EU trade deals risk affordability of generic medicines for Global South

We appreciate the cooperation of retail pharmacists and distributors who helped us in collection of the data.

• It meets 40% of the generic demand in the US and provides a quarter of all medicines in the UK.
• China has already demonstrated its willingness to use its economic leverage in peacetime with commodities like rare earths and graphite.
• Interview guides were used to conduct in-depth interviews of physicians and pharmacists.
• Table 3 shows the extent of availability of medicine at PMBJP pharmacies across all levels of care in Mumbai and Palghar.
• This is because in India, there is an inadequate R&D infrastructure and lower industry-academia connection for research.
• The intense pressure to lower prices of generic pharmaceuticals has led to a different global structure.
• According to the PBBJP portal, 29 PMBJP pharmacies are currently functional across these two districts.

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The study findings show that PMBJP’s unbranded generics offer great opportunities for substantial cost savings. But, in order to fully realise the potential of this scheme, some policy actions are urgently required. Fourth, PMBJP’s medicine procurement and distribution policies must be reviewed to address the supply chain issues. Moreover, there is a need for major pharmaceutical policy reforms to promote generic medicines in a big way.

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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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Indeed, a number of the larger players are looking at acquisitions in key markets across the globe. The generic landscape is rapidly changing with cost pressures slowing down domestic offtake, pricing pressures in developed markets such as the United States and Europe, as well as pricing pressures being introduced in India. Moreover, regulatory bodies are demanding stricter compliance, pushing up compliance costs.

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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 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.

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The skilled labor force is available in Indian cities at very competitive salaries compared to most other destinations. Subsequently, the trade balance of the sector was analyzed to understand the state of the art and potential development trajectories of growth/development compared to the rest of the world. The data reported in Table 2 (with the details of various categories) and Table 3 (with the related balance of the same categories) provide evidence about the progress of the Indian pharmaceutical industry and its international business.

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A 3-tiered public healthcare delivery system is catering to the needs of the population of these two districts. 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. The mid-level of the pyramid, which is the secondary care level, includes rural hospitals and municipal general hospitals, and at the top level, tertiary care institutions like medical colleges are there. According to the PBBJP portal, 29 PMBJP pharmacies are currently functional across these two districts.

• The U.N. Special Rapporteur on the Right to Health proposed that “developed countries should not encourage developing countries to enter into” free trade agreements with TRIPS-plus measures, and that they should “be mindful of actions which may infringe upon the right to health.” In the same vein, as U.N.
• 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.
• IQVIA Decentralized Trials deliver purpose-built clinical services and technologies that engage the right patients wherever they are.
• The second chapter highlights the role that Indian companies play in the supply of drugs to the U.S. in terms prescriptions, patient access, resilience, and savings.
• 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.
• However, to fully understand whether rebranding of JAS as PMBJP improved the accessibility of essential medicines, a pre/post evaluation study would have provided better insights but that could not be performed due to the non-availability of comparable baseline survey data.

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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. What that patient is unlikely to know is the drug’s active ingredients come from a company called Dr. Reddy’s Laboratories Ltd. in India — or that U.S. inspectors made some eye-opening discoveries recently at the plant that produces them. The medicine will be only for personal use and not more than 3 month supply at a time. Quality and price of medicines were studied to evaluate the two versions of the same therapeutic molecule.

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But your income and the cost of the drugs you need may affect your ability to qualify for discounts. Information about these programs is free and available from your doctor, pharmacists, and the government. We already know from previous experience that such proposals — known as TRIPS-plus — can have devastating consequences for access to medicines. The disproportionate intellectual property protections the bloc proposes erlotinib price in singapore could threaten the affordability of generics that countries like India and Indonesia export to poorer nations. Professor Schondelmeyer favors creating what he calls “concentric circles” starting with the most at-risk drugs, which start with drugs produced in at-risk countries in only one factory, then move out to include those produced at multiple facilities or multiple countries and those in current shortage.

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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].

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Of the 10 drugs already on the market and recalled because of quality defects since New Year’s Eve, four were made in Indian factories, Health Canada says. They included lots of a generic version of the antibiotic cefazolin, pulled because of fears the intravenous solution contained foreign particles. This push to make generics ever cheaper is saving the health-care system billions of dollars. But, says Dinesh Thakur, a soft-spoken chemical engineer and former executive with Ranbaxy Laboratories, it comes with a price of its own. This means about one in 20 of this country’s finished drugs are now made in India – roughly 20 million prescriptions a year.

