India’s healthcare market is dynamic and rapidly expanding, driven by economic growth, demographic changes and government initiatives. While significant challenges remain, particularly in terms of infrastructure and workforce distribution, the opportunities for growth and improvement are substantial. The datasets, including the qualitative dataset concern the implementation of a government scheme related with specific places and actors, making anonymising and removing any potentially sensitive observations, especially from interview transcripts difficult. Some physicians reported that they face difficulties in prescribing generics as patients have negative attitudes towards cheaper medicines.

A Cost Analysis of the Jan Aushadhi Scheme in India

However, the LDA had revealed the most acceptable quality attributes for the price range of 1–2 rupees and alike higher money value medicine, i.e., 2–3 rupees. The Commission is right to do this for its citizens’ health, and the lesson applies to other parts of the world too. However, in trade agreements, the bloc has continued to pressure developing countries to include disproportionate intellectual property protections that go far beyond the TRIPS agreement. Table 1 shows America’s top ten sources of pharmaceutical products last year by weight. China led the rankings, with 217.2 million kilograms (kg) or 477.8 million lbs of pharmaceutical imports. The IQVIA Human Data Science Cloud is our unique capability designed to enable healthcare-grade analytics, tools, and data management solutions to deliver fit-for-purpose global data at scale.

Selection of medicines for the survey

In India, many pharmaceutical companies manufacture two types of products for the same molecule, i.e. the branded product which they advertise and push through doctors and branded-generic which they expect retailers to push in the market. The so-called branded medicines in India are manufactured and promoted by multinationals or by reputed Indian manufacturers. Branded-generics, sunitinib price in malaysia on the other hand, are not promoted or advertized by the manufacturer. Patients’ and doctors’ perception for all branded-generics irrespective of company is the same. The Common Review Missions serve as a platform to not only highlight various state level experiences but also signal the way forward to overcome systemic challenges in access to essential medicines.

• For the industry to retain its position as the largest generic drug supplier, it must continue improving regulatory compliance of manufacturing sites, as well as developing cost-effective and high-quality manufacturing processes.
• In India, the IPR regime is important at all levels – statutory, administrative, and judicial.
• The following investigation provides general elements for the examination of the current and expected scenarios of the Indian pharmaceutical sector to respond to RQ1 and RQ2.
• The informed written consent of study participants’ including the pharmacists of surveyed PMBJP outlets was obtained prior to conducting interviews and reviewing stock records.
• The study protocol was approved by the School of Health Systems Studies, Tata Institute of Social Sciences, Mumbai.
• While significant challenges remain, particularly in terms of infrastructure and workforce distribution, the opportunities for growth and improvement are substantial.
• This has been underpinned by several changing global market dynamics as well as pressures faced at home in the domestic arena.
• Likewise, cost-effective, affordable, and quality services are linked to mechanisms promoting rational and scientific prescription practices of authorized providers.
• Cost is the primary reason, with 91% citing it as the driving factor, followed by availability (34%).
• As a sign of the shift, Canadian generic giant Apotex Inc. locates about 10% of its production at two Indian factories.

1 The scenario of the Indian pharmaceutical industry: descriptive and inferential analysis

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.

Limitations of this study

There are a large number of drugs that went off patents, providing many pharmaceutical companies with huge opportunities to enter the market. The increased inclination toward the health insurance sector and the growth of per capita income have expanded the purchasing capacity of patients/consumers, providing a long-term perspective for the development of the pharmaceutical sector. Hence, India can become a global outsourcing hub for pharmaceutical products due to its low-cost production ability combined with FDA-approved manufacturing plants (Vaidya et al., 2018). While drug pricing control on essential medicines is critical to ensure affordability and access to pharmaceutical products, it may have an adverse effect on value creation and innovation in pharmaceutical products. Therefore, another key policy aspect which ought to operate in tandem with drug pricing is drug reimbursement, i.e. rules and processes that determine the amount and conditions under which healthcare payers will pay for pharmaceutical products.

Beginning of Generics

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.

