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

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.

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Given the role of various interlinking factors, states need to establish robust procurement systems, strengthen the existing infrastructure, ensure adequate HRH backed with robust HRH policy, expand the range of services, and strengthen CPHC for supporting holistic efforts. An overall health system strengthening is the way forward to expedite the realization of universal access to free essential medicines at public health facilities. As previously mentioned, the AYUSH Ministry was formed in 2014 for the development and spread of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy treatments. Earlier, it was known as the Department of Indian System of Medicine and Homeopathy (ISM&H), founded in 1995.

• Though not an exhaustive list, state-specific experiences over the years highlight the determinants of access, and pertinent systemic challenges needing redressal.
• Besides, since April 2017, bioequivalence studies have become an essential requirement for the manufacture of a generic medicine in India [14].
• Some physicians reported that they face difficulties in prescribing generics as patients have negative attitudes towards cheaper medicines.
• 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.
• With tools like EHR systems and patient portals, they can easily track preferences, share resources, set up payment plans, and discuss treatment options.
• 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.
• 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.

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According to a 2022 study released by GS1 India, a global supply chain standards organization, more than 50 per cent of Pharma and medical devices manufacturers lose 1 per cent of their sales due to expiry and pilferage. Counterfeit medications not only pose a significant threat to public health but also erode consumer trust in the pharmaceutical industry. 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. Along with that, the overall supply chain, logistics and warehousing costs in India is 15 per cent higher compared to other countries,” the report added. Healthcare expenditure continues to rise in countries where healthcare is not a priority. Generic drugs offer an important tool for reducing the overall healthcare expenditure.[17] As more and more patents expire, the generic versions of the pharmaceutical market are expected to continue for increased sales.

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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.

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According to Qyobo’s data, atorvastatin is available from nine different drugmakers, including companies based in Germany, Bangladesh and Turkey. But all of those drugmakers depend on an Indian company, Ind-Swift Laboratories Ltd, for the active pharmaceutical ingredients (APIs) to make atorvastatin. And Ind-Swift depends on five companies, all of them Chinese, for the key starting materials (KSMs) to make the APIs. Unknown to American doctors or patients, the entire supply chain for this drug depends on China. The intense pressure to lower prices of generic pharmaceuticals has led to a different global structure. Generic production has moved increasingly to India and China as the lowest-cost manufacturing centers in the world.

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• At the same time, pharma imports from China and India increased their share of total pharma imports, reaching 58% by weight.
• That’s what they call hepatitis C, which is so common in parts of India’s Punjab state that the tailor-shop gossips might not be off base in their estimate.
• Price-to-patient, retailer mark-up and qualitative analysis of branded and branded-generic medicines.
• Inspired by “vertebrae,” our name embodies our mission to be the backbone of healthcare success.
• Generic drugs savings totaled $292.6 billion in 2018, according to the AAM Access & Savings Report (2019).
• Nevertheless, the study findings show that PMBJP’s unbranded generics offer great opportunities for substantial cost savings.

Reservation or allocation of land for the health-care sector will boost the growth and development of the industry, resulting in employment and self-employment of health-care staff, even at the pharmaceutical level. Financially poor people use India’s public health-care system and reserving land in cities for public facilities will serve the population’s low-income earners. Consider that the Indian pharmaceutical industry has significantly reduced the burden on the U.S. public health system by making much needed medicines affordable and readily available.

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Transparency in fixing the MRP by the manufacturer and clear guidelines for mark-ups at least for branded-generics is required in pharmaceutical trade. The government must take up generic promotional schemes, general awareness programs on quality of generics to build confidence among prescribers, pharmacists, and consumers. Availability of generics or branded-generics in the market with lower price tag and assured quality is essential to make the medicines affordable. Results of our study revealed that price-to-patient for the branded-generic version was not much less than to its branded counterpart; branded-generic was available at % cost of the branded product. Medicine prices are under the purview of Department of Pharmaceuticals which itself is under ministry of chemicals and fertilizers. The Drug Price Control Order (DPCO) identifies active pharmaceutical ingredients (APIs) for which a pricing formula is used to set the MRP.

