India’s Solution To Drug Costs: Ignore Patents And Control Prices Except For Home Grown Drugs

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.

Availability of essential generic medicines at pmbjp pharmacies/ kendras across mumbai and palghar region

• Because open-heart surgery and the stents needed for angioplasty are not affordable to all, DPCO could offer a potential solution for these and other medical treatments (Wadhera et al., 2017).
• Taking into consideration some of the most authoritative reports and issues in the field at the institutional and corporate levels (e.g. Biospectrum Bureau, Fortis Healthcare, IBEF, McKinsey, etc.), a content analysis was performed to identify the most relevant issues for the sector.
• 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.
• Developing a medicine involves many aspects and is quite costly; hence, reducing their prices and profit margins has generated complex situations for pharmaceutical companies.
• Of this, an estimated savings totaling $80 billion in 2017 can be attributed to the contributions from Indian generic companies.
• 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.
• 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.
• 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.
• The primary task of the Committee is to strike a balance between pricing and availability of essential medicines while offering incentives to the industry to foster growth and exports.

Further, in order to generate demand for unbranded generic medicines, in 2017, the erstwhile Medical Council of India issued a circular to the medical fraternity to comply with its regulation for prescribing medicines by generic names [14]. Besides, since April 2017, bioequivalence studies have become an essential requirement for the manufacture of a generic medicine in India [14]. While the idea of popularising non-branded generic drugs is a robust policy response to improve access and reduce pharmaceutical spending, little is known about how far these initiatives have been effective in making generic drugs accessible at affordable prices. 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.

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• For instance, if availability of 7 (N) antimicrobials medicines in 02 PMBJP pharmacies (P) at PHC level in Palghar was evaluated, then overall 14 units (PXN) would be examined.
• Making the healthcare supply chain resilient will require end-to-end supply chain visibility through digitalisation and use of global standards which facilitate interoperability.
• One reason could be that the country’s pharmaceutical price controls measures generally disincentivise pharma companies from developing novel originator medicines while incentivising the production of generics.
• Thus, there is a continuous boost in the demand for pharmaceutical products and a consequent strain on the supply chain.
• 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.
• To make quality generic medicine affordable, India’s People’s Medicine Scheme (Jan Aushadhi) was launched in 2008 and then revamped and rebranded as Pradhan Mantri Bhartiya Jan Ausadhi Pariyojana (PMBJP) in 2015.

Furthermore, as reported in Table 4, the positive trade balance trend appears to be confirmed for the future, most likely by virtue of renewed attention of the global economies on India’s pharmaceutical industry due to the COVID-19 pandemic. The Indian federal Department of Health Jan. 28 is soliciting price quotes on 504 drugs including painkillers, antibiotics and medicines to treat respiratory, cardiovascular and gastroenterological diseases for a program to improve access to generic drugs. A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by patents. Because the active chemical substance is the same, the medical profile of generics is believed to be equivalent in performance. As per statistics, about 60% of Indians cannot afford to buy their daily medicines because of unnecessary high prices of medicines in the Indian pharmaceutical market.

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“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. Given the interlinkages within various systemic processes, a move towards improving access to essential medicines must be subsumed under overall health systems strengthening across the states. Education curricular changes sensitizing providers on generic medicines, rational prescription, STGs/STPs, and continuum of care can mitigate undesirable practices. In Jordan, for instance, between 2002 and 2006, the less expensive generic alternatives of 79 percent of medicines were delayed by data exclusivity, threatening the financial sustainability of government public health programs. Similarly, Guatemalans found themselves unable to access medicines readily available in most countries at affordable prices, as Guatemala is bound by data exclusivity clauses in its free trade agreement with the United States. This is a statin or blood-thinner used by millions of patients at risk of cardiovascular disease.

