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.
3 Human capital in the patent-based regime
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.
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The Indian Pharmaceutical Alliance (IPA) represents 23 research-based national pharmaceutical companies focused on patient health and safety with a commitment to provide quality drugs to patients throughout the world. Even more surprising is the fact that more than a third of these drugs were likely manufactured in India. This country’s ability to produce affordable, generic drugs has led to its reputation of being the “pharmacy of the world.” By export volume, India is currently the largest provider of generic medicines globally, supplying 18 percent of global generic medicines. 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. The primary task of the Committee is to strike a balance between pricing and availability of essential medicines while offering incentives to the industry to foster growth and exports.
Get the latest in CPA news, industry analysis, opinion, and updates from Team CPA.
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, 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.
Generic drugs – The Indian scenario
- The aim is to adopt a balanced approach that considers the needs of the patients, while simultaneously ensuring the creation of a sustainable healthcare system and incentivisation for pharmaceutical companies to innovate and create value.
- This includes vigorously efficient quality control and quality assurance systems alongside training programs and workshops, building an omnipresent culture of quality.
- 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.
- Delightaid health will not responsible for any consequences, effects or harm caused due to avoiding professional medical advice from certified doctors.
- The Indian medicine market has recently witnessed the launch of Palbociclib’s generic version – Paleno.
- Given the role of various interlinking factors, states need to establish robust procurement systems, strengthen the existing infrastructure, ensure adequate HRH backed with robust HRH policy, expand the range of services, and strengthen CPHC for supporting holistic efforts.
- India is the world leader in generic medicines, which contain the same ingredients as the originator version, and go on the market after the original patent has expired.
The qualitative data was collected to understand the perception of the doctors and pharmacists on generic medicine as well as their views on PMBJP scheme. Following informed consent, the interviews were audiotaped while the first author also took notes. Recordings were translated from the local languages such as Marathi and Hindi in English, and then transcribed verbatim. We used thematic analysis [21], which warranted reading and rereading the transcripts in order to generate the potential themes.
- It indicates where Chinese pharma might be headed, and may drive up its production costs for formulations – thus potentially benefiting India.
- 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.
- Although the sector still shows more relevant values concerning production quantity than production turnover, pharmaceutical exports are expected to reach US$16.28bn in FY20 (ibidem).
- The very high profit margins on branded drugs have enabled drugmakers to manufacture those products in the U.S. or Europe.
- The industry benefits from cost competitiveness, driven by factors such as lower labor costs, economies of scale, and efficient manufacturing processes.
Acceptability of PMBJP medicine
The Indian pharmaceutical industry has been living a situation of constant growth in recent years, as shown by statistical analyses of the field at the descriptive and inferential levels. There are increased expectations regarding both the production amount and the trade balance value. There was an enormous effect of price policies on brands and drugs that had similar contents. These branded drugs showed a variation in pricing, also known as inter-brand price variation. There was ample availability of multiple brands for identical drugs in India, and therefore, after DPCO was revised in 2013, a so-called tug of war between these branded drugs began.
Erlonat Erlotinib 150 mg Tablets Price in India
The bottom line is that India’s manufacturers are seeing slimmer margins and losing their global cost-competitiveness. Further to that, the challenges faced by Indian pharma companies in the United States are growing in other aspects as well. The United States recently ended India’s Generalized System of Preferences Status (GSP) – a tariff reduction on imports – after President Trump determined that India did not adequately meet his trade demands.
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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.
Indian pharma is being squeezed – and it’s bad news for drug access in developing countries
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, in order to fully realise the potential of this scheme, some policy actions are urgently required.
- 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.
- The focus on growing regulatory requirements, improved healthcare infrastructure, and surge in research and development spend bodes well for the pharma industry.
- The current study focuses on the availability, affordability and acceptability aspects of PMBJP essential medicines.
- 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.
- Subsequently, the trade balance of the sector was analyzed to understand the state of the art and potential development trajectories of growth/development compared to the rest of the world.
Sun Pharma PALENO (Palbociclib)
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.
Creating Huge Little Moments for Patients
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%). More than 70% of PMBJP pharmacies across all levels of care had the medicines in categories of cardiovascular, analgesics, antacids and vitamins. On the other hand, the availability of antiasthmatic and antipsychotic medicines was very low-only a third of the PMBJP pharmacies had them. Anticancer and electrolyte balancer were not available in more than four-fifth of PMBJP stores, while half of the pharmacies had antimicrobial, antidiabetics, palliative care medicines, anti-epileptics.
