Ensuring we communicate this vision and quality-centric focus will be essential to the bright future between manufacturers and those who rely on these medicines. The availability of the above-mentioned generic versions of Cabozantinib enhances the affordability. This has resulted in growing its access, particularly in regions where treatment costs are a huge barrier to healthcare. In conclusion, it is clear that the evolving landscape of the healthcare and pharmaceutical industry in India offers an exceptional opportunity for new entrants to expand and diversify in the market. However, players who aspire to be successful must be ready to innovate, evolve new healthcare delivery models, be open to adapting to changing patient needs and expectations, and be willing to invest in talent, technology and expert legal and regulatory advice.

EVALUATION OF PRICE DISPARITY AMONG GENERIC MEDICINES IN INDIA

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.

Navigating the supply chain roadblocks

CPA supports the Producing Incentives for Long-term Production of Lifesaving Supply of Medicines Act, known as the PILLS Act, which would provide corporate tax credits for pharmaceutical companies investing in U.S.-based manufacturing facilities. 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. Still another example is the antibiotic benzathine penicillin, which is now on shortage. According to an article in medical journal International Health, its production is entirely dependent on three Chinese API manufacturers. The shortage is said to be due to a combination of manufacturing constraints and unexpectedly increased demand. The true causes are always somewhat obscure because pharmaceutical companies try to conceal the thinness of their supply chain and its exposure to single points of failure, such as unexpected decisions by foreign governments to shut a facility.

• It also highlights areas of concern around lack of diversification in the manufacturing of Key Starting Materials and Active Pharmaceutical Ingredients in the broader supply chain for affordable drugs and discusses the role India could play as a partner to the U.S. in de-risking this supply chain.
• We first examined the selected medicine list of PMBJP to assess the extent of coverage of essential 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.
• In order to collect data in an accurate and reliable manner, one of the researchers personally visited the selected PMBJP outlets to check the availability of generic medicines.
• This may include deploying advanced refrigeration systems, GPS tracking, and real-time monitoring to maintain ideal conditions throughout the transportation process.

Harness the power to transform clinical development

And while the Republicans generally favor more market-based solutions—including the importation of drugs from other countries and increased price transparency—reducing drug costs in the U.S. has become one of the few bi-partisan issues. To compare and evaluate the price and quality of “branded” and branded-generic equivalents of some commonly used medicines manufactured by the same pharmaceutical company in India. Prior to that, the state level commitment for free medicine policy had been differential. Fund shortages pushed states to appropriate budget heads under benefit schemes (e.g., Janani Shishu Suraksha Karyakaram- JSSK) or use revenue from services like diagnostics to ensure the provision of free medicines, thereby shifting the burden to other determinants of OOPE.

Diversity Fuels Innovation in Teva’s R&D Management Team

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.

Teva Announces Strong Financial Results for the Third Quarter of 2024, led by Generics Performance a…

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.

Medicine pricing in India

Yet he and other experts agree one of the key problems with the Indian industry is a regulatory system that is not up to the job. That refers to testing done for the presence of active ingredients or unwanted impurities, both of which can have a direct impact on whether a drug does what it is supposed to do, experts say. Sloppy practices and even outright fraud at some – though not all — Indian facilities have been repeatedly documented. A National Post investigation found quality issues are directly affecting Canada in several ways. Reddy’s Laboratories is accused of ignoring tests showing unknown impurities in some of its drugs.

business advice for growth

The company ignored tests showing unknown impurities in some drugs, and inspectors came across samples with bacteria and mould that were “TNTC,” too numerous to count. What that patient is unlikely to know is the drug’s active ingredients come from a company called Dr. Reddy’s Laboratories Ltd. in India — or that U.S. inspectors made some eye-opening discoveries recently at the plant that produces them. The medicine will be only for personal use and not more than 3 month supply at a time. Quality and price of medicines were studied to evaluate the two versions of the same therapeutic molecule.

A Cost Analysis of the Jan Aushadhi Scheme in India

But branding and marketing cost makes the medicines expensive which leads customers to buy medicines at a higher price. Upon evaluation of these facts, it is morally imperative to respond to the current negative media portrayal of Indian generic companies in the U.S. It can be argued that it is unreasonable and unwarranted to cast aspersions on an entire country’s pharmaceutical sector based on one-off incidents, rather than solid science, while disregarding the immense value it brings to healthcare across the world. This issue was again in the news last week when the Indian Supreme Court denied a patent application for Glivec (also known as Gleevec), an important treatment for leukemia made by Novartis. This is good for the company that will profit from usurping all of the R&D that Novartis put into the discovery and development of Glivec.

