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

(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.

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The Inflation Reduction Act authorized Medicare to negotiate the prices of a limited number of drugs directly with their manufacturers, and it capped annual drug costs for Medicare beneficiaries at $2,000. In addition, the Biden administration recently funneled billions of dollars from a Medicare trust fund under a “demonstration” program to offset Medicare Part D premium increases that otherwise would have occurred in 2025. The combination of high and rapidly rising drug prices and the obvious disparity between what many drugs cost in the U.S. and what they cost in other countries has made government intervention all but inevitable, and it is already happening. Tebra, headquartered in Southern California, empowers independent healthcare practices with cutting-edge AI and automation to drive growth, streamline care, and boost efficiency.

Life Effects Stories from Patients and Caregivers

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.

Industry Products

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.

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

Supply chain management (SCM) is the regulation of the flow of goods, finances, and information related to products or services spanning from procurement to distribution to the end-users. Efficient SCM practices are important to ensure the timely distribution of the right products in the right quantity at the right place. Furthermore, the Indian pharma supply chain grapples with issues related to counterfeit drugs and supply chain integrity.

The World’s Pharmacy: India’s Generic Drug Industry

• PMBJP, originally called Jan Aushadhi Scheme (JAS), was initiated by the United Progressive Alliance (UPA) Government in 2008.
• The FDA produces smaller figures because they count only shortages at the national level.
• For more commonly used medications, such as allergy relief, patients can save up to 83% per prescription by choosing the generic alternative.
• The issue of access to medicine is a primary cause of the skewed healthcare utilisation pattern in India.
• 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.
• The legal framework for intellectual property rights, i.e. the law and policy relating to patent protection and/or compulsory licensing, also affects the availability and pricing of pharmaceuticals, especially innovative and biologic drugs.

Paradoxically, low entry barriers have led to fragmented industries that make the sector highly accessible due to competition (Mahajan et al., 2018). Further, we did not fully follow WHO-HAI methodology for calculating availability of essential medicines as the list of surveyed medicines was modified to meet the contextual requirements. Besides, we did not compare the prices lapatinib price in singapore of unbranded generics with international reference prices as recommended by WHO-HAI methodology since there is already overwhelming evidence showing that generic prices in India are less expensive compared with international standards. Thus, the scope for generalisability of the study findings, especially on availability and affordability of PMBJP medicines is limited.

Why Not Regulate Prices?

According to National Sample Survey Organisation, public facilities accounted for only 30% of the overall healthcare services in the year 2017–18 [4]. This means that majority of the people had to obtain healthcare including medicines from private providers. Moreover, even those who access healthcare from public facilities end up purchasing drugs from the market as the prescribed medicines are often not available in pharmacies of public hospitals. Currently, almost all medicines in India are sold under a brand (trade) name and medicines are called as branded medicines or branded-generic. In real sense, Indian market does not have branded medicines (a name commonly given to an innovator product) because till January 2005 product patent was not applicable in India.

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Generic drugs savings totaled $292.6 billion in 2018, according to the AAM Access & Savings Report (2019). Of this, an estimated savings totaling $80 billion in 2017 can be attributed to the contributions from Indian generic companies. The foremost challenge is ensuring a fair and just regulatory framework, which is stable and predictable. This uncertainty in the regulatory framework affects the ease of doing business for pharmaceutical companies, which has a detrimental impact on innovation and value creation. Besides, CDSO must ensure that generic medicines available in the Indian pharmaceutical market are bioequivalent and those qualifying bioequivalence tests should be listed along with their branded counterparts and price on a public or PMBJP portal.

Beginning of Generics

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.

• 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.
• Besides, since April 2017, bioequivalence studies have become an essential requirement for the manufacture of a generic medicine in India [14].
• Some physicians reported that they face difficulties in prescribing generics as patients have negative attitudes towards cheaper medicines.
• 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.
• Though not an exhaustive list, state-specific experiences over the years highlight the determinants of access, and pertinent systemic challenges needing redressal.
• With tools like EHR systems and patient portals, they can easily track preferences, share resources, set up payment plans, and discuss treatment options.

The rise and rise of the pharmaceutical supply chain in India

She used the structured schedule to collect data on availability and stock-out of selected medicines and consumables. Those medicines not found in stock on the day of survey, the number of days of stock-outs in the last 6 months were recorded through manual checking of registers. We first reviewed the WHO-HAI core list of medicines, medicines that are listed on India’s Essential Medicine List and drugs listed under various national health programmes [18, 19].

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.

• According to Qyobo’s data, atorvastatin is available from nine different drugmakers, including companies based in Germany, Bangladesh and Turkey.
• The second reason for not regulating prices is that the pharmaceutical industry is a major part of the U.S. economy, generating more than $700 billion in annual sales ($600 billion more than the pharmaceutical industry in the second-ranked country) and supporting more than 4 million jobs.
• Indian generic manufacturers are also producing in the U.S. and in other countries whenever necessary.
• Even among the beneficiaries, the range of medicines given free of cost was not as per the EML nor based on epidemiological load.
• 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.
• 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.

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If anything, recent Indian policies are sending a signal that intellectual property is tenuous in this country and will be granted only in those cases where it can benefit India. But, when it comes to drug pricing and intellectual property, the plane is severely tilted in India’s favor. At Delightaid Health, we can help you to get high quality generic Cabozantinib medicine at the lowest discounted cost.Please contact us via Email, WhatsApp or simply filling query form in our website bottom section or contact us page.

India’s share of the US generic market is growing rapidly, and the number of companies and manufacturing facilities supplying to the U.S. market is growing fast. The focus on growing regulatory requirements, improved healthcare infrastructure, and surge in research and development spend bodes well for the pharma industry. The Indian government believes that the prices of lifesaving drugs shouldn’t be set by market forces. In a country where very few people have health insurance, 70% of Indians pay for healthcare expenses out of their own pockets. 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 process of securing reimbursement for a pharmaceutical product varies and depends entirely on the specific processes provided under the respective policy.

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.

A narrative strengths, weaknesses, opportunities and threats analysis of the Indian pharmaceutical industry

A challenge is also posed by the exponential growth in population, and epidemiological changes in the population resulting from shift in lifestyles. Thus, there is a continuous boost in the demand for pharmaceutical products and a consequent strain on the supply chain. The growth in population also affects reimbursement policies, since the Government has to allocate an increasing number of funds to public health insurance schemes and may be affected by budgetary constraints.

How are drug prices set? What is the relationship between pricing and reimbursement?

The second reason for not regulating prices is that the pharmaceutical industry is a major part of the U.S. economy, generating more than $700 billion in annual sales ($600 billion more than the pharmaceutical industry in the second-ranked country) and supporting more than 4 million jobs. In addition, prescription drugs are a significant export category, representing percent of all U.S. exports while showcasing America’s innovative capabilities in ways that save and improve lives globally. While it is essential to prioritize streamlining procurement mechanisms, it is equally important that such provisions effectively translate to better access and availability of medicines across all levels of care. The state experiences underscore the need towards establishing robust tracking mechanisms for the efficient utilization of resources.

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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.