In the present scenario, the changes in the patent regime may benefit MNCs, while domestic companies may face more challenges. Similarly, the threats possibly deriving from other low-cost countries – China above all – are real. The negotiations with MNCs, international rules and domestic regulations are imbalanced, while there are increasingly stringent regulations and nontariff barriers to generic drugs in developed countries (Dhar and Joseph, 2019). After the 1990s, India emerged ibrutinib cost uk as an information technology and information technology-enabled services hub for the world due to trained manpower, a very high number of computer engineers, and a cheaper workforce that could speak foreign languages, mostly English. Similarly, pharmaceutical research and development can be carried out in India by global pharmaceutical MNCs. India has many pharmaceutical, bioscience and chemistry colleges that churn out huge amounts of high-quality graduates every year.
Quality Issues
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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Doctors regularly write angry letters to newspapers complaining that they cannot find the drugs their patients need. The heart of the problem is that we have driven prices too low, moved supply of generic medicines to a small number of the cheapest-of-the-cheap offshore suppliers, and sacrificed resiliency, manufacturing quality, and backup supply to chase the false god of low prices. Often hailed as the ‘pharmacy of the world,’ the Indian pharmaceutical industry is booming. It jumped from $40 billion in 2021 to an expected $130 billion in 2030, with projections hitting $450 billion by 2047. Beyond just keeping up with the demand at home, the Indian pharma industry commands over 20% of the global pharma supply chain and addresses approximately 60% of the worldwide demand for vaccines.
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While in a few, they are observed to be efficient (e.g., Tamil Nadu, Kerala, Rajasthan, Andhra Pradesh), challenges reported in many states are largely due to implementation gaps confounded by other systemic challenges. We have sought to establish an ML link between the price and sample age of AMLO besylate containing FPPs and acceptable quality attributes of the same. The analysis of nine top-selling AMLO besylate-containing marketed FPPs was exercised using a validated analytical method.
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Regulatory authorities need to provide more emphasis on quality control of generic medicines.” (P4). “We are ready to prescribe generic only, but there is no mechanism to ensure that private pharmacy shop chemists would dispense right and cost-effective generic medicines. Because there are hundreds of generics with different prices are available in the market, chemists can substitute for prescribed medicine as per their wish and earn high profit margins. Clinicians working in the public sector said that they prescribe 99% medicines in generic form as the government supplies only generic medicines to public health facilities.
What is the process of securing reimbursement for a pharmaceutical product?
An in-depth exploration of the global healthcare ecosystem with timely research, insightful analysis, and scientific expertise. Nevertheless, India has a massive population with low per capita income, and stricter patent rules would probably mean less access to medicine for a significant part of the population. The affordability of pharmaceuticals is a critical challenge in India and South Asia in general, raising questions of life and death. DPCO is a blessing for those who use medicine and has boosted their hopes of the availability of cheaper and better medicines, leading to a great psychological impact on consumers (Venkiteswaran, 2013). For example, heart attacks and cardiac arrests are increasing in India, and treatments for these newly emerging diseases are very expensive.
- This accountability occurs even in incidences where the FDA has come down hard on companies for even the smallest of deviations.
- Please be sure to read the privacy policy and terms of use of the websites that you visit.
- Our increased reliance on very few suppliers who ultimately depend on ingredients from China for many life-critical products is a huge risk to the health and safety of the American people.
- The cardiovascular disease (CVD) treatment market is one of the leading pharmaceutical markets in India, as the country accounts for one-fifth of all cardiovascular-related deaths worldwide.
- (2016), “R&D, technology transfer and productivity in the Indian pharmaceutical industry”, International Journal of Innovation Management, Vol.
- Around 50% of antimicrobials, antidiabetics, antiepileptics and consumables were out of stock for the period of 3–6 months.
- In fact, Indian pharmaceutical companies are now also becoming a key source of medicine for the rest of the developing world.
