Indian Generic Price

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.

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Reservation or allocation of land for the health-care sector will boost the growth and development of the industry, resulting in employment and self-employment of health-care staff, even at the pharmaceutical level. Financially poor people use India’s public health-care system and reserving land in cities for public facilities will serve the population’s low-income earners. Consider that the Indian pharmaceutical industry has significantly reduced the burden on the U.S. public health system by making much needed medicines affordable and readily available.

Quality Issues

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.

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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.

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  • The second chapter highlights the role that Indian companies play in the supply of drugs to the U.S. in terms prescriptions, patient access, resilience, and savings.
  • IQVIA Decentralized Trials deliver purpose-built clinical services and technologies that engage the right patients wherever they are.
  • Doctors ask us to ensure efficacy of generic medicines by claiming it in writing.” (P8).
  • The prepared sample was filtered using a 0.45 μm membrane filter and injected into a chromatograph in duplicate.
  • For ciprofloxacin, the MRP of both the branded and branded-generic product was same but the branded-generic was available to retailer at 3.6 times less price than branded medicine from the same company.
  • 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.

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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Indian Generic Price

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.

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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.

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Not only would this be bad news for India’s economy, it could make it harder for developing countries to access the medicines they need – threatening the UN Sustainable Development Goals in the process. In my last two articles, I discussed the recent surge in prescription drug costs, the reasons for the surge, and possible solutions. In this article, I’ll discuss why drugs frequently cost so much more in the U.S. than they do in other countries, why this disparity may be justified, and where we go from here. 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.

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SII separately has a manufacturing agreement with AstraZeneca to produce one billion doses of the Covishield vaccine, which the UK company is developing with the University of Oxford. Another challenge to India is wealthy countries protecting their pharma industries to ensure drug security. In August, President Trump issued an executive order that called for the elimination of drug imports, both as active ingredients lenvima price uk and formulations. The price ceiling policy has been in place for more than 20 years, but it has neither been very successful nor free of consequences for pharma companies. Generic drug manufacturers do not have to spend extra money for drug discovery and preclinical and clinical trials. Generics are available at a lower cost; they provide an opportunity for savings in drug expenditure in a country.

  • It jumped from $40 billion in 2021 to an expected $130 billion in 2030, with projections hitting $450 billion by 2047.
  • Education curricular changes sensitizing providers on generic medicines, rational prescription, STGs/STPs, and continuum of care can mitigate undesirable practices.
  • 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.
  • Among the medicines unavailable in PMBJP stores at the time of the survey, around 42% were out of stock for the period of 3–6 months, while 11% and 7% of drugs were found to be out of stock for 1–3 months and up to 1 month respectively (Fig. 3).
  • Chinese and Indian manufacturers have demonstrated a pattern of repeatedly violating FDA regulations.
  • While imports from those two countries dominate the $208 billion in total imports, their dominance is much greater in specific drugs and medicines, sometimes reaching 100%.
  • Unfortunately, access to medicine is mainly determined by socioeconomic status in low and middle income countries, with poor medicine access among disadvantaged populations [].

Views on PMBJP scheme

Through the years, some SCM practices are identified to stand out as desirable and cost-effective. Additionally, the use of IT-based platforms for procurement and inventory management (i.e., storage, quality testing, tracking, monitoring, and allocation based on consumption patterns across the empaneled health facilities) are pivotal for a highly responsive and accountable system. The U.N. Special Rapporteur on the Right to Health proposed that “developed countries should not encourage developing countries to enter into” free trade agreements with TRIPS-plus measures, and that they should “be mindful of actions which may infringe upon the right to health.” In the same vein, as U.N. System leaders, we supported a 2016 report acknowledging governments’ limited policy space to enact actions regarding access to medicines due to TRIPS-plus measures in trade deals, which undermines their ability to protect the human right to health.

Indian Generic Price

The study findings show that PMBJP’s unbranded generics offer great opportunities for substantial cost savings. But, in order to fully realise the potential of this scheme, some policy actions are urgently required. Fourth, PMBJP’s medicine procurement and distribution policies must be reviewed to address the supply chain issues. Moreover, there is a need for major pharmaceutical policy reforms to promote generic medicines in a big way.

  • 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.
  • In terms of per capita income, Maharashtra is one of the richer states in India and Mumbai is its capital city.
  • Faced with shortages and a limited number of suppliers, almost all of them overseas, the FDA is actually being forced to relax its standards, just to find any supplier of certain badly-needed drugs.
  • 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.
  • There is also a presence of good technical and technological expertise together with the availability of low-cost skilled human resources.
  • 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.
  • Currently, almost all medicines in India are sold under a brand (trade) name and medicines are called as branded medicines or branded-generic.

The price the NHS pays for some generic cancer drugs has risen by between 100% and more than 1,200% over the past five years, according to research presented at the European Cancer Conference held in Amsterdam. Consider that the receipt of an FDA “warning letter” often results in staff changes at the most senior levels of leadership at Indian generic companies. This accountability occurs even in incidences where the FDA has come down hard on companies for even the smallest of deviations.