The Same Pill That Costs $1,000 in America Sells for $4 in India
The pharmacists, they claimed, will sell noneffective, or highly overpriced drugs once the authority to decide the drug for a given indication is bestowed upon the pharmacists through the policy of compulsory active ingredient prescribing. Nevertheless, they claimed that generic medicines are not as effective as branded medicines. They also believed poor bioavailability is the reason why the price of generic medicines is less than branded medicines. Most of the blockbuster drugs that fuelled Big-Pharma profits over the last two decades went off patent in the last few years, opening the market to generic copies.
This transformation has enabled the implementation of on-demand delivery models, employing strategies like direct-to-patient approaches and B2B eCommerce platforms. In fact, Indian pharmaceutical companies are now also becoming a key source of medicine for the rest of the developing world. Of note, they are playing a pivotal role in bringing down the price of lifesaving, antiretroviral drugs that have helped contain the AIDS epidemic.
India
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%). When patients choose between brand-name and generic medications, cost, trust, and availability all come into play. These factors and others revealed below influence how people decide which option is best for their needs.
The five medicines chosen were alprazolam, (0.25 mg), cetirizine (10 mg), ciprofloxacin (500 mg), fluoxetine (20 mg), and lansoprazole (30 mg). The lack of well-established linkages between procurement and logistics often results in inefficient inventory management practices (temperature control, storage space, adherence to stock movement protocols, IT- enabled inventory management). Additionally, poor quality assurance mechanisms (empaneled labs for testing, accreditation, timely reporting), and insufficient supply down to the district and peripheral level facilities were observed in some states. The analysis of marketed AMLO containing FPPs was exercised using a validated analytical method. For each selected brand of AMLO FPP, two strips containing 20–30 tablets (in total), were taken. 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.
For method development, method validation, and degradation sample analysis, an Agilent high-performance liquid chromatography Infinity 1260-II (Agilent Technologies company, Santa Clara, CA, USA) equipped with a quaternary pump, an online degasser, and a multiple wavelength or diode array ultraviolet detector was used. For data acquisition and processing, the OpenLabTM CDS software (version 2.6) (Agilent Technologies, Palo Alto, CA, USA) was used. Indian drugmaker Intas was making cancer drugs for the United States at the plant where, in a trash bin, inspectors found documents doused in acetic acid.
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.
In fact, we did carry out prescription audit as part of the overall study, but its findings are not included here. The present study adopted descriptive cross sectional research design to assess the current situation of PMBJP scheme in two districts of Maharashtra. 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. Hence, N X P gave the total number of drugs in that therapeutic category which were surveyed at all PMBJP pharmacies at PHC level in Palghar. For instance, if availability of 7 (N) antimicrobials medicines in 02 PMBJP pharmacies (P) at PHC level in Palghar was evaluated, then overall 14 units (PXN) would be examined.
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].
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. This scale has been essential in driving production efficiencies and achieving the lower sustainable pricing secured today, strengthening country-led efforts to reach all people living with HIV who need TLD. Empowering patients to personalize their healthcare and connecting them to caregivers has the potential to change the care delivery paradigm. Building on a rich history of developing AI for healthcare, IQVIA AI connects the right data, technology, and expertise to address the unique needs of healthcare. By submitting this form, I agree to receive logistics related news and marketing updates from A.
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.
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.
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.
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. Earlier these medical stores were earning 5-10% profit margins but now they can earn 40% profit margins from Generic Aadhaar’ Franchise Outlets. What’s more, Indian manufacturers are being audited by inspectors from every market they export to — UK, Germany, South Korea, Japan, Brazil, to name a few — who regularly visit and evaluate Indian pharmaceutical factories.
- 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.
- 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.
- Data were gathered on the availability, stock-outs, price and affordability of 35 essential medicines and 2 consumables.
- Besides, since April 2017, bioequivalence studies have become an essential requirement for the manufacture of a generic medicine in India [14].
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 lenvatinib price in singapore 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.
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.
(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.
Generics cost less on average and often prove just as effective, making them a practical choice for budget-conscious consumers. However, trust in brand names and appealing product packaging, especially among younger generations like Gen Z, are affecting purchasing decisions. When choosing between generic and brand-name medications, Americans face decisions influenced by both their wallets and their health needs. With medication costs rising, many are looking for ways to save money without compromising their well-being.