India Solicits Price QuotesFor More Than 500 Generic Drugs

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.

• 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.
• Price-to-patient, retailer mark-up and qualitative analysis of branded and branded-generic medicines.
• This would not only contribute to increased demand generation but also mitigate the burden of accessing quality medicines and consequent financial hardship.
• Nevertheless, the study findings show that PMBJP’s unbranded generics offer great opportunities for substantial cost savings.
• At the same time, pharma imports from China and India increased their share of total pharma imports, reaching 58% by weight.
• It also does not have national standards for drug production, instead leaving pharmaceutical regulation to its 38 states.
• Inspired by “vertebrae,” our name embodies our mission to be the backbone of healthcare success.

Company

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.

Browse the Drugs alphabetically

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.

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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.

CONVERGENCE OF NATIONAL HEALTH PROGRAMMES

As hospitals and insurers seek to drive down the price of generic drugs, the process has pushed generic manufacturing into the hands of fewer and fewer companies, with an ever-larger percentage of them in India and China. The offshoring of production to China and India has put the U.S. in a dangerous position, dependent on unreliable suppliers. Chinese and Indian manufacturers have demonstrated a pattern of repeatedly violating FDA regulations. FDA inspections are ineffective at controlling quality standards at Chinese and Indian facilities.

Quality Issues

On the other hand, Palghar is an economically backward district with a population of nearly 3 million and is primarily inhabited by the tribal people. Others are not so sure anything has happened to dramatically curb manufacturing shortcomings, and argue that far from being too strict, the FDA ensures only the minimum standards are maintained. India’s Ministry of Health and Family Welfare did not respond to a request for comment. The chief drug regulator, however, has said he plans to add hundreds more staff and promised more oversight of the manufacturing process, while signing a co-operation agreement with the FDA last year. Three years ago, an Indian parliamentary committee looking at the drug-approval process concluded regulators were often in bed with the companies they governed, putting consumers’ interests last.

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

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

• So, what needs to be done beyond the practical steps being taken by Indian generic manufacturers to embrace a culture of quality?
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• 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.
• 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.
• Second, the level of economic development varies considerably across states and between rural and urban areas in India and this needs to be taken into account while extrapolating results of this study to other states and national level.
• Thus, from a practical point of view, Indian pharmaceutical companies are somehow forced to continue to leverage their expertise in generic drugs, considering the positive financial impact of these productions.

The cost of generic medicines of PMBJP outlets for treating various conditions range from 0.01 days’ wages to 0.47 days’ wages for the lowest paid unskilled worker in Maharashtra. One inherent limitation of this study is that we have tested pair of branded and branded-generic medicines that were manufactured by the same “reputed” company. Though it is expected that both the versions should have the same quality but perception for any branded-generic is same among doctors and patients. So to start with, we have taken both branded and branded-generic products of the same company and studied not only the quality but also the price structure.

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.

In fact, we did carry out prescription audit as part of the overall study, but its findings are not included here. The present study adopted descriptive cross sectional research design to assess the current situation of PMBJP scheme in two districts of Maharashtra. 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. Hence, N X P gave the total number of drugs in that therapeutic category which were surveyed at all PMBJP pharmacies at PHC level in Palghar. 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.

• Counterfeit medications not only pose a significant threat to public health but also erode consumer trust in the pharmaceutical industry.
• While the procurement mechanisms are usually centralized, logistics and distribution are widely channelized through regional and/ or district- level distribution centers like warehouses, central medical store depots or district medicine stores.
• 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.
• While it is essential to prioritize streamlining procurement mechanisms, it is equally important that such provisions effectively translate to better access and availability of medicines across all levels of care.
• In real sense, Indian market does not have branded medicines (a name commonly given to an innovator product) because till January 2005 product patent was not applicable in India.
• Retailer is earning INR 22.76 for 10 tablets of branded-generic cetirizine versus Rs 8.16 for the branded version from the same company.
• The Common Review Missions serve as a platform to not only highlight various state level experiences but also signal the way forward to overcome systemic challenges in access to essential medicines.
• If hostilities between the U.S. and China rose or if we entered a genuine military confrontation over Taiwan or another global hotspot, we would be at grave risk of seeing vital pharmaceutical supplies reduced or cut off entirely.