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Following this, we picked the essential drugs from the PMBJP product basket, which were found on all the above-mentioned lists. Of the 35 surveyed medicines, 22 were from the first (for global burden of disease) and second (specific to Southeast Asia) core medicine lists recommended by WHO/HAI methodology and 13 were drawn from the NLEM, 2015. Information was obtained on the availability of essential medicines at PMBJP outlets across primary, secondary and tertiary levels of health care delivery system against the basket of 22, 28 and 35 medicines respectively selected according to therapeutic category. Among the medicines included in the survey, 22 are universal medicines, which are supposed to be available at all levels. Apart from the universal medicines, 6 more medicines were considered at the secondary level, while, in addition to the medicines at the primary and secondary levels, 7 other medicines were assessed for availability at the tertiary level. The list of medicines and consumables has been provided as an additional file (Additional file 1).

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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].

• The affordability of pharmaceuticals is a critical challenge in India and South Asia in general, raising questions of life and death.
• 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.
• Further, a robust drug reimbursement policy is equally important to ensure access and affordability for patients, since out-of-pocket expenses contribute to more than 45% of healthcare expenditure in India,[vii] despite the presence of price-control regulation.
• Contrast this with China, which is reportedly using its own vaccine projects as a commercial negotiating tool with countries who stand to benefit.
• 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.

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This sort of rule is favoured by the “innovator” pharma industries that we see in the west, and is opposed by generic pharma industries like India’s. It indicates where Chinese pharma might be headed, and may drive up its production costs for formulations – thus potentially benefiting India. China’s rising share of formulations has been aided by improved standards that appear to be making the world less apprehensive about Chinese medicine quality. Notably, the China Food and Drug Administration issued guidelines in 2013 to make generic medicines bioequivalent to the originals, and in 2016, the government made them mandatory.

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Moreover, the margins that Indian suppliers can earn in the United States are higher than those they can achieve in the more saturated Indian market. There are also ample opportunities presenting themselves across Asia for India’s pharma players, especially as talks of a free-trade agreement (FTA) with the Eurasian Economic Union and Regional Comprehensive Economic Partnership in Asia progress. Although the market continues to diversify with new players springing up from within India as well as internationally, a handful of national players continue to have a sizeable footprint in the domestic and international generics industry. Piramal, Torrent, Cipla, Sun Pharma, Aurobindo, Dr. Reddy’s and Glenmark, to name a few, represent a number of the success stories in India’s pharma industry landscape. With the biopharmaceutical industry rapidly evolving across the globe, inorganic growth has been an important part of company strategy for expanding footprints, retaining market share and moving into new areas of the value chain. For example, Torrent acquired Bio-Pharma Inc. (BPI) in early 2018 – its first acquisition of a manufacturing site outside of India – to diversify and strengthen its product pipeline.

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

In response to this growing regulatory environment, pharmaceutical companies in India continue to strengthen their processes, while improving automation, operating procedures and quality management systems. This includes vigorously efficient quality control and quality assurance systems alongside training programs and workshops, building an omnipresent culture of quality. The result is a focus on quality that starts at a shop-floor level for machine operators, ensuring compliance from the ground up. In the past few years, expectations of regulatory organizations around the world have increased. With the number of companies and manufacturing facilities supplying to the regulated market growing fast, it is natural that the agencies are intensifying their efforts.

HEALTH SYSTEM FACTORS INFLUENCING SUPPLY CHAIN OF MEDICINES

It is administered orally and requires careful dosing and monitoring by healthcare professionals to manage side effects and ensure the best therapeutic outcomes. Ms. Chawla has authorised and contributed to various academic articles and journals on topics relating to cyber laws and copyright laws. She has represented the firm at national and international conferences and conclaves in India and Dubai. Further, she has also conducted workshops on IP law for university students and has been invited as a judge for several prestigious moot court and negotiation competitions at the university level.

