail price of different brands of the same medicine which is seen in the market (Table 2). Differences between retail prices of perhaps a lesser magnitude are seen across therapeutic categories of medicines in India. The disconcerting fact is that in India the market leader in a particular therapeutic segment is also the price leader, or amongst the highest priced medicines in that segment. For example, Atorva, an anti-lipid brand name drug, outsells hundreds of brands, some of which are 10 times cheaper (Table 2). This is clearly an indication that market forces fail to regulate drug prices, as was naively assumed by the government over the years. This state of affairs exists because patients pay but do not decide, while doctors – the key players who are often heavily influenced by the pharmaceutical companies – decide but do not pay. In such a situation, patients with diseases like diabetes, hypertension or cancer pay substantially more if their doctor prescribes the more expensive brand for each of these conditions.

The second inexplicable difference in prices is between the price to retailer and the price to consumer for branded generics. A study found trader margins for the branded generics promoted through retailers of the order of 201-1,016% (23). These enormous trade margins have been known to the government since 1998 as pointed out by the Drug Price Indian Journal of Medical Ethics Vol X No 2 April-June 2013 Control Review Committee. This vast differential points to the enormous mark-ups which exist in drugs and which are being pocketed either by the pharmaceutical trader or the company (hospitals and doctors who dispense the drugs also share the profits). If drug makers agree to reduce the exorbitant profit margins, and drug prices are tightly regulated, all drugs might become available at affordable prices. while there are 131 brands of thiazides in combination with other medicine

The final revealing differential is between the price paid for purchase of medicines in pooled public procurement programmes in Tamil Nadu and other states which buy quality assured medicines, and of the brands which sell in the market. For example, Tamil Nadu procured 10 tablets of Omeprazole (a commonly used drug for acid peptic disease) for Rs 2.4 while the market leader sells at Rs 39.7 for 10 tablets (46). Similarly, Tamil Nadu procured human insulin at nearly a third of the prevailing market price. The variation in retail prices, the margins offered to the traders, hospitals and doctors who dispense the drugs and the difference between retail prices and prices in pooled procurement are unique to the pharmaceutical sector.

These differentials raise an ethical question for public policy. These price variations may not be illegal, but are they morally right? Are these wide variations in drug prices – which have no parallel amongst all other commodities – ethically acceptable when access to medicines can constitute the difference between life and death? Should the government not intervene to ensure that patients are not at the mercy of the prescribers’ whims and the vagaries of the market? Should the ambit of price regulation not cover all medicines as suggested by the National Commission of Macroeconomics and Health (37), rather than just the 348 medicines mentioned in the NLEM? Won’t this control of prices, limited to those of essential medicines, induce the industry to migrate from production of price-controlled medicines to those outside control? This selective approach to price control could ultimately promote the production and marketing of medicines which are not in the NLEM.

3. The need for evidence-based drug approval and improved access to essential medicines

India and its pharmaceutical industry have acquitted themselves very creditably on the global platform. Indian generics account for about 40% of the anti-retroviral medicines provided globally. Worldwide, these low-cost high-quality medicines are a lifeline to millions of people. There are an estimated 10,563 manufacturers in India, and more than 65,000 formulation (47).

These numbers look impressive but the paradox is that, at home, large portions of the population lack access to even the most essential drugs. The limited funds available are frequently spent on ineffective, unnecessary, or dangerous medications.(48:16.2). The money spent on overpriced medicines is very often also a waste of precious resources. This is because the Indian pharmaceutical market is full of ineffective, unnecessary medicines. Since these medicines outnumber those which are cost-effective, they directly impact the availability of and access to essential medicines (49).

Lack of essential medicines in the market

Iron deficiency anaemia is an important public health problem in India, associated with low birth weight in infants, pregnancyrelated deaths, and decreased work capacity. Ferrous sulphate and ferrous fumarate – low cost medicines recommended for treatment of iron deficiency which are distributed free of cost in public health facilities – are not available in most drug stores in India. The July 2012 edition of Current Index of Medical Specialities (CIMS), a prescriber handbook, does not mention a single preparation which contains ferrous sulphate in the dose mentioned in the NLEM 2011 (46). Hundreds of iron preparations are available in the market they contain salts with poor efficacy or co-existing with other nutrients (vitamins, minerals including zinc, amino acids) which do not increase their efficacy (50). Yet they cost much more than simple iron preparations and push up the cost of treatment of iron deficiency anaemia as much as 70-fold, according to an estimate (51). We are unable to understand why such ineffective and irrational preparations continue to be in the market and why iron pills are not under price control.

