Generic drugs The Indian scenario

As hospitals and insurers seek to drive down the price of generic drugs, the process has pushed generic manufacturing into the hands of fewer and fewer companies, with an ever-larger percentage of them in India and China. The offshoring of production to China and India has put the U.S. in a dangerous position, dependent on unreliable suppliers. Chinese and Indian manufacturers have demonstrated a pattern of repeatedly violating FDA regulations. FDA inspections are ineffective at controlling quality standards at Chinese and Indian facilities.

How to buy Cabozantinib online in India

Over the years, it has been noted that states with autonomous bodies for procurement demonstrate relatively improved governance, decreased wastage, improved availability of quality medicines and less burden on end-users in terms of out-of-pocket expenditure (OOPE). The latter models face relatively more constraints to meet district- level demands, often resulting in delays and disproportionate local purchases. Even among states with procurement bodies, their efficiency in achieving desirable outcomes is tied to state-specific customization of the procurement and distribution system. Interestingly, the European Commission does appear to recognize that overly restrictive intellectual property rules can be harmful. 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. Whatever the cause of the benzathine shortage, Professor Stephen Schondelmeyer says that it has led to more outbreaks of syphilis in the U.S. than were expected.

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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.

1 Growth of the sector

Not only would this be bad news for India’s economy, it could make it harder for developing countries to access the medicines they need – threatening the UN Sustainable Development Goals in the process. In my last two articles, I discussed the recent surge in prescription drug costs, the reasons for the surge, and possible solutions. In this article, I’ll discuss why drugs frequently cost so much more in the U.S. than they do in other countries, why this disparity may be justified, and where we go from here. The government should ensure uniform quality across all the generics, and experts in the field of medicine say only then will doctors prescribe them willingly and with confidence.

Key drugs losing patent protection in 2025

• 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.
• Additionally, 60% said they would prefer to buy brand-name medications but opt for generics because of the lower price.
• Even among the beneficiaries, the range of medicines given free of cost was not as per the EML nor based on epidemiological load.
• According to Qyobo’s data, atorvastatin is available from nine different drugmakers, including companies based in Germany, Bangladesh and Turkey.
• 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 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.
• Indian generic manufacturers are also producing in the U.S. and in other countries whenever necessary.

In response to this growing regulatory environment, pharmaceutical companies in India continue to strengthen their processes, while improving automation, operating procedures and quality management systems. This includes vigorously efficient quality control and quality assurance systems alongside training programs and workshops, building an omnipresent culture of quality. The result is a focus on quality that starts at a shop-floor level for machine operators, ensuring compliance from the ground up. In the past few years, expectations of regulatory organizations around the world have increased. With the number of companies and manufacturing facilities supplying to the regulated market growing fast, it is natural that the agencies are intensifying their efforts.

Views on PMBJP scheme

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.

Navigating the supply chain roadblocks

A second policy challenge that affects pricing and reimbursement is lack of patient affordability for drugs that are not subject to the DPCO price control, particularly in the case of non-essential or newer drugs which do not form a part of the formularies. Since reimbursement schemes do not have uniform formulary inclusions, patients do not have clear guidance on which drugs are covered under the scheme, leading to unanticipated out-of-pocket expenses. Moreover, complex reimbursement procedures, including documentation requirements and approval processes, can delay or deter patients from accessing timely reimbursements. One of the key findings of our study is that PMBJP list included only 214 essential drugs, implying that it excluded more than 50% of drugs listed under NLEM, 2015. The inclusion of FDCs of antimicrobials, FDCs for CVDs and other diseases pose a public health concern. It is worth noting that though considerable research showed issues with some antibiotic FDCs, these FDCs still find their way to the Indian market [28].

