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.

EVALUATION OF PRICE DISPARITY AMONG GENERIC MEDICINES IN INDIA

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. The implementation of market-based price ceilings on a set of essential medicines, including on-patent and generic drugs, is a form of pharmaceutical price control applied by the Indian Government and intended to make drugs accessible to people at an affordable price and address drug shortages. GlobalData examined a similar price increase for 146 essential medicines in Pakistan under the hardship category to subsidise the rising cost of active pharmaceutical ingredients (APIs) and production, which led to an acute nationwide shortage of essential drugs.

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One challenge is coming from China, which has increasingly been exporting active pharmaceutical ingredients in recent years. Indian companies have managed to turn this into an opportunity by using these ingredients to supply medicines at reasonable prices while reducing their production costs and R&D spend. In India, generic substitution is legally not allowed so patients’ awareness about generics is limited and doctors and patients do not want pharmacist to change the trade name written by doctor.

• The mean drug availability at PMBJP stores located in the vicinity of PHCs and district/rural hospitals was 51% and 61% respectively.
• While the upward revision of drug prices is positive for their respective producers, patients must increase their out-of-pocket (OOP) spending to cover the increased prices.
• 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.

Drug Resources

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).

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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.

Links to NCBI Databases

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.

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It does not include all information about the possible uses, directions, side effects, warnings, precautions, interactions, adverse effects, or risks that may apply to this product. This is prescription medicine and if you want to buy this medication legally from Delightaid Health, we require a valid prescription from you. Please read the disclaimer and prescription-related full details at the bottom of this website. The physicians, especially those from the rural Palghar district wondered why the generic drug stores are not opened in rural areas where it is needed more. Besides that, the public physicians stressed on the need for establishing the PMBJP outlets within the hospital premises, while private physicians asked for dissemination of information regarding the drugs listed under the PMBJP scheme.

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• 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.
• However, as shown in Table 2, PMBJP medicine list has as many as 130 FDCs in different therapeutic categories.
• The Bureau of Pharma Sector Undertakings (BPSU) working under the Department of Pharmaceuticals, Government of India, was entrusted with the responsibility of implementing JAS, i.e., to coordinate procurement, supply and marketing of generic drugs through JAS outlets.
• 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.
• Dhiraj Singh/BloombergAbout one in 20 of Canada’s finished drugs are now made in India – roughly 20 million prescriptions a year.

Particularly, the country exports generic medicines on a large scale, with a major impact in the American and European markets. Assessing the availability and affordability of generic medicine at PMBJP outlets is important, but perhaps it is even more important to know the physicians’ attitude towards generic drugs and PMBJP scheme, as they play a key role in prescribing generic medicines. Most of the physicians argued that generic and branded medicines have the same active substance(s). Table 6 shows the cost of standard treatments, as recommended by WHO, with surveyed medicines at PMBJP price and at branded generic price for a number of health conditions [22, 23]. We find that for all selected disease conditions, the drug cost of the thirty-day treatment reduce by 6–1129% if PMBJP’s unbranded medicines are used instead of their largest selling branded-generic counterparts. For the treatment of Type 2 diabetes, the monthly expenditure on the PMBJP medicine (Glimepiride) was estimated to be almost 50% lower compared to its equivalent branded-generic counterpart.

Pharmacists’ views on PMBJP

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.

The World’s Pharmacy: India’s Generic Drug Industry

The profiles of the physicians and pharmacists are provided as additional files (Additional files 2 and 3). The fact anyone is paying attention to the quality of Indian-made medicines is arguably because of Mr. Thakur. In 2004, he noticed a generic antibiotic produced for the Indian market failed to curb his son’s severe ear infection; a switch to the brand-name version knocked down the boy’s worrying high fever overnight.

Palbociclib is a targeted or biological therapy drug, that is USFDA, EMA, and CDSCO approved. Paleno, which contains Palbociclib is a medicine used to treat breast cancer treatment. Baladol, developed by PNB Vesper Life Sciences, has become the first new drug for treating COVID to enter phase II clinical trials around the world. Studies so far have shown that it reduces death rates by 80% – whereas WHO-approved medication dexamethasone reduces them by 20%.

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

Ensuring we communicate this vision and quality-centric focus will be essential to the bright future between manufacturers and those who rely on these medicines. The availability of the above-mentioned generic versions of Cabozantinib enhances the affordability. This has resulted in growing its access, particularly in regions where treatment costs are a huge barrier to healthcare. In conclusion, it is clear that the evolving landscape of the healthcare and pharmaceutical industry in India offers an exceptional opportunity for new entrants to expand and diversify in the market. However, players who aspire to be successful must be ready to innovate, evolve new healthcare delivery models, be open to adapting to changing patient needs and expectations, and be willing to invest in talent, technology and expert legal and regulatory advice.

• The first chapter of this report summarizes data on the importance of affordable medicines.
• Cabotres is the medicine by the Cipla brand that harnesses the therapeutic benefits of cabozantinib.
• These prices can fluctuate based on the pharmacy and specific dosage requirements like Cabozantinib 20mg, 40mg and 60mg.
• The first-line sellers will receive different percentages of margins to apply, including distributors, wholesalers, retailers (chemists) and hospitals.
• Califf admitted that the stakes are too high (i.e. patients are sicker for longer and some are even dying due to drug shortages) he said the economics of the industry need to be altered to boost domestic production of generic drugs.
• It is another reason why India’s position as pharmacy of the world has a value far beyond its borders.

