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

Unfortunately, access to medicine is mainly determined by socioeconomic status in low and middle income countries, with poor medicine access among disadvantaged populations []. Indians mainly rely on private purchases for healthcare including medicine, and the country’s low public spending on health at 1.3% of GDP coupled with majority of people being either uninsured or underinsured makes this especially unaffordable for the poor [25]. Purchase of medicine contributes the most (60.6%) to the OOP health payments by households, and pushes more than 3% Indians into poverty every year [3, 25]. In response to poor medicine access and reduce the financial burden of medicine, Government of India has been promoting the use of unbranded generics by rebranding and expanding its generic medicine scheme (PMBJP).

Pricing & Reimbursement Laws and Regulations 2024 – India

The website you are about to access may be governed by different regional policies, regulations or advertising codes. Please be sure to read the privacy policy and terms of use of the websites that you visit. Cabotres is the medicine by the Cipla brand that harnesses the therapeutic benefits of cabozantinib. In addition to litigation, the firm advises clients on representations to be made to governmental regulatory bodies like the NPPA. 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. Regarding her contributions in international conferences, Ms. Sharma has been elected as an executive member of AIPPI for the Indian Group, is an active member of the APAA and regularly participates and attends the INTA.

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Thus, manufacturers have the freedom to set prices for their own drugs on the basis of various market forces, unless corrective measures are warranted. Moreover, patented drugs are not immediately subject to price control and entitled to a five-year exemption from the date of marketing.[vi]  Only essential and life-saving medicines, i.e. ‘controlled/scheduled drugs’ are subjected to price regulation by the NPPA as per the provisions of the DPCO. The NPPA is responsible to fix, revise and monitor the pricing of such ‘controlled drugs’, which are listed by the Government in the dynamic National List of Essential Medicines (NLEM). The list is revised from time to time and some examples of essential medicines included in the NLEM are paracetamol, insulin, antibiotics, etc.

Apigat (Apixaban) 5 mg Tablet in India

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.

• Manufacturers and pharmaceutical companies may revise the prices of the product following the routine annual change in the Wholesale Price Index (WPI) of the preceding calendar year.
• The designed digital architecture of SCM should not only facilitate maximum utility but also prioritize interoperability, real- time data management, and monitoring through a centralized dashboard in each state.
• Further, it is required to be covered under the reimbursement schemes, which are listed in formularies approved by the respective authorities.
• While India’s pharma exports grew by 11% in FY 2019 and appear to be promising, the industry is increasingly facing problems across its export markets.
• 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.
• Recordings were translated from the local languages such as Marathi and Hindi in English, and then transcribed verbatim.
• Faster decision making and reduced risk so you can deliver life-changing therapies faster.

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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.

Selection of medicines for the survey

We found that switching from branded-generic medicine to unbranded generic medicines would lead to substantial cost savings for medicine consumers. Our estimates suggest that unbranded generic substitution would reduce pharmaceutical expenditure by 6–1129% of patient’s spending. However, caution must be exercised while interpreting affordability because of the following reasons. First, affordability might differ depending upon the compliance of the minimum wages act of the Maharashtra government. 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.

• It stands to reason that when the media raises concerns about the safety and scope of imported generic medicines, consumers question the quality of medicines essential to their health.
• Schondelmeyer, a professor of pharmaceutical management and economics at the University of Minnesota, testified on drug shortages before the House Ways and Means Committee in February, urging the Congress to take action to address the growing problem of generic drug shortages.
• 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.
• EHR systems with e-prescribing capabilities help providers identify cost-saving opportunities, such as more affordable generic or therapeutic alternatives.
• A sustained, affordable supply of generic medicines is essential for health — as well as for preventing the next pandemic.
• 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.
• The United States recently ended India’s Generalized System of Preferences Status (GSP) – a tariff reduction on imports – after President Trump determined that India did not adequately meet his trade demands.
• The latter models face relatively more constraints to meet district- level demands, often resulting in delays and disproportionate local purchases.

India’s Solution To Drug Costs: Ignore Patents And Control Prices – Except For Home Grown Drugs

(2010), “Status of home based care provision to bedridden elderly in Chandigarh”, Journal of the Indian Academy of Geriatrics, Vol. In India, the IPR regime is important at all levels – statutory, administrative, and judicial. Starting in 1995, an agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) was established after negotiation with the World Trade Organization, defining regorafenib price philippines the minimum standards for the protection and enforcement of IPRs in member countries. These calculations, as emerging from Figures 2 and 3, allow us to respond positively to RQ2 (“Are the expectations about the trade balance positive or negative?”). These calculations allow us to respond positively to RQ1 (“Are the expectations about the global value of the industry positive or negative?”).

