This is because in India, there is an inadequate R&D infrastructure and lower industry-academia connection for research. 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. This sector has been hamstrung by a lack of product patents, due to which foreign companies do not introduce new drugs in the Indian market, discouraging innovation and drug discovery.
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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. This improved pricing – a 25% reduction – will allow governments in resource-limited settings to expand access to critical HIV services. Data from the American Society of Health System Pharmacists (ASHP) shows that the number of drugs in shortage reached 301 at the end of 2023, one of the highest figures since data began. The FDA produces smaller figures because they count only shortages at the national level. The ASHP considers regional and local shortages too, a measure that doctors and health economists consider more relevant to the quality of care provided to patients.
Cabozantinib price in India
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 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.
Do lower prices make generic medications the top choice for Americans?
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 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.
Beginning of Generics
All these factors are making the larger Indian players conscious of how best to evolve from their current offering. “I would also advise to focus strongly on reliable quality and being ahead of the curve on FDA requirements, to rapidly establish yourself,” he continued. The price ceiling policy has been in place for more than two decades, but it has neither been very successful nor free of consequences for pharma companies. Instead of the existing price controls, other mechanisms such as promoting competition among local manufacturers and increasing public healthcare spending should be focused on. It remains to be seen if the NPPA will schedule additional price adjustments for essential medicines in the current fiscal year ahead of the national elections, which are set to take place between 19 April and 1 June 2024. India’s independent drug pricing regulator, the National Pharmaceutical Pricing Authority (NPPA), has issued a marginal increase of 0.0055% to the maximum retail price (MRP) of medicines included in India’s national list of essential medicines (NLEM), which took effect on 1 April 2024.
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Both cabozantinib and sorafenib are multi-kinase inhibitors used to treat advanced cancers like RCC and HCC. Common side effects include gastrointestinal issues and fatigue for both drugs, but specific side effects and patient responses may vary. S&S was the first law firm in India to challenge the constitutional validity of the provisions of the Drugs (Price Control) Order, (DPCO) 2013, representing 15 pharmaceutical companies before the Delhi High Court in this groundbreaking case. In Mumbai region, among the surveyed medicines which were not available at the time of survey, around 50% were out of stock for the period of 3–6 months while about 38% of medicines were out of stock for the period of less than 1 month (Fig. 4). Around 50% of antimicrobials, antidiabetics, antiepileptics and consumables were out of stock for the period of 3–6 months.
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- This enables firms like XtaIPi to identify thousands of molecules which could be used to treat a disease with fewer resources and time.
- “Established in 1992, BPI has a proven track record in the research & development and manufacturing of oral solutions, suspensions and suppositories,” underlined Jinesh Shah, director at Torrent Pharma.
- These policy issues, along with market forces, drive the response of the public and private sectors to reimbursement policies, as well as determine the extent of price control on pharmaceutical products.
- Infrastructure constraints present another significant hurdle for the Indian pharma supply chain.
- Similarly, a defense strategy seems realistic when combining the experience with generic drug production with DPCO limits, thinking about a competitive strategy based on cost leadership, which may be sustainable considering the huge population of the country.
- Indian pharmaceutical companies have been a critical partner in the supply of these drugs by providing affordable medicines for major health conditions that enhance patient access, improve management of health conditions, and bring savings and resilience to the overall health system.
- There are a large number of drugs that went off patents, providing many pharmaceutical companies with huge opportunities to enter the market.
- For example, melphalan to treat ovarian cancer cost the UK £1.82 for 2mg but in India its generic cost is 8p, a rise of 2,171%, the findings show.
Ask your doctor to write a prescription allowing the pharmacist to substitute a generic drug when it’s appropriate. PTR is the price at which wholesaler (distributor) sells the product to the retailer and the bill (voucher) given to retailer by wholesaler mentions the PTR. This price was checked and confirmed from Form V (under DPCO, 1995) available at the distributors of the company. It is mandatory for all the companies to give Form V that gives details of the product with MRP, PTR, taxes paid, etc to their distributors. Qualified standards of AMLO besylate were purchased from Sigma-Aldrich (Bangalore, India). For the experiment purpose, nine top-selling AMLO containing FPPs were purchased from local pharmacy outlets in Guwahati (Assam, India).
Five Years into the Product Patent Regime: India’s Response
In the fourth edition of the Re-Pharma Summit 2024, panelist Sabina Sawliwala highlighted the differences in costs and logistical difficulties between companies operating in India and more developed economies like the US and Europe. “Our logistics and transportation costs are literally double-digit, whereas if go to America or Europe, these are single-digit costs,” she added. Poor road connectivity, congested ports, and limited cold chain facilities impede the timely and safe delivery of pharmaceutical products, particularly to remote and rural areas.
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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 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.
Creating Huge Little Moments for Patients
With these tools, providers can offer personalized recommendations, share cost comparisons, and provide educational materials through secure messaging. This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. Haiti’s plight is a reminder of the international community’s wider and longer-term responsibilities to the country. India’s negotiators note they’ve “firmly communicated” that data exclusivity and patent term extensions are “redlines” for them in these negotiations. Last year, the FDA allowed the cancer drug cisplatin to be sold in the U.S. from an uninspected lab in China.
