The Same Pill That Costs $1,000 in America Sells for $4 in India

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.

Generic drug

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.

How to buy PALENO in India?

Also, a formulary containing the details of therapeutically interchangeable products is available for reference [36]. And for ensuring the quality of generics, information regarding bioequiavailability is sought from companies before they place the products on the market. Aside from the supply side initiatives, demand side measures such as physicians’ motivation to prescribe generic drugs, consumers’ attitude towards generic drugs have shown some results [42,43,44].

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This study aims to access, analyze and highlight opportunities and problems of the Indian pharmaceutical sector in the broader national health-care industry. The recent changes in the field, at the institutional and corporate levels, have placed India in the spotlight of the global pharmaceutical market, but several threats and weaknesses could limit this expansion. It stands to reason that when the media raises concerns about the safety and scope of imported generic medicines, consumers question the quality of medicines essential to their health. These concerns raise fears among patients that taking drugs made in India may result in unpredictable effects.

• 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).
• Ensuring compliance with diverse regulatory requirements across different markets poses a considerable challenge for Indian pharmaceutical companies as it would for any company operating globally and subject to multiple jurisdictions.
• Generic substitution rates have increased remarkably there, probably due to greater acceptance by physicians and pharmacists as well as encouragement from the third party payers.[20]Cheaper generics are one of the important factors to reduce health-care cost.
• Most of the blockbuster drugs that fuelled Big-Pharma profits over the last two decades went off patent in the last few years, opening the market to generic copies.
• Authors would like to thank the pharmacists, PMBJP pharmacy owners and physicians who participated in the study.
• This uncertainty in the regulatory framework affects the ease of doing business for pharmaceutical companies, which has a detrimental impact on innovation and value creation.
• While margins may be reducing due to the extra costs and regulatory fees, on average, Indian drugs cost 33% less in comparison to their U.S. counterparts, bringing much needed relief to the notoriously high healthcare prices in the United States and elsewhere.
• Fluctuations in input costs (raw materials, manufacturing equipment, etc.) and inflationary pressures, which are unpredictable and beyond the purview of control of pharmaceutical companies, also pose a hurdle to the determination of price fixation of non-essential medicines.

Learning Essential Caregiver Communication Skills

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.

India Solicits Price QuotesFor More Than 500 Generic Drugs

Schondelmeyer, a professor of pharmaceutical management and economics at the University of Minnesota, testified on drug shortages before the House Ways and Means Committee in February, urging the Congress to take action to address the growing problem of generic drug shortages. After developing the above topics, it is possible to implement a potential framework to oversee the current and future conditions of the Indian pharmaceutical industry. Naturally, the peculiar situation is considered due to the COVID-19 pandemic, whose impact in the near and far future may greatly influence scenario analysis. For these reasons, we opted for a narrative SWOT analysis, similar to other studies (Vandevelde and Halleux, 2017; Septinaningrum and Nugraha, 2019; Cowx et al., 2010). Special economic zones (SEZs) are popular because they provide tax benefits for companies. To create new business opportunities for the pharmaceutical industry, SEZs can be a powerful option, especially if established near airports, stations and ports.

GENERIC DRUG: PRESCRIBER’S PERSPECTIVE

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.

Pradhan Mantari Jan Aushadi Kendra â Demonetarization of Medicine Prices in India

Among the antidiabetics, cardiovascular and consumables not available on the survey day, 44% and 33% respectively were out of stock for the period of 3–6 months. Nearly 30% of palliative care medicines and vitamins, about 17% of antiasthmatics and consumables were out of stock for a period of 1–3 months. The pharmaceutical industry was once concentrated in Europe and North America, but has spread increasingly into the developing world, where low costs cater to a growing Western pressure. No wonder Palbociclib suppliers in India are looked upon as major game changers for Breast Cancer treatment. As Sun Pharmaceutical has introduced cheap medicines in India, addressing breast cancer has become accessible and affordable.

