Prices for generic cancer drugs in the UK have soared over a five-year period, conference hears

The Inflation Reduction Act authorized Medicare to negotiate the prices of a limited number of drugs directly with their manufacturers, and it capped annual drug costs for Medicare beneficiaries at $2,000. In addition, the Biden administration recently funneled billions of dollars from a Medicare trust fund under a “demonstration” program to offset Medicare Part D premium increases that otherwise would have occurred in 2025. sofosbuvir price in vietnam The combination of high and rapidly rising drug prices and the obvious disparity between what many drugs cost in the U.S. and what they cost in other countries has made government intervention all but inevitable, and it is already happening. Tebra, headquartered in Southern California, empowers independent healthcare practices with cutting-edge AI and automation to drive growth, streamline care, and boost efficiency.

Pfizer and Flynn Pharma fined £69m for ‘excessive’ pricing of epilepsy drug

Not only would this be bad news for India’s economy, it could make it harder for developing countries to access the medicines they need – threatening the UN Sustainable Development Goals in the process. In my last two articles, I discussed the recent surge in prescription drug costs, the reasons for the surge, and possible solutions. In this article, I’ll discuss why drugs frequently cost so much more in the U.S. than they do in other countries, why this disparity may be justified, and where we go from here. The government should ensure uniform quality across all the generics, and experts in the field of medicine say only then will doctors prescribe them willingly and with confidence.

CONVERGENCE OF NATIONAL HEALTH PROGRAMMES

In most of the states, free medicines were restricted to targeted beneficiaries like BPL families, beneficiaries of JSSK, Janani Suraksha Yojana (JSY), and enrollees of state-specific insurance schemes. Even among the beneficiaries, the range of medicines given free of cost was not as per the EML nor based on epidemiological load. In Colombia, data exclusivity increased the public health system’s costs by $396 million between 2003 and 2011. Meanwhile, in 2006, the Korean National Health Insurance Corporation calculated that a four-year patent term extension would cost 722.5 billion won — the equivalent of $757 million at the time. This issue came to a head during the COVID-19 pandemic when, after relentless pharmaceutical industry lobbying, the EU and other wealthy countries blocked India and South Africa’s proposal to temporarily waive some TRIPS obligations for COVID-19 medical products. It was the influx of affordable generics from India that helped drive down the price of treatment from over $10,000 to under $100 per year, saving countless lives.

Selection of rational, affordable essential medicines and quality assurance criteria for PMBJP medicine list

The mean drug availability at PMBJP stores located in the vicinity of PHCs and district/rural hospitals was 51% and 61% respectively. While more than 70% of PMBJP pharmacies across all levels of care in Palghar region had palliative care medicines, anti-epileptics, analgesics and antacids, the availability of anti-cancer, anti-asthmatic and electrolyte balancing drugs were found to be very poor (less than 30%). Aside from collecting primary data, secondary data such as the price information of some PMBJP medicines and their leading brand name counterparts (in terms of market share) were gathered from the web portals of PMBJP and MedGuideIndia.com respectively. The website provides information on a wide range of drugs available in the Indian pharmaceutical market including their prices.

Mission is to Protect your Businesses & Much More

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].

• Further, inadequate healthcare infrastructure, particularly in rural areas, affects the distribution and accessibility of pharmaceuticals, impacting both pricing and reimbursement effectiveness.
• Pharmaceutical price control is a popular technique that has been used by other countries to address the shortages of medicines following the Covid-19 pandemic and relieve pharma companies that are suffering from high production costs.
• Almost 70% of antipsychotics and antiasthmatics, more than 85% of anticancer and electrolyte balancing medicines were found to be out of stock for 3–6 months.
• More focus on patents for innovative drugs is required, instead of concentrating primarily on generic drugs.
• This means about one in 20 of this country’s finished drugs are now made in India – roughly 20 million prescriptions a year.
• Regulations to support mandatory generic prescribing and generic substitution by pharmacists are needed.