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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.

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This is the first limitation of the research, thus, further investigations expanding the range of the data under examination would improve the reliability of the results. In value terms, the sector, considering the total manufacturing of pharmaceuticals, medicinal chemicals and botanicals (Table 1), is worth Rs. 145,841.1m in 2018–2019. 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%. These three pharmaceutical categories alone are worth approximately 60% of the entire Indian pharmaceutical production.

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The Indian Government in its interim Budget for financial year 2024–2025 has allocated an amount of Rs 90,658.63 crores to the Ministry of Health, which constitutes a 12.59% increase from last year, reflecting the Government’s prioritisation of development of the Indian healthcare system. That’s what they call hepatitis C, which is so common in parts of India’s Punjab state that the tailor-shop gossips might not be off base in their estimate. Drugmakers have made the village of Lande Rode one of the theaters in a battle to grab market share for sofosbuvir, a miracle cure that Gilead Sciences Inc. sells in the U.S. as Sovaldi at a retail price of $1,000 a pill. Gilead licensed 11 Indian companies to make generic versions, and they sealed marketing deals with others.

Details of five “pairs” of medicines including their trade name as sold in the Indian market, strength, dosage form, and the pharmaceutical company that manufactures these products are given in Table 1. Price-to-patient (MRP) and price-to-retailer (PTR) found for all the five ‘pair’ of medicines is tabulated in Table 1. PTR for the branded product of cetirizine was 11 times the price for branded-generic by the same company. Retailer is earning INR 22.76 for 10 tablets of branded-generic cetirizine versus Rs 8.16 for the branded version from the same company. For ciprofloxacin, the MRP of both the branded and branded-generic product was same but the branded-generic was available to retailer at 3.6 times less price than branded medicine from the same company.

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Drug reimbursement policy has a substantial impact on the pharmaceutical industry, since it affects the incentives and outcomes of pharmaceutical research and development. Further, a robust drug reimbursement policy is equally important to ensure access and affordability for patients, since out-of-pocket expenses contribute to more than 45% of healthcare expenditure in India,[vii] despite the presence of price-control regulation. Although India’s case is lot more complex than most countries given the dominating presence of ‘branded’ generics in the Indian pharmaceutical market, it is worth learning from countries which achieved reasonable success in promoting the utilisation of generics. USA, the first country to implement a generic drug implementation policy, achieved 89% share of generic drugs in 2016 and this reduced the medical insurance expenditure by US$ 67.7 billion [37]. Japan, Canada, Australia, European countries as well as LMICs such as Philippines had similar experience regarding generic drug use [38, 39]. All these countries have either made it compulsory to prescribe drugs with active substance names or passed laws for mandatory generic substitution.

PALENO (Palbociclib) Generic Online in India

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.

• Given the role of various interlinking factors, states need to establish robust procurement systems, strengthen the existing infrastructure, ensure adequate HRH backed with robust HRH policy, expand the range of services, and strengthen CPHC for supporting holistic efforts.
• Delightaid health will not responsible for any consequences, effects or harm caused due to avoiding professional medical advice from certified doctors.
• The aim is to adopt a balanced approach that considers the needs of the patients, while simultaneously ensuring the creation of a sustainable healthcare system and incentivisation for pharmaceutical companies to innovate and create value.
• Patients’ and doctors’ perception for all branded-generics irrespective of company is the same.
• 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.
• 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.
• This includes vigorously efficient quality control and quality assurance systems alongside training programs and workshops, building an omnipresent culture of quality.
• The Indian medicine market has recently witnessed the launch of Palbociclib’s generic version – Paleno.
• But generic medicines for diabetes and hypertension are very good and cost effective for the patients for chronic illnesses.” (PuP3).
• “The Indian drug industry is like the wild west on steroids,” Professor Schondelmeyer told us.

