In fact, AYUSH represents a mass-niche market, requiring peculiar attention mostly in terms of competitive strategies that would have a focus orientation. 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. The most relevant contribution of the research relies on the shift to innovative production that Indian companies must adopt (after years of focusing only on generic drugs), and in this vein, appropriate industrial marketing solutions are indispensable. In order to collect data in an accurate and reliable manner, one of the researchers personally visited the selected PMBJP outlets to check the availability of generic medicines. The researcher cum field investigator is trained in both pharmacy and public health with previous experience of conducting primary data collection for health systems research.
- They have embraced advanced technologies like machine learning and artificial intelligence.
- However, several issues cannot be highlighted by the positive numbers so far analyzed, representing weaknesses and threats for the industry that have emerged from a qualitative analysis that has been deployed to provide the basis for a subsequent narrative SWOT analysis.
- 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 more detailed information, refer to the prescribing information and consult a healthcare professional.
- Given the objective to understand the determinants of access to medicines in the Indian public health system, the CRM reports between 2007 and 2021 were reviewed.
- The process of securing reimbursement for a pharmaceutical product varies and depends entirely on the specific processes provided under the respective policy.
- 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).
- This improved pricing – a 25% reduction – will allow governments in resource-limited settings to expand access to critical HIV services.
Prices for generic cancer drugs in the UK have soared over a five-year period, conference hears
The website is regularly updated by the Trust with assistance from Ministry of Consumer Affairs, Government of India. Indeed, the United States – a key destination for India’s generic exports – has made it increasingly costly and time-consuming for generic producers across the globe. This is in part due to the prescription drug user fee act (PDUFA), which requires pharmaceutical companies to pay fees ranging from US$1.5 million to US$2.7 million when submitting a candidate for approval.
Generic drug
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.
Evolution of PMBJP
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.
Creating Huge Little Moments for Patients
Because more than half of India’s pharmaceutical exports are to highly regulated markets such as the United States, Indian manufacturers must comply with strict U.S. Food and Drug Administration (FDA) guidelines that include regular and rigorous inspections to ensure compliance. However, some key obstacles remain to be addressed for the country to fully realise the remarkable growth potential of its healthcare market. These are limited resources, infrastructure deficits, shortage of health professionals, access and affordability of medicines in rural and semi-urban areas, as well as lack of public awareness about available healthcare benefits. Some reported that quality issues are hindering the uptake of unbranded generics, and asked for strong regulatory framework for quality control. “When we write any generic medicines and if it is not available in hospital pharmacy, patients have to go to other pharmacies to buy it.
solutions total link parallel
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. In addition, prescription drugs are a significant export category, representing percent of all U.S. exports while showcasing America’s innovative capabilities in ways that save and improve lives globally. While it is essential to prioritize streamlining procurement mechanisms, it is equally important that such provisions effectively translate to better access and availability of medicines across all levels of care. The state experiences underscore the need towards establishing robust tracking mechanisms for the efficient utilization of resources.
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India’s healthcare market is dynamic and rapidly expanding, driven by economic growth, demographic changes and government initiatives. While significant challenges remain, particularly in terms of infrastructure and workforce distribution, the opportunities for growth and improvement are substantial. 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. Some physicians reported that they face difficulties in prescribing generics as patients have negative attitudes towards cheaper medicines.
PALENO (Palbociclib) price in India
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.
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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 velcade price in mexico 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.
Why Does an $84,000 Drug in the U.S. Cost Less Than $1,000 in India
Our increased reliance on very few suppliers who ultimately depend on ingredients from China for many life-critical products is a huge risk to the health and safety of the American people. The first chapter of this report summarizes data on the importance of affordable medicines. 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. The last two chapters discuss the state of the overall supply chain of affordable medicines, concerns raised by U.S., EU and India, and possible opportunities for partnering to address these concerns. Nonetheless, despite being a global market leader in generic drug formulations, the Indian pharmaceutical industry is highly dependent on China for raw material supply to produce pharmaceutical formulations and even medicines.
Successful market access
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 other generic alternatives brands in India
- It can be argued that it is unreasonable and unwarranted to cast aspersions on an entire country’s pharmaceutical sector based on one-off incidents, rather than solid science, while disregarding the immense value it brings to healthcare across the world.
- In India, a dispensing pharmacist is not authorized to substitute a branded medicine with a branded-generic (or generic) as per the provisions under Rule 65 of the Drugs and Cosmetics Act, 1940 and Rules, 1945, which also add to the patient’s burden.
- Indian companies will continue to expand globally, enriching their manufacturing capabilities to meet the growing demand in the world.
- Quality and price of medicines were studied to evaluate the two versions of the same therapeutic molecule.
- 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.
- Some reported that quality issues are hindering the uptake of unbranded generics, and asked for strong regulatory framework for quality control.
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.
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. This policy is not applicable to patented drugs or fixed-dose combination (FDC) drugs. However, this year’s price increase is so marginal as to be almost equivalent to zero, especially compared to the significantly higher price increases observed in the last three years. In 2021, the NPPA approved a 10.7% increase to the MRP of drugs enlisted in the NLEM and a 12.1% increase in 2023. Therefore, the insignificant price increase for the new fiscal year (FY 2024–2025) will come as a huge blow to pharmaceutical developers as they grapple with the global tightening of price control mechanisms alongside the rising costs of raw materials, shipping, and production.
Some of these practices reportedly originated as ad-hoc measures in the service delivery chain and continued in the absence of root-cause mitigation efforts; while some continue to exist due to the lack of capacity building measures. They are relatively more prevalent in primary healthcare facilities and community health centers than in district hospitals. Given this as background, we are presenting a study, in that linear discrimination analysis (LDA) models for deducing the correlations between acceptable quality attributes of AMLO FPPs and independent variables would be helpful in establishing outcome effects.
Pfizer and Flynn Pharma fined £69m for ‘excessive’ pricing of epilepsy drug
Hence, consumer awareness for the generics, variety of trade names available in the market, and price variation is very limited. Hence, there is need to conduct a study that can document the price structure and quality of the branded product and their branded-generic versions manufactured in India. Difference in price-to-patient was not as huge as it is expected for generics but margins for retailer were very high for branded-generics.
Five Years into the Product Patent Regime: India’s Response
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.
Envisioning the challenges of the pharmaceutical sector in the Indian health-care industry: a scenario analysis
However, the LDA had revealed the most acceptable quality attributes for the price range of 1–2 rupees and alike higher money value medicine, i.e., 2–3 rupees. The Commission is right to do this for its citizens’ health, and the lesson applies to other parts of the world too. However, in trade agreements, the bloc has continued to pressure developing countries to include disproportionate intellectual property protections that go far beyond the TRIPS agreement. Table 1 shows America’s top ten sources of pharmaceutical products last year by weight. China led the rankings, with 217.2 million kilograms (kg) or 477.8 million lbs of pharmaceutical imports. The IQVIA Human Data Science Cloud is our unique capability designed to enable healthcare-grade analytics, tools, and data management solutions to deliver fit-for-purpose global data at scale.