We are all infor better health

While in a few, they are observed to be efficient (e.g., Tamil Nadu, Kerala, Rajasthan, Andhra Pradesh), challenges reported in many states are largely due to implementation gaps confounded by other systemic challenges. We have sought to establish an ML link between the price and sample age of AMLO besylate containing FPPs and acceptable quality attributes of the same. The analysis of nine top-selling AMLO besylate-containing marketed FPPs was exercised using a validated analytical method.

Scope for costsavings on medicine and affordability of PMBJP medicines

(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.

Generic drug prescribing experience

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.

In the USA substitution is allowed and patients accept generic substitution if physician approves of the same. Generic substitution rates have increased remarkably there, probably due to greater acceptance by physicians and pharmacists as well as encouragement from the third party payers.[20]Cheaper generics are one of the important factors to reduce health-care cost. Studies involving comparative evaluation on quality of branded and their generic counterpart may be made mandatory for the generic (or branded-generic) manufacturer and their reports should be made public to promote generic use and prescriptions. Unlike developed countries, people in developing countries pay the cost of medicines out-of-pocket. Universal access to medicines, a critical component of Sustainable Development Goals, is intended to ‘ensure access to safe, effective, quality and affordable essential medicines for all [24].

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.

• Making the healthcare supply chain resilient will require end-to-end supply chain visibility through digitalisation and use of global standards which facilitate interoperability.
• In addition to litigation, the firm advises clients on representations to be made to governmental regulatory bodies like the NPPA.
• For instance, if availability of 7 (N) antimicrobials medicines in 02 PMBJP pharmacies (P) at PHC level in Palghar was evaluated, then overall 14 units (PXN) would be examined.
• Thus, there is a continuous boost in the demand for pharmaceutical products and a consequent strain on the supply chain.
• She was Italian member of the Core Group and Standing Committee for the Social Sciences – European Science Foundation.
• 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.
• 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.

In other words, drugs that can extend lives by stopping deadly diseases like cancer or AIDS, provide relief from excruciating pain caused by preventable and curable diseases are not available and accessible to more than a quarter of the world population. In India, despite the presence of a thriving generic pharmaceutical industry, a principal barrier to access continues to be the cost of medicines. (2004), 65% Indians or nearly 650 million lacked access to essential medicines and medicine constitutes 63% of household’s total out-of-pocket (OOP) health payments, thereby impoverishing millions of people every year [2, 3]. Indian pharmaceutical companies have been a critical partner in the supply of these drugs by providing affordable medicines for major health conditions that enhance patient access, improve management of health conditions, and bring savings and resilience to the overall health system. It also highlights areas of concern around lack of diversification in the manufacturing of Key Starting Materials and Active Pharmaceutical Ingredients in the broader supply chain for affordable drugs and discusses the role India could play as a partner to the U.S. in de-risking this supply chain.

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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.

• 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.
• Those medicines not found in stock on the day of survey, the number of days of stock-outs in the last 6 months were recorded through manual checking of registers.
• (2004), 65% Indians or nearly 650 million lacked access to essential medicines and medicine constitutes 63% of household’s total out-of-pocket (OOP) health payments, thereby impoverishing millions of people every year [2, 3].
• To make the sample representative and consistent with the distribution of PMBJP outlets in Mumbai and Palghar, 11 pharmacies were selected for the study covering all levels of health care delivery system.

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.

How can I get generic drugs?

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.

Andrea Curry is an award-winning journalist with over 15 years of storytelling under her belt. She has won multiple awards for her work and is now the head of editorial at The Intake, where she puts her passion for helping independent healthcare practices into action. Inspired by “vertebrae,” our name embodies our mission to be the backbone of healthcare success. With over 165,000 providers and 190 million patient records, Tebra is redefining healthcare through innovation and a commitment to customer success. Electronic health records (EHR) and patient portals make it easier for providers to track patient preferences, allergies, and past prescriptions.

The Indian pharmaceutical industry has been living a situation of constant growth in recent years, as shown by statistical analyses of the field at the descriptive and inferential levels. There are increased expectations regarding both the production amount and the trade balance value. There was an enormous effect of price policies on brands and drugs that had similar contents. These branded drugs showed a variation in pricing, also known as inter-brand price variation. There was ample availability of multiple brands for identical drugs in India, and therefore, after DPCO was revised in 2013, a so-called tug of war between these branded drugs began.

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.

