The sale of PMBJP medicines is mainly dependent on the prescription of generic drugs by the physicians. But doctors from private health care facilities hardly mention the generic or chemical names of drugs on the prescription slips and only 60 percent of the prescriptions from public health facilities contain generic names [27]. We found that, in spite of the awareness campaign by the PMBJP, physicians, especially those having private practice remained apprehensive regarding the therapeutic efficacy and the quality of unbranded generic medicines. In low-income and middle-income countries (LMICs) such as India, patients and healthcare providers (both public and private) often struggle with high and increasing pharmaceutical prices due to low and weak health insurance coverage, which restricts patient access.

• Additionally, 60% said they would prefer to buy brand-name medications but opt for generics because of the lower price.
• 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.
• Even among the beneficiaries, the range of medicines given free of cost was not as per the EML nor based on epidemiological load.
• The study also found that “best-in-class pharma companies globally have an inventory period of 64 days as compared to Indian counterparts that have 98 days.
• The firm regularly attends hearings before forums such as the Ministry of Chemicals & Fertilisers and the Department of Pharmaceutics on behalf of its clients, providing strategic legal support in these highly regulated environments.
• According to Qyobo’s data, atorvastatin is available from nine different drugmakers, including companies based in Germany, Bangladesh and Turkey.

3 Human capital in the patent-based regime

Many of the Global Fund’s major pharmaceutical suppliers are based in India and are also critical partners in efforts to scale up regional manufacturing sustainably, particularly in Africa. This improved pricing – a 25% reduction – will allow governments in resource-limited settings to expand access to critical HIV services. Data from the American Society of Health System Pharmacists pazopanib price in mexico (ASHP) shows that the number of drugs in shortage reached 301 at the end of 2023, one of the highest figures since data began. The FDA produces smaller figures because they count only shortages at the national level. The ASHP considers regional and local shortages too, a measure that doctors and health economists consider more relevant to the quality of care provided to patients.

• 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).
• According to a study, the availability of medicines in JAS was abysmally low (33%) [13, 14].
• 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.
• 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.
• Moreover, complex reimbursement procedures, including documentation requirements and approval processes, can delay or deter patients from accessing timely reimbursements.
• Efficient SCM practices are important to ensure the timely distribution of the right products in the right quantity at the right place.

Limitations of this study

In a nutshell, with Paleno making its way into Indian medicine markets, the availability of Palbociclib is manifolded. With these generic drug versions by Indian brands, Breast Cancer patients with HR +ve, HER –ve have hope as they have better access to affordable treatment opportunities. The Indian medicine market has recently witnessed the launch of Palbociclib’s generic version – Paleno.

Services

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.

• 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.
• The principal aim of this study is to conduct an explorative investigation of the current and future situation of the Indian pharmaceutical industry, with the development of a narrative SWOT analysis to generate an overall scenario analysis.
• To maximize the outcome of this progress, the Global Fund, together with PEPFAR and the National Department of Health, Republic of South Africa, will host the annual ARV Buyer Seller Summit in Maputo, Mozambique, starting on 30 October.
• A “pair” of product from the same company was chosen to appreciate the price structure and mark-ups for the two versions.
• 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.
• But branding and marketing cost makes the medicines expensive which leads customers to buy medicines at a higher price.

EVALUATION OF PRICE DISPARITY AMONG GENERIC MEDICINES IN INDIA

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.

The rise and rise of the pharmaceutical supply chain in India

• Authors would like to thank the pharmacists, PMBJP pharmacy owners and physicians who participated in the study.
• Ensuring compliance with diverse regulatory requirements across different markets poses a considerable challenge for Indian pharmaceutical companies as it would for any company operating globally and subject to multiple jurisdictions.
• Earlier these medical stores were earning 5-10% profit margins but now they can earn 40% profit margins from Generic Aadhaar’ Franchise Outlets.
• 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.
• But India’s thriving generics industry could only do this because these medicines were developed before it had to implement the 1995 World Trade Organization (WTO) agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
• This uncertainty in the regulatory framework affects the ease of doing business for pharmaceutical companies, which has a detrimental impact on innovation and value creation.
• While margins may be reducing due to the extra costs and regulatory fees, on average, Indian drugs cost 33% less in comparison to their U.S. counterparts, bringing much needed relief to the notoriously high healthcare prices in the United States and elsewhere.
• Most of the blockbuster drugs that fuelled Big-Pharma profits over the last two decades went off patent in the last few years, opening the market to generic copies.

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 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.

Life Effects Stories from Patients and Caregivers

On top of all these problems is the large and growing national security risk as more and more drugs become dependent on suppliers from China. Even the common knowledge that we are becoming dependent on a small number of large drug companies for generic drugs understates the dependency on China. Qyobo is a software startup that collects pharmaceutical data from dozens of national and international databases to provide a picture of the drug supply chain that is not only superior to what the patient or the doctor sees, it is probably superior to the knowledge of the FDA.

