India Solicits Price QuotesFor More Than 500 Generic Drugs

Following this, we picked the essential drugs from the PMBJP product basket, which were found on all the above-mentioned lists. Of the 35 surveyed medicines, 22 were from the first (for global burden of disease) and second (specific to Southeast Asia) core medicine lists recommended by WHO/HAI methodology and 13 were drawn from the NLEM, 2015. Information was obtained on the availability of essential medicines at PMBJP outlets across primary, secondary and tertiary levels of health care delivery system against the basket of 22, 28 and 35 medicines respectively selected according to therapeutic category. Among the medicines included in the survey, 22 are universal medicines, which are supposed to be available at all levels. Apart from the universal medicines, 6 more medicines were considered at the secondary level, while, in addition to the medicines at the primary and secondary levels, 7 other medicines were assessed for availability at the tertiary level. The list of medicines and consumables has been provided as an additional file (Additional file 1).

2 The scenario of the Indian pharmaceutical industry: contextual analysis

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.

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Again, this involves a minimum of one billion doses for India and other low to middle income countries. This is the lowest quoted price in the world for a COVID vaccine, and will see them distributed in low and middle-income countries. By comparison, German biotech firm BioNTech’s deal with US involves a price of US$19.50 per dose, while the Moderna/US deal is set at between US$32 and US$37 per dose. You can share this content on Americans’ preferences for generic versus brand-name medications for noncommercial purposes as long as you provide a link to this source page. Exploring cost savings, perceived effectiveness, and the role of medication type in American buying habits. Generic medications go through testing for quality, strength, purity, and potency to show effectiveness before being approved by the FDA.

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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 abiraterone price in usa 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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• Food and Drug Administration (FDA) guidelines that include regular and rigorous inspections to ensure compliance.
• We conducted a total of 16 in-depth interviews (IDIs) – 10 with pharmacists and 6 with physicians.
• From a theoretical point of view, the contribution of intellectual capital to the financial stability and economic prosperity of the pharmaceutical industry, most of all due to patents as immaterial assets deriving from human, structural and/or relational capital, seems indispensable (Festa et al., 2020).
• Such measures risk decreasing sales of price-controlled products, which in turn could discourage multinational pharmaceutical companies from launching new products in the Indian market.
• As mentioned earlier, overall, mean drug availability was found to be around 51% with highest at PMBJP pharmacies at secondary level of care i.e., at peripheral hospitals (52.5%), followed by tertiary level i.e. medical college (50.8%) and primary level i.e. health post (48.7%).
• 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.
• Table 1 shows America’s top ten sources of pharmaceutical products last year by weight.

Doctors regularly write angry letters to newspapers complaining that they cannot find the drugs their patients need. The heart of the problem is that we have driven prices too low, moved supply of generic medicines to a small number of the cheapest-of-the-cheap offshore suppliers, and sacrificed resiliency, manufacturing quality, and backup supply to chase the false god of low prices. Often hailed as the ‘pharmacy of the world,’ the Indian pharmaceutical industry is booming. It jumped from $40 billion in 2021 to an expected $130 billion in 2030, with projections hitting $450 billion by 2047. Beyond just keeping up with the demand at home, the Indian pharma industry commands over 20% of the global pharma supply chain and addresses approximately 60% of the worldwide demand for vaccines.

Key drugs losing patent protection in 2025

In spite of being the ‘pharmacy of the world’, access to essential medicines for a large majority of Indians is constrained by both physical and financial reasons. According to an estimate, medicines account for 69% of household out-of-pocket spending on health care. To make quality generic medicine affordable, India’s People’s Medicine Scheme (Jan Aushadhi) was launched in 2008 and then revamped and rebranded as Pradhan Mantri Bhartiya Jan Ausadhi Pariyojana (PMBJP) in 2015. The current study focuses on the availability, affordability and acceptability aspects of PMBJP essential medicines. Infrastructure constraints present another significant hurdle for the Indian pharma supply chain. Despite substantial progress in recent years, inadequate transportation and logistics infrastructure continue to hamper the efficient movement of goods within the country.

• 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.
• IQVIA Decentralized Trials deliver purpose-built clinical services and technologies that engage the right patients wherever they are.
• 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.