Dexorange was a market leader for the treatment of iron deficiency anaemia. Although this drug contained a poorly absorbed salt of iron and haemoglobin that came from slaughterhouse blood (52), it enjoyed a lot of support from medical professionals between 1970 and 2000 (when the use of haemoglobin in anaemia preparations was finally banned). This combination had no parallel anywhere in the world. Similarly, the market is flooded with irrational fixed dose combinations to treat infectious diseases, as well as “me-too” drugs — members of the same group as essential medicines which do not confer any therapeutic advantage but are more expensive. It is a moot point whether the 11 calcium channel blockers available in the Indian market fulfil any therapeutic need (46). On the other hand, essential medicines are scarce. Thiazide diuretics are amongst the cornerstones of treatment of hypertension. However, there were only five brands of thiazides listed in CIMS , while there are 131 brands of thiazides in combination with other medicines (26).

Unnecessary and irrational fixed dose combinations

Fixed dose combinations (FDCs) are combinations of drugs, used in situations where such a combination is pharmacologically justified. More than 40% of the formulations in India are composed of FDCs (53), a proportion which is unprecedented. For example the NLEM which lists 348 medicines has only 15 combinations of medicines (10). In contrast, in the market there are more than 15 combinations of paracetamol alone.

FDCs are justified when the combination of the active drugs increases efficacy, decreases adverse effects, reduces the risk of drug resistance, lowers prescription cost, simplifies therapy or promotes adherence to therapy (21). Such combinations with a Indian Journal of Medical Ethics Vol X No 2 April-June 2013 therapeutic advantage are therefore justified (some examples are oral contraceptives, anti-malaria therapy, anti-TB drugs, HIV therapy, and drugs for asthma, hypertension and diabetes). A basic requirement is that the drugs comprising the FDC should have compatible pharmacokinetics and pharmacodynamics. The major disadvantage of FDCs is an inability to vary the dose of the individual components of the combination, and increased incidence of adverse effects (21).

In India, the FDCs often lack pharmacological justification. India’s most widely available antibiotic combination of ampicillin/amoxicillin and cloxacillin is pharmacologically irrational (54), compromises the treatment of staphylococcal infections because the dose of cloxacillin in the FDC is half of what it ought to be, and promotes the development of drug resistance. The use of other FDCs of antibiotics like ciprofloxacin + metronidazole has contributed to increasing resistance in enteric infections like typhoid fever.

FDCs often also contain chemicals which lack efficacy but increase the cost of therapy. For example, an FDC of painkillers with serratiopeptidase, a drug isolated from silkworm intestine, is commonly prescribed in India. This drug was voluntarily withdrawn from the market in Japan by its manufacturer Takeda in 2011, when clinical trials failed to show evidence of its efficacy compared to placebo, but continues to be popular in India (55).

A number of FDCs are downright hazardous. The European Medicines Evaluation Agency approved Nimesulide only for restricted and short term use in adults. The agency warned that combination of this drug with other painkillers like paracetamol could adversely affect the liver (56). Yet, several leading Indian companies (Lupin, IPCA, and Dr Reddy’s Laboratories) market such FDCs in India.

Table 3 lists the irrational FDCs made in India. Indian pharmaceutical manufacturers have WHO good manufacturing practices certification and a number of them have US FDA approval. Is it not axiomatic that the content of medicines manufactured be also such that would stand the scrutiny of an agency outside India? The presence of unnecessary and ineffective drugs makes the process of drug regulation even more daunting as the authorities waste their time and resources fixing the prices or monitoring the quality of preparations which should not have been manufactured in the first place. For example, the National Pharmaceutical Pricing Authority has determined prices for 78 formulations of cloxacillin, a medicine which is under price control. All these 78 formulations are irrational as they contain combinations of cloxacillin with various other antibiotics (ampicillin, amoxicillin, cefixime, cefpodoxime), and varying concentration of lactobacillus spores (20-60 million) (57).

