التصنيف : Indian generic price

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.

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However, as the European Union now negotiates free trade agreements with India and Indonesia — another major generics-producing nation — the bloc’s been proposing far stricter protection of intellectual property rights. And such protection could threaten the affordability of generic medicines these countries export to the Global South. Increased offshoring of drug manufacturing has made imports a growing share of the U.S. pharmaceutical industry. In the five years from 2017 to 2022, imports rose to $197.9 billion, worth almost one third (32.8%) of the cash spent by American patients, insurers, hospitals, and the government on pharmaceuticals (Figure 1). On current trends, the value of imports and their share in the total pharmaceutical spend is likely to continue to rise.

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Although the sector must tackle several issues concerning internal (fragmented) and external (innovative) competition, drug price controls and patent regimes have a significant influence on its effective functioning, which is why the Indian pharmaceutical industry is still mainly concentrated on generic drugs. Although some Indian companies have invested significantly in R&D initiatives, most of them prefer remaining in the business of generic drugs. Because it does not require huge efforts to invent new molecules, there are still numerous small companies that produce the same generic drugs, creating tough competition in the domestic market (Pardhe, 2019). The low availability of medicines at PMBJP outlets reflects the implementation issues faced by the scheme. Nevertheless, the study findings show that PMBJP’s unbranded generics offer great opportunities for substantial cost savings.

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There is a concrete risk of confusion in the minds of patients/consumers regarding which drug should be considered due to this price variation. Therefore, price controls were effective at analyzing this price variation and are attempting to decrease the difference even more (Jhanwar and Sharma, 2018). With specific reference to single commercial relationships, the USA and other developed countries are major trade partners as far as exports are concerned, while India depends significantly on imports of APIs from China (Rbi.org.in). More broadly, the Indian pharmaceutical industry has major exports to North America and Europe and major imports from Asia and Europe.

Pharmacists’ views on PMBJP

It was argued that, in case of market based ceiling price, medicines would be way too expensive than under the cost-based pricing approach followed by DPCO, 1995 [12]. That the prices of drugs fixed by NPPA remained high and majority of medicines including several essential and lifesaving drugs were kept out of DPCO posed a challenge in terms of making the drugs affordable and accessible to the people [12, 13]. The issue of access to medicine is a primary cause of the skewed healthcare utilisation pattern in India.

Acceptability of PMBJP medicine

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.

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But your income and the cost of the drugs you need may affect your ability to qualify for discounts. Information about these programs is free and available from your doctor, pharmacists, and the government. We already know from previous experience that such proposals — known as TRIPS-plus — can have devastating consequences for access to medicines. The disproportionate intellectual property protections the bloc proposes could threaten the affordability of generics that countries like India and Indonesia export to poorer nations. Professor Schondelmeyer favors creating what he calls “concentric circles” starting with the most at-risk drugs, which start with drugs produced in at-risk countries in only one factory, then move out to include those produced at multiple facilities or multiple countries and those in current shortage.

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• Almost 70% of antibiotic FDCs available on the market are not registered with Central Drugs Standard Control Organisation (CDSO) [29].
• India sees the second most significant generic market penetration in the Asia-Pacific (APAC) region, just behind Malaysia.
• Across Mumbai and Palghar districts, around 50% and 42% of medicines were found to be out of stock for the period of 3–6 months respectively.
• In the five years from 2017 to 2022, imports rose to $197.9 billion, worth almost one third (32.8%) of the cash spent by American patients, insurers, hospitals, and the government on pharmaceuticals (Figure 1).
• 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.
• Together, we can help lead the future of healthcare with the extensive IQVIA network of assets, resources, clients, and partners.
• Efficient SCM practices are important to ensure the timely distribution of the right products in the right quantity at the right place.

A 3-tiered public healthcare delivery system is catering to the needs of the population of these two districts. At the bottom of the health services pyramid, there are primary health centres (PHC), sub-centres (SC) and health posts (HP), which focus on primary care. The mid-level of the pyramid, which is the secondary care level, includes rural hospitals and municipal general hospitals, and at the top level, tertiary care institutions like medical colleges are there. According to the PBBJP portal, 29 PMBJP pharmacies are currently functional across these two districts.

Generic drug prescribing experience

Third, the unemployment rate is quite high (6.5%) and absolute poverty is widespread in the country (23%) [33]. As a large section of the population continues to live in hand to mouth condition, the PMBJP medicines may still be unaffordable to many people. Findings of the present study indicate that both the branded and branded-generic versions of the five “paired” medicines had identical quality and they fulfilled all the criteria prescribed by the statutory standards. Hence, the general notion and doubt regarding the quality of the branded-generic version of medicines needs to be erased conducting more such studies and publishing them widely.Suitable changes in the drug price policy may be made to have lower prices for branded-generic versions.

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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.

An in-depth exploration of the global healthcare ecosystem with timely research, insightful analysis, and scientific expertise. Nevertheless, India has a massive population with low per capita income, and stricter patent rules would probably mean less access to medicine for a significant part of the population. The affordability of pharmaceuticals is a critical challenge in India and South Asia in general, raising questions of life and death. DPCO is a blessing for those who use medicine and has boosted their hopes of the availability of cheaper and better medicines, leading to a great psychological impact on consumers (Venkiteswaran, 2013). For example, heart attacks and cardiac arrests are increasing in India, and treatments for these newly emerging diseases are very expensive.

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• The bill uses the tax credit techniques of the Inflation Reduction Act to stimulate U.S. companies to invest in the production of APIs and finished doses of generic medicines in either pill or injectable form.
• They included lots of a generic version of the antibiotic cefazolin, pulled because of fears the intravenous solution contained foreign particles.
• Following the Covid-19 pandemic, pharmaceutical supply chains have evolved to become more agile, transparent, and resilient.
• Paradoxically, low entry barriers have led to fragmented industries that make the sector highly accessible due to competition (Mahajan et al., 2018).
• 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.
• Pharmaceutical companies market their brands by branding their bioavailability results.
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• Prior to that, the state level commitment for free medicine policy had been differential.

