The regulatory framework in India for pharmaceutical pricing and reimbursement aims to ensure fair pricing of essential drugs and provision of adequate reimbursement mechanisms to facilitate patient access and simultaneously also promote innovation and enhancement of production capacity of healthcare providers. Lack of access to essential medicines is a major health policy concern globally, even more so in the low-and middle-income countries. According to the World Health Organisation, a whopping 2 billion people worldwide are not having access to essential medicines [1].
A SURVEY BASED STUDY IN CURRENT SCENARIO OF GENERIC AND BRANDED MEDICINES
For example, an attack strategy seems realistic when combining strengths such as the industry’s manufacturing ability and the rising economy of the country, thinking about a competitive strategy based on differentiation and/or niche orientation for innovative and patented drugs. Similarly, a defense strategy seems realistic when combining the experience with generic drug production with DPCO limits, thinking about a competitive strategy based on cost leadership, which may be sustainable considering the huge population of the country. Consequently, domestic businesses will be hindered to some extent, and exports may blossom. For example, India has been universally considered the pioneer in the export market for generic drugs. In the case of other medicines, if the drug is under DPCO in India, it may be possible to sell it under price control domestically and to collect maximum revenue from exports, thus helping to enhance the country’s economy (Das, 2013). Nonetheless, DPCO policies had an adverse influence on the imports of medicines to India in the form of a fall in trade due to price regulations.
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Here’s a breakdown of the cost differences between generics and brand names for over-the-counter and prescription drugs. To better understand the factors shaping these decisions, Tebra surveyed over 1,000 Americans and compared the costs of popular medications in five major US cities. This report explores how patient preferences, medication types, and healthcare tools like EHR systems shape the way Americans approach their healthcare choices. New drugs are protected by patents, so only the company that came up with the drug can sell it. Once the patent expires, other companies can get a generic version of the drug approved by the FDA and start selling it.
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- Second, the level of economic development varies considerably across states and between rural and urban areas in India and this needs to be taken into account while extrapolating results of this study to other states and national level.
- Even more surprising is the fact that more than a third of these drugs were likely manufactured in India.
- Thus, from a practical point of view, Indian pharmaceutical companies are somehow forced to continue to leverage their expertise in generic drugs, considering the positive financial impact of these productions.
- As per statistics, about 60% of Indians cannot afford to buy their daily medicines because of unnecessary high prices of medicines in the Indian pharmaceutical market.
According to National Sample Survey Organisation, public facilities accounted for only 30% of the overall healthcare services in the year 2017–18 [4]. This means that majority of the people had to obtain healthcare including medicines from private providers. Moreover, even those who access healthcare from public facilities end up purchasing drugs from the market as the prescribed medicines are often not available in pharmacies of public hospitals. Currently, almost all medicines in India are sold under a brand (trade) name and medicines are called as branded medicines or branded-generic. In real sense, Indian market does not have branded medicines (a name commonly given to an innovator product) because till January 2005 product patent was not applicable in India.
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But your income and the cost of the drugs you need may affect your ability to qualify for discounts. Information about these programs is free and available from your doctor, pharmacists, and the government. We already know from previous experience that such proposals — known as TRIPS-plus — can have devastating consequences for access to medicines. The disproportionate intellectual property protections the bloc proposes could threaten the affordability of generics that countries like India and Indonesia export to poorer nations. Professor Schondelmeyer favors creating what he calls “concentric circles” starting with the most at-risk drugs, which start with drugs produced in at-risk countries in only one factory, then move out to include those produced at multiple facilities or multiple countries and those in current shortage.
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The quotes are being sought for generic drugs, although they are also allowed for imported or combination drugs by their trade or brand names. Cipla’s introduction of Cabotres when it launch is constantly making cancer treatments more accessible and affordable. The brand’s commitment to quality ensures that Cabotres is a reliable option for patients. “Now what happens is most of the time we don’t get adequate supply of these Jan Aushadhi products in definite time. Hence, government can increase number of wholesalers, distributors in the scheme to improve availability of medicines at the stores.” (P9). The survey was undertaken to find out the extent of availability and stock-out of medicines at PMBJP outlets.
Do lower prices make generic medications the top choice for Americans?