1 Growth of the sector

Our all-in-one EHR and billing platform delivers everything you need to attract and engage your patients, including online scheduling, reputation management, and digital communications. On average, generic medications cost approximately 79% less than their brand-name counterparts, offering substantial savings for consumers. For more commonly used medications, such as allergy relief, patients can save up to 83% per prescription by choosing the generic alternative. These savings are a driving factor for many, particularly as medication prices continue to rise in the US. State experiences highlight the importance of an established IT- enabled supply chain management system. The designed digital architecture of SCM should not only facilitate maximum utility but also prioritize interoperability, real- time data management, and monitoring through a centralized dashboard in each state.

Selection of medicines for the survey

The International Criminal Court has become part of a global justice system feared by those who commit crimes against humanity. Food and Drug Administration were far from home, investigating a pharmaceutical factory in western India. To maximize the outcome of this progress, the Global Fund, together with PEPFAR and the National Department of Health, Republic of South Africa, will host the annual ARV Buyer Seller Summit in Maputo, Mozambique, starting on 30 October. The event is a large forum to facilitate exchanges between partners across the antiretroviral supply ecosystem.

Availability of data and materials

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.

Again, this involves a minimum of one billion doses for India and other low to middle income countries. This is the lowest quoted price in the world for a COVID vaccine, and will see them distributed in low and middle-income countries. By comparison, German biotech firm BioNTech’s deal with US involves a price of US$19.50 per dose, while the Moderna/US deal is set at between US$32 and US$37 per dose. You can share this content on Americans’ preferences for generic versus brand-name medications for noncommercial purposes as long as you provide a link to this source page. Exploring cost savings, perceived effectiveness, and the role of medication type in American buying habits. Generic medications go through testing for quality, strength, purity, and potency to show effectiveness before being approved by the FDA.

This would not only contribute to increased demand generation but also mitigate the burden of accessing quality medicines and consequent financial hardship. 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. Under the NCD control programme, medicines were first made available free of cost in the states like Kerala and Tamil Nadu. 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.

Yet he and other experts agree one of the key problems with the Indian industry is a regulatory system that is not up to the job. That refers to testing done for the presence of active ingredients or unwanted impurities, both of which can have a direct impact on whether a drug does what it is supposed to do, experts say. Sloppy practices and even outright fraud at some – though not all — Indian facilities have been repeatedly documented. A National Post investigation found quality issues are directly affecting Canada in several ways. Reddy’s Laboratories is accused of ignoring tests showing unknown impurities in some of its drugs.

There is a robust low-cost manufacturing setup available in India, where the industry can produce drugs at a cost that is 40%–50% lower than the rest of the world and sometimes even as much as 90%. There is also a presence of good technical and technological expertise together with the availability of low-cost skilled human resources. The growth of the middle-class population is leading to a new lifestyle, providing a huge market for lifestyle drugs, which are currently the lowest contributor to revenues from the sector.

Cabozantinib Generic Price in India

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.

• 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.
• This push to make generics ever cheaper is saving the health-care system billions of dollars.
• In line with this, irrational prescriptions and poor adherence to STPs/STGs and EML may be attributed to lack of awareness.
• The maximum number of fixed dose formulations listed in PMBJP is for vitamins and micronutrient deficiency followed by gastrointestinal complaints and cardiovascular disorders.
• The true causes are always somewhat obscure because pharmaceutical companies try to conceal the thinness of their supply chain and its exposure to single points of failure, such as unexpected decisions by foreign governments to shut a facility.
• 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.

This chapter has been written by a member of GLI’s international panel of experts, who has been exclusively appointed for this task as a leading professional in their field by Global Legal Group, GLI’s publisher. GLI’s in-house editorial team carefully reviews and edits each chapter, updated annually, and audits each one for originality, relevance and style, including anti-plagiarism and AI-detection tools. All methods were performed in accordance with the relevant guidelines and regulations. The study protocol was approved by the School of Health Systems Studies, Tata Institute of Social Sciences, Mumbai. Besides, the permission to conduct the study was obtained from Bureau of Public Pharmaceutical Undertakings (BPPI), Department of Pharmaceuticals, Government of India. The informed written consent of study participants’ including the pharmacists of surveyed PMBJP outlets was obtained prior to conducting interviews and reviewing stock records.

In India, the pharmaceutical market is majorly dominated by generics, accounting for 78.33% of all drugs in the Indian market, while patent-protected drugs account for 21.67% of the market share, according to GlobalData’s Price Intelligence (POLI) database. India sees the second most significant generic market penetration in the Asia-Pacific (APAC) region, just behind Malaysia. 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. This policy works in India’s favour, however, as the country is one of the leading producers and exporters of generics globally. The use of generic drugs is steadily increasing internationally as a result of economic pressure on drug budgets.

Almost 70% of antipsychotics and antiasthmatics, more than 85% of anticancer and electrolyte balancing medicines were found to be out of stock for 3–6 months. The IPCA factory in Pithampur, for instance, chose not to reject drug products that failed to meet specifications in initial “trial” tests, the FDA reported. Inspectors said these negative results at the plant , which makes an anti-psychotic, an opioid pain drug and an anti-nausea medicine for Canada, were not documented, reported or investigated.