Cabozantinib Generic Price in India

This provides an added advantage to the nation, which assists in developing processes that are cost-effective (Mahajan, 2019). DPCO has been a drawback for drug companies because it caused a decrease in ribociclib price in malaysia their profit margins. Developing a medicine involves many aspects and is quite costly; hence, reducing their prices and profit margins has generated complex situations for pharmaceutical companies.

However, as shown in Table 2, PMBJP medicine list has as many as 130 FDCs in different therapeutic categories. The maximum number of fixed dose formulations listed in PMBJP is for vitamins and micronutrient deficiency followed by gastrointestinal complaints and cardiovascular disorders. As a protectionist tide sweeps across the globe, the Indian pharmaceutical industry needs to continue evolving.

The study highlights the need to modify the drug price policy, regulate the mark-ups in generic supply chain, conduct and widely publicize the quality testing of generics for awareness of all stakeholders. Supply chain management practices backed by IT-based platforms have shaped estimation, tracking, and monitoring practices for medicines, equipment, and consumables in the Indian health system. Early implementation of such platforms is identified as a key determinant to promote skill development and skill refinement among trained users, allowing the states to gradually saturate and establish them throughout.

PALENO (Palbociclib) Generic Online in India

Indeed, a number of the larger players are looking at acquisitions in key markets across the globe. The generic landscape is rapidly changing with cost pressures slowing down domestic offtake, pricing pressures in developed markets such as the United States and Europe, as well as pricing pressures being introduced in India. Moreover, regulatory bodies are demanding stricter compliance, pushing up compliance costs.

The generic drugs industry continues to strengthen itself as a key pillar of India’s burgeoning economy. As the largest provider of generics in the world, the sector contributes to 40% of the United States’ generic demand with Indian companies receiving 304 Abbreviated New Drug Application approvals from the United States Food and Drug Administration (USFDA) in 2017. Moreover, the industry exports to almost every nation, and has significant footprints in all the highly-regulated developed markets.

• The national regulator reportedly has fewer than 400 staff to police more than 1,300 factories, and does not even oversee many of the drugs exported to places like Canada.
• That leads to widely differing standards across India, with the temptation to lower standards to attract more manufacturers.
• New drugs are protected by patents, so only the company that came up with the drug can sell it.
• Here, ni was the number of drugs from a specific therapeutic category available in a PMBJP pharmacy at a particular health care level and Pi was the number of facilities in that particular level of care and Ni was the total number of drugs listed in particular therapeutic category as per the survey medicine list.
• 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.
• In this respect, however, foreign companies, as well as national companies, have been reluctant to invest in R&D in India (Ghai, 2010).
• Common side effects include gastrointestinal issues and fatigue for both drugs, but specific side effects and patient responses may vary.

Remarkably, 36% of China’s exports are to the EU and North America, where regulations are the most stringent, compared to 19% in 2009. Beijing’s “Made in China 2025” policy has identified pharmaceuticals as one of its strategic industries. Now, the advantages that have enabled India to play this role are in danger of being eroded.

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

In the home market, drug prices are controlled by the drug price control order; therefore, there is strong pressure on revenues and subsequently on costs. In the international market, threats derived from pharmaceutical multinational companies are emerging as tough obstacles to overcome. Indian generic manufacturers are also producing in the U.S. and in other countries whenever necessary.

Drug Price List: Generics and Matching Brands

In the USA substitution is allowed and patients accept generic substitution if physician approves of the same. Generic substitution rates have increased remarkably there, probably due to greater acceptance by physicians and pharmacists as well as encouragement from the third party payers.[20]Cheaper generics are one of the important factors to reduce health-care cost. Studies involving comparative evaluation on quality of branded and their generic counterpart may be made mandatory for the generic (or branded-generic) manufacturer and their reports should be made public to promote generic use and prescriptions. Unlike developed countries, people in developing countries pay the cost of medicines out-of-pocket. Universal access to medicines, a critical component of Sustainable Development Goals, is intended to ‘ensure access to safe, effective, quality and affordable essential medicines for all [24].

One of the reasons for this decrease was the transition of the pricing strategy from cost-based to market-based policies, a noticeable cause due to the implications deriving from DPCO (PTI, 2013). 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. Further, international pricing trends and regulations, as well as global supply chain disruptions, have immense influence on local drug pricing and availability in India, particularly for those drugs for which there is no local production and reliance is purely on exports.

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, 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.

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.

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.

