Prices for generic cancer drugs in the UK have soared over a five-year period, conference hears

The qualitative data was collected to understand the perception of the doctors and pharmacists on generic medicine as well as their views on PMBJP scheme. Following informed consent, the interviews were audiotaped while the first author also took notes. Recordings were translated from the local languages such as Marathi and Hindi in English, and then transcribed verbatim. We used thematic analysis [21], which warranted reading and rereading the transcripts in order to generate the potential themes.

Do all drugs have generic versions?

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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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.

India Solicits Price QuotesFor More Than 500 Generic Drugs

Of the 10 drugs already on the market and recalled because of quality defects since New Year’s Eve, four were made in Indian factories, Health Canada says. They included lots of a generic version of the antibiotic cefazolin, pulled because of fears the intravenous solution contained foreign particles. This push to make generics ever cheaper is saving the health-care system billions of dollars. But, says Dinesh Thakur, a soft-spoken chemical engineer and former executive with Ranbaxy Laboratories, it comes with a price of its own. This means about one in 20 of this country’s finished drugs are now made in India – roughly 20 million prescriptions a year.

Make a difference to people’s health, every day

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.

Industry Products

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].

PALENO (Palbociclib) price in India

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.

• 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.
• The USFDA has been more critical whilst carrying out inspections of manufacturing facilities, giving warnings to a number of Indian national players.
• 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.
• If there is a lack of proper supply of medicine to the needy, this would be in contradiction with the objectives of social justice (Mrinali, 2013).
• We first examined the selected medicine list of PMBJP to assess the extent of coverage of essential medicines.

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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). But just to begin to pursue that objective requires more information than the FDA has today. The FDA has pretty much admitted that it is ineffective at managing America’s generic drug shortage problem, pointing the finger at the drug and medical device makers. In May 2022, FDA Director Dr. Robert Califf admitted in congressional testimony that supply chains are too narrow and too dependent on single sources. Another example is in contrast dyes, which are administered to patients before CT scans to improve health care professionals’ visibility of the circulatory system and help identify blood clots in cancer patients.

FREE DRUG SERVICE INITIATIVE AND COMPREHENSIVE PRIMARY HEALTH CARE

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.

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In fact, AYUSH represents a mass-niche market, requiring peculiar attention mostly in terms of competitive strategies that would have a focus orientation. This study provides a global overview of the potential growth and development of the Indian pharmaceutical sector, comparing it with internal trends and external competition. The most relevant contribution of the research relies on the shift to innovative production that Indian companies must adopt (after years of lapatinib price in singapore focusing only on generic drugs), and in this vein, appropriate industrial marketing solutions are indispensable. In order to collect data in an accurate and reliable manner, one of the researchers personally visited the selected PMBJP outlets to check the availability of generic medicines. The researcher cum field investigator is trained in both pharmacy and public health with previous experience of conducting primary data collection for health systems research.

India’s share of the US generic market is growing rapidly, and the number of companies and manufacturing facilities supplying to the U.S. market is growing fast. The focus on growing regulatory requirements, improved healthcare infrastructure, and surge in research and development spend bodes well for the pharma industry. The Indian government believes that the prices of lifesaving drugs shouldn’t be set by market forces. In a country where very few people have health insurance, 70% of Indians pay for healthcare expenses out of their own pockets. There is no way that people in India can pay even a fraction of the cost for drugs that can be priced at $50,000/year in the West. The process of securing reimbursement for a pharmaceutical product varies and depends entirely on the specific processes provided under the respective policy.

How Can We Use AI to Make Medicines More Efficiently?

Maria Rosaria Carli was formerly Director of the Institute of Research on Mediterranean Economies of Italian CNR. Her research interests are focused on Economics of Development and she was Adjunct Professor of Economics of Developing Countries at the “Parthenope” University of Naples, Italy. She was Italian member of the Core Group and Standing Committee for the Social Sciences – European Science Foundation. She is scientific coordinator for the CNR on R&D projects and has published articles on national and international journals, as well as essays on collective volumes. After all, a clear understanding of our record of accomplishment and emphasis on quality supports the ongoing efforts of Indian generic manufacturers to provide quality solutions that ultimately benefit consumers across the globe. This medication is administered under the guidance of an oncologist and has specific dosing instructions to ensure effectiveness and minimize side effects.