Andrea Curry is an award-winning journalist with over 15 years of storytelling under her belt. She has won multiple awards for her work and is now the head of editorial at The Intake, where she puts her passion for helping independent healthcare practices into action. Inspired by “vertebrae,” our name embodies our mission to be the backbone of healthcare success. With over 165,000 providers and 190 million patient records, Tebra is redefining healthcare through innovation and a commitment to customer success. Electronic health records (EHR) and patient portals make it easier for providers to track patient preferences, allergies, and past prescriptions.
While the upward revision of drug prices is positive for their respective producers, patients must increase their out-of-pocket (OOP) spending to cover the increased prices. This is also the case in India, where OOP healthcare expenditure accounts for more than 50% of total healthcare expenditure, despite India having among the lowest drug prices in the world. Making medicine accessible at affordable prices to the masses will require more than the somewhat piecemeal approach to generic drug promotion that currently exists in the form of PMBJP scheme.
In-depth interviews were intended to capture the perspectives of physicians and pharmacists on generic medicine in general and PMBJP scheme in particular. India, meanwhile, has developed a $15-billion generic-pharmaceutical industry, with labour costs about one-tenth of those in Canada. 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. India’s top pharma firms include Cipla, Aurobindo Pharma,Lupin, Dr Reddy’s Laboratories and Sun Pharmaceutical Industries. While each of these cost reduction initiatives has some merit, the challenge will be to reign in prescription drug costs without removing all of the financial incentives that have helped to make our domestic pharmaceutical industry a world leader and critical part of the U.S. economy.
Radha Iyer vice president and Head of Quality and Scientific Affairs
- These concerns raise fears among patients that taking drugs made in India may result in unpredictable effects.
- The industry operates within a complex regulatory landscape characterized by stringent quality standards and evolving regulations.
- Similarly, pharmaceutical research and development can be carried out in India by global pharmaceutical MNCs.
- Pharmaceutical imports rose again in 2023, and continue to be the second largest import category for U.S. consumer goods.
- Therefore, a better distribution of medicine in the middle-income groups, who need medicines for several treatments, has been observed.
- Whatever the cause of the benzathine shortage, Professor Stephen Schondelmeyer says that it has led to more outbreaks of syphilis in the U.S. than were expected.
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.
Addressing these infrastructure gaps requires substantial investment and collaborative efforts between the public and private sectors. Several factors have an impact on pharmaceutical patents in India, such as an increasing level of income, a consistent growth rate of the domestic economy, and rapid growth in the diffusion of better economic conditions. In this respect, however, foreign companies, as well as national companies, have been reluctant to invest in R&D in India (Ghai, 2010). Indeed, compared to developed nations, Indian pharmaceutical companies concentrate less on innovation, where they allocate less budget. For all the above-described reasons, they find manufacturing generic drugs more lucrative, as the outcome is guaranteed. Taking into account the above considerations, from a narrative and then qualitative point of view, a positive scenario for the Indian pharmaceutical industry can be highlighted, thus providing a response to RQ3 (“What are the most relevant SWOT for the future?”).
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.
- 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].
- 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.
- 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.
- Following informed consent, the interviews were audiotaped while the first author also took notes.
- “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.
- Besides that, the public physicians stressed on the need for establishing the PMBJP outlets within the hospital premises, while private physicians asked for dissemination of information regarding the drugs listed under the PMBJP scheme.
The three major medicines for breast cancer – Palbociclib, Ribociclib, and Abemaciclib are popular internationally. Despite India’s contribution to global access to medicines, the government has never tried to use this as an instrument of foreign policy. One silver lining is that China is proposing a new regulation that would give its firms exclusive control over their clinical test data.
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.
To make the sample representative and consistent with the distribution of PMBJP outlets in Mumbai and Palghar, 11 pharmacies were selected for the study covering all levels of health care delivery system. The PMBJP pharmacies were purposively selected based on their proximity to public health facilities such as medical college (Tertiary level), Municipal General Hospital (Secondary Level) and PHCs and HPs (Primary level). PMBJP pharmacy’s proximity to the public health facilities was assessed using google maps (Fig. 1). All the selected PMBJP outlets agreed to participate in the study; and a written consent form was signed before data collection.
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.
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.
Almost 70% of antibiotic FDCs available on the market are not registered with Central Drugs Standard Control Organisation (CDSO) [29]. In view of growing antibiotic resistance and concerns regarding safety and efficacy of FDCs manufactured in India, it is worrying to find that the use of FDCs is being promoted by PMBJP. The FDCs, except the ones of proven quality, should be removed from the PMBJP’s list of medicines to safeguard public health. Pharmaceutical companies market their brands by branding their bioavailability results.
Also, a formulary containing the details of therapeutically interchangeable products is available for reference [36]. And for ensuring the quality of generics, information regarding bioequiavailability is sought from companies before they place the products on the market. Aside from the supply side initiatives, demand side measures such as physicians’ motivation to prescribe generic drugs, consumers’ attitude towards generic drugs have shown some results [42,43,44].