- Furthermore, efforts by Governments to promote the development of their own national pharmaceutical industries in key markets across Latin America, Sub-Saharan Africa and Southeast Asia have made the playing field more challenging as exporters encounter increasingly rigid regulatory policies.
Pricing & Reimbursement Laws and Regulations 2024 – 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].
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- 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.
- Similarly, pharmaceutical research and development can be carried out in India by global pharmaceutical MNCs.
- The NPPA’s revised ceiling prices are calculated based on the average retail price of the named formulation(s) having a market share of 1% or more and being in accordance with the Drug Price Control Orders (DPCO) 2013.
- An overall health system strengthening is the way forward to expedite the realization of universal access to free essential medicines at public health facilities.
- The industry operates within a complex regulatory landscape characterized by stringent quality standards and evolving regulations.
- These concerns raise fears among patients that taking drugs made in India may result in unpredictable effects.
- This has resulted in growing its access, particularly in regions where treatment costs are a huge barrier to healthcare.
- Therefore, a better distribution of medicine in the middle-income groups, who need medicines for several treatments, has been observed.
In a country notorious for unsafe drinking water, they found Dr. Reddy’s has no way to ensure the water used to make the ingredients forming part of medications taken by Canadians is free of biological contamination. Delightaid health will not responsible for any consequences, effects or harm caused due to avoiding professional medical advice from certified doctors. Before sending the shipment, the prescription will be fully checked by our qualified Pharmacist.
Drug Price List: Generics and Matching Brands
The mean drug availability at PMBJP stores located in the vicinity of PHCs and district/rural hospitals was 51% and 61% respectively. 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%). Aside from collecting primary data, secondary data such as the price information of some PMBJP medicines and their leading brand name counterparts (in terms of market share) were gathered from the web portals of PMBJP and MedGuideIndia.com respectively. The website provides information on a wide range of drugs available in the Indian pharmaceutical market including their prices.
- For more detailed information, refer to the prescribing information and consult a healthcare professional.
- 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.
- 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.
- 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).
- However, several issues cannot be highlighted by the positive numbers so far analyzed, representing weaknesses and threats for the industry that have emerged from a qualitative analysis that has been deployed to provide the basis for a subsequent narrative SWOT analysis.
- 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.
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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.
How To Get Generic Drugs and Low-Cost Prescriptions
Among the antidiabetics, cardiovascular and consumables not available on the survey day, 44% and 33% respectively were out of stock for the period of 3–6 months. Nearly 30% of palliative care medicines and vitamins, about 17% of antiasthmatics and consumables were out of stock for a period of 1–3 months. The pharmaceutical industry was once concentrated in Europe and North America, but has spread increasingly into the developing world, where low costs cater to a growing Western pressure. No wonder Palbociclib suppliers in India are looked upon as major game changers for Breast Cancer treatment. As Sun Pharmaceutical has introduced cheap medicines in India, addressing breast cancer has become accessible and affordable.
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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.
The industry benefits from cost competitiveness, driven by factors such as lower labor costs, economies of scale, and efficient manufacturing processes. This cost advantage enables Indian pharmaceutical firms to provide competitively priced products both domestically and globally. The extensive scale and diversity of the Indian pharma industry offer resilience and adaptability to the demands of supply chain, enabling it to cater to diverse needs and maneuver through market fluctuations effectively. Such a widespread presence on the global stage underscores the importance of robust supply chain networks capable of meeting stringent regulatory mandates, ensuring high-quality standards, and overcoming logistical hurdles. According to DPCO, the trade margins in the pharmaceutical supply chain should be reduced to allow better penetration of medicines under DPCO and allow a larger population to obtain access. The first-line sellers will receive different percentages of margins to apply, including distributors, wholesalers, retailers (chemists) and hospitals.