Overall, the pharma and healthcare industry in India presents tremendous potential for growth especially in innovation, research, early detection, and futuristic solutions like robotics-assisted surgery. By leveraging its strengths, embracing technological advancements, and fostering collaboration, the Indian pharmaceutical industry can continue to play a pivotal role in shaping the future of healthcare delivery both domestically and internationally. Making the healthcare supply chain resilient will require end-to-end supply chain visibility through digitalisation and use of global standards which facilitate interoperability. According to the study, “over 80 per cent of the Pharmaceutical and Medical Devices Manufacturers do not have product visibility till point of care. In October 2023, OPPI and EY conducted primary research, engaging with approximately 40 Chief Executive Officers (CXOs) representing prominent Indian and multinational pharmaceutical companies, as well as other industry organizations.

Notable 2024 FDA decisions

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. In the international market, threats derived from pharmaceutical multinational companies are emerging as tough obstacles to overcome. Indian generic manufacturers are also producing in the U.S. and in other countries whenever necessary.

Key drugs losing patent protection in 2025

This will be a tough balance to achieve, but it appears that all stakeholders recognize the urgent need for it to occur. Nearly 1 in 10 Americans said they believe generic drugs aren’t tested as rigorously as brand-name, with Gen Z being the most likely to have this view (11%). Some also questioned whether generics are FDA-approved (7% of Gen Z), and 12% of Millennials believed that generics took longer to work compared to brand-name medications.

The website you are about to access may be governed by different regional policies, regulations or advertising codes. Please be sure to read the privacy policy and terms of use of the websites that you visit. Cabotres is the medicine by the Cipla brand that harnesses the therapeutic benefits of cabozantinib. In addition to litigation, the firm advises clients on representations to be made to governmental regulatory bodies like the NPPA. 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. Regarding her contributions in international conferences, Ms. Sharma has been elected as an executive member of AIPPI for the Indian Group, is an active member of the APAA and regularly participates and attends the INTA.

Harness the power to transform clinical development

Both countries have used government subsidies, export incentives, and other tools to lower their costs of production and build locally-owned drug manufacturing centers. One of the foremost challenges confronting the Indian pharma supply chain is regulatory compliance. The industry operates within a complex regulatory landscape characterized by stringent quality standards and evolving regulations. 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. The pharmaceutical business function of R&D has been significantly affected by the DPCO. Due to price controls, companies have not dedicated themselves to inventing and developing new medicines.

The three major medicines for breast cancer – Palbociclib, Ribociclib, and Abemaciclib are popular internationally. Despite India’s contribution to global access to medicines, the government has never tried to use this as an instrument of foreign policy. One silver lining is that China is proposing a new regulation that would give its firms exclusive control over their clinical test data.

The quotes are being sought for generic drugs, although they are also allowed for imported or combination drugs by their trade or brand names. Cipla’s introduction of Cabotres when it launch is constantly making cancer treatments more accessible and affordable. The brand’s commitment to quality ensures that Cabotres is a reliable option for patients. “Now what happens is most of the time we don’t get adequate supply of these Jan Aushadhi products in definite time. Hence, government can increase number of wholesalers, distributors in the scheme to improve availability of medicines at the stores.” (P9). The survey was undertaken to find out the extent of availability and stock-out of medicines at PMBJP outlets.

• In the case of ‘overcharging’ by manufacturers and/or violation of pricing regulations, the NPPA has the power to seek recovery of overcharged amount along with interest, as well as penalties in some cases.
• Progress in the direction of infrastructure expansion and strengthening improves both service delivery and availability of medicines for the end-users.
• Some reported that quality issues are hindering the uptake of unbranded generics, and asked for strong regulatory framework for quality control.
• It remains to be seen if the NPPA will schedule additional price adjustments for essential medicines in the current fiscal year ahead of the national elections, which are set to take place between 19 April and 1 June 2024.
• 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.
• In India, a dispensing pharmacist is not authorized to substitute a branded medicine with a branded-generic (or generic) as per the provisions under Rule 65 of the Drugs and Cosmetics Act, 1940 and Rules, 1945, which also add to the patient’s burden.

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.

• Importantly, beyond presenting an evidence-based case that generics manufactured in India are efficacious and safe, we must also demonstrate the enormous good these drugs provide to consumers.
• Dhiraj Singh/BloombergAbout one in 20 of Canada’s finished drugs are now made in India – roughly 20 million prescriptions a year.
• The Bureau of Pharma Sector Undertakings (BPSU) working under the Department of Pharmaceuticals, Government of India, was entrusted with the responsibility of implementing JAS, i.e., to coordinate procurement, supply and marketing of generic drugs through JAS outlets.
• 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.

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].

Ask your doctor to write a prescription allowing the pharmacist to substitute a generic drug when it’s appropriate. PTR is the price at which wholesaler (distributor) sells the product to the retailer and the bill (voucher) given to retailer by wholesaler mentions the PTR. This price was checked and confirmed from Form V (under DPCO, 1995) available at the distributors of the company. It is mandatory for all the companies to give Form V that gives details of the product with MRP, PTR, taxes paid, etc to their distributors. Qualified standards of AMLO besylate were purchased from Sigma-Aldrich (Bangalore, India). For the experiment purpose, nine top-selling AMLO containing FPPs were purchased from local pharmacy outlets in Guwahati (Assam, India).