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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.

  • 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).
  • This cost advantage enables Indian pharmaceutical firms to provide competitively priced products both domestically and globally.
  • 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].
  • Sloppy practices and even outright fraud at some – though not all — Indian facilities have been repeatedly documented.
  • The use of generic drugs is steadily increasing internationally as a result of economic pressure on drug budgets.
  • It does not include all information about the possible uses, directions, side effects, warnings, precautions, interactions, adverse effects, or risks that may apply to this product.

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Drugs registered under DPCO must be sold within the price range, which is mandatory for the company and therefore, the break-even point is sometimes barely reached (Paul, 2018). Indian companies will continue to expand globally, enriching their manufacturing capabilities to meet the growing demand in the world. The future will see a major role in global healthcare by Indian pharma, not only in making medicines affordable, but also in strengthening India’s position as a global hub for making innovative and high-quality medicines. 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.

Pharmacists’ views on PMBJP

Further, inadequate healthcare infrastructure, particularly in rural areas, affects the distribution and accessibility of pharmaceuticals, impacting both pricing and reimbursement effectiveness. A rise in the profit margin of businesses having product prices below DPCO was registered, which resulted in economies of scale (Venugopal and Jampala, 2019). 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). Therefore, a better distribution of medicine in the middle-income groups, who need medicines for several treatments, has been observed. There was social and economic injustice because the low- and middle-income classes could not afford costly medicines, and DPCO resulted in socioeconomic justice for many poor people in India, a developing country.

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.

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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 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.

The Indian Government in its interim Budget for financial year 2024–2025 has allocated an amount of Rs 90,658.63 crores to the Ministry of Health, which constitutes a 12.59% increase from last year, reflecting the Government’s prioritisation of development of the Indian healthcare system. That’s what they call hepatitis C, which is so common in parts of India’s Punjab state that the tailor-shop gossips might not be off base in their estimate. Drugmakers have made the village of Lande Rode one of the theaters in a battle to grab market share for sofosbuvir, a miracle cure that Gilead Sciences Inc. sells in the U.S. as Sovaldi at a retail price of $1,000 a pill. Gilead licensed 11 Indian companies to make generic versions, and they sealed marketing deals with others.

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. 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. Consequently, domestic businesses will be hindered to some extent, and exports may blossom. For example, India has been universally considered the pioneer in the export market for generic drugs. In the case of other medicines, if the drug is under DPCO in India, it may be possible to sell it under price control domestically and to collect maximum revenue from exports, thus helping to enhance the country’s economy (Das, 2013). Nonetheless, DPCO policies had an adverse influence on the imports of medicines to India in the form of a fall in trade due to price regulations.

Thus, the Indian government should establish ongoing support to small- and medium-sized Indian companies in training and implementing FDA standards, as it provides easy global access to those and similar international markets. 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. India’s limited development of service platforms is a result of the scarce functioning of the bureaucracy, but conditions have improved in recent years. There is a need to reserve appropriate sizes of land for the health-care sector in cities and for pharmaceutical companies in industrial belts during the planning process. In India, the public health-care system is not strong, and most of the middle class and above prefer to visit private hospitals for treatment.

Affordability was calculated on the basis of number of days of wages that an unskilled worker requires to expend for a standard course of treatment for common acute and chronic conditions [22, 23]. 5, the cost of the treatment with PMBJP medicines was between 0.01 days’ wages and 0.48 days’ wages, suggesting that unbranded generic medicines at PMBJP pharmacies were relatively affordable than their branded counterparts. At 0.01 and 0.5 day’s wage, diazepam for treating anxiety and diclofenac for treating arthritis respectively were the cheapest generic medicines at PMBJP stores. 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.

Hence, consumer awareness for the generics, variety of trade names available in the market, and price variation is very limited. Hence, there is need to conduct a study that can document the price structure and quality of the branded product and their branded-generic versions manufactured in India. Difference in price-to-patient was not as huge as it is expected for generics but margins for retailer were very high for branded-generics.

The rise of drug shortages, the unreliable quality of the output of Chinese and Indian facilities, and the increasing concentration of the industry to one or two manufacturers for many drugs or key ingredients raises real questions over the FDA’s ability to address the shortage problem. Following the Covid-19 pandemic, pharmaceutical supply chains have evolved to become more agile, transparent, and resilient. They have embraced advanced technologies like machine learning and artificial intelligence. There is a significant ongoing investment in automating manufacturing and packaging processes to enhance productivity, operational cost efficiency, and labeling precision.

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.

The following were identified as the key focus areas to bolster the Indian pharmaceutical and healthcare sectors. Thus, from a practical point of view, Indian pharmaceutical companies should invest more in R&D, attempting to attract talented human capital. Otherwise, they will lose the highly qualified national workforce that will favor MNCs in the field.

I was in the range of 1–3, where 1,2,3 represented three different health care facility levels such as primary (Health Post in urban area /PHC in rural area), secondary (District Hospital/Peripheral Hospital) and tertiary (Medical college & hospital). 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. Similarly, stock-out of medicines was calculated for the reference period of six months.

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