India’s challenges

Particularly, the country exports generic medicines on a large scale, with a major impact in the American and European markets. Assessing the availability and affordability of generic medicine at PMBJP outlets is important, but perhaps it is even more important to know the physicians’ attitude towards generic drugs and PMBJP scheme, as they play a key role in prescribing generic medicines. Most of the physicians argued that generic and branded medicines have the same active substance(s). Table 6 shows the cost of standard treatments, as recommended by WHO, with surveyed medicines at PMBJP price and at branded generic price for a number of health conditions [22, 23]. 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 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.

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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.

Will my doctor automatically prescribe generic drugs?

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.

A SURVEY BASED STUDY IN CURRENT SCENARIO OF GENERIC AND BRANDED MEDICINES

• 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.
• In spite of being the ‘pharmacy of the world’, access to essential medicines for a large majority of Indians is constrained by both physical and financial reasons.
• Faced with shortages and a limited number of suppliers, almost all of them overseas, the FDA is actually being forced to relax its standards, just to find any supplier of certain badly-needed drugs.

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.

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.

Why Not Regulate Prices?

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.

Do lower prices make generic medications the top choice for Americans?

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.

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.

1 Growth of the sector

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Evolution of PMBJP

That leads to widely differing standards across India, with the temptation to lower standards to attract more manufacturers. “The Indian drug industry is like the wild west on steroids,” Professor Schondelmeyer told us. There is less emphasis on R&D in pharmaceuticals, which have a major focus on generics.

• In comparison, Gen X was the most likely to prefer generic medications, mainly due to cost (95%), previous experience (28%), availability (26%), and higher trust (15%).
• By our calculations, China’s global share of formulations exports trebled from 0.4% in 2009 to 1.2% in 2018, while India’s doubled over the same period from 1.5% to 3.6%.
• The future will see a major role in global healthcare by Indian pharma, not only in making medicines affordable, but also in strengthening India’s position as a global hub for making innovative and high-quality medicines.
• In value terms, the sector, considering the total manufacturing of pharmaceuticals, medicinal chemicals and botanicals (Table 1), is worth Rs. 145,841.1m in 2018–2019.
• Recently, in March 2024, the Indian Government constituted a five-member Committee to oversee reform efforts for the pricing of drugs and medical devices and supervise the drafting of a new Drugs and Medical Devices (Control) Order.
• Again, this involves a minimum of one billion doses for India and other low to middle income countries.
• Generic Aadhaar is providing business opportunities to start a new business also giving opportunities to the long existing medical stores to get the brand value and all segments of Medicines as well.

CPA supports the Producing Incentives for Long-term Production of Lifesaving Supply of Medicines Act, known as the PILLS Act, which would provide corporate tax credits for pharmaceutical companies investing in U.S.-based manufacturing facilities. 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. Still another example is the antibiotic benzathine penicillin, which is now on shortage. According to an article in medical journal International Health, its production is entirely dependent on three Chinese API manufacturers. The shortage is said to be due to a combination of manufacturing constraints and unexpectedly increased demand. The true causes are always somewhat obscure because pharmaceutical companies try to conceal the thinness of their supply chain and its exposure to single points of failure, such as unexpected decisions by foreign governments to shut a facility.

Yet he and other experts agree one of the key problems with the Indian industry is a regulatory system that is not up to the job. That refers to testing done for the presence of active ingredients or unwanted impurities, both of which can have a direct impact on whether a drug does what it is supposed to do, experts say. Sloppy practices and even outright fraud at some – though not all — Indian facilities have been repeatedly documented. A National Post investigation found quality issues are directly affecting Canada in several ways. Reddy’s Laboratories is accused of ignoring tests showing unknown impurities in some of its drugs.

Effective systems are those which are not only apprised of local and aggregate demands for medicines but also have commensurate capacities to meet the demands. 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. Besides adequate HRH being one of the prime determinants for ensuring services and medicines, the plurality of job roles across the cadres brings out additional aspects for inspection and redressal. Learnings from states indicate that the ability of the community health workers to deliver community-based services (e.g., HBNC) is dependent on timely and adequate supply of medicine kits. Likewise, cost-effective, affordable, and quality services are linked to mechanisms promoting rational and scientific prescription practices of authorized providers.