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).

Availability of data and materials

In spite of being the ‘pharmacy of the world’, access to essential medicines for a large majority of Indians is constrained by both physical and financial reasons. According to an estimate, medicines account for 69% of household out-of-pocket spending on health care. To make quality generic medicine affordable, India’s People’s Medicine Scheme (Jan Aushadhi) was launched in 2008 and then revamped and rebranded as Pradhan Mantri Bhartiya Jan Ausadhi Pariyojana (PMBJP) in 2015. The current study focuses on the availability, affordability and acceptability aspects of PMBJP essential medicines. Infrastructure constraints present another significant hurdle for the Indian pharma supply chain. Despite substantial progress in recent years, inadequate transportation and logistics infrastructure continue to hamper the efficient movement of goods within the country.

• Patient experience software makes conversations between providers and patients easier so practices can provide timely information to clear up doubts and reinforce trust.
• On current trends, the value of imports and their share in the total pharmaceutical spend is likely to continue to rise.
• 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.
• The list is revised from time to time and some examples of essential medicines included in the NLEM are paracetamol, insulin, antibiotics, etc.
• 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.
• Following this, we picked the essential drugs from the PMBJP product basket, which were found on all the above-mentioned lists.

Why Does an $84,000 Drug in the U.S. Cost Less Than $1,000 in India

• 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.
• India has witnessed rapid population and economic growth in the past two decades, and this expansion has created a demand for larger and better infrastructure in cities and industrial parks.
• Doctors did not seem to be very much confident about the effectiveness of generic medicines.
• The challenges are reportedly more pronounced in North-Eastern states and for facilities under the National Urban Health Mission (NUHM).
• “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.
• Furthermore, the Indian pharma supply chain grapples with issues related to counterfeit drugs and supply chain integrity.

The skilled labor force is available in Indian cities at very competitive salaries compared to most other destinations. 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. The data reported in Table 2 (with the details of various categories) and Table 3 (with the related balance of the same categories) provide evidence about the progress of the Indian pharmaceutical industry and its international business.

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• 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.
• There are increased expectations regarding both the production amount and the trade balance value.
• There is a concrete risk of confusion in the minds of patients/consumers regarding which drug should be considered due to this price variation.
• State experiences highlight the importance of an established IT- enabled supply chain management system.
• 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.

This will be a tough balance to achieve, but it appears that all stakeholders recognize the urgent need for it to occur. Nearly 1 in 10 Americans said they believe generic drugs aren't tested as rigorously as brand-name, with Gen Z being the most likely to have this view (11%). Some also questioned whether generics are FDA-approved (7% of Gen Z), and 12% of Millennials believed that generics took longer to work compared to brand-name medications.

Capacity building of skilled cadres across the levels of care like facility-in-charge, store-keepers, ANMs and pharmacists in inventory/ material management, demand estimation, and indenting is required to support their state-specific practices. Professor Schondelmeyer told us that the U.S. is now dependent on India for 45% of the generic medicines we buy. 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. Another reason is that India has not joined the International Council for Harmonization, a body that sets global standards for drug production. It also does not have national standards for drug production, instead leaving pharmaceutical regulation to its 38 states.

The Same Pill That Costs $1,000 in America Sells for $4 in India

However, some policy issues continue to persist and present complex challenges for the legislature, as well as all other public and private stakeholders. Pharmaceutical pricing and reimbursement are critical components of the Indian healthcare policy. The interplay of pricing and reimbursement policies is aimed at ensuring affordability of pharmaceutical products for patients, as well as continuous innovation and value creation in the industry. The regulatory landscape is constantly evolving and new initiatives by the Government and the private sector, as well as by public–private partnerships, are paving the way for an overhaul of old policies. In many cases the generic drugs do not produce the desired effect in the expected time which branded ones do.

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.

Effective systems are those which are not only apprised of local and aggregate demands for medicines but also have commensurate capacities to meet the demands. In this regard, the government of India has revised the national list of essential medicine to also include a newer range of services to ensure that healthcare facilities are equipped to provide services aligned with changing health needs.5 Likewise, states need to update their EMLs customized to their needs. Besides adequate HRH being one of the prime determinants for ensuring services and medicines, the plurality of job roles across the cadres brings out additional aspects for inspection and redressal. Learnings from states indicate that the ability of the community health workers to deliver community-based services (e.g., HBNC) is dependent on timely and adequate supply of medicine kits. Likewise, cost-effective, affordable, and quality services are linked to mechanisms promoting rational and scientific prescription practices of authorized providers.

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.

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.

While in a few, they are observed to be efficient (e.g., Tamil Nadu, Kerala, Rajasthan, Andhra Pradesh), challenges reported in many states are largely due to implementation gaps confounded by other systemic challenges. 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. The analysis of nine top-selling AMLO besylate-containing marketed FPPs was exercised using a validated analytical method.

The quotes are being sought for generic drugs, although they are also allowed for imported or combination drugs by their trade or brand names. Cipla’s introduction of Cabotres when it launch is constantly making cancer treatments more accessible and affordable. The brand’s commitment to quality ensures that Cabotres is a reliable option for patients. “Now what sorafenib price in uae happens is most of the time we don’t get adequate supply of these Jan Aushadhi products in definite time. Hence, government can increase number of wholesalers, distributors in the scheme to improve availability of medicines at the stores.” (P9). The survey was undertaken to find out the extent of availability and stock-out of medicines at PMBJP outlets.