“The two major reasons for the cost pressures are slowing down of the domestic offtake and pricing pressures in developed markets such as the United States and Europe, in addition to some of the pricing pressures also being introduced in India in the domestic markets,” commented Raisinghani. “This is further compounded by regulatory bodies demanding stricter compliance, which are leading to higher compliance costs,” he added. If sponsors, healthcare providers, and regulators work together effectively, then effective use of generic drugs will make medical costs cheaper and also ensure sound treatment options for the patients. Early issuance of guidance notes on the prescription of generic medicines, clarity in dispensing rights, state notification of FDSI, and mandated display of EML at the facilities heighten the awareness of both providers and community members. In line with this, irrational prescriptions and poor adherence to STPs/STGs and EML may be attributed to lack of awareness.

Against a group of these units, if 03 antimicrobials medicines were available in a PMBJP store and 04 antimicrobials medicines were available in another store, then the overall availability of anti-microbials in PMBJP pharmacies at primary level facilities of Palghar was 50% [((3X1) + (4X1)) X100/14]. In addition to streamlined procurement and communication channels, systematic reporting across the programmes is pivotal in aligning the demand for medicines with the state’s disease burden. For chronic conditions, the pace of NCD services uptake, especially at primary level healthcare facilities significantly influences demand-driven access to NCD-specific essential medicines. For example, in negotiations with Indonesia, the bloc proposed an extensive intellectual property enforcement regime that could adversely impact access to medicines. It has also sought to extend the duration a pharmaceutical producer is granted a patent monopoly and expand exclusive rights to data, both of which would delay the marketing of affordable generic versions.

The sale of PMBJP medicines is mainly dependent on the prescription of generic drugs by the physicians. But doctors from private health care facilities hardly mention the generic or chemical names of drugs on the prescription slips and only 60 percent of the prescriptions from public health facilities contain generic names [27]. We found that, in spite of the awareness campaign by the PMBJP, physicians, especially those having private practice remained apprehensive regarding the therapeutic efficacy and the quality of unbranded generic medicines. In low-income and middle-income countries (LMICs) such as India, patients and healthcare providers (both public and private) often struggle with high and increasing pharmaceutical prices due to low and weak health insurance coverage, which restricts patient access.

In the above, API stands for Active Pharmaceutical Ingredient and AYUSH stands for Ayurveda, Yoga, Unani, Siddha and Homeopathy. Starting in 2014 in India, a Ministry of AYUSH was established, indicating the extraordinary relevance in the country of these specific items. More focus on patents for innovative drugs is required, instead of concentrating primarily on generic drugs. There is a need for policymakers to work on the sustainability and development of the industry, while the companies must redesign their orientation toward enhancing innovation capabilities. In addition, at the level of corporate strategy, firms should establish collaborations and alliances and expand their industrial marketing vision.

In-depth interviews were intended to capture the perspectives of physicians and pharmacists on generic medicine in general and PMBJP scheme in particular. India, meanwhile, has developed a $15-billion generic-pharmaceutical industry, with labour costs about one-tenth of those in Canada. India is the world leader in generic medicines, which contain the same ingredients as the originator version, and go on the market after the original patent has expired. India’s top pharma firms include Cipla, Aurobindo Pharma,Lupin, Dr Reddy’s Laboratories and Sun Pharmaceutical Industries. While each of these cost reduction initiatives has some merit, the challenge will be to reign in prescription drug costs without removing all of the financial incentives that have helped to make our domestic pharmaceutical industry a world leader and critical part of the U.S. economy.

Tebra is constantly exploring new ways to leverage technology and partnerships to improve healthcare. Our partnership with GoodRx demonstrates this commitment, with features like automated coupon retrieval paving the way for a more patient-centric and cost-effective future. Addressing patient concerns and misconceptions about medication quality and effectiveness starts with clear communication and easy access to resources. Patient experience software makes conversations between providers and patients easier so practices can provide timely information to clear up doubts and reinforce trust. Interestingly, 1 in 10 Gen Z and Millennial Americans said they base their preference for brand names on the packaging alone — that’s some pretty effective product design at work.

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India’s share of the US generic market is growing rapidly, and the number of companies and manufacturing facilities supplying to the U.S. market is growing fast. The focus on growing regulatory requirements, improved healthcare infrastructure, and surge in research and development spend bodes well for the pharma industry. The Indian government believes that the prices of lifesaving drugs shouldn’t be set by market forces. In a country where very few people have health insurance, 70% of Indians pay for healthcare expenses out of their own pockets. There is no way that people in India can pay even a fraction of the cost for drugs that can be priced at $50,000/year in the West. The process of securing reimbursement for a pharmaceutical product varies and depends entirely on the specific processes provided under the respective policy.