A Cost Analysis of the Jan Aushadhi Scheme in India

A second policy challenge that affects pricing and reimbursement is lack of patient affordability for drugs that are not subject to the DPCO price control, particularly in the case of non-essential or newer drugs which do not form a part of the formularies. Since reimbursement schemes do not have uniform formulary inclusions, patients do not have clear guidance on which drugs are covered under the scheme, leading to unanticipated out-of-pocket expenses. Moreover, complex reimbursement procedures, including documentation requirements and approval processes, can delay or deter patients from accessing timely reimbursements. One of the key findings of our study is that PMBJP list included only 214 essential drugs, implying that it excluded more than 50% of drugs listed under NLEM, 2015. The inclusion of FDCs of antimicrobials, FDCs for CVDs and other diseases pose a public health concern. It is worth noting that though considerable research showed issues with some antibiotic FDCs, these FDCs still find their way to the Indian market [28].

India Solicits Price QuotesFor More Than 500 Generic Drugs

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 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?”).

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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.

• Meanwhile, in 2006, the Korean National Health Insurance Corporation calculated that a four-year patent term extension would cost 722.5 billion won — the equivalent of $757 million at the time.
• According to Qyobo’s data, atorvastatin is available from nine different drugmakers, including companies based in Germany, Bangladesh and Turkey.
• The study also found that “best-in-class pharma companies globally have an inventory period of 64 days as compared to Indian counterparts that have 98 days.
• Even among the beneficiaries, the range of medicines given free of cost was not as per the EML nor based on epidemiological load.
• The second reason for not regulating prices is that the pharmaceutical industry is a major part of the U.S. economy, generating more than $700 billion in annual sales ($600 billion more than the pharmaceutical industry in the second-ranked country) and supporting more than 4 million jobs.
• Additionally, 60% said they would prefer to buy brand-name medications but opt for generics because of the lower price.
• The firm regularly attends hearings before forums such as the Ministry of Chemicals & Fertilisers and the Department of Pharmaceutics on behalf of its clients, providing strategic legal support in these highly regulated environments.

Teva to Present at the 43rd Annual J.P. Morgan Healthcare Conference

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.

New Steel Trade Measures Needed as Import Issues Impact Additional Plants

Almost 70% of antibiotic FDCs available on the market are not registered with Central Drugs Standard Control Organisation (CDSO) [29]. In view of growing antibiotic resistance and concerns regarding safety and efficacy of FDCs manufactured in India, it is worrying to find that the use of FDCs is being promoted by PMBJP. The FDCs, except the ones of proven quality, should be removed from the PMBJP’s list of medicines to safeguard public health. Pharmaceutical companies market their brands by branding their bioavailability results.

(2016), “R&D, technology transfer and productivity in the Indian pharmaceutical industry”, International Journal of Innovation Management, Vol. The infrastructure of the industry and the R&D capabilities of domestic businesses have improved considerably in recent years, but many challenges remain, mainly related to pricing regulation, sector fragmentation and intellectual property. Not surprisingly, all of them, directly or indirectly, concern patents, which are central issues of debate in the national industry. Tiered pricing, also known as differential pricing , is often practised by pharmaceutical companies based on the ability of countries to pay, but Hill was unavailable to comment. Several factors have contributed to this significant growth of the healthcare industry in India – which includes a combination of public sector initiatives and expansion of private-sector enterprises.

• The negotiations with MNCs, international rules and domestic regulations are imbalanced, while there are increasingly stringent regulations and nontariff barriers to generic drugs in developed countries (Dhar and Joseph, 2019).
• There was an enormous effect of price policies on brands and drugs that had similar contents.
• State- level autonomous bodies and state government- owned agencies are empowered to procure and distribute 80 per cent to 100 per cent of medicines and diagnostic products of the total requirement.
• At the same time, according to an ambidextrous perspective, they should try to invest in R&D for innovative drugs to capture new opportunities arising from the demands for good health from the growing income classes.
• The disproportionate intellectual property protections the bloc proposes could threaten the affordability of generics that countries like India and Indonesia export to poorer nations.

Hence, the critical issues that affect the quality of generic drugs are purity, potency, stability, and drug release, and these should be controlled within an appropriate limit, range, or distribution to ensure the desired drug quality. EHR systems with e-prescribing capabilities help providers identify cost-saving opportunities, such as more affordable generic or therapeutic alternatives. With additional tools like coupon finders, EHR systems can locate the best local prescription prices and provide real-time data for drug-specific directions, enabling providers to offer more personalized and budget-friendly care.