In other words, drugs that can extend lives by stopping deadly diseases like cancer or AIDS, provide relief from excruciating pain caused by preventable and curable diseases are not available and accessible to more than a quarter of the world population. In India, despite the presence of a thriving generic pharmaceutical industry, a principal barrier to access continues to be the cost of medicines. (2004), 65% Indians or nearly 650 million lacked access to essential medicines and medicine constitutes 63% of household’s total out-of-pocket (OOP) health payments, thereby impoverishing millions of people every year [2, 3]. 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. It also highlights areas of concern around lack of diversification in the manufacturing of Key Starting Materials and Active Pharmaceutical Ingredients in the broader supply chain for affordable drugs and discusses the role India could play as a partner to the U.S. in de-risking this supply chain.

The bottom line is that India’s manufacturers are seeing slimmer margins and losing their global cost-competitiveness. Further to that, the challenges faced by Indian pharma companies in the United States are growing in other aspects as well. The United States recently ended India’s Generalized System of Preferences Status (GSP) – a tariff reduction on imports – after President Trump determined that India did not adequately meet his trade demands.

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. Earlier these medical stores were earning 5-10% profit margins but now they can earn 40% profit margins from Generic Aadhaar’ Franchise Outlets. What’s more, Indian manufacturers are being audited by inspectors from every market they export to — UK, Germany, South Korea, Japan, Brazil, to name a few — who regularly visit and evaluate Indian pharmaceutical factories.

A second policy challenge that affects pricing and reimbursement is lack of patient affordability for drugs that are not subject to the DPCO price control, particularly in the case of non-essential or newer drugs which do not form a part of the formularies. 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. Moreover, complex reimbursement procedures, including documentation requirements and approval processes, can delay or deter patients from accessing timely reimbursements. 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. The inclusion of FDCs of antimicrobials, FDCs for CVDs and other diseases pose a public health concern. 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].

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.

For method development, method validation, and degradation sample analysis, an Agilent high-performance liquid chromatography Infinity 1260-II (Agilent Technologies company, Santa Clara, CA, USA) equipped with a quaternary pump, an online degasser, and a multiple wavelength or diode array ultraviolet detector was used. For data acquisition and processing, the OpenLabTM CDS software (version 2.6) (Agilent Technologies, Palo Alto, CA, USA) was used. Indian drugmaker Intas was making cancer drugs for the United States at the plant where, in a trash bin, inspectors found documents doused in acetic acid.

In most of the states, free medicines were restricted to targeted beneficiaries like BPL families, beneficiaries of JSSK, Janani Suraksha Yojana (JSY), and enrollees of state-specific insurance schemes. Even among the beneficiaries, the range of medicines given free of cost was not as per the EML nor based on epidemiological load. In Colombia, data exclusivity increased the public health system’s costs by $396 million between 2003 and 2011. Meanwhile, in 2006, the Korean National Health Insurance Corporation calculated that a four-year patent term extension would cost 722.5 billion won — the equivalent of $757 million at the time. This issue came to a head during the COVID-19 pandemic when, after relentless pharmaceutical industry lobbying, the EU and other wealthy countries blocked India and South Africa’s proposal to temporarily waive some TRIPS obligations for COVID-19 medical products. It was the influx of affordable generics from India that helped drive down the price of treatment from over $10,000 to under $100 per year, saving countless lives.

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.

Table 3 shows the extent of availability of medicine at PMBJP pharmacies across all levels of care in Mumbai and Palghar. Overall, the mean availability of medicines across study districts was found to be 52%, though the mean availability of medicine was slightly higher in Palghar (54%) than in Mumbai (51%). The findings suggest that availability of medicines vary significantly, ranging from 8 to 72% in Palghar and from 0 to 83% in Mumbai.