These operations need huge amounts of capital, but DPCO measures, which limit drug prices, do not contribute to establishing a favorable scenario concerning capital budgeting for R&D. In fact, if the developed drug comes under DPCO, then it is likely that sales will be hindered, affecting the expansion of the industry due to regulations pertaining to that medicine (Biospectrum Bureau, 2016). The medical tourism segment in the global health industry is increasing rapidly because the cost of health-care is significantly lower in India than that in Korea, Malaysia, Thailand and many other countries in the region. Improved medical facilities, modernization of hospitals and lower and affordable treatment costs for most developed and developing countries’ nationals are all reasons for this boom (Fortis Healthcare, 2019). The market is dominated by generic products with 71% of the total market share and 20% of global exports in terms of volume, which makes India the largest supplier of generics globally (IBEF, 2016), with particular importance in the field of vaccines (Chattopadhyay and Bercovitz, 2020). These factors affected the country in many ways; one of the most relevant impacts was less priority given to the health sector for growth and modernization, with smaller cities and remote areas covered with the inefficient national health-care service or small hospitals and practitioners (Abrol et al., 2011).
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However, pharmaceutical companies may lose interest in the Indian market due to the fixation of prices, which can lead to economic uncertainty since the Indian market is under rigorous pricing laws (Kumar et al., 2020). Another major concern is that medicines are not available where needed due to an inadequate supply chain and to the absence of potential producers that may not be attracted by these restrictions. If there is a lack of proper supply of medicine to the needy, this would be in contradiction with the objectives of social justice (Mrinali, 2013). Thus, the Indian government should take effective measures to better balance the positive and negative effects of DPCO. This study reported the availability, stock-outs and affordability of a basket of essential medicines (unbranded) and consumables in selected PMBJP stores in the districts of Palghar and Mumbai in Maharashtra. Besides affordability, we did cost comparison of unbranded and branded generic equivalents of some commonly used medicines.
- Our increased reliance on very few suppliers who ultimately depend on ingredients from China for many life-critical products is a huge risk to the health and safety of the American people.
- The cardiovascular disease (CVD) treatment market is one of the leading pharmaceutical markets in India, as the country accounts for one-fifth of all cardiovascular-related deaths worldwide.
- In fact, Indian pharmaceutical companies are now also becoming a key source of medicine for the rest of the developing world.
- Around 50% of antimicrobials, antidiabetics, antiepileptics and consumables were out of stock for the period of 3–6 months.
- Furthermore, efforts by Governments to promote the development of their own national pharmaceutical industries in key markets across Latin America, Sub-Saharan Africa and Southeast Asia have made the playing field more challenging as exporters encounter increasingly rigid regulatory policies.
- (2016), “R&D, technology transfer and productivity in the Indian pharmaceutical industry”, International Journal of Innovation Management, Vol.
- All these factors are making the larger Indian players conscious of how best to evolve from their current offering.
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Following this, we picked the essential drugs from the PMBJP product basket, which were found on all the above-mentioned lists. Of the 35 surveyed medicines, 22 were from the first (for global burden of disease) and second (specific to Southeast Asia) core medicine lists recommended by WHO/HAI methodology and 13 were drawn from the NLEM, 2015. Information was obtained on the availability of essential medicines at PMBJP outlets across primary, secondary and tertiary levels of health care delivery system against the basket of 22, 28 and 35 medicines respectively selected according to therapeutic category. Among the medicines included in the survey, 22 are universal medicines, which are supposed to be available at all levels. Apart from the universal medicines, 6 more medicines were considered at the secondary level, while, in addition to the medicines at the primary and secondary levels, 7 other medicines were assessed for availability at the tertiary level. The list of medicines and consumables has been provided as an additional file (Additional file 1).
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The three major medicines for breast cancer – Palbociclib, Ribociclib, and Abemaciclib are popular internationally. Despite India’s contribution to global access to medicines, the government has never tried to use this as an instrument of foreign policy. One silver lining is that China is proposing a new regulation that would give its firms exclusive control over their clinical test data.
Furthermore, as reported in Table 4, the positive trade balance trend appears to be confirmed for the future, most likely by virtue of renewed attention of the global economies on India’s pharmaceutical industry due to the COVID-19 pandemic. The Indian federal Department of Health Jan. 28 is soliciting price quotes on 504 drugs including painkillers, antibiotics and medicines to treat respiratory, cardiovascular and gastroenterological diseases for a program to improve access to generic drugs. A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by patents. Because the active chemical substance is the same, the medical profile of generics is believed to be equivalent in performance. As per statistics, about 60% of Indians cannot afford to buy their daily medicines because of unnecessary high prices of medicines in the Indian pharmaceutical market.