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 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.

In spite of being the ‘pharmacy of the world’, access to essential medicines for a large majority of Indians is constrained by both physical and financial reasons. According to an estimate, medicines account for 69% of household out-of-pocket spending on health care. To make quality generic medicine affordable, India’s People’s Medicine Scheme (Jan Aushadhi) was launched in 2008 and then revamped and rebranded as Pradhan Mantri Bhartiya Jan Ausadhi Pariyojana (PMBJP) in 2015. The current study focuses on the availability, affordability and acceptability aspects of PMBJP essential medicines. Infrastructure constraints present another significant hurdle for the Indian pharma supply chain. Despite substantial progress in recent years, inadequate transportation and logistics infrastructure continue to hamper the efficient movement of goods within the country.

Chinese pharma has also placed much emphasis on using AI and genetics for developing new drugs. This enables firms like XtaIPi to identify thousands of molecules which could be used to treat a disease with fewer resources and time. Jean Lee is a content expert with a background in journalism and marketing, driven by a passion for storytelling that inspires and informs. As the managing editor of The Intake, she is committed to supporting independent practices with content, insights, and resources tailored to help them navigate challenges and succeed in today’s evolving healthcare landscape. For many Americans, the decision between generic and brand-name medications often comes down to cost.

International Markets

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.

• A second policy challenge that affects pricing and reimbursement is lack of patient affordability for drugs that are not subject to the DPCO price control, particularly in the case of non-essential or newer drugs which do not form a part of the formularies.
• The NHS prices that trusts are actually charged can be found on the Department of Health’s electronic market information database (eMIT), says a spokesperson.
• Both cabozantinib and sorafenib are multi-kinase inhibitors used to treat advanced cancers like RCC and HCC.
• This policy is not applicable to patented drugs or fixed-dose combination (FDC) drugs.
• To create new business opportunities for the pharmaceutical industry, SEZs can be a powerful option, especially if established near airports, stations and ports.
• India’s limited development of service platforms is a result of the scarce functioning of the bureaucracy, but conditions have improved in recent years.
• The following were identified as the key focus areas to bolster the Indian pharmaceutical and healthcare sectors.

Generic drugs – The Indian scenario

• 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.
• As the breast cancer rate is multiplying in India, the need to have affordable treatment that is easily available is increasing.
• In a nutshell, with Paleno making its way into Indian medicine markets, the availability of Palbociclib is manifolded.
• This means that majority of the people had to obtain healthcare including medicines from private providers.
• Maximum retail price (MRP) is the price-to-patient and is always printed on the package in India.
• The brand’s commitment to quality ensures that Cabotres is a reliable option for patients.
• But all of those drugmakers depend on an Indian company, Ind-Swift Laboratories Ltd, for the active pharmaceutical ingredients (APIs) to make atorvastatin.

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.

And while the Republicans generally favor more market-based solutions—including the importation of drugs from other countries and increased price transparency—reducing drug costs in the U.S. has become one of the few bi-partisan issues. To compare and evaluate the price and quality of “branded” and branded-generic equivalents of some commonly used medicines manufactured by the same pharmaceutical company in India. Prior to that, the state level commitment for free medicine policy had been differential. Fund shortages pushed states to appropriate budget heads under benefit schemes (e.g., Janani Shishu Suraksha Karyakaram- JSSK) or use revenue from services like diagnostics to ensure the provision of free medicines, thereby shifting the burden to other determinants of OOPE.

In a country notorious for unsafe drinking water, they found Dr. Reddy’s has no way to ensure the water used to make the ingredients forming part of medications taken by Canadians is free of biological contamination. Delightaid health will not responsible for any consequences, effects or harm caused due to avoiding professional medical advice from certified doctors. Before sending the shipment, the prescription will be fully checked by our qualified Pharmacist.

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.

Regulatory authorities need to provide more emphasis on quality control of generic medicines.” (P4). “We are ready to prescribe generic only, but there is no mechanism to ensure that private pharmacy shop chemists would dispense right and cost-effective generic medicines. Because there are hundreds of generics with different prices are available in the market, chemists can substitute for prescribed medicine as per their wish and earn high profit margins. Clinicians working in the public sector said that they prescribe 99% medicines in generic form as the government supplies only generic medicines to public health facilities.