This may include deploying advanced refrigeration systems, GPS tracking, and real-time monitoring to maintain ideal conditions throughout the transportation process. Based on the above background, the following research questions have been formulated regarding the Indian pharmaceutical sector. 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.

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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.

• The pharmacists, they claimed, will sell noneffective, or highly overpriced drugs once the authority to decide the drug for a given indication is bestowed upon the pharmacists through the policy of compulsory active ingredient prescribing.
• Although we reported availability, stock-outs and affordability of medicines in the PMBJP pharmacy outlets, a more comprehensive assessment of the accessibility of essential medicines may have included measurement of medicine prices, prescription pattern and out-of-pocket payments on medicines.
• This study provides a global overview of the potential growth and development of the Indian pharmaceutical sector, comparing it with internal trends and external competition.
• According to a 2022 study released by GS1 India, a global supply chain standards organization, more than 50 per cent of Pharma and medical devices manufacturers lose 1 per cent of their sales due to expiry and pilferage.
• For many Americans, the decision between generic and brand-name medications often comes down to cost.
• Under the DPCO, manufacturers are required to be aware of price fixation and revision by the NPPA since it is mandatory to follow the ceiling prices fixed and notified by the NPPA.

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The study highlights the need to modify the drug price policy, regulate the mark-ups in generic supply chain, conduct and widely publicize the quality testing of generics for awareness of all stakeholders. Supply chain management practices backed by IT-based platforms have shaped estimation, tracking, and monitoring practices for medicines, equipment, and consumables in the Indian health system. Early implementation of such platforms is identified as a key determinant to promote skill development and skill refinement among trained users, allowing the states to gradually saturate and establish them throughout.

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.

All these factors are making the larger Indian players conscious of how best to evolve from their current offering. “I would also advise to focus strongly on reliable quality and being ahead of the curve on FDA requirements, to rapidly establish yourself,” he continued. The price ceiling policy has been in place for more than two decades, but it has neither been very successful nor free of consequences for pharma companies. Instead of the existing price controls, other mechanisms such as promoting competition among local manufacturers and increasing public healthcare spending should be focused on. It remains to be seen if the NPPA will schedule additional price adjustments for essential medicines in the current fiscal year ahead of the national elections, which are set to take place between 19 April and 1 June 2024. India’s independent drug pricing regulator, the National Pharmaceutical Pricing Authority (NPPA), has issued a marginal increase of 0.0055% to the maximum retail price (MRP) of medicines included in India’s national list of essential medicines (NLEM), which took effect on 1 April 2024.

The quotes are being sought for generic drugs, although they are also allowed for imported or combination drugs by their trade or brand names. Cipla’s introduction of Cabotres when it launch is constantly making cancer treatments more accessible and affordable. The brand’s commitment to quality ensures that Cabotres is a reliable option for patients. “Now what happens is most of the time we don’t get adequate supply of these Jan Aushadhi products in definite time. Hence, government can increase number of wholesalers, distributors in the scheme to improve availability of medicines at the stores.” (P9). The survey was undertaken to find out the extent of availability and stock-out of medicines at PMBJP outlets.

On the other hand, Palghar is an economically backward district with a population of nearly 3 million and is primarily inhabited by the tribal people. Others are not so sure anything has happened to dramatically curb manufacturing shortcomings, and argue that far from being too strict, the FDA ensures only the minimum standards are maintained. India’s Ministry of Health and Family Welfare did not respond to a request Abiraterone price philippines for comment. The chief drug regulator, however, has said he plans to add hundreds more staff and promised more oversight of the manufacturing process, while signing a co-operation agreement with the FDA last year. Three years ago, an Indian parliamentary committee looking at the drug-approval process concluded regulators were often in bed with the companies they governed, putting consumers’ interests last.

A “pair” of product from the same company was chosen to appreciate the price structure and mark-ups for the two versions. This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. In the first LDA multivariate model development approach, the AMLO FPPs were classified for AMLO quality parameters and other independent variables. The chromatographic calculations were done as per the method stated in the material and method section.