India sees insignificant revision to price ceiling in 2024

Addressing these infrastructure gaps requires substantial investment and collaborative efforts between the public and private sectors. Several factors have an impact on pharmaceutical patents in India, such as an increasing level of income, a consistent growth rate of the domestic economy, and rapid growth in the diffusion of better economic conditions. In this respect, however, foreign companies, as well as national companies, have been reluctant to invest in R&D in India (Ghai, 2010). Indeed, compared enzalutamide cost uk to developed nations, Indian pharmaceutical companies concentrate less on innovation, where they allocate less budget. For all the above-described reasons, they find manufacturing generic drugs more lucrative, as the outcome is guaranteed. Taking into account the above considerations, from a narrative and then qualitative point of view, a positive scenario for the Indian pharmaceutical industry can be highlighted, thus providing a response to RQ3 (“What are the most relevant SWOT for the future?”).

• The researchers had also compared the prices in the UK, a developed economy, with the prices listed on a generics medicines website in India, an emerging market.
• Price erosion has made it more difficult for low-cost manufacturers in India to justify their margins as the price of generics formulations falls globally.
• For example, Torrent acquired Bio-Pharma Inc. (BPI) in early 2018 – its first acquisition of a manufacturing site outside of India – to diversify and strengthen its product pipeline.
• One key reason generic drug production moved (and is still moving) to India is the high level of subsidies offered by the Indian government to drug manufacturers and exporters.
• After the 1990s, India emerged as an information technology and information technology-enabled services hub for the world due to trained manpower, a very high number of computer engineers, and a cheaper workforce that could speak foreign languages, mostly English.

Company

Moreover, the margins that Indian suppliers can earn in the United States are higher than those they can achieve in the more saturated Indian market. There are also ample opportunities presenting themselves across Asia for India’s pharma players, especially as talks of a free-trade agreement (FTA) with the Eurasian Economic Union and Regional Comprehensive Economic Partnership in Asia progress. Although the market continues to diversify with new players springing up from within India as well as internationally, a handful of national players continue to have a sizeable footprint in the domestic and international generics industry. Piramal, Torrent, Cipla, Sun Pharma, Aurobindo, Dr. Reddy’s and Glenmark, to name a few, represent a number of the success stories in India’s pharma industry landscape. With the biopharmaceutical industry rapidly evolving across the globe, inorganic growth has been an important part of company strategy for expanding footprints, retaining market share and moving into new areas of the value chain. For example, Torrent acquired Bio-Pharma Inc. (BPI) in early 2018 – its first acquisition of a manufacturing site outside of India – to diversify and strengthen its product pipeline.

Generic drug

However, as the European Union now negotiates free trade agreements with India and Indonesia — another major generics-producing nation — the bloc’s been proposing far stricter protection of intellectual property rights. And such protection could threaten the affordability of generic medicines these countries export to the Global South. Increased offshoring of drug manufacturing has made imports a growing share of the U.S. pharmaceutical industry. In the five years from 2017 to 2022, imports rose to $197.9 billion, worth almost one third (32.8%) of the cash spent by American patients, insurers, hospitals, and the government on pharmaceuticals (Figure 1). On current trends, the value of imports and their share in the total pharmaceutical spend is likely to continue to rise.

• By making bolder strategic moves in uncharted geographies, products, and technologies, Indian generic manufacturers seek to reclaim their position as a world-class provider of affordable, high-quality drugs.
• With the availability and usage of generic drugs, the experience with these drugs will increase and it will be possible to compare the real-time effectiveness of generic drugs vis-à -vis brand drugs.
• Reimagine clinical development by intelligently connecting data, technology, and analytics to optimize your trials.
• The largest market share concerns ayurvedic and homeopathic medicaments (AYUSH medicines) with 24.37%, followed by antibiotics (API and formulations) with 18.82%, and anti-retroviral drugs for HIV (Human Immunodeficiency Virus) treatment with 15.89%.
• Unknown to American doctors or patients, the entire supply chain for this drug depends on China.
• We, therefore, critically looked at the selection criteria for medicines included in the PMBJP list.

Key drugs losing patent protection in 2025

As such, pharmaceutical companies are permitted to increase the prices of their drugs by this percentage. The marginal price adjustment is expected to affect 923 scheduled formulations listed in the NLEM, including antibiotics, cardiovascular medicines, tuberculosis drugs, and Parkinson’s and dementia medicines, among others; the small scale of the adjustment renders it meaningless compared to previous price adjustments. However, it instead tipped the balance in favor of the pharmaceutical industry’s commercial interests, and away from access to affordable medicines. 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. India has long been known as the “pharmacy of the world,” producing generic medicines at prices that other developing countries and global institutions can afford. The country was the single largest supplier of pharmaceutical products to Africa in 2018, and accounted for a fifth of the continent’s pharmaceutical imports.