• Improved medical facilities, modernization of hospitals and lower and affordable treatment costs for most developed and developing countries’ nationals are all reasons for this boom (Fortis Healthcare, 2019).
• 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).
• The remaining 5% are either reimbursed, insured, or participate in a very generous co-pay program.
• Moreover, the margins that Indian suppliers can earn in the United States are higher than those they can achieve in the more saturated Indian market.
• To exploit that “patent cliff,” governments and insurers in Canada have pushed for lower and lower prices on the copies, and often mandate that patients’ prescriptions be filled with generics.
• Physicians working in public or private sector and practicing in the periphery of PMBJP pharmacies were selected for the study.
• Further, individual tablets were weighed, triturated followed by weigh equivalent to 2.0 mg of AMLO besylate was taken and diluted to 20 mL with selected diluent.

A “pair” of product from the same company was chosen to appreciate the price structure and mark-ups for the two versions. This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. In the first LDA multivariate model development approach, the AMLO FPPs were classified for AMLO quality parameters and other independent variables. The chromatographic calculations were done as per the method stated in the material and method section.

Therefore, it will be crucial to see the direction in which the pharmaceutical pricing policy of India is moving. Fluctuations in input costs (raw materials, manufacturing equipment, etc.) and inflationary pressures, which are unpredictable and beyond the purview of control of pharmaceutical companies, also pose a hurdle to the determination of price fixation of non-essential medicines. As a result, manufacturers often find it difficult to recuperate costs of research and development and costs of innovation. Drug pricing and reimbursement within India are shaped by a complex interplay of regulatory, economic and policy factors. The aim is to adopt a balanced approach that considers the needs of the patients, while simultaneously ensuring the creation of a sustainable healthcare system and incentivisation for pharmaceutical companies to innovate and create value. In this endeavour, the Government continuously evaluates and reforms existing policies relating to pharmaceutical pricing and reimbursement.

Interview guides were used to conduct in-depth interviews of physicians and pharmacists. We conducted a total of 16 in-depth interviews (IDIs) – 10 with pharmacists and 6 with physicians. Physicians working in public or private sector and practicing in the periphery of PMBJP pharmacies were selected for the study. Only qualified allopathic doctors and the pharmacists registered under the state or central pharmacy council were considered for IDIs. Both quantitative and qualitative data were collected concurrently between January, 2019 and June, 2019. But that is only the latest fallout from this country’s growing dependence on medicines made in India, as foreign regulators monitoring the booming South Asian industry uncover questionable manufacturing standards, manipulated records and even defective drugs.

Thus, manufacturers have the freedom to set prices for their own drugs on the basis of various market forces, unless corrective measures are warranted. Moreover, patented drugs are not immediately subject to price control and entitled to a five-year exemption from the date of marketing.[vi]  Only essential and life-saving medicines, i.e. ‘controlled/scheduled drugs’ are subjected to price regulation by the NPPA as per the provisions of the DPCO. The NPPA is responsible to fix, revise and monitor the pricing of such ‘controlled drugs’, which are listed by the Government in the dynamic National List of Essential Medicines (NLEM). The list is revised from time to time and some examples of essential medicines included in the NLEM are paracetamol, insulin, antibiotics, etc.

Drug reimbursement policy has a substantial impact on the pharmaceutical industry, since it affects the incentives and outcomes of pharmaceutical research and development. Further, a robust drug reimbursement policy is equally important to ensure access and affordability for patients, since out-of-pocket expenses contribute to more than 45% of healthcare expenditure in India,[vii] despite the presence of price-control regulation. Although India’s case is lot more complex than most countries given the dominating presence of ‘branded’ generics in the Indian pharmaceutical market, it is worth learning from countries which achieved reasonable success in promoting the utilisation of generics. USA, the first country to implement a generic drug implementation policy, achieved 89% share of generic drugs in 2016 and this reduced the medical insurance expenditure by US$ 67.7 billion [37]. Japan, Canada, Australia, European countries as well as LMICs such as Philippines had similar experience regarding generic drug use [38, 39]. All these countries have either made it compulsory to prescribe drugs with active substance names or passed laws for mandatory generic substitution.

