India pharma quality lapses force U S. to look to China for vital drugs

Furthermore, the physicians expressed the need for developing a regulatory framework to contain the proliferation of brands by the firms operating in the Indian pharmaceutical market, which, according to them, pose a barrier in prescribing generic medicines. Some brands of antibiotics are found to be more effective as compared to their generic counterparts. For example, augmentin brand gives effective and quick results as compared to its simple generic amoxicillin clavulanate version. But generic medicines for diabetes and hypertension are very good and cost effective for the patients for chronic illnesses.” (PuP3).

India

A sustained, affordable supply of generic medicines is essential for health — as well as for preventing the next pandemic. Yet, the stricter intellectual property rules EU negotiators propose for India and Indonesia would undermine — and even thwart — access to affordable medicines in developing countries. The production of pharmaceuticals, medicinal chemicals and botanicals for health-care has been growing yearly in India.

India pharma quality lapses force U.S. to look to China for vital drugs

Of the 10 drugs already on the market and recalled because of quality defects since New Year’s Eve, four were made in Indian factories, Health Canada says. They included lots of a generic version of the antibiotic cefazolin, pulled because of fears the intravenous solution contained foreign particles. This push to make generics ever cheaper is saving the health-care system billions of dollars. But, says Dinesh Thakur, a soft-spoken chemical engineer and former executive with Ranbaxy Laboratories, it comes with a price of its own. This means about one in 20 of this country’s finished drugs are now made in India – roughly 20 million prescriptions a year.

Indian pharma is being squeezed – and it’s bad news for drug access in developing countries

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.

Cabozantinib Generic Price in India

(2016), “R&D, technology transfer and productivity in the Indian pharmaceutical industry”, International Journal of Innovation Management, Vol. The infrastructure of the industry and the R&D capabilities of domestic businesses have improved considerably in recent years, but many challenges remain, mainly related to pricing regulation, sector fragmentation and intellectual property. Not surprisingly, all of them, directly or indirectly, concern patents, which are central issues of debate in the national industry. Tiered pricing, also known as differential pricing , is often practised by pharmaceutical companies based on the ability of countries to pay, but Hill was unavailable to comment. Several factors have contributed to this significant growth of the healthcare industry in India – which includes a combination of public sector initiatives and expansion of private-sector enterprises.

Cabozantinib Brands in India

Both countries have used government subsidies, export incentives, and other tools to lower their costs of production and build locally-owned drug manufacturing centers. One of the foremost challenges confronting the Indian pharma supply chain is regulatory compliance. The industry operates within a complex regulatory landscape characterized by stringent quality standards and evolving regulations. 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. The pharmaceutical business function of R&D has been significantly affected by the DPCO. Due to price controls, companies have not dedicated themselves to inventing and developing new medicines.

3 Human capital in the patent-based regime

Moreover, the margins that Indian suppliers can earn in the United States are higher than those they can achieve in the more saturated Indian market. There are also ample opportunities presenting themselves across Asia for India’s pharma players, especially as talks of a free-trade agreement (FTA) with the Eurasian Economic Union and Regional Comprehensive Economic Partnership in Asia progress. Although the market continues to diversify with new players springing up from within India as well as internationally, a handful of national players continue to have a sizeable footprint in the domestic and international generics industry. Piramal, Torrent, Cipla, Sun Pharma, Aurobindo, Dr. Reddy’s and Glenmark, to name a few, represent a number of the success stories in India’s pharma industry landscape. With the biopharmaceutical industry rapidly evolving across the globe, inorganic growth has been an important part of company strategy for expanding footprints, retaining market share and moving into new areas of the value chain. For example, Torrent acquired Bio-Pharma Inc. (BPI) in early 2018 – its first acquisition of a manufacturing site outside of India – to diversify and strengthen its product pipeline.

