Surge in Pharmaceutical Imports Threatens U S. National Security as India China Dominance Grows

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.

• Both quantitative and qualitative data were collected concurrently between January, 2019 and June, 2019.
• This means about one in 20 of this country’s finished drugs are now made in India – roughly 20 million prescriptions a year.
• More focus on patents for innovative drugs is required, instead of concentrating primarily on generic drugs.
• Furthermore, India’s Department of Pharmaceuticals (DoP) recently announced plans for a new pricing reform for pharmaceutical products and the induction of price control for medical devices, which would induce more stringent rules over pharmaceutical pricing.
• Pharmaceutical price control is a popular technique that has been used by other countries to address the shortages of medicines following the Covid-19 pandemic and relieve pharma companies that are suffering from high production costs.
• Regulations to support mandatory generic prescribing and generic substitution by pharmacists are needed.
• When patients choose between brand-name and generic medications, cost, trust, and availability all come into play.
• Further, inadequate healthcare infrastructure, particularly in rural areas, affects the distribution and accessibility of pharmaceuticals, impacting both pricing and reimbursement effectiveness.

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In other words, the overall coverage of essential drugs in PMBJP list is just 57%, when compared to the total number of essential medicines included in NLEM. We have used a mixed-methods approach, with the survey-based quantitative component supplemented by a qualitative component consisting of in-depth interviews (IDIs). Data were gathered on the availability, stock-outs, price and affordability of 35 essential medicines and 2 consumables. Our unparalleled team of in-house experts monitor P&R policy developments, outcomes and data analytics around the world every day to give our clients the edge by providing critical early warning signals and insights. With the availability and usage of generic drugs, the experience with these drugs will increase and it will be possible to compare the real-time effectiveness of generic drugs vis-à -vis brand drugs.

• A National Post investigation found quality issues are directly affecting Canada in several ways.
• This policy works in India’s favour, however, as the country is one of the leading producers and exporters of generics globally.
• 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.
• There is no way that people in India can pay even a fraction of the cost for drugs that can be priced at $50,000/year in the West.
• The bottom line is that India’s manufacturers are seeing slimmer margins and losing their global cost-competitiveness.

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• The world’s supply of generic medicines is a lifeline for the Global South — and this is more important than the profits of a handful of companies.
• The survey was undertaken to find out the extent of availability and stock-out of medicines at PMBJP outlets.
• 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.
• 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.
• In the present scenario, the changes in the patent regime may benefit MNCs, while domestic companies may face more challenges.
• This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition.

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.

India’s global reach

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.

3 Human capital in the patent-based regime

Previous studies suggest that doctors’ negative perceptions regarding generics was a major constraint faced by JAS leading to its poor success [15,]. PMBJP’s stated objective is to gain the confidence of the medical community and consumers in unbranded generics by generating awareness through education and publicity. In this study, we have assessed the acceptability of PMBJP’s unbranded generics It is worth noting that the Indian pharmaceutical market is flooded with irrational or non-essential drugs. For example, majority of fixed dose combinations (FDC) that are marketed in India are therapeutically non-beneficial and unsafe for use [16, 17]. Notwithstanding, such FDCs account for more than 50% of the pharmaceutical formulations in India [17]. We, therefore, critically looked at the selection criteria for medicines included in the PMBJP list.

ARTICLES FROM THIS PUBLICATION

Furthermore, India’s Department of Pharmaceuticals (DoP) recently announced plans for a new pricing reform for pharmaceutical products and the induction of price control for medical devices, which would induce more stringent rules over pharmaceutical pricing. 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. In India, a dispensing pharmacist is not authorized to substitute a branded medicine with a branded-generic (or generic) as per the provisions under Rule 65 of the Drugs and Cosmetics Act, 1940 and Rules, 1945, which also add to the patient’s burden.