• Recordings were translated from the local languages such as Marathi and Hindi in English, and then transcribed verbatim.
• The Indian government believes that the prices of lifesaving drugs shouldn’t be set by market forces.
• While India’s pharma exports grew by 11% in FY 2019 and appear to be promising, the industry is increasingly facing problems across its export markets.
• Faster decision making and reduced risk so you can deliver life-changing therapies faster.
• Manufacturers and pharmaceutical companies may revise the prices of the product following the routine annual change in the Wholesale Price Index (WPI) of the preceding calendar year.
• Earlier, it was known as the Department of Indian System of Medicine and Homeopathy (ISM&H), founded in 1995.
• 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.

As a result of Covid-related factory shutdowns in Shanghai, China in early 2022, GE Healthcare was unable to produce enough contrast dye to supply the American market. According to a CNN report, about half the hospitals in the U.S. rely on GE Healthcare for the contrast dye. Vital scans were postponed or denied to patients at many hospitals as doctors and radiologists scrambled to find dye, used only in the most critical cases. “In the case of generic medicines used in hospitals, it is important to distinguish between the actual price paid by trusts and the much higher list prices often quoted,” he concludes.

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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.

• 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.
• Besides affordability, we did cost comparison of unbranded and branded generic equivalents of some commonly used medicines.
• We will not dispense any prescription medicine without a valid prescription from a licensed/certified doctor physician.
• Starting in 2014 in India, a Ministry of AYUSH was established, indicating the extraordinary relevance in the country of these specific items.
• Since reimbursement schemes do not have uniform formulary inclusions, patients do not have clear guidance on which drugs are covered under the scheme, leading to unanticipated out-of-pocket expenses.

According to Qyobo’s data, atorvastatin is available from nine different drugmakers, including companies based in Germany, Bangladesh and Turkey. But all of those drugmakers depend on an Indian company, Ind-Swift Laboratories Ltd, for the active pharmaceutical ingredients (APIs) to make atorvastatin. And Ind-Swift depends on five companies, all of them Chinese, for the key starting materials (KSMs) to make the APIs. Unknown to American doctors or patients, the entire supply chain for this drug depends on China. The intense pressure to lower prices of generic pharmaceuticals has led to a different global structure. Generic production has moved increasingly to India and China as the lowest-cost manufacturing centers in the world.

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.

The prepared sample was filtered using a 0.45 μm membrane filter and injected into a chromatograph in duplicate. The chromatographic achievements and relationship models were developed using a licensed version of SPSS 28.0 (SPSS Inc., Chicago, IL, USA). Sequentially, the assay result biasness was ± 5%, and the quantitative value of genotoxic impurities equal to or more than threshold of toxicological concern limit was counted as acceptable quality attributes for AMLO besylate-containing FPPs. The European Parliament has similarly recognized the importance of medicines as global public goods, and it has repeatedly called on the Commission to exclude TRIPS-plus requirements in trade negotiations — much like in its 2021 resolution to ensure all HIV antiretroviral treatments are affordable.

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. This is prescription medicine and if you want to buy this medication legally from Delightaid Health, we require a valid prescription from you. Please read the disclaimer and prescription-related full details at the bottom of this everolimus price in usa website. The physicians, especially those from the rural Palghar district wondered why the generic drug stores are not opened in rural areas where it is needed more. 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.

Manufacturers and pharmaceutical companies may revise the prices of the product following the routine annual change in the Wholesale Price Index (WPI) of the preceding calendar year. This policy is not applicable to patented drugs or fixed-dose combination (FDC) drugs. However, this year’s price increase is so marginal as to be almost equivalent to zero, especially compared to the significantly higher price increases observed in the last three years. In 2021, the NPPA approved a 10.7% increase to the MRP of drugs enlisted in the NLEM and a 12.1% increase in 2023. Therefore, the insignificant price increase for the new fiscal year (FY 2024–2025) will come as a huge blow to pharmaceutical developers as they grapple with the global tightening of price control mechanisms alongside the rising costs of raw materials, shipping, and production.