• More than 70% of PMBJP pharmacies across all levels of care had the medicines in categories of cardiovascular, analgesics, antacids and vitamins.
• After the 1990s, India emerged as an information technology and information technology-enabled services hub for the world due to trained manpower, a very high number of computer engineers, and a cheaper workforce that could speak foreign languages, mostly English.
• For example, Torrent acquired Bio-Pharma Inc. (BPI) in early 2018 – its first acquisition of a manufacturing site outside of India – to diversify and strengthen its product pipeline.
• One key reason generic drug production moved (and is still moving) to India is the high level of subsidies offered by the Indian government to drug manufacturers and exporters.
• Most of the physicians argued that generic and branded medicines have the same active substance(s).
• The researchers had also compared the prices in the UK, a developed economy, with the prices listed on a generics medicines website in India, an emerging market.
• 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.
• This transformation has enabled the implementation of on-demand delivery models, employing strategies like direct-to-patient approaches and B2B eCommerce platforms.

How are drug prices set? What is the relationship between pricing and reimbursement?

Chinese pharma has also placed much emphasis on using AI and genetics for developing new drugs. This enables firms like XtaIPi to identify thousands of molecules which could be used to treat a disease with fewer resources and time. Jean Lee is a content expert with a background in journalism and marketing, driven by a passion for storytelling that inspires and informs. As the managing editor of The Intake, she is committed to supporting independent practices with content, insights, and resources tailored to help them navigate challenges and succeed in today’s evolving healthcare landscape. For many Americans, the decision between generic and brand-name medications often comes down to cost.

Drug Price List: Generics and Matching Brands

The company ignored tests showing unknown impurities in some drugs, and inspectors came across samples with bacteria and mould that were “TNTC,” too numerous to count. What that patient is unlikely to know is the drug’s active ingredients come from a company called Dr. Reddy’s Laboratories Ltd. in India — or that U.S. inspectors made some eye-opening discoveries recently at the plant that produces them. The medicine will be only for personal use and not more than 3 month supply at a time. Quality and price of medicines were studied to evaluate the two versions of the same therapeutic molecule.

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

Through the years, some SCM practices are identified to stand out as desirable and cost-effective. Additionally, the use of IT-based platforms for procurement and inventory management (i.e., storage, quality testing, tracking, monitoring, and allocation based on consumption patterns across the empaneled health facilities) are pivotal for a highly responsive and accountable system. The U.N. Special Rapporteur on the Right to Health proposed that “developed countries should not encourage developing countries to enter into” free trade agreements with TRIPS-plus measures, and that they should “be mindful of actions which may infringe upon the right to health.” In the same vein, as U.N. System leaders, we supported a 2016 report acknowledging governments’ limited policy space to enact actions regarding access to medicines due to TRIPS-plus measures in trade deals, which undermines their ability to protect the human right to health.

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.

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The three major medicines for breast cancer – Palbociclib, Ribociclib, and Abemaciclib are popular internationally. Despite India’s contribution to global access to medicines, the government has never tried to use this as an instrument of foreign policy. One silver lining is that China is proposing a new regulation that would give its firms exclusive control over their clinical test data.

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.

• The generic drugs industry continues to strengthen itself as a key pillar of India’s burgeoning economy.
• Further, individual tablets were weighed, triturated followed by weigh equivalent to 2.0 mg of AMLO besylate was taken and diluted to 20 mL with selected diluent.
• To exploit that “patent cliff,” governments and insurers in Canada have pushed for lower and lower prices on the copies, and often mandate that patients’ prescriptions be filled with generics.
• Improved medical facilities, modernization of hospitals and lower and affordable treatment costs for most developed and developing countries’ nationals are all reasons for this boom (Fortis Healthcare, 2019).
• Drugs registered under DPCO must be sold within the price range, which is mandatory for the company and therefore, the break-even point is sometimes barely reached (Paul, 2018).
• The remaining 5% are either reimbursed, insured, or participate in a very generous co-pay program.

Key drugs losing patent protection in 2025

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.

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.

• As a result, manufacturers often find it difficult to recuperate costs of research and development and costs of innovation.
• 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.
• Once the patent expires, other companies can get a generic version of the drug approved by the FDA and start selling it.
• Tell them you want the most effective drug at the best price, and that you want prescriptions for generic drugs when possible.
• Therefore, another key policy aspect which ought to operate in tandem with drug pricing is drug reimbursement, i.e. rules and processes that determine the amount and conditions under which healthcare payers will pay for pharmaceutical products.
• 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].
• Generics cost less on average and often prove just as effective, making them a practical choice for budget-conscious consumers.

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.