Five Years into the Product Patent Regime: India’s Response

The regulatory framework in India for pharmaceutical pricing and reimbursement aims to ensure fair pricing of essential drugs and provision of adequate reimbursement mechanisms to facilitate patient access and simultaneously also promote innovation and enhancement of production capacity of healthcare providers. Lack of access to essential medicines is a major health policy concern globally, even more so in the low-and middle-income countries. According to the World Health Organisation, a whopping 2 billion people worldwide are not having access to essential medicines [1].

3 Human capital in the patent-based regime

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 afatinib price in usa 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.

• 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.
• 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.
• “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.
• 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.
• 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.
• 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.

CBO Report Confirms CPA View that Tariffs Raise Trillions in Government Revenue and Benefit US Industries

We further observed that the PMBJP drug (enalapril) used for the treatment of hypertension costs 725% lower per month than that of the reference branded-generic drug. WHO model list of essential medicines has total 37 FDCs, while NLEM, 2015 consists of 24 FDCs. As far as the NLEM list is concerned, majority of these FDCs are aimed at improving treatment adherence and preventing drug resistance in diseases of public health concerns such as malaria, TB and HIV-AIDS.

Drug reimbursement policy has a substantial impact on the pharmaceutical industry, since it affects the incentives and outcomes of pharmaceutical research and development. Further, a robust drug reimbursement policy is equally important to ensure access and affordability for patients, since out-of-pocket expenses contribute to more than 45% of healthcare expenditure in India,[vii] despite the presence of price-control regulation. Although India’s case is lot more complex than most countries given the dominating presence of ‘branded’ generics in the Indian pharmaceutical market, it is worth learning from countries which achieved reasonable success in promoting the utilisation of generics. USA, the first country to implement a generic drug implementation policy, achieved 89% share of generic drugs in 2016 and this reduced the medical insurance expenditure by US$ 67.7 billion [37]. Japan, Canada, Australia, European countries as well as LMICs such as Philippines had similar experience regarding generic drug use [38, 39]. All these countries have either made it compulsory to prescribe drugs with active substance names or passed laws for mandatory generic substitution.

• Qyobo is a software startup that collects pharmaceutical data from dozens of national and international databases to provide a picture of the drug supply chain that is not only superior to what the patient or the doctor sees, it is probably superior to the knowledge of the FDA.
• While the idea of popularising non-branded generic drugs is a robust policy response to improve access and reduce pharmaceutical spending, little is known about how far these initiatives have been effective in making generic drugs accessible at affordable prices.
• There is a concrete risk of confusion in the minds of patients/consumers regarding which drug should be considered due to this price variation.
• 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.
• State experiences highlight the importance of an established IT- enabled supply chain management system.
• There are increased expectations regarding both the production amount and the trade balance value.

We appreciate the cooperation of retail pharmacists and distributors who helped us in collection of the data.

Healthy Future: Sustainability at Teva

The challenges are reportedly more pronounced in North-Eastern states and for facilities under the National Urban Health Mission (NUHM). Given the objective to understand the determinants of access to medicines in the Indian public health system, the CRM reports between 2007 and 2021 were reviewed. Core themes pertaining to medicines were identified and each theme was analysed to deduce the context-specific determinants influencing their availability and accessibility in the public health system. The findings were appraised for relevance and validated for aptness by comparing the recent reports with the former ones to ascertain their contextual underpinnings. Core themes in the Indian Public Health System, their interlinkages and key determinants for ensuring access to medicines are discussed below. As part of its NextGen market-shaping approach, the Global Fund will continue to work with manufacturers to secure a sustainable supply of affordable HIV treatment.

It does not include all information about the possible uses, directions, side effects, warnings, precautions, interactions, adverse effects, or risks that may apply to this product. This is prescription medicine and if you want to buy this medication legally from Delightaid Health, we require a valid prescription from you. Please read the disclaimer and prescription-related full details at the bottom of this website. The physicians, especially those from the rural Palghar district wondered why the generic drug stores are not opened in rural areas where it is needed more. Besides that, the public physicians stressed on the need for establishing the PMBJP outlets within the hospital premises, while private physicians asked for dissemination of information regarding the drugs listed under the PMBJP scheme.

