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.
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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.
Product
- Drug Supply Chain Security Act (DSCSA) was enacted in Congress on November 27th 2013 with the aim of making drug products safer by creating a framework for enabling pharmaceutical product traceability, its implementation has been far slower than expected.
- “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.
- Doctors did not seem to be very much confident about the effectiveness of generic medicines.
- NLEM, 2015 has 376 essential drugs whereas the PMBJP list contains 214 essential medicines.
- India has witnessed rapid population and economic growth in the past two decades, and this expansion has created a demand for larger and better infrastructure in cities and industrial parks.
- 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.
- Furthermore, the Indian pharma supply chain grapples with issues related to counterfeit drugs and supply chain integrity.
- The challenges are reportedly more pronounced in North-Eastern states and for facilities under the National Urban Health Mission (NUHM).
- The IQVIA Innovation Hub connects start-ups with the extensive IQVIA network of assets, resources, clients, and partners.
- 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.
Addressing these infrastructure gaps requires substantial investment and collaborative efforts between the public and private sectors. Several factors have an impact on pharmaceutical patents in India, such as an increasing level of income, a consistent growth rate of the domestic economy, and rapid growth in the diffusion of better economic conditions. In this respect, however, foreign companies, as well as national companies, have been reluctant to invest in R&D in India (Ghai, 2010). Indeed, compared to developed nations, Indian pharmaceutical companies concentrate less on innovation, where they allocate less budget. For all the above-described reasons, they find manufacturing generic drugs more lucrative, as the outcome is guaranteed. Taking into account the above considerations, from a narrative and then qualitative point of view, a positive scenario for the Indian pharmaceutical industry can be highlighted, thus providing a response to RQ3 (“What are the most relevant SWOT for the future?”).
Pharmaceutical pricing and reimbursement
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Thus, the Indian government should establish ongoing support to small- and medium-sized Indian companies in training and implementing FDA standards, as it provides easy global access to those and similar international markets. India has witnessed rapid population and economic growth in the past two decades, and this expansion has created a demand for larger and better infrastructure in cities and industrial parks. India’s limited development pomalidomide price philippines of service platforms is a result of the scarce functioning of the bureaucracy, but conditions have improved in recent years. There is a need to reserve appropriate sizes of land for the health-care sector in cities and for pharmaceutical companies in industrial belts during the planning process. In India, the public health-care system is not strong, and most of the middle class and above prefer to visit private hospitals for treatment.
Radha Iyer vice president and Head of Quality and Scientific Affairs
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.
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In most of the states, free medicines were restricted to targeted beneficiaries like BPL families, beneficiaries of JSSK, Janani Suraksha Yojana (JSY), and enrollees of state-specific insurance schemes. Even among the beneficiaries, the range of medicines given free of cost was not as per the EML nor based on epidemiological load. In Colombia, data exclusivity increased the public health system’s costs by $396 million between 2003 and 2011. Meanwhile, in 2006, the Korean National Health Insurance Corporation calculated that a four-year patent term extension would cost 722.5 billion won — the equivalent of $757 million at the time. 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. It was the influx of affordable generics from India that helped drive down the price of treatment from over $10,000 to under $100 per year, saving countless lives.
Browse the Drugs alphabetically
This chapter has been written by a member of GLI’s international panel of experts, who has been exclusively appointed for this task as a leading professional in their field by Global Legal Group, GLI’s publisher. GLI’s in-house editorial team carefully reviews and edits each chapter, updated annually, and audits each one for originality, relevance and style, including anti-plagiarism and AI-detection tools. All methods were performed in accordance with the relevant guidelines and regulations. The study protocol was approved by the School of Health Systems Studies, Tata Institute of Social Sciences, Mumbai. Besides, the permission to conduct the study was obtained from Bureau of Public Pharmaceutical Undertakings (BPPI), Department of Pharmaceuticals, Government of India. The informed written consent of study participants’ including the pharmacists of surveyed PMBJP outlets was obtained prior to conducting interviews and reviewing stock records.
Publications
- New drugs are protected by patents, so only the company that came up with the drug can sell it.
- One of the foremost challenges confronting the Indian pharma supply chain is regulatory compliance.
- In this respect, however, foreign companies, as well as national companies, have been reluctant to invest in R&D in India (Ghai, 2010).
- With price rises of more than 1,000 per cent in the generics sector, academics would like to see better price regulation.
- Common side effects include gastrointestinal issues and fatigue for both drugs, but specific side effects and patient responses may vary.
- 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.
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.
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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.
- Unlike developed countries, people in developing countries pay the cost of medicines out-of-pocket.
- In addition, at the level of corporate strategy, firms should establish collaborations and alliances and expand their industrial marketing vision.
- Paleno, which contains Palbociclib is a medicine used to treat breast cancer treatment.
- More papers with manufacturing and drug testing data were shredded and tucked away in plastic bags under a stairwell, indicating that Intas executives had manipulated data and tried to cover it up.
- 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.
SII separately has a manufacturing agreement with AstraZeneca to produce one billion doses of the Covishield vaccine, which the UK company is developing with the University of Oxford. Another challenge to India is wealthy countries protecting their pharma industries to ensure drug security. In August, President Trump issued an executive order that called for the elimination of drug imports, both as active ingredients and formulations. The price ceiling policy has been in place for more than 20 years, but it has neither been very successful nor free of consequences for pharma companies. Generic drug manufacturers do not have to spend extra money for drug discovery and preclinical and clinical trials. Generics are available at a lower cost; they provide an opportunity for savings in drug expenditure in a country.
How much is the Palbociclib cost in India?
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.
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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.
Cabozantinib Generic Price in India
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.
“Established in 1992, BPI has a proven track record in the research & development and manufacturing of oral solutions, suspensions and suppositories,” underlined Jinesh Shah, director at Torrent Pharma. Given the interlinkages within various systemic processes, a move towards improving access to essential medicines must be subsumed under overall health systems strengthening across the states. Education curricular changes sensitizing providers on generic medicines, rational prescription, STGs/STPs, and continuum of care can mitigate undesirable practices. In Jordan, for instance, between 2002 and 2006, the less expensive generic alternatives of 79 percent of medicines were delayed by data exclusivity, threatening the financial sustainability of government public health programs. Similarly, Guatemalans found themselves unable to access medicines readily available in most countries at affordable prices, as Guatemala is bound by data exclusivity clauses in its free trade agreement with the United States. This is a statin or blood-thinner used by millions of patients at risk of cardiovascular disease.
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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 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.
There are only 74 bulk drugs which are under price control[15]and are called scheduled medicines. For scheduled medicines, the NPPA pricing formula sets the 8% mark-up for wholesalers and 16% for retailers. For non-scheduled medicines, these markups are not set, but it is agreed by the partners of the trade that for branded medicines average mark-up would be around 10% and 20% for wholesalers and retailers, respectively. Diverse systemic determinants of access to quality and affordable medicines have been documented through CRMs. Though not an exhaustive list, state-specific experiences over the years highlight the determinants of access, and pertinent systemic challenges needing redressal.