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In the present scenario, the changes in the patent regime may benefit MNCs, while domestic companies may face more challenges. Similarly, the threats possibly deriving from other low-cost countries – China above all – are real. The negotiations with MNCs, international rules and domestic regulations are imbalanced, while there are increasingly stringent regulations and nontariff barriers to generic drugs in developed countries (Dhar and Joseph, 2019). After the 1990s, India emerged as an information technology and information technology-enabled services hub for the world due to trained manpower, a very high number of computer engineers, and a cheaper workforce that could speak foreign languages, mostly English. Similarly, pharmaceutical research and development can be carried out in India by global pharmaceutical MNCs. India has many pharmaceutical, bioscience and chemistry colleges that churn out huge amounts of high-quality graduates every year.

Andrew Hill, senior research fellow in pharmacology and therapeutics at the University of Liverpool, told the conference on 27 January 2017 that these data provide a “reliable indicator of the amount of money which the UK NHS pays for drugs”. With price rises of more than 1,000 per cent in the generics sector, academics would like to see better price regulation. 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.

China has already demonstrated its willingness to use its economic leverage in peacetime with commodities like rare earths and graphite. If hostilities between the U.S. and China rose or if we entered a genuine military confrontation over Taiwan or another global hotspot, we would be at grave risk of seeing vital pharmaceutical supplies reduced or cut off entirely. By making intelligent connections between your needs, our capabilities, and the healthcare ecosystem, we can help you be more agile, accelerate results, and improve patient outcomes. Orchestrate your success across the complete compliance lifecycle with best-in-class services and solutions for safety, regulatory, quality and medical information. Moving forward requires investing in modern, technology-enabled logistics facilities and ensuring the highest standards of quality in drug storage and handling. Adopting smaller, more efficient packaging not only cuts down on storage and shipping expenses but also promotes sustainability and economic benefits.

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, abiraterone cost uk 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.

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.

• But all of those drugmakers depend on an Indian company, Ind-Swift Laboratories Ltd, for the active pharmaceutical ingredients (APIs) to make atorvastatin.
• The brand’s commitment to quality ensures that Cabotres is a reliable option for patients.
• In a nutshell, with Paleno making its way into Indian medicine markets, the availability of Palbociclib is manifolded.
• This means that majority of the people had to obtain healthcare including medicines from private providers.
• Maximum retail price (MRP) is the price-to-patient and is always printed on the package in India.
• This study reported the availability, stock-outs and affordability of a basket of essential medicines (unbranded) and consumables in selected PMBJP stores in the districts of Palghar and Mumbai in Maharashtra.

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.

This provides an added advantage to the nation, which assists in developing processes that are cost-effective (Mahajan, 2019). DPCO has been a drawback for drug companies because it caused a decrease in their profit margins. Developing a medicine involves many aspects and is quite costly; hence, reducing their prices and profit margins has generated complex situations for pharmaceutical companies.

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. One inherent limitation of this study is that we have tested pair of branded and branded-generic medicines that were manufactured by the same “reputed” company. Though it is expected that both the versions should have the same quality but perception for any branded-generic is same among doctors and patients. So to start with, we have taken both branded and branded-generic products of the same company and studied not only the quality but also the price structure.

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.

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. This improved pricing – a 25% reduction – will allow governments in resource-limited settings to expand access to critical HIV services. Data from the American Society of Health System Pharmacists (ASHP) shows that the number of drugs in shortage reached 301 at the end of 2023, one of the highest figures since data began. The FDA produces smaller figures because they count only shortages at the national level. The ASHP considers regional and local shortages too, a measure that doctors and health economists consider more relevant to the quality of care provided to patients.

In the above, API stands for Active Pharmaceutical Ingredient and AYUSH stands for Ayurveda, Yoga, Unani, Siddha and Homeopathy. Starting in 2014 in India, a Ministry of AYUSH was established, indicating the extraordinary relevance in the country of these specific items. More focus on patents for innovative drugs is required, instead of concentrating primarily on generic drugs. There is a need for policymakers to work on the sustainability and development of the industry, while the companies must redesign their orientation toward enhancing innovation capabilities. In addition, at the level of corporate strategy, firms should establish collaborations and alliances and expand their industrial marketing vision.

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).