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Further, in order to generate demand for unbranded generic medicines, in 2017, the erstwhile Medical Council of India issued a circular to the medical fraternity to comply with its regulation for prescribing medicines by generic names [14]. Besides, since April 2017, bioequivalence studies have become an essential requirement for the manufacture of a generic medicine in India [14]. While the idea of popularising non-branded generic drugs is a robust policy response to improve access and reduce pharmaceutical spending, little is known about how far these initiatives have been effective in making generic drugs accessible at affordable prices. 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.

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Thus, the Indian government should establish ongoing support to small- and medium-sized Indian companies in training and implementing FDA standards, as it provides easy global access to those and similar international markets. India has witnessed rapid population and economic growth in the past two decades, and this expansion has created a demand for larger and better infrastructure in cities and industrial parks. India’s limited development of service platforms is a result of the scarce functioning of the bureaucracy, but conditions have improved in recent years. There is a need to reserve appropriate sizes of land for the health-care sector in cities and for pharmaceutical companies in industrial belts during the planning process. In India, the public health-care system is not strong, and most of the middle class and above prefer to visit private hospitals for treatment.

2 The scenario of the Indian pharmaceutical industry: contextual analysis

So, what needs to be done beyond the practical steps being taken by Indian generic manufacturers to embrace a culture of quality? Importantly, beyond presenting an evidence-based case that generics manufactured in India are efficacious and safe, we must also demonstrate the enormous good these drugs provide to consumers. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition.

• These concerns raise fears among patients that taking drugs made in India may result in unpredictable effects.
• The industry operates within a complex regulatory landscape characterized by stringent quality standards and evolving regulations.
• Similarly, pharmaceutical research and development can be carried out in India by global pharmaceutical MNCs.
• Therefore, a better distribution of medicine in the middle-income groups, who need medicines for several treatments, has been observed.

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In other words, the overall coverage of essential drugs in PMBJP list is just 57%, when compared to the total number of essential medicines included in NLEM. We have used a mixed-methods approach, with the survey-based quantitative component supplemented by a qualitative component consisting of in-depth interviews (IDIs). Data were gathered on the availability, stock-outs, price and affordability of 35 essential medicines and 2 consumables. Our unparalleled team of in-house experts monitor P&R policy developments, outcomes and data analytics around the world every day to give our clients the edge by providing critical early warning signals and insights. With the availability and usage of generic drugs, the experience with these drugs will increase and it will be possible to compare the real-time effectiveness of generic drugs vis-à -vis brand drugs.

India

There is a robust low-cost manufacturing setup available in India, where the industry can produce drugs at a cost that is 40%–50% lower than the rest of the world and sometimes even as much as 90%. There is also a presence of good technical and technological expertise together with the availability of low-cost skilled human resources. The growth of the middle-class population is leading to a new lifestyle, providing a huge market for lifestyle drugs, which are currently the lowest contributor to revenues from the sector.

Availability of essential generic medicines at pmbjp pharmacies/ kendras across mumbai and palghar region

Over the years, it has been noted that states with autonomous bodies for procurement demonstrate relatively improved governance, decreased wastage, improved availability of quality medicines and less burden on end-users in terms of out-of-pocket expenditure (OOPE). The latter models face relatively more constraints to meet district- level demands, often resulting in delays and disproportionate local purchases. Even among states with procurement bodies, their efficiency in achieving desirable outcomes is tied to state-specific customization of the procurement and distribution system. Interestingly, the European Commission does appear to recognize that overly restrictive intellectual property rules can be harmful. It recently proposed a seismic package of reforms to pharmaceutical and intellectual property regulations — seemingly an attempt to wrestle back some balance between such restrictions and access to medicines in Europe. Whatever the cause of the benzathine shortage, Professor Stephen Schondelmeyer says that it has led to more outbreaks of syphilis in the U.S. than were expected.