• In the past few years, expectations of regulatory organizations around the world have increased.
• The first chapter of this report summarizes data on the importance of affordable medicines.
• These prices can fluctuate based on the pharmacy and specific dosage requirements like Cabozantinib 20mg, 40mg and 60mg.
• 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.
• It is another reason why India’s position as pharmacy of the world has a value far beyond its borders.
• Cabotres is the medicine by the Cipla brand that harnesses the therapeutic benefits of cabozantinib.

This is because in India, there is an inadequate R&D infrastructure and lower industry-academia connection for research. As mentioned above, DPCO establishes the various pricing parameters according to which the price is to be decided, and this policy reduces the profitability of the companies that would invest in innovative drugs, which requires huge capital. This sector has been hamstrung by a lack of product patents, due to which foreign companies do not introduce new drugs in the Indian market, discouraging innovation and drug discovery.

Market introduction/overview

Descriptive and inferential analyses have been based on empirical data extracted from authenticated data sources. Subsequently, a narrative strengths, weaknesses, opportunities and threats analysis was performed based on the results of prior investigations and on qualitative data that were retrieved from a marketing intelligence examination to generate an overall scenario analysis. 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. And ethinylestradiol to treat breast cancer which has a cost of 3p, according to the Indian generics website, cost the NHS £7.14 per tablet, a rise of 26,197%.

PREVALENT STATE MECHANISMS FOR PROCUREMENT OF MEDICINES

There is a robust low-cost manufacturing setup available in India, where the industry can produce drugs at a cost that is 40%–50% lower than the rest of the world and sometimes even as much as 90%. There is also a presence of good technical and technological expertise together with the availability of low-cost skilled human resources. The growth of the middle-class population is leading to a new lifestyle, providing a huge market for lifestyle drugs, which are currently the lowest contributor to revenues from the sector.

Indian industry and government have also suggested manufacturers are being unfairly attacked and subjected to overly stringent oversight by the Americans. Neither IPCA nor Dr. Reddy’s responded to requests for comment, but Amir Attaran, a health-policy expert at the University of Ottawa who tracks the industry, said the findings are troubling. Dhiraj Singh/BloombergAbout one in 20 of Canada’s finished drugs are now made in India – roughly 20 million prescriptions a year. When Health Canada launched a new “Inspection Tracker” website this month listing concerns about standards at pharmaceutical factories, 11 of the 15 plants on the list were in India, seven of them now subject to import restrictions. As a sign of the shift, Canadian generic giant Apotex Inc. locates about 10% of its production at two Indian factories.

• However, players who aspire to be successful must be ready to innovate, evolve new healthcare delivery models, be open to adapting to changing patient needs and expectations, and be willing to invest in talent, technology and expert legal and regulatory advice.
• Tebra is constantly exploring new ways to leverage technology and partnerships to improve healthcare.
• 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).
• Contrast this with China, which is reportedly using its own vaccine projects as a commercial negotiating tool with countries who stand to benefit.
• The affordability of pharmaceuticals is a critical challenge in India and South Asia in general, raising questions of life and death.
• 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.
• 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.
• However, some policy issues continue to persist and present complex challenges for the legislature, as well as all other public and private stakeholders.

However, pharmaceutical companies may lose interest in the Indian market due to the fixation of prices, which can lead to economic uncertainty since the Indian market is under rigorous pricing laws (Kumar et al., 2020). Another major concern is that medicines are not available where needed due to an inadequate supply chain and to the absence of potential producers that may not be attracted by these restrictions. If there is a lack of proper supply of medicine to the needy, this would be in contradiction with the objectives of social justice (Mrinali, 2013). Thus, the Indian government should take effective measures to better balance the positive and negative effects of DPCO. 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. Besides affordability, we did cost comparison of unbranded and branded generic equivalents of some commonly used medicines.

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.

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.

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.

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.