India must adapt to maintain its position as the world’s largest supplier of generic drugs. COVID-19 underlines India’s importance to developing countries when it comes to drug access. Healthcare providers can help patients make informed medication decisions by offering personalized care and professional insights on cost and effectiveness. With tools like EHR systems and patient portals, they can easily track preferences, share resources, set up payment plans, and discuss treatment options. Balancing affordability with individual needs helps providers deliver patient-centered care that builds trust and improves health outcomes. One of the top reasons Americans choose generic medications is the potential for savings.

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.

• Data were gathered on the availability, stock-outs, price and affordability of 35 essential medicines and 2 consumables.
• In India, generic substitution is legally not allowed so patients’ awareness about generics is limited and doctors and patients do not want pharmacist to change the trade name written by doctor.
• With tools like EHR systems and patient portals, they can easily track preferences, share resources, set up payment plans, and discuss treatment options.
• Special economic zones (SEZs) are popular because they provide tax benefits for companies.
• Besides, since April 2017, bioequivalence studies have become an essential requirement for the manufacture of a generic medicine in India [14].
• It recently proposed a seismic package of reforms to pharmaceutical and intellectual property regulations — seemingly an attempt to wrestle back some balance between such restrictions and access to medicines in Europe.

Canadian, Australian and European regulators also gave passing grades to Ranbaxy, despite the company’s guilty plea to seven offences in the U.S., notes Dinkar Saran, a pharmaceutical-industry consultant with PriceWaterhouseCoopers in Boston. The national regulator reportedly has fewer than 400 staff to police more than 1,300 factories, and does not even oversee many of the drugs exported to places like Canada. That job falls to state-level officials, who have a reputation for being under-trained and corrupt. We will not dispense any prescription medicine without a valid prescription from a licensed/certified doctor physician. A bottle of 21 capsules costs between 5000 and 6000 Indian Rupees, depending on the strength of the medicine, making it very affordable.

• 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.
• One of the top reasons Americans choose generic medications is the potential for savings.
• 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 study findings show that PMBJP’s unbranded generics offer great opportunities for substantial cost savings.
• Consequentially, there is a strong emphasis on generic CVD drugs over branded drugs due to their affordability.
• 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].

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.

We found that switching from branded-generic medicine to unbranded generic medicines would lead to substantial cost savings for medicine consumers. Our estimates suggest that unbranded generic substitution would reduce pharmaceutical expenditure by 6–1129% of patient’s spending. However, caution must be exercised while interpreting affordability because of the following reasons. First, affordability might differ depending upon the compliance of the minimum wages act of the Maharashtra government. Second, the level of economic development varies considerably across states and between rural and urban areas in India and this needs to be taken into account while extrapolating results of this study to other states and national level.

While in a few, they are observed to be efficient (e.g., Tamil Nadu, Kerala, Rajasthan, Andhra Pradesh), challenges reported in many states are largely due to implementation gaps confounded by other systemic challenges. We have sought to establish an ML link between the price and sample age of AMLO besylate containing FPPs and acceptable quality attributes of the same. The analysis of nine top-selling AMLO besylate-containing marketed FPPs was exercised using a validated analytical method.

Ask your doctor to write a prescription allowing the pharmacist to substitute a generic drug when it’s appropriate. PTR is the price at which wholesaler (distributor) sells the product to the retailer and the bill (voucher) given to retailer by wholesaler mentions the PTR. This price was checked and confirmed from Form V (under DPCO, 1995) available at the distributors of the company. It is mandatory for all the companies to give Form V that gives details of the product with MRP, PTR, taxes paid, etc to their distributors. Qualified standards of AMLO besylate were purchased from Sigma-Aldrich (Bangalore, India). For the experiment purpose, nine top-selling AMLO containing FPPs were purchased from local pharmacy outlets in Guwahati (Assam, India).

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.

The International Criminal Court has become part of a global justice system feared by those who commit crimes against humanity. Food and Drug Administration were far from home, investigating a pharmaceutical factory in western India. To maximize the outcome of this progress, the Global Fund, together with PEPFAR and the National Department of Health, Republic of South Africa, will host the annual ARV Buyer Seller Summit in Maputo, Mozambique, starting on 30 October. The event is a large forum to facilitate exchanges between partners across the antiretroviral supply ecosystem.