In some cases, pharmaceutical reimbursement may involve direct billing between healthcare providers and insurance companies or government agencies. 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. In the case of ‘overcharging’ by manufacturers and/or violation of pricing regulations, the NPPA has the power to seek recovery of overcharged amount along with interest, as well as penalties in some cases. 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.

Typically, a claim for reimbursement of a new pharmaceutical product requires a valid prescription from a registered medical practitioner. Further, it is required to be covered under the reimbursement schemes, which are listed in formularies approved by the respective authorities. 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. Thereafter, such claims are processed, and reimbursement is provided based on the scheme’s guidelines and approval procedures.

Further, the private physicians underlined the need for developing strong regulatory mechanisms to ensure that generic drugs meet high standards of quality. “We are ready to prescribe low cost generics, but it becomes difficult for me to convince my patients to take such a low-cost generic medicine. Most of the time patients want relief from pain as quick as possible and thus they are ready to pay even high for medicines. We first examined the selected medicine list of PMBJP to assess the extent of coverage of essential medicines. NLEM, 2015 has 376 essential drugs whereas the PMBJP list contains 214 essential medicines.

In response to this growing regulatory environment, pharmaceutical companies in India continue to strengthen their processes, while improving automation, operating procedures and quality management systems. This includes vigorously efficient quality control and quality assurance systems alongside training programs and workshops, building an omnipresent culture of quality. The result is a focus on quality that starts at a shop-floor level for machine operators, ensuring compliance from the ground up. In the past few years, expectations of regulatory organizations around the world have increased. With the number of companies and manufacturing facilities supplying to the regulated market growing fast, it is natural that the agencies are intensifying their efforts.

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In the home market, drug prices are controlled by the drug price control order; therefore, there is strong pressure on revenues and subsequently on costs. In the international market, threats derived from pharmaceutical multinational companies are emerging as tough obstacles to overcome. Indian generic manufacturers are also producing in the U.S. and in other countries whenever necessary.

The prepared sample was filtered using a 0.45 μm membrane filter and injected into a chromatograph in duplicate. The chromatographic achievements and relationship models were developed using a licensed version of SPSS 28.0 (SPSS Inc., Chicago, IL, USA). Sequentially, the assay result biasness was ± 5%, and the quantitative value of genotoxic impurities equal to or more than threshold of toxicological concern limit was counted as acceptable quality attributes for AMLO besylate-containing FPPs. The European Parliament has similarly recognized the importance of medicines as global public goods, and it has repeatedly called on the Commission to exclude TRIPS-plus requirements in trade negotiations — much like in its 2021 resolution to ensure all HIV antiretroviral treatments are affordable.

Previous studies suggest that doctors’ negative perceptions regarding generics was a major constraint faced by JAS leading to its poor success [15,]. PMBJP’s stated objective is to gain the confidence of the medical community and consumers in unbranded generics by generating awareness through education and publicity. In this study, we have assessed the acceptability of PMBJP’s unbranded generics It is worth noting that the Indian pharmaceutical market is flooded with irrational or non-essential drugs. For example, majority of fixed dose combinations (FDC) that are marketed in India are therapeutically non-beneficial and unsafe for use [16, 17]. Notwithstanding, such FDCs account for more than 50% of the pharmaceutical formulations in India [17]. We, therefore, critically looked at the selection criteria for medicines included in the PMBJP list.

• 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.
• 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.
• Faster decision making and reduced risk so you can deliver life-changing therapies faster.
• 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.
• Recordings were translated from the local languages such as Marathi and Hindi in English, and then transcribed verbatim.
• Earlier, it was known as the Department of Indian System of Medicine and Homeopathy (ISM&H), founded in 1995.
• The Indian government believes that the prices of lifesaving drugs shouldn’t be set by market forces.
• 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.
• Further, it is required to be covered under the reimbursement schemes, which are listed in formularies approved by the respective authorities.

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. The PMBJP pharmacies were purposively selected based on their proximity to public health facilities such as medical college (Tertiary level), Municipal General Hospital (Secondary Level) and PHCs and HPs (Primary level). PMBJP pharmacy’s proximity to the public health facilities was assessed using google maps (Fig. 1). All the selected PMBJP outlets agreed to participate in the study; and a written consent form was signed before data collection.

Remarkably, 36% of China’s exports are to the EU and North America, where regulations are the most stringent, compared to 19% in 2009. Beijing’s “Made in China 2025” policy has identified pharmaceuticals as one of its strategic industries. Now, the advantages that have enabled India to play this role are in danger of being eroded.