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Drug Price List: Generics and Matching Brands

Many of the Global Fund’s major pharmaceutical suppliers are based in India and are also critical partners in efforts to scale up regional manufacturing sustainably, particularly in Africa. This improved pricing – a 25% reduction – will allow governments in resource-limited settings to expand access to critical HIV services. Data from the American Society of Health System Pharmacists (ASHP) shows that the number of drugs in shortage reached 301 at the end of 2023, one of the highest figures since data began. The FDA produces smaller figures because they count only shortages at the national level. The ASHP considers regional and local shortages too, a measure that doctors and health economists consider more relevant to the quality of care provided to patients.

• “This is further compounded by regulatory bodies demanding stricter compliance, which are leading to higher compliance costs,” he added.
• The company ignored tests showing unknown impurities in some drugs, and inspectors came across samples with bacteria and mould that were “TNTC,” too numerous to count.
• As a protectionist tide sweeps across the globe, the Indian pharmaceutical industry needs to continue evolving.
• Exploring cost savings, perceived effectiveness, and the role of medication type in American buying habits.
• Thereafter, such claims are processed, and reimbursement is provided based on the scheme’s guidelines and approval procedures.
• At $208 billion worth of imports last year, pharmaceuticals are gaining quickly on motor vehicles, and likely to surpass them in a year or two.
• The datasets, including the qualitative dataset concern the implementation of a government scheme related with specific places and actors, making anonymising and removing any potentially sensitive observations, especially from interview transcripts difficult.
• 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.

Successful market access

It is administered orally and requires careful dosing and monitoring by healthcare professionals to manage side effects and ensure the best therapeutic outcomes. Ms. Chawla has authorised and contributed to various academic articles and journals on topics relating to cyber laws and copyright laws. She has represented the firm at national and international conferences and conclaves in India and Dubai. Further, she has also conducted workshops on IP law for university students and has been invited as a judge for several prestigious moot court and negotiation competitions at the university level.

Limitations of this study

An in-depth exploration of the global healthcare ecosystem with timely research, insightful analysis, and scientific expertise. Nevertheless, India has a massive population with low per capita income, and stricter patent rules would probably mean less access to medicine for a significant part of the population. The affordability of pharmaceuticals is a critical challenge in India and South Asia erlotinib price in singapore in general, raising questions of life and death. DPCO is a blessing for those who use medicine and has boosted their hopes of the availability of cheaper and better medicines, leading to a great psychological impact on consumers (Venkiteswaran, 2013). For example, heart attacks and cardiac arrests are increasing in India, and treatments for these newly emerging diseases are very expensive.

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. Additionally, existing resources like untied funds or funds from rural/urban local governing bodies support the facilities to undertake local purchases to meet emergency demand or shortages. While the procurement mechanisms are usually centralized, logistics and distribution are widely channelized through regional and/ or district- level distribution centers like warehouses, central medical store depots or district medicine stores. EU negotiators should drop TRIPS-plus proposals, and entirely avoid them in future negotiations with developing countries. The world’s supply of generic medicines is a lifeline for the Global South — and this is more important than the profits of a handful of companies.

In comparison, Gen X was the most likely to prefer generic medications, mainly due to cost (95%), previous experience (28%), availability (26%), and higher trust (15%). When patients choose between brand-name and generic medications, cost, trust, and availability all come into play. These factors and others revealed below influence how people decide which option is best for their needs.

To exploit that “patent cliff,” governments and insurers in Canada have pushed for lower and lower prices on the copies, and often mandate that patients’ prescriptions be filled with generics. India’s pharmaceutical industry is renowned for selling medicines to the world at reasonable prices, especially developing countries. To find out if there’s a generic drug that will work just as well for you as a brand-name drug you’re taking, talk to your doctor or pharmacist. Tell them you want the most effective drug at the best price, and that you want prescriptions for generic drugs when possible. In India, procurement of medicines is coordinated through various mechanisms such as state- level autonomous bodies, state government- owned agencies, procurement division/cell of the state government, and public-private partnership arrangements.

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.

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.

The purpose of this research is to anchor the debate on the relationship between the cost of medicine and the availability and affordability of quality generic medicines in mid to low-income countries. FDA Commissioner Robert Califf admitted as much last year, when he warned that “there’s not enough reserve and supply” of generic drugs in the United States. Califf admitted that the stakes are too high (i.e. patients are sicker for longer and some are even dying due to drug shortages) he said the economics of the industry need to be altered to boost domestic production of generic drugs. Finally, the study has revealed in a current and future scenario analysis that the overall situation of the Indian pharmaceutical industry is positive at the economic, business and commercial levels, even though with many concerns. Most likely, however, the real challenge of the sector will entail a sustainable compromise between the legitimate expectations of innovative growth from the business point of view and the fundamental exigencies of affordable health from a social point of view.

At the time, this unprecedented pricing was a breakthrough toward ensuring the worldwide availability of high-quality treatment for HIV. Since then, through global partnerships and country-led efforts, about 19 million people living with HIV in resource-constrained settings are now receiving TLD, according to the Clinton Health Access Initiative. The very high profit margins on branded drugs have enabled drugmakers to manufacture those products in the U.S. or Europe. European governments, especially the Irish government, have used subsidies and tax breaks to lure global pharmaceutical giants to manufacture there. The result is that Ireland is the number one source by dollar value for U.S. pharmaceutical imports (Table 2).