- 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].
- And such protection could threaten the affordability of generic medicines these countries export to the Global South.
- 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.
- Baladol, developed by PNB Vesper Life Sciences, has become the first new drug for treating COVID to enter phase II clinical trials around the world.
- 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.
- Through the years, some SCM practices are identified to stand out as desirable and cost-effective.
If these Jan Aushadhi stores are available in Government hospital premises, patient can get those medicines easily.”(PuP2). If government wants us to prescribe drug through their molecule names, why do they allow so many brand names and why are there such wide price variations? By doing so, the brand has presented a cost-effective treatment for many patients of (HR+) (HER2-) advanced or metastatic breast cancer patients. Learn more about the Indian generic versions of Palbociclib and how it is a breakthrough in breast cancer treatment.
- The analysis of marketed AMLO containing FPPs was exercised using a validated analytical method.
- On the other hand, the availability of antiasthmatic and antipsychotic medicines was very low-only a third of the PMBJP pharmacies had them.
- For example, augmentin brand gives effective and quick results as compared to its simple generic amoxicillin clavulanate version.
- These three pharmaceutical categories alone are worth approximately 60% of the entire Indian pharmaceutical production.
- 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.
- While more than 70% of PMBJP pharmacies across all levels of care in Palghar region had palliative care medicines, anti-epileptics, analgesics and antacids, the availability of anti-cancer, anti-asthmatic and electrolyte balancing drugs were found to be very poor (less than 30%).
- The country was the single largest supplier of pharmaceutical products to Africa in 2018, and accounted for a fifth of the continent’s pharmaceutical imports.
- Since then, through global partnerships and country-led efforts, about 19 million people living with HIV in resource-constrained settings are now receiving TLD, according to the Clinton Health Access Initiative.
On top of all these problems is the large and growing national security risk as more and more drugs become dependent on suppliers from China. Even the common knowledge that we are becoming dependent on a small number of large drug companies for generic drugs understates the dependency on China. 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.
According to a 2022 study released by GS1 India, a global supply chain standards organization, more than 50 per cent of Pharma and medical devices manufacturers lose 1 per cent of their sales due to expiry and pilferage. Counterfeit medications not only pose a significant threat to public health but also erode consumer trust in the pharmaceutical industry. 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. 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. Healthcare expenditure continues to rise in countries where healthcare is not a priority. Generic drugs offer an important tool for reducing the overall healthcare expenditure.[17] As more and more patents expire, the generic versions of the pharmaceutical market are expected to continue for increased sales.
Particularly, the country exports generic medicines on a large scale, with a major impact in the American and European markets. Assessing the availability and affordability of generic medicine at PMBJP outlets is important, but perhaps it is even more important to know the physicians’ attitude towards generic drugs and PMBJP scheme, as they play a key role in prescribing generic medicines. Most of the physicians argued that generic and branded medicines have the same active substance(s). Table 6 shows the cost of standard treatments, as recommended by WHO, with surveyed medicines at PMBJP price and at branded generic price for a number of health conditions [22, 23]. We find that for all selected disease conditions, the drug cost of the thirty-day treatment reduce by 6–1129% if PMBJP’s unbranded medicines are used instead of their largest selling branded-generic counterparts. For the treatment of Type 2 diabetes, the monthly expenditure on the PMBJP medicine (Glimepiride) was estimated to be almost 50% lower compared to its equivalent branded-generic counterpart.
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.
Transparency in fixing the MRP by the manufacturer and clear guidelines for mark-ups at least for branded-generics is required in pharmaceutical trade. The government must take up generic promotional schemes, general awareness programs on quality of generics to build confidence among prescribers, pharmacists, and consumers. Availability of generics or branded-generics in the market with lower price tag and assured quality is essential to make the medicines affordable. harvoni cost uk Results of our study revealed that price-to-patient for the branded-generic version was not much less than to its branded counterpart; branded-generic was available at % cost of the branded product. Medicine prices are under the purview of Department of Pharmaceuticals which itself is under ministry of chemicals and fertilizers. The Drug Price Control Order (DPCO) identifies active pharmaceutical ingredients (APIs) for which a pricing formula is used to set the MRP.
As such, pharmaceutical companies are permitted to increase the prices of their drugs by this percentage. The marginal price adjustment is expected to affect 923 scheduled formulations listed in the NLEM, including antibiotics, cardiovascular medicines, tuberculosis drugs, and Parkinson’s and dementia medicines, among others; the small scale of the adjustment renders it meaningless compared to previous price adjustments. However, it instead tipped the balance in favor of the pharmaceutical industry’s commercial interests, and away from access to affordable medicines. For example, the development of a range of long-acting HIV prevention and treatment medicines could be transformative in advancing the end of AIDS — but this can only happen if those medicines are made widely available at low prices through large-scale generic production. India has long been known as the “pharmacy of the world,” producing generic medicines at prices that other developing countries and global institutions can afford. The country was the single largest supplier of pharmaceutical products to Africa in 2018, and accounted for a fifth of the continent’s pharmaceutical imports.