Scope for costsavings on medicine and affordability of PMBJP medicines

• 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.
• 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.
• Even among the beneficiaries, the range of medicines given free of cost was not as per the EML nor based on epidemiological load.
• 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.
• The firm regularly attends hearings before forums such as the Ministry of Chemicals & Fertilisers and the Department of Pharmaceutics on behalf of its clients, providing strategic legal support in these highly regulated environments.

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.

CONVERGENCE OF NATIONAL HEALTH PROGRAMMES

Here’s a breakdown of the cost differences between generics and brand names for over-the-counter and prescription drugs. To better understand the factors shaping these decisions, Tebra surveyed over 1,000 Americans and compared the costs of popular medications in five major US cities. This report explores how patient preferences, medication types, and healthcare tools like EHR systems shape the way Americans approach their healthcare choices. New drugs are protected by patents, so only the company that came up with the drug can sell it. Once the patent expires, other companies can get a generic version of the drug approved by the FDA and start selling it.

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.

For example, an attack strategy seems realistic when combining strengths such as the industry’s manufacturing ability and the rising economy of the country, thinking about a competitive strategy based on differentiation and/or niche orientation for innovative and patented drugs. Similarly, a defense strategy seems realistic when combining the experience with generic drug production with DPCO limits, thinking about a competitive strategy based on cost leadership, which may be sustainable considering the huge population of the country. Consequently, domestic businesses will be hindered to some extent, and exports may blossom. For example, India has been universally considered the pioneer in the export market for generic drugs. In the case of other medicines, if the drug is under DPCO in India, it may be possible to sell it under price control domestically and to collect maximum revenue from exports, thus helping to enhance the country’s economy (Das, 2013). Nonetheless, DPCO policies had an adverse influence on the imports of medicines to India in the form of a fall in trade due to price regulations.

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.

Worth the price? Push for cheaper generic drugs has Canadians buying questionable medicines from India

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.

• For example, melphalan to treat ovarian cancer cost the UK £1.82 for 2mg but in India its generic cost is 8p, a rise of 2,171%, the findings show.
• There are a large number of drugs that went off patents, providing many pharmaceutical companies with huge opportunities to enter the market.
• These policy issues, along with market forces, drive the response of the public and private sectors to reimbursement policies, as well as determine the extent of price control on pharmaceutical products.
• Indian pharmaceutical companies have been a critical partner in the supply of these drugs by providing affordable medicines for major health conditions that enhance patient access, improve management of health conditions, and bring savings and resilience to the overall health system.
• S&S was the first law firm in India to challenge the constitutional validity of the provisions of the Drugs (Price Control) Order, (DPCO) 2013, representing 15 pharmaceutical companies before the Delhi High Court in this groundbreaking case.
• We appreciate the cooperation of retail pharmacists and distributors who helped us in collection of the data.
• Similarly, a defense strategy seems realistic when combining the experience with generic drug production with DPCO limits, thinking about a competitive strategy based on cost leadership, which may be sustainable considering the huge population of the country.
• “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.

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 lenvatinib price in singapore 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.

• Particularly, the country exports generic medicines on a large scale, with a major impact in the American and European markets.
• The cost of generic medicines of PMBJP outlets for treating various conditions range from 0.01 days’ wages to 0.47 days’ wages for the lowest paid unskilled worker in Maharashtra.
• Additionally, barriers in communication and coordination between the states, districts, healthcare facilities, and procurement bodies cause duplication of purchases.
• An in-depth exploration of the global healthcare ecosystem with timely research, insightful analysis, and scientific expertise.
• In many cases the generic drugs do not produce the desired effect in the expected time which branded ones do.

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.