• Though not an exhaustive list, state-specific experiences over the years highlight the determinants of access, and pertinent systemic challenges needing redressal.
• Data were gathered on the availability, stock-outs, price and affordability of 35 essential medicines and 2 consumables.
• 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.
• 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.
• As mentioned above, DPCO establishes the various pricing parameters according to which the price is to be decided, and this policy reduces the profitability of the companies that would invest in innovative drugs, which requires huge capital.
• Besides, since April 2017, bioequivalence studies have become an essential requirement for the manufacture of a generic medicine in India [14].
• 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.

Canadian, Australian and European regulators also gave passing grades to Ranbaxy, despite the company’s guilty plea to seven offences in the U.S., notes Dinkar Saran, a pharmaceutical-industry consultant with PriceWaterhouseCoopers in Boston. The national regulator reportedly has fewer than 400 staff to police more than 1,300 factories, and does not even oversee many of the drugs exported to places like Canada. That job falls to state-level officials, who have a reputation for being under-trained and corrupt. We will not dispense any prescription medicine without a valid prescription from a licensed/certified doctor physician. A bottle of 21 capsules costs between 5000 and 6000 Indian Rupees, depending on the strength of the medicine, making it very affordable.

This would not only contribute to increased demand generation but also mitigate the burden of accessing quality medicines and consequent financial hardship. In the years of NRHM ( ), a few states like Kerala, Assam, and Jharkhand already had state policies for free services and medicines for BPL families. Under the NCD control programme, medicines were first made available free of cost in the states like Kerala and Tamil Nadu. After the launch of NHM (subsuming NRHM and NUHM), most of the states adopted a policy for free medicines in public health facilities, which gradually brought down the OOPE on medicines.

The website is regularly updated by the Trust with assistance from Ministry of Consumer Affairs, Government of India. Indeed, the United States – a key destination for India’s generic exports – has made it increasingly costly and time-consuming for generic producers across the globe. This is in part due to the prescription drug user fee act (PDUFA), which requires pharmaceutical companies to pay fees ranging from US$1.5 million to US$2.7 million when submitting a candidate for approval.

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.

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.

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.

• 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.
• The process of securing reimbursement for a pharmaceutical product varies and depends entirely on the specific processes provided under the respective policy.
• Along with that, the overall supply chain, logistics and warehousing costs in India is 15 per cent higher compared to other countries,” the report added.
• For more detailed information, refer to the prescribing information and consult a healthcare professional.
• They have embraced advanced technologies like machine learning and artificial intelligence.
• The expenditure on health care in India has ultimately reduced the costs of medicines under DPCO, and essential drugs are coming under the ceiling price every day (Kuchey and Jan, 2018).

Schondelmeyer, a professor of pharmaceutical management and economics at the University of Minnesota, testified on drug shortages before the House Ways and Means Committee in February, urging the Congress to take action to address the growing problem of generic drug shortages. After developing the above topics, it is possible to implement a potential framework to oversee the current and future conditions of the Indian pharmaceutical industry. Naturally, the peculiar situation is considered due to the COVID-19 pandemic, whose impact in the near and far future may greatly influence scenario analysis. For these reasons, we opted for a narrative SWOT analysis, similar to other studies (Vandevelde and Halleux, 2017; Septinaningrum and Nugraha, 2019; Cowx et al., 2010). Special economic zones (SEZs) are popular because they provide tax benefits for companies. To create new business opportunities for the pharmaceutical industry, SEZs can be a powerful option, especially if established near airports, stations and ports.

The Bureau of Pharma Sector Undertakings (BPSU) working under the Department of Pharmaceuticals, Government of India, was entrusted with the responsibility of implementing JAS, i.e., to coordinate procurement, supply and marketing of generic drugs through JAS outlets. The scheme envisaged to sell generic medicines at affordable prices through exclusive outlets namely JAS stores across the country, starting from the district to sub-divisional headquarters and to towns and villages. However, JAS never really took off; there were only 99 JAS outlets across India which were selling 131 medicines till 2014. According to a study, the availability of medicines in JAS was abysmally low (33%) [13, 14]. Against this backdrop, in September 2015, the union government decided to expand its generic drug scheme called “Pradhan Mantri Bhartiya Jan Aushadhi Pariyojna (PMBJP)”, which envisaged making unbranded quality-assured generic medicinesFootnote 4 available at affordable prices to all people and especially the poor.

Further, the healthcare professionals stated that generics do not yield good results while treating for acute conditions like bacterial infections, but they expressed confidence in generic medicines for chronic illnesses. Apart from the limited coverage of essential medicines and the significant presence of Fixed dose combinations (FDCs) in the PMBJP medicine list, the availability of surveyed essential drugs was also found to be low (47%) in PMBJP outlets. 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.