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Typically, a claim for reimbursement of a new pharmaceutical product requires a valid prescription from a registered medical practitioner. Further, it is required to be covered under the reimbursement schemes, which are listed in formularies approved by the respective authorities. The beneficiary or healthcare provider is required to submit its claim to the respective authority, along with the prescriptions and relevant documents pertaining to the insurance or health scheme authorities. Thereafter, such claims are processed, and reimbursement is provided based on the scheme’s guidelines and approval procedures.
- The pharmaceutical business function of R&D has been significantly affected by the DPCO.
- Drug reimbursement policy has a substantial impact on the pharmaceutical industry, since it affects the incentives and outcomes of pharmaceutical research and development.
- Among the medicines included in the survey, 22 are universal medicines, which are supposed to be available at all levels.
- This is the first limitation of the research, thus, further investigations expanding the range of the data under examination would improve the reliability of the results.
- Branded medications typically command higher prices due to factors such as high R&D costs, patent protection, post-marketing surveillance, and marketing expenses, which generally grant them monopolistic control over the market.
- According to an article in medical journal International Health, its production is entirely dependent on three Chinese API manufacturers.
- At the time, this unprecedented pricing was a breakthrough toward ensuring the worldwide availability of high-quality treatment for HIV.
- Adequate infrastructure is one of the prerequisites for efficient storage and distribution of medicines.
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.
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The USA represents a large pharmaceutical demand as companies obtain substantially higher prices for medicines sold in that market. FDA approvals are considered benchmarks across many countries; therefore, these authorizations are very important for Indian pharmaceutical industries for the access, export, presence and profit they represent at the global level. Although Indian companies have received the highest number of FDA approvals in the last decade and in 2019–2020 particularly, there is an ongoing need to obtain these authorizations. The FDA regulations are stringent and time-consuming, making it difficult for midsized Indian companies to access the North American market and other similarly developed markets.
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However, as the European Union now negotiates free trade agreements with India and Indonesia — another major generics-producing nation — the bloc’s been proposing far stricter protection of intellectual property rights. And such protection could threaten the affordability of generic medicines these countries export to the Global South. Increased offshoring of drug manufacturing has made imports a growing share of the U.S. pharmaceutical industry. In the five years from 2017 to 2022, imports rose to $197.9 billion, worth almost one third (32.8%) of the cash spent by American patients, insurers, hospitals, and the government on pharmaceuticals (Figure 1). On current trends, the value of imports and their share in the total pharmaceutical spend is likely to continue to rise.
However, it must be noted that Novartis provides Glivec free of charge to 16,000 patients in India, roughly 95% of those who need it via the Novartis “Glivec International Patient Assistance Program”. The remaining 5% are either reimbursed, insured, or participate in a very generous co-pay program. Thus, not granting a patent for Glivec really hasn’t prevented patients from getting this life-saving medication. Dr. Reddy’s Laboratories, a well-known global pharmaceutical company, manufactures Cabzored as part of its oncology treatments. (launching link) It is designed to offer a cost-effective and accessible treatment option for patients with specific types of cancer. In fact, the physicians have also cited other reasons for not prescribing generic medicines.
Regulations to support mandatory generic prescribing and generic substitution by pharmacists are needed. The cardiovascular disease (CVD) treatment market is one of the leading pharmaceutical markets in India, as the country accounts for one-fifth of all cardiovascular-related deaths worldwide. According to national statistics, India’s cardiovascular market was worth $2.52bn in 2022 and is forecast to reach $4.26bn by 2030. Consequentially, there is a strong emphasis on generic CVD drugs over branded drugs due to their affordability.
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].
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.
Given the role of various interlinking factors, states need to establish robust procurement systems, strengthen the existing infrastructure, ensure adequate HRH backed with robust HRH policy, expand the range of services, and strengthen CPHC for supporting holistic efforts. An overall health system strengthening is the way forward to expedite the realization of universal access to free essential medicines at public health facilities. As previously mentioned, the AYUSH Ministry was formed in 2014 for the development and spread of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy treatments. Earlier, it was known as the Department of Indian System of Medicine and Homeopathy (ISM&H), founded in 1995.