The Bureau of Pharma Sector Undertakings (BPSU) working under the Department of Pharmaceuticals, Government of India, was entrusted with the responsibility of implementing JAS, i.e., to coordinate procurement, supply and marketing of generic drugs through JAS outlets. The scheme envisaged to sell generic medicines at affordable prices through exclusive outlets namely JAS stores across the country, starting from the district to sub-divisional headquarters and to towns and villages. However, JAS never really took off; there were only 99 JAS outlets across India which were selling 131 medicines till 2014. According to a study, the availability of medicines in JAS was abysmally low (33%) [13, 14]. Against this backdrop, in September 2015, the union government decided to expand its generic drug scheme called “Pradhan Mantri Bhartiya Jan Aushadhi Pariyojna (PMBJP)”, which envisaged making unbranded quality-assured generic medicinesFootnote 4 available at affordable prices to all people and especially the poor.

Overall, the pharma and healthcare industry in India presents tremendous potential for growth especially in innovation, research, early detection, and futuristic solutions like robotics-assisted surgery. By leveraging its strengths, embracing technological advancements, and fostering collaboration, the Indian pharmaceutical industry can continue to play a pivotal role in shaping the future of healthcare delivery both domestically and internationally. Making the healthcare supply chain resilient will require end-to-end supply chain visibility through digitalisation and use of global standards which facilitate interoperability. According to the study, “over 80 per cent of the Pharmaceutical and Medical Devices Manufacturers do not have product visibility till point of care. In October 2023, OPPI and EY conducted primary research, engaging with approximately 40 Chief Executive Officers (CXOs) representing prominent Indian and multinational pharmaceutical companies, as well as other industry organizations.

It is administered orally and requires careful dosing and monitoring by healthcare professionals to manage side effects and ensure the best therapeutic outcomes. Ms. Chawla has authorised and contributed to various academic articles and journals on topics relating to cyber laws and copyright laws. She has represented the firm at national and international conferences and conclaves in India and Dubai. Further, she has also conducted workshops on IP law for university students and has been invited as a judge for several prestigious moot court and negotiation competitions at the university level.

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.

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. This has been underpinned by several changing global market dynamics as well as pressures faced at home in the domestic arena. Price erosion has made it more difficult for low-cost manufacturers in India to justify their margins as the price of generics formulations falls globally. Furthermore, efforts by Governments to promote the development of their own national pharmaceutical industries in key markets across Latin America, Sub-Saharan Africa and Southeast Asia have made the playing field more challenging as exporters encounter increasingly rigid regulatory policies.

The current regulations are not yet designed to promote patent filings (Chaudhuri, 2019), and this situation strongly impacts the internationalization perspective. 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). Although the sector still shows more relevant values concerning production quantity than production turnover, pharmaceutical exports are expected to reach US$16.28bn in FY20 (ibidem).

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.

Against a group of these units, if 03 antimicrobials medicines were available in a PMBJP store and 04 antimicrobials medicines were available in another store, then the overall availability of anti-microbials in PMBJP pharmacies at primary level facilities of Palghar was 50% [((3X1) + (4X1)) X100/14]. In addition to streamlined procurement and communication channels, systematic reporting across the programmes is pivotal in aligning the demand for medicines with the state’s disease burden. For chronic conditions, the pace of NCD services uptake, especially at primary level healthcare facilities significantly influences demand-driven access to NCD-specific essential medicines. For example, in negotiations with Indonesia, the bloc proposed an extensive intellectual property enforcement regime that could adversely impact access to medicines. It has also sought to extend the duration a pharmaceutical producer is granted a patent monopoly and expand exclusive rights to data, both of which would delay the marketing of affordable generic versions.

Competition has been so fierce it’s driven down the cost and spurred thousands to be tested. Doctors did not seem to be very much confident about the effectiveness of generic medicines. Doctors ask us to ensure efficacy of generic medicines by claiming it in writing.” (P8). Among the medicines unavailable in PMBJP stores at the time of the survey, around 42% were out of stock for the period of 3–6 months, while 11% and 7% of drugs were found to be out of stock for 1–3 months and up to 1 month respectively (Fig. 3). In Palghar, about 86% of anticancer and electrolyte balancing medicines, which were unavailable at the time of survey, were out of stock for 3–6 months.

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 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.

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 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.