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.
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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 (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.
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The generic drugs industry continues to strengthen itself as a key pillar of India’s burgeoning economy. As the largest provider of generics in the world, the sector contributes to 40% of the United States’ generic demand with Indian companies receiving 304 Abbreviated New Drug Application approvals from the United States Food and Drug Administration (USFDA) in 2017. Moreover, the industry exports to almost every nation, and has significant footprints in all the highly-regulated developed markets.
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In some cases, pharmaceutical reimbursement may involve direct billing between healthcare providers and insurance companies or government agencies. Under the DPCO, manufacturers are required to be aware of price fixation and revision by the NPPA since it is mandatory to follow the ceiling prices fixed and notified by the NPPA. 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. Although we reported availability, stock-outs and affordability of medicines in the PMBJP pharmacy outlets, a more comprehensive assessment of the accessibility of essential medicines may have included measurement of medicine prices, prescription pattern and out-of-pocket payments on medicines.
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Against a group of these units, if 03 antimicrobials medicines were available in a PMBJP store and 04 antimicrobials medicines were available in another store, then the overall availability of anti-microbials in PMBJP pharmacies at primary level facilities of Palghar was 50% [((3X1) + (4X1)) X100/14]. In addition to streamlined procurement and communication channels, systematic reporting across the programmes is pivotal in aligning the demand for medicines with the state’s disease burden. For chronic conditions, the pace of NCD services uptake, especially at primary level healthcare facilities significantly influences demand-driven access to NCD-specific essential medicines. For example, in negotiations with Indonesia, the bloc proposed an extensive intellectual property enforcement regime that could adversely impact access to medicines. It has also sought to extend the duration a pharmaceutical producer is granted a patent monopoly and expand exclusive rights to data, both of which would delay the marketing of affordable generic versions.
Costs and affordability
However, some policy issues continue to persist and present complex challenges for the legislature, as well as all other public and private stakeholders. Pharmaceutical pricing and reimbursement are critical components of the Indian healthcare policy. The interplay of pricing and reimbursement policies is aimed at ensuring affordability of pharmaceutical products for patients, as well as continuous innovation and value creation in the industry. The regulatory landscape is constantly evolving and new initiatives by the Government and the private sector, as well as by public–private partnerships, are paving the way for an overhaul of old policies. In many cases the generic drugs do not produce the desired effect in the expected time which branded ones do.
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Almost 10% of the factories that supply drugs or active ingredients to Canada are in the south Asian country, says Health Canada. “The numbers here are so large – in terms of the facilities and types of drugs being made and ingested – and it’s just a drop in the bucket how many are getting inspected,” says Andrew Beato, a Washington lawyer involved in a major prosecution of an Indian drug company. If you want to buy PALENO (Palbociclib) by Sun Pharmaceuticals in India than you can contact us.We can help you to get high quality generic medicine at the lowest discounted cost.Please contact us via Email, WhatsApp or simply filling query form in our website bottom section or contact us page. As other major pharmaceutical brands introduce similar medications, expect significant price reductions for Paleno (Palbociclib) in the near future. As the breast cancer rate is multiplying in India, the need to have affordable treatment that is easily available is increasing.
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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].
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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.
- The implementation of market-based price ceilings on a set of essential medicines, including on-patent and generic drugs, is a form of pharmaceutical price control applied by the Indian Government and intended to make drugs accessible to people at an affordable price and address drug shortages.
- The analysis of marketed AMLO containing FPPs was exercised using a validated analytical method.
- These three pharmaceutical categories alone are worth approximately 60% of the entire Indian pharmaceutical production.
- While more than 70% of PMBJP pharmacies across all levels of care in Palghar region had palliative care medicines, anti-epileptics, analgesics and antacids, the availability of anti-cancer, anti-asthmatic and electrolyte balancing drugs were found to be very poor (less than 30%).
- Since then, through global partnerships and country-led efforts, about 19 million people living with HIV in resource-constrained settings are now receiving TLD, according to the Clinton Health Access Initiative.
- For example, augmentin brand gives effective and quick results as compared to its simple generic amoxicillin clavulanate version.
- Also, a formulary containing