The drug approval process in India and its lacunae

Drug regulatory agencies all over the world approve medicines for use in their countries on the basis of an evidence-based process which evaluates the data on their efficacy (obtained through randomised controlled trials) and safety. In India in light of the public health problems that we face, the widespread poverty and high out-of-pocket expenditure incurred by patients, the drug regulatory authorities have an additional responsibility: to ensure that the medicines being approved for manufacture serve the public health needs of the country and are cost-effective.

The Drugs Controller General of India (DCGI) heads the Central Drug Standards Control Organization (CDSCO) which oversees the process of approval of medicines for India. This process needs to be rigourous, transparent and evidence-based, as is the case with drug regulatory agencies in the developed countries. The website of the CDSCO should list the approval letters, approved indications, and information for patients who are to use the product.

However, the drug regulatory agencies in India have paid inadequate attention to rigourous, impartial review of the scientific evidence, public health relevance, transparency and public disclosure before approving a drug. A parliamentary committee report on the functioning of the CDSCO in 2012 observed: A review of the opinions submitted by the experts on various drugs shows that an overwhelming majority are recommendations based on personal perception without giving any hard scientific evidence or data. Such opinions are of extremely limited value and merely a formality. Still worse, there is adequate documentary evidence to come to the conclusion that many opinions were actually written by the invisible hands of drug manufacturers and experts merely obliged by putting their signatures (58:17).

The issue of irrational FDCs in India is a pointer to the lacunae in the drug approval process. The genesis of many irrational FDCs has been at the state level where the state licensing officers in contravention of the amended Drugs and Cosmetics Act were found to be issuing licenses to companies for the manufacture of FDCs. The DCGI issued a directive in 2002 to all the state drug controllers to refrain from issuing any new drug licensing for the manufacture of FDCs (59). But as was noted by the parliamentary committee, no action has been taken in the past 11 years on this issue (58).

In response to a public interest litigation the DCGI’s office had identified 294 FDCs which had been sanctioned by the state licensing authorities without its approval (60, 61). Such FDCs are illegal and could have been banned immediately, but even these have yet to be withdrawn. One example from this list of FDCs that was approved by a state licensing agency, though classified as ‘absurd’ by the DCGI, is a combination of non-steroidal anti-inflammatory drugs and other drugs, chlorzoxazone + Ibuprofen+Paracetamol+diclofenac+Oxyphe nbutazone+Magnesium hydroxide (61).

While state drug controllers can be blamed for many irrational FDCs, irrational FDCs have been approved in recent years by the CDSCO. FDCs of antibiotics are clearly dangerous to public health – as pointed out in the recent parliamentary committee report. For example, the DCGI has approved an Indian Journal of Medical Ethics Vol X No 2 April-June 2013 FDC of Moxifloxacin with cefixime for the treatment of lower respiratory tract infections (Table 3). Moxifloxacin is a newer generation fluoroquinolone and one of the few orally effective drugs for multi-drug resistant tuberculosis. Such a combination, if used frequently to treat pneumonia, could further complicate the problem of multi-drug resistant TB.

Need for transparency in the approval process

In its report, the parliamentary committee drew attention to a collusive nexus between drug manufacturers, some CDSCO functionaries and some medical experts (58:20) which resulted in irregular drug approvals. On the issue of irrational FDCs, it stated in very clear terms, The Committee is of the view that Section 26A is adequate to deal with the problem of irrational and/or FDCs not cleared by CDSCO. There is a need to make the process of approving and banning FDCs more transparent and fair. In general, if an FDC is not approved anywhere in the world, it may not be cleared for use in India unless there is a specific disease or disorder prevalent in India, or a very specific reason backed by scientific evidence and irrefutable data applicable specifically to India that justifies the approval of a particular FDC. The Committee strongly recommends that a clear, transparent policy may be framed for approving FDCs based on scientific principles (58: 27).

Irrational FDCs continue to thrive because drug companies take advantage of the lengthy litigation in Indian courts. In such cases the onus of proof – that the FDCs are harmful – lies on the complainant. With virtually no system of post-marketing surveillance, it is nearly impossible to gather evidences of harm against FDCs in India.

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.