Further, inadequate healthcare infrastructure, particularly in rural areas, affects the distribution and accessibility of pharmaceuticals, impacting both pricing and reimbursement effectiveness. A rise in the profit margin of businesses having product prices below DPCO was registered, which resulted in economies of scale (Venugopal and Jampala, 2019). The expenditure on health care in India has ultimately reduced the costs of medicines under DPCO, and essential drugs are coming under the ceiling price every day (Kuchey and Jan, 2018). Therefore, a better distribution of medicine in the middle-income groups, who need medicines for several treatments, has been observed. There was social and economic injustice because the low- and middle-income classes could not afford costly medicines, and DPCO resulted in socioeconomic justice for many poor people in India, a developing country.

Fortunately, the reality is that the generic medicines manufactured in India are as safe and efficacious as those made in the United States. For instance, many people are taken aback to learn that more than 90 percent of the medicines prescribed by doctors in the U.S. are generics. These prices can fluctuate based on the pharmacy and specific dosage requirements like Cabozantinib 20mg, 40mg and 60mg. To purchase generic Cabozantinib online in India, you can directly consult supplier and ask discount, any offers. The availability of such generic formulations plays a crucial role in enhancing the accessibility and affordability of essential cancer treatments.

But India’s thriving generics industry could only do this because these medicines were developed before it had to implement the 1995 World Trade Organization (WTO) agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). But just to begin to pursue that objective requires more information than the FDA has today. The FDA has pretty much admitted that it is ineffective at managing America’s generic drug shortage problem, pointing the finger at the drug and medical device makers. In May 2022, FDA Director Dr. Robert Califf admitted in congressional testimony that supply chains are too narrow and too dependent on single sources. Another example is in contrast dyes, which are administered to patients before CT scans to improve health care professionals’ visibility of the circulatory system and help identify blood clots in cancer patients.

This transformation has enabled the implementation of on-demand delivery models, employing strategies like direct-to-patient approaches and B2B eCommerce platforms. In fact, Indian pharmaceutical companies are now also becoming a key source of medicine for the rest of the developing world. Of note, they are playing a pivotal role in bringing down the price of lifesaving, antiretroviral drugs that have helped contain the AIDS epidemic.

Again, this involves a minimum of one billion doses for India and other low to middle income countries. This is the lowest quoted price in the world for a COVID vaccine, and will see them distributed in low and middle-income countries. By comparison, German biotech firm BioNTech’s deal with US involves a price of US$19.50 per dose, while the Moderna/US deal is set at between US$32 and US$37 per dose. You can share this content on Americans’ preferences for generic versus brand-name medications for noncommercial purposes as long as you provide a link to this source page. Exploring cost savings, perceived effectiveness, and the role of medication type in American buying habits. Generic medications go through testing for quality, strength, purity, and potency to show effectiveness before being approved by the FDA.

We further observed that the PMBJP drug (enalapril) used for the treatment of hypertension costs 725% lower per month than that of the reference branded-generic drug. WHO model list of essential medicines has total 37 FDCs, while NLEM, 2015 consists of 24 FDCs. As far as the NLEM list is concerned, majority of these FDCs are aimed at improving treatment adherence and preventing drug resistance in diseases of public health concerns such as malaria, TB and HIV-AIDS.

In a nutshell, with Paleno making its way into Indian medicine markets, the availability of Palbociclib is manifolded. With these generic drug versions by Indian brands, Breast Cancer patients with HR +ve, HER –ve have hope as they have better access to affordable treatment opportunities. The Indian medicine market has recently witnessed the launch of Palbociclib’s generic version – Paleno.

With these tools, providers can offer personalized recommendations, share cost comparisons, and provide educational materials through secure messaging. This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. Haiti’s plight is a reminder of the international community’s wider and longer-term responsibilities to the country. India’s negotiators note they’ve “firmly communicated” that data exclusivity and patent term extensions are “redlines” for them in these negotiations. Last year, the FDA allowed the cancer drug cisplatin to be sold in the U.S. from an uninspected lab in China.