A 3-tiered public healthcare delivery system is catering to the needs of the population of these two districts. At the bottom of the health services pyramid, there are primary health centres (PHC), sub-centres (SC) and health posts (HP), which focus on primary care. The mid-level of the pyramid, which is the secondary care level, includes rural hospitals and municipal general hospitals, and at the top level, tertiary care institutions like medical colleges are there. According to the PBBJP portal, 29 PMBJP pharmacies are currently functional across these two districts.
The Indian Government in its interim Budget for financial year 2024–2025 has allocated an amount of Rs 90,658.63 crores to the Ministry of Health, which constitutes a 12.59% increase from last year, reflecting the Government’s prioritisation of development of the Indian healthcare system. That’s what they call hepatitis C, which is so common in parts of India’s Punjab state that the tailor-shop gossips might not be off base in their estimate. Drugmakers have made the village of Lande Rode one of the theaters in a battle to grab market share for sofosbuvir, a miracle cure that Gilead Sciences Inc. sells in the U.S. as Sovaldi at a retail price of $1,000 a pill. Gilead licensed 11 Indian companies to make generic versions, and they sealed marketing deals with others.
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In India, the pharmaceutical market is majorly dominated by generics, accounting for 78.33% of all drugs in the Indian market, while patent-protected drugs account for 21.67% of the market share, according to GlobalData’s Price Intelligence (POLI) database. India sees the second most significant generic market penetration in the Asia-Pacific (APAC) region, just behind Malaysia. One reason could be that the country’s pharmaceutical price controls measures generally disincentivise pharma companies from developing novel originator medicines while incentivising the production of generics. This policy works in India’s favour, however, as the country is one of the leading producers and exporters of generics globally. The use of generic drugs is steadily increasing internationally as a result of economic pressure on drug budgets.
- Although some Indian companies have invested significantly in R&D initiatives, most of them prefer remaining in the business of generic drugs.
- When choosing between generic and brand-name medications, Americans face decisions influenced by both their wallets and their health needs.
- For example, the development of a range of long-acting HIV prevention and treatment medicines could be transformative in advancing the end of AIDS — but this can only happen if those medicines are made widely available at low prices through large-scale generic production.
- Thus, the Indian government should take effective measures to better balance the positive and negative effects of DPCO.
- The heart of the problem is that we have driven prices too low, moved supply of generic medicines to a small number of the cheapest-of-the-cheap offshore suppliers, and sacrificed resiliency, manufacturing quality, and backup supply to chase the false god of low prices.
However, as shown in Table 2, PMBJP medicine list has as many as 130 FDCs in different therapeutic categories. The maximum number of fixed dose formulations listed in PMBJP is for vitamins and micronutrient deficiency followed by gastrointestinal complaints and cardiovascular disorders. As a protectionist tide sweeps across the globe, the Indian pharmaceutical industry needs to continue evolving.
This will be a tough balance to achieve, but it appears that all stakeholders recognize the urgent need for it to occur. Nearly 1 in 10 Americans said they believe generic drugs aren’t tested as rigorously as brand-name, with Gen Z being the most likely to have this view (11%). Some also questioned whether generics are FDA-approved (7% of Gen Z), and 12% of Millennials believed that generics took longer to work compared to brand-name medications.
- In this study, we have assessed the acceptability of PMBJP’s unbranded generics It is worth noting that the Indian pharmaceutical market is flooded with irrational or non-essential drugs.
- The recent changes in the field, at the institutional and corporate levels, have placed India in the spotlight of the global pharmaceutical market, but several threats and weaknesses could limit this expansion.
- After this initial overview of the current and future situation of the Indian pharmaceutical sector, a positive picture has emerged.
- Starting in 1995, an agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) was established after negotiation with the World Trade Organization, defining the minimum standards for the protection and enforcement of IPRs in member countries.
It meets 40% of the generic demand in the US and provides a quarter of all medicines in the UK. It has undergone a remarkable transformation, evolving into a dynamic powerhouse driving healthcare advancements worldwide. Interestingly, India is the biggest contributor to UNESCO, with a share of over 50-60%. The principal aim of this study is to conduct an explorative investigation of the current and future situation of the Indian pharmaceutical industry, with the development of a narrative SWOT analysis to generate an overall scenario analysis.