Availability of essential generic medicines at pmbjp pharmacies/ kendras across mumbai and palghar region

India’s healthcare market is dynamic and rapidly expanding, driven by economic growth, demographic changes and government initiatives. While significant challenges remain, particularly in terms of infrastructure and workforce distribution, the opportunities for growth and improvement are substantial. The datasets, including the qualitative dataset concern the implementation of a government scheme related with specific places and actors, making anonymising and removing any potentially sensitive observations, especially from interview transcripts difficult. Some physicians reported that they face difficulties in prescribing generics as patients have negative attitudes towards cheaper medicines.

Market introduction/overview

(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.

Teva Announces New Patient Access Program with Direct Relief to Provide Access to Inhalers for Unins…

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. India’s pharmaceutical industry is renowned for selling medicines to the world at reasonable prices, especially developing countries. To find out if there’s a generic drug that will work just as well for you as a brand-name drug you’re taking, talk to your doctor or pharmacist. Tell them you want the most effective drug at the best price, and that you want prescriptions for generic drugs when possible. In India, procurement of medicines is coordinated through various mechanisms such as state- level autonomous bodies, state government- owned agencies, procurement division/cell of the state government, and public-private partnership arrangements.

HEALTH SYSTEM FACTORS INFLUENCING SUPPLY CHAIN OF MEDICINES

The industry benefits from cost competitiveness, driven by factors such as lower labor costs, economies of scale, and efficient manufacturing processes. This cost advantage enables Indian pharmaceutical firms to provide competitively priced products both domestically and globally. The extensive scale and diversity of the Indian pharma industry offer resilience and adaptability to the demands of supply chain, enabling it to cater to diverse needs and maneuver through market fluctuations effectively. 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. According to DPCO, the trade margins in the pharmaceutical supply chain should be reduced to allow better penetration of medicines under DPCO and allow a larger population to obtain access. The first-line sellers will receive different percentages of margins to apply, including distributors, wholesalers, retailers (chemists) and hospitals.

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 ibrutinib price philippines 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.

• 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.
• 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%.
• 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.
• 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.
• The event is a large forum to facilitate exchanges between partners across the antiretroviral supply ecosystem.

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.

Pharmacists’ views on PMBJP

The following were identified as the key focus areas to bolster the Indian pharmaceutical and healthcare sectors. Thus, from a practical point of view, Indian pharmaceutical companies should invest more in R&D, attempting to attract talented human capital. Otherwise, they will lose the highly qualified national workforce that will favor MNCs in the field.

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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.

Almost 70% of antipsychotics and antiasthmatics, more than 85% of anticancer and electrolyte balancing medicines were found to be out of stock for 3–6 months. The IPCA factory in Pithampur, for instance, chose not to reject drug products that failed to meet specifications in initial “trial” tests, the FDA reported. Inspectors said these negative results at the plant , which makes an anti-psychotic, an opioid pain drug and an anti-nausea medicine for Canada, were not documented, reported or investigated.

Views on PMBJP scheme

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.

• The IPCA factory in Pithampur, for instance, chose not to reject drug products that failed to meet specifications in initial “trial” tests, the FDA reported.
• 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.
• 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.
• For example, in negotiations with Indonesia, the bloc proposed an extensive intellectual property enforcement regime that could adversely impact access to medicines.
• 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.
• India’s Ministry of Health and Family Welfare did not respond to a request for comment.

Pharmaceutical price control is a popular technique that has been used by other countries to address the shortages of medicines following the Covid-19 pandemic and relieve pharma companies that are suffering from high production costs. The implementation of market-based price ceilings on a set of essential medicines, including on-patent and generic drugs, is a form of pharmaceutical price control applied by the Indian Government and intended to make drugs accessible to people at an affordable price and address drug shortages. GlobalData examined a similar price increase for 146 essential medicines in Pakistan under the hardship category to subsidise the rising cost of active pharmaceutical ingredients (APIs) and production, which led to an acute nationwide shortage of essential drugs.

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.

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.

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.

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.