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.

• In Palghar, about 86% of anticancer and electrolyte balancing medicines, which were unavailable at the time of survey, were out of stock for 3–6 months.
• Paleno, which contains Palbociclib is a medicine used to treat breast cancer treatment.
• Unlike developed countries, people in developing countries pay the cost of medicines out-of-pocket.
• Nonetheless, despite being a global market leader in generic drug formulations, the Indian pharmaceutical industry is highly dependent on China for raw material supply to produce pharmaceutical formulations and even medicines.
• More papers with manufacturing and drug testing data were shredded and tucked away in plastic bags under a stairwell, indicating that Intas executives had manipulated data and tried to cover it up.
• In fact, AYUSH represents a mass-niche market, requiring peculiar attention mostly in terms of competitive strategies that would have a focus orientation.

All these factors are making the larger Indian players conscious of how best to evolve from their current offering. “I would also advise to focus strongly on reliable quality and being ahead of the curve on FDA requirements, to rapidly establish yourself,” he continued. The price ceiling policy has been in place for more than two decades, but it has neither been very successful nor free of consequences for pharma companies. Instead of the existing price controls, other mechanisms such as promoting competition among local manufacturers and increasing public healthcare spending should be focused on. It remains to be seen if the NPPA will schedule additional price adjustments for essential medicines in the current fiscal year ahead of the national elections, which are set to take place between 19 April and 1 June 2024. India’s independent drug pricing regulator, the National Pharmaceutical Pricing Authority (NPPA), has issued a marginal increase of 0.0055% to the maximum retail price (MRP) of medicines included in India’s national list of essential medicines (NLEM), which took effect on 1 April 2024.

• Moreover, complex reimbursement procedures, including documentation requirements and approval processes, can delay or deter patients from accessing timely reimbursements.
• Together, we can help lead the future of healthcare with the extensive IQVIA network of assets, resources, clients, and partners.
• Almost 70% of antibiotic FDCs available on the market are not registered with Central Drugs Standard Control Organisation (CDSO) [29].
• 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).
• 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.
• Efficient SCM practices are important to ensure the timely distribution of the right products in the right quantity at the right place.
• 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.

Ensuring we communicate this vision and quality-centric focus will be essential to the bright future between manufacturers and those who rely on these medicines. The availability of the above-mentioned generic versions of Cabozantinib enhances the affordability. This has resulted in growing its access, particularly in regions where treatment costs are a huge barrier to healthcare. In conclusion, it is clear that the evolving landscape of the healthcare and pharmaceutical industry in India offers an exceptional opportunity for new entrants to expand and diversify in the market. 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, the private physicians underlined the need for developing strong regulatory mechanisms to ensure that generic drugs meet high standards of quality. “We are ready to prescribe low cost generics, but it becomes difficult for me to convince my patients to take such a low-cost generic medicine. Most of the time patients want relief from pain as quick as possible and thus they are ready to pay even high for medicines. We first examined the selected medicine list of PMBJP to assess the extent of coverage of essential medicines. NLEM, 2015 has 376 essential drugs whereas the PMBJP list contains 214 essential medicines.

Because more than half of India’s pharmaceutical exports are to highly regulated markets such as the United States, Indian manufacturers must comply with strict U.S. Food and Drug Administration (FDA) guidelines that include regular and rigorous inspections to ensure compliance. However, some key obstacles remain to be addressed for the country to fully realise the remarkable growth potential of its healthcare market. These are limited resources, infrastructure deficits, shortage of health professionals, access and affordability of medicines in rural and semi-urban areas, as well as lack of public awareness about available healthcare benefits. Some reported that quality issues are hindering the uptake of unbranded generics, and asked for strong regulatory framework for quality control. “When we write any generic medicines and if it is not available in hospital pharmacy, patients have to go to other pharmacies to buy it.

Tebra is constantly exploring new ways to leverage technology and partnerships to improve healthcare. Our partnership with GoodRx demonstrates this commitment, with features like automated coupon retrieval paving the way for a more patient-centric and cost-effective future. Addressing patient concerns and misconceptions about medication quality and effectiveness starts with clear communication and easy access to resources. Patient experience software makes conversations between providers and patients easier so practices can provide timely information to clear up doubts and reinforce trust. Interestingly, 1 in 10 Gen Z and Millennial Americans said they base their preference for brand names on the packaging alone — that’s some pretty effective product design at work.