Typically, a claim for reimbursement of a new pharmaceutical product requires a valid prescription from a registered medical practitioner. Further, it is required to be covered under the reimbursement schemes, which are listed in formularies approved by the respective authorities. The beneficiary or healthcare provider is required to submit its claim to the respective authority, along with the prescriptions and relevant documents pertaining to the insurance or health scheme authorities. Thereafter, such claims are processed, and reimbursement is provided based on the scheme’s guidelines and approval procedures.
- Pharmaceutical imports rose again in 2023, and continue to be the second largest import category for U.S. consumer goods.
- These concerns raise fears among patients that taking drugs made in India may result in unpredictable effects.
- Similarly, pharmaceutical research and development can be carried out in India by global pharmaceutical MNCs.
- The industry operates within a complex regulatory landscape characterized by stringent quality standards and evolving regulations.
- The NPPA’s revised ceiling prices are calculated based on the average retail price of the named formulation(s) having a market share of 1% or more and being in accordance with the Drug Price Control Orders (DPCO) 2013.
- Therefore, a better distribution of medicine in the middle-income groups, who need medicines for several treatments, has been observed.
Our increased reliance on very few suppliers who ultimately depend on ingredients from China for many life-critical products is a huge risk to the health and safety of the American people. The first chapter of this report summarizes data on the importance of affordable medicines. The second chapter highlights the role that Indian companies play in the supply of drugs to the U.S. in terms prescriptions, patient access, resilience, and savings. The last two chapters discuss the state of the overall supply chain of affordable medicines, concerns raised by U.S., EU and India, and possible opportunities for partnering to address these concerns. Nonetheless, despite being a global market leader in generic drug formulations, the Indian pharmaceutical industry is highly dependent on China for raw material supply to produce pharmaceutical formulations and even medicines.
As a result of Covid-related factory shutdowns in Shanghai, China in early 2022, GE Healthcare was unable to produce enough contrast dye to supply the American market. According to a CNN report, about half the hospitals in the U.S. rely on GE Healthcare for the contrast dye. Vital scans were postponed or denied revolade price philippines to patients at many hospitals as doctors and radiologists scrambled to find dye, used only in the most critical cases. “In the case of generic medicines used in hospitals, it is important to distinguish between the actual price paid by trusts and the much higher list prices often quoted,” he concludes.
China has already demonstrated its willingness to use its economic leverage in peacetime with commodities like rare earths and graphite. If hostilities between the U.S. and China rose or if we entered a genuine military confrontation over Taiwan or another global hotspot, we would be at grave risk of seeing vital pharmaceutical supplies reduced or cut off entirely. By making intelligent connections between your needs, our capabilities, and the healthcare ecosystem, we can help you be more agile, accelerate results, and improve patient outcomes. Orchestrate your success across the complete compliance lifecycle with best-in-class services and solutions for safety, regulatory, quality and medical information. Moving forward requires investing in modern, technology-enabled logistics facilities and ensuring the highest standards of quality in drug storage and handling. Adopting smaller, more efficient packaging not only cuts down on storage and shipping expenses but also promotes sustainability and economic benefits.
This sort of rule is favoured by the “innovator” pharma industries that we see in the west, and is opposed by generic pharma industries like India’s. It indicates where Chinese pharma might be headed, and may drive up its production costs for formulations – thus potentially benefiting India. China’s rising share of formulations has been aided by improved standards that appear to be making the world less apprehensive about Chinese medicine quality. Notably, the China Food and Drug Administration issued guidelines in 2013 to make generic medicines bioequivalent to the originals, and in 2016, the government made them mandatory.
Affordability was calculated on the basis of number of days of wages that an unskilled worker requires to expend for a standard course of treatment for common acute and chronic conditions [22, 23]. 5, the cost of the treatment with PMBJP medicines was between 0.01 days’ wages and 0.48 days’ wages, suggesting that unbranded generic medicines at PMBJP pharmacies were relatively affordable than their branded counterparts. At 0.01 and 0.5 day’s wage, diazepam for treating anxiety and diclofenac for treating arthritis respectively were the cheapest generic medicines at PMBJP stores. The maximum price differential was observed for atorvastatin and clopidogrel, used for treating hypocholesteraemia and clopidogrel respectively, indicating that the unbranded medicines can be fairly affordable.
