EU trade deals risk affordability of generic medicines for Global South

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.

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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.

Drug Resources

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.

EVALUATION OF PRICE DISPARITY AMONG GENERIC MEDICINES IN INDIA

• The skilled labor force is available in Indian cities at very competitive salaries compared to most other destinations.
• Further, the functioning of PMBJP scheme is often disrupted by supply chain shortage from causes such as procurement or/and distribution issues.
• India’s export growth for FY 2019 was one of its highest growth rates in the last decade.
• In India, the pharmaceutical market is majorly dominated by generics, accounting for 78.33% of all drugs in the Indian market, while patent-protected drugs account for 21.67% of the market share, according to GlobalData’s Price Intelligence (POLI) database.
• The quotes are being sought for generic drugs, although they are also allowed for imported or combination drugs by their trade or brand names.
• Qualified standards of AMLO besylate were purchased from Sigma-Aldrich (Bangalore, India).
• 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.

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.

International Markets

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.

We are all infor better health

For more detailed information, refer to the prescribing information and consult a healthcare professional. It’s used for advanced RCC post anti-angiogenic therapy, HCC after sorafenib treatment, and progressive, metastatic, or unresectable MTC, effectively slowing disease progression and reducing tumor size. The firm frequently engages in cases that challenge price ceiling notifications, price fixation of scheduled drugs, and office memorandums as notified by the National Pharmaceutical Pricing Authority (NPPA). Further, the functioning of PMBJP scheme is often disrupted by supply chain shortage from causes such as procurement or/and distribution issues.

Company

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.

Tips for Better Asthma Control

In some cases, pharmaceutical reimbursement may involve direct billing between healthcare providers and insurance companies or government agencies. Under the DPCO, manufacturers are required to be aware of price fixation and revision by the NPPA since it is mandatory to follow the ceiling prices fixed and notified by the NPPA. In the case of ‘overcharging’ by manufacturers and/or violation of pricing regulations, erlotinib price in philippines the NPPA has the power to seek recovery of overcharged amount along with interest, as well as penalties in some cases. Although we reported availability, stock-outs and affordability of medicines in the PMBJP pharmacy outlets, a more comprehensive assessment of the accessibility of essential medicines may have included measurement of medicine prices, prescription pattern and out-of-pocket payments on medicines.

Enzalutamide Bdenza 40 mg Price in India

Both cabozantinib and sorafenib are multi-kinase inhibitors used to treat advanced cancers like RCC and HCC. Common side effects include gastrointestinal issues and fatigue for both drugs, but specific side effects and patient responses may vary. 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. In Mumbai region, among the surveyed medicines which were not available at the time of survey, around 50% were out of stock for the period of 3–6 months while about 38% of medicines were out of stock for the period of less than 1 month (Fig. 4). Around 50% of antimicrobials, antidiabetics, antiepileptics and consumables were out of stock for the period of 3–6 months.

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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.

There are only 74 bulk drugs which are under price control[15]and are called scheduled medicines. For scheduled medicines, the NPPA pricing formula sets the 8% mark-up for wholesalers and 16% for retailers. For non-scheduled medicines, these markups are not set, but it is agreed by the partners of the trade that for branded medicines average mark-up would be around 10% and 20% for wholesalers and retailers, respectively. Diverse systemic determinants of access to quality and affordable medicines have been documented through CRMs. Though not an exhaustive list, state-specific experiences over the years highlight the determinants of access, and pertinent systemic challenges needing redressal.

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).

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.

The sale of PMBJP medicines is mainly dependent on the prescription of generic drugs by the physicians. But doctors from private health care facilities hardly mention the generic or chemical names of drugs on the prescription slips and only 60 percent of the prescriptions from public health facilities contain generic names [27]. We found that, in spite of the awareness campaign by the PMBJP, physicians, especially those having private practice remained apprehensive regarding the therapeutic efficacy and the quality of unbranded generic medicines. In low-income and middle-income countries (LMICs) such as India, patients and healthcare providers (both public and private) often struggle with high and increasing pharmaceutical prices due to low and weak health insurance coverage, which restricts patient access.

Because open-heart surgery and the stents needed for angioplasty are not affordable to all, DPCO could offer a potential solution for these and other medical treatments (Wadhera et al., 2017). Taking into consideration some of the most authoritative reports and issues in the field at the institutional and corporate levels (e.g. Biospectrum Bureau, Fortis Healthcare, IBEF, McKinsey, etc.), a content analysis was performed to identify the most relevant issues for the sector. After this initial overview of the current and future situation of the Indian pharmaceutical sector, a positive picture has emerged. However, several issues cannot be highlighted by the positive numbers so far analyzed, representing weaknesses and threats for the industry that have emerged from a qualitative analysis that has been deployed to provide the basis for a subsequent narrative SWOT analysis. The following investigation provides general elements for the examination of the current and expected scenarios of the Indian pharmaceutical sector to respond to RQ1 and RQ2.

• 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.
• More papers with manufacturing and drug testing data were shredded and tucked away in plastic bags under a stairwell, indicating that Intas executives had manipulated data and tried to cover it up.
• Purchase of medicine contributes the most (60.6%) to the OOP health payments by households, and pushes more than 3% Indians into poverty every year [3, 25].
• Nonetheless, despite being a global market leader in generic drug formulations, the Indian pharmaceutical industry is highly dependent on China for raw material supply to produce pharmaceutical formulations and even medicines.
• Unlike developed countries, people in developing countries pay the cost of medicines out-of-pocket.
• Paleno, which contains Palbociclib is a medicine used to treat breast cancer treatment.
• This provides an added advantage to the nation, which assists in developing processes that are cost-effective (Mahajan, 2019).
• In fact, AYUSH represents a mass-niche market, requiring peculiar attention mostly in terms of competitive strategies that would have a focus orientation.

However, the LDA had revealed the most acceptable quality attributes for the price range of 1–2 rupees and alike higher money value medicine, i.e., 2–3 rupees. The Commission is right to do this for its citizens’ health, and the lesson applies to other parts of the world too. However, in trade agreements, the bloc has continued to pressure developing countries to include disproportionate intellectual property protections that go far beyond the TRIPS agreement. Table 1 shows America’s top ten sources of pharmaceutical products last year by weight. China led the rankings, with 217.2 million kilograms (kg) or 477.8 million lbs of pharmaceutical imports. The IQVIA Human Data Science Cloud is our unique capability designed to enable healthcare-grade analytics, tools, and data management solutions to deliver fit-for-purpose global data at scale.

Envisioning the challenges of the pharmaceutical sector in the Indian health-care industry: a scenario analysis

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.

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.