Interview guides were used to conduct in-depth interviews of physicians and pharmacists. We conducted a total of 16 in-depth interviews (IDIs) – 10 with pharmacists and 6 with physicians. Physicians working in public or private sector and practicing in the periphery of PMBJP pharmacies were selected for the study. Only qualified allopathic doctors and the pharmacists registered under the state or central pharmacy council were considered for IDIs. Both quantitative and qualitative data were collected concurrently between January, 2019 and June, 2019. But that is only the latest fallout from this country’s growing dependence on medicines made in India, as foreign regulators monitoring the booming South Asian industry uncover questionable manufacturing standards, manipulated records and even defective drugs.
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Maria Rosaria Carli was formerly Director of the Institute of Research on Mediterranean Economies of Italian CNR. Her research interests are focused on Economics of Development and she was Adjunct Professor of Economics of Developing Countries at the “Parthenope” University of Naples, Italy. She was Italian member of the Core Group and Standing Committee for the Social Sciences – European Science Foundation. She is scientific coordinator for the CNR on R&D projects and has published articles on national and international journals, as well as essays on collective volumes. After all, a clear understanding of our record of accomplishment and emphasis on quality supports the ongoing efforts of Indian generic manufacturers to provide quality solutions that ultimately benefit consumers across the globe. This medication is administered under the guidance of an oncologist and has specific dosing instructions to ensure effectiveness and minimize side effects.
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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.
Making the case for Indian generic drug manufacturing
I was in the range of 1–3, where 1,2,3 represented three different health care facility levels such as primary (Health Post in urban area /PHC in rural area), secondary (District Hospital/Peripheral Hospital) and tertiary (Medical college & hospital). Here, ni was the number of drugs from a specific therapeutic category available everolimus price in usa in a PMBJP pharmacy at a particular health care level and Pi was the number of facilities in that particular level of care and Ni was the total number of drugs listed in particular therapeutic category as per the survey medicine list. Similarly, stock-out of medicines was calculated for the reference period of six months.
3 Human capital in the patent-based regime
Aurobindo has had numerous well-documented safety and quality issues, as well as instances of corruption and lack of transparency. At the same time, pharma imports from China and India increased their share of total pharma imports, reaching 58% by weight. While imports from those two countries dominate the $208 billion in total imports, their dominance is much greater in specific drugs and medicines, sometimes reaching 100%. In many cases, pharmaceuticals from India are dependent on ingredients or starting materials that come from China.
Pradhan Mantari Jan Aushadi Kendra â Demonetarization of Medicine Prices in India
These objectives of the investigation highlight the essential explorative nature of the study, which has been finalized as a scenario analysis, adopting a mixed approach of quantitative and qualitative methods. To empirically carry out the investigation, secondary data have been extracted from the authenticated databases of the Centre for Monitoring Indian Economy (Cmie.com) and the Reserve Bank of India (Rbi.org.in), particularly to respond to RQ1 and RQ2. After determining the most relevant coordinates of the field, specific reports and issues from other governmental and corporate institutions have been purposively retrieved and analyzed through a content analysis for generating a narrative SWOT analysis, particularly to respond to RQ3. The figures came to light after academics collated the NHS price of 14 generic cancer drugs between 2011 and 2016 using information from the British National Formulary, the indicative NHS price and the Drugs Tariff and Prescription Cost Analysis data.
Surge in Pharmaceutical Imports Threatens U.S. National Security as India/China Dominance Grows
According to National Sample Survey Organisation, public facilities accounted for only 30% of the overall healthcare services in the year 2017–18 [4]. This means that majority of the people had to obtain healthcare including medicines from private providers. Moreover, even those who access healthcare from public facilities end up purchasing drugs from the market as the prescribed medicines are often not available in pharmacies of public hospitals. Currently, almost all medicines in India are sold under a brand (trade) name and medicines are called as branded medicines or branded-generic. In real sense, Indian market does not have branded medicines (a name commonly given to an innovator product) because till January 2005 product patent was not applicable in India.
- It was argued that, in case of market based ceiling price, medicines would be way too expensive than under the cost-based pricing approach followed by DPCO, 1995 [12].
- The disproportionate intellectual property protections the bloc proposes could threaten the affordability of generics that countries like India and Indonesia export to poorer nations.
- At the same time, according to an ambidextrous perspective, they should try to invest in R&D for innovative drugs to capture new opportunities arising from the demands for good health from the growing income classes.
- 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.
- There was an enormous effect of price policies on brands and drugs that had similar contents.
- Notwithstanding, such FDCs account for more than 50% of the pharmaceutical formulations in India [17].
- 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.
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If anything, recent Indian policies are sending a signal that intellectual property is tenuous in this country and will be granted only in those cases where it can benefit India. But, when it comes to drug pricing and intellectual property, the plane is severely tilted in India’s favor. At Delightaid Health, we can help you to get high quality generic Cabozantinib medicine at the lowest discounted cost.Please contact us via Email, WhatsApp or simply filling query form in our website bottom section or contact us page.
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In a country notorious for unsafe drinking water, they found Dr. Reddy’s has no way to ensure the water used to make the ingredients forming part of medications taken by Canadians is free of biological contamination. Delightaid health will not responsible for any consequences, effects or harm caused due to avoiding professional medical advice from certified doctors. Before sending the shipment, the prescription will be fully checked by our qualified Pharmacist.
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The industry benefits from cost competitiveness, driven by factors such as lower labor costs, economies of scale, and efficient manufacturing processes. This cost advantage enables Indian pharmaceutical firms to provide competitively priced products both domestically and globally. The extensive scale and diversity of the Indian pharma industry offer resilience and adaptability to the demands of supply chain, enabling it to cater to diverse needs and maneuver through market fluctuations effectively. Such a widespread presence on the global stage underscores the importance of robust supply chain networks capable of meeting stringent regulatory mandates, ensuring high-quality standards, and overcoming logistical hurdles. According to DPCO, the trade margins in the pharmaceutical supply chain should be reduced to allow better penetration of medicines under DPCO and allow a larger population to obtain access. The first-line sellers will receive different percentages of margins to apply, including distributors, wholesalers, retailers (chemists) and hospitals.
- The bill uses the tax credit techniques of the Inflation Reduction Act to stimulate U.S. companies to invest in the production of APIs and finished doses of generic medicines in either pill or injectable form.
- The growth of the middle-class population is leading to a new lifestyle, providing a huge market for lifestyle drugs, which are currently the lowest contributor to revenues from the sector.
- Paradoxically, low entry barriers have led to fragmented industries that make the sector highly accessible due to competition (Mahajan et al., 2018).
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- They included lots of a generic version of the antibiotic cefazolin, pulled because of fears the intravenous solution contained foreign particles.
Generic Aadhaar is giving identity to the old medical stores and making it easy for them who are dealing with huge competition and online Pharmacy in the Market. Earlier these medical stores were earning 5-10% profit margins but now they can earn 40% profit margins from Generic Aadhaar’ Franchise Outlets. What’s more, Indian manufacturers are being audited by inspectors from every market they export to — UK, Germany, South Korea, Japan, Brazil, to name a few — who regularly visit and evaluate Indian pharmaceutical factories.
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. EHR systems with e-prescribing capabilities help providers identify cost-saving opportunities, such as more affordable generic or therapeutic alternatives. With additional tools like coupon finders, EHR systems can locate the best local prescription prices and provide real-time data for drug-specific directions, enabling providers to offer more personalized and budget-friendly care.
The rise of drug shortages, the unreliable quality of the output of Chinese and Indian facilities, and the increasing concentration of the industry to one or two manufacturers for many drugs or key ingredients raises real questions over the FDA’s ability to address the shortage problem. Following the Covid-19 pandemic, pharmaceutical supply chains have evolved to become more agile, transparent, and resilient. They have embraced advanced technologies like machine learning and artificial intelligence. There is a significant ongoing investment in automating manufacturing and packaging processes to enhance productivity, operational cost efficiency, and labeling precision.
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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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If these Jan Aushadhi stores are available in Government hospital premises, patient can get those medicines easily.”(PuP2). If government wants us to prescribe drug through their molecule names, why do they allow so many brand names and why are there such wide price variations? By doing so, the brand has presented a cost-effective treatment for many patients of (HR+) (HER2-) advanced or metastatic breast cancer patients. Learn more about the Indian generic versions of Palbociclib and how it is a breakthrough in breast cancer treatment.
- 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.
- A 3-tiered public healthcare delivery system is catering to the needs of the population of these two districts.
- There are only 74 bulk drugs which are under price control[15]and are called scheduled medicines.
- The profiles of the physicians and pharmacists are provided as additional files (Additional files 2 and 3).
- “Now what happens is most of the time we don’t get adequate supply of these Jan Aushadhi products in definite time.
- 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.
- The Indian pharmaceutical industry is among the top producers in the world, supplying over 50% of the global demand for various vaccines, 40% of generic demand in the USA and 25% of all medicines in the UK (IBEF, 2020).
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- The customer will have to present a medical prescription (legal) prescribed from a doctor.
- 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.
- These branded drugs showed a variation in pricing, also known as inter-brand price variation.
- 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.
- Hence, consumer awareness for the generics, variety of trade names available in the market, and price variation is very limited.
- In this regard, the government of India has revised the national list of essential medicine to also include a newer range of services to ensure that healthcare facilities are equipped to provide services aligned with changing health needs.5 Likewise, states need to update their EMLs customized to their needs.
- EU negotiators should drop TRIPS-plus proposals, and entirely avoid them in future negotiations with developing countries.
The USA represents a large pharmaceutical demand as companies obtain substantially higher prices for medicines sold in that market. FDA approvals are considered benchmarks across many countries; therefore, these authorizations are very important for Indian pharmaceutical industries for the access, export, presence and profit they represent at the global level. Although Indian companies have received the highest number of FDA approvals in the last decade and in 2019–2020 particularly, there is an ongoing need to obtain these authorizations. The FDA regulations are stringent and time-consuming, making it difficult for midsized Indian companies to access the North American market and other similarly developed markets.
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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.
On top of all these problems is the large and growing national security risk as more and more drugs become dependent on suppliers from China. Even the common knowledge that we are becoming dependent on a small number of large drug companies for generic drugs understates the dependency on China. Qyobo is a software startup that collects pharmaceutical data from dozens of national and international databases to provide a picture of the drug supply chain that is not only superior to what the patient or the doctor sees, it is probably superior to the knowledge of the FDA.
The following were identified as the key focus areas to bolster the Indian pharmaceutical and healthcare sectors. Thus, from a practical point of view, Indian pharmaceutical companies should invest more in R&D, attempting to attract talented human capital. Otherwise, they will lose the highly qualified national workforce that will favor MNCs in the field.
But branding and marketing cost makes the medicines expensive which leads customers to buy medicines at a higher price. Upon evaluation of these facts, it is morally imperative to respond to the current negative media portrayal of Indian generic companies in the U.S. 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. This issue was again in the news last week when the Indian Supreme Court denied a patent application for Glivec (also known as Gleevec), an important treatment for leukemia made by Novartis. This is good for the company that will profit from usurping all of the R&D that Novartis put into the discovery and development of Glivec.
In addition to modern medicine, Ayurveda and the other mentioned treatments are highly popular in India. Patanjali, Himalaya, Vicco Laboratories and Dabur are the major companies manufacturing in the field (Mehrotra et al., 2017). Indian companies engaged in AYUSH production and distribution will have to consider a long-term perspective; in the near future, positive results are likely, but in long-range planning, with the tremendous increase of technology, focusing on this segment could be very risky.
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.
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].