Furthermore, India’s Department of Pharmaceuticals (DoP) recently announced plans for a new pricing reform for pharmaceutical products and the induction of price control for medical devices, which would induce more stringent rules over pharmaceutical pricing. Such measures risk decreasing sales of price-controlled products, which in turn could discourage multinational pharmaceutical companies from launching new products in the Indian market. In India, a dispensing pharmacist is not authorized to substitute a branded medicine with a branded-generic (or generic) as per the provisions under Rule 65 of the Drugs and Cosmetics Act, 1940 and Rules, 1945, which also add to the patient’s burden.

Do all drugs have generic versions?

A challenge is also posed by the exponential growth in population, and epidemiological changes in the population resulting from shift in lifestyles. Thus, there is a continuous boost in the demand for pharmaceutical products and a consequent strain on the supply chain. The growth in population also affects reimbursement policies, since the Government has to allocate an increasing number of funds to public health insurance schemes and may be affected by budgetary constraints.

There are only 74 bulk drugs which are under price control[15]and are called scheduled medicines. For scheduled medicines, the NPPA pricing formula sets the 8% mark-up for wholesalers and 16% for retailers. For non-scheduled medicines, these markups are not set, but it is agreed by the partners of the trade that for branded medicines average mark-up would be around 10% and 20% for wholesalers and retailers, respectively. Diverse systemic determinants of access to quality and affordable medicines have been documented through CRMs. Though not an exhaustive list, state-specific experiences over the years highlight the determinants of access, and pertinent systemic challenges needing redressal.

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That leads to widely differing standards across India, with the temptation to lower standards to attract more manufacturers. “The Indian drug industry is like the wild west on steroids,” Professor Schondelmeyer told us. There is less emphasis on R&D in pharmaceuticals, which have a major focus on generics.

Browse the Drugs alphabetically

The Indian Pharmaceutical Alliance (IPA) represents 23 research-based national pharmaceutical companies focused on patient health and safety with a commitment to provide quality drugs to patients throughout the world. Even more surprising is the fact that more than a third of these drugs were likely manufactured in India. This country’s ability to produce affordable, generic drugs has led to its reputation of being the “pharmacy of the world.” By export volume, India is currently the largest provider of generic medicines globally, supplying 18 percent of global generic medicines. Recently, in March 2024, the Indian Government constituted a five-member Committee to oversee reform efforts for the pricing of drugs and medical devices and supervise the drafting of a new Drugs and Medical Devices (Control) Order. The primary task of the Committee is to strike a balance between pricing and availability of essential medicines while offering incentives to the industry to foster growth and exports.

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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.

This is because in India, there is an inadequate R&D infrastructure and lower industry-academia connection for research. As mentioned above, DPCO establishes the various pricing parameters according to which the price is to be decided, and this policy reduces the profitability of the companies that would invest in innovative drugs, which requires huge capital. This sector has been hamstrung by a lack of product patents, due to which foreign companies do not introduce new drugs in the Indian market, discouraging innovation and drug discovery.

For method development, method validation, and degradation sample analysis, an Agilent high-performance liquid chromatography Infinity 1260-II (Agilent Technologies company, Santa Clara, CA, USA) equipped with a quaternary pump, an online degasser, and a multiple wavelength or diode array ultraviolet detector was used. For data acquisition and processing, the OpenLabTM CDS software (version 2.6) (Agilent Technologies, Palo Alto, CA, USA) was used. Indian drugmaker Intas was making cancer drugs for the United States at the plant where, in a trash bin, inspectors found documents doused in acetic acid.

Among the antidiabetics, cardiovascular and consumables not available on the survey day, 44% and 33% respectively were out of stock for the period of 3–6 months. Nearly 30% of palliative care medicines and vitamins, about 17% of antiasthmatics and consumables were out of stock for a period of 1–3 months. The pharmaceutical industry was once concentrated in Europe and North America, but has spread increasingly into the developing world, where low costs cater to a growing Western pressure. No wonder Palbociclib suppliers in India are looked upon as major game changers for Breast Cancer treatment. As Sun Pharmaceutical has introduced cheap medicines in India, addressing breast cancer has become accessible and affordable.

Paradoxically, low entry barriers have led to fragmented industries that make the sector highly accessible due to competition (Mahajan et al., 2018). Further, we did not fully follow WHO-HAI methodology for calculating availability of essential medicines as the list of surveyed medicines was modified to meet the contextual requirements. Besides, we did not compare the prices of unbranded generics with international reference prices as recommended by WHO-HAI methodology since there is already overwhelming evidence showing that generic prices in India are less expensive compared with international standards. Thus, the scope for generalisability of the study findings, especially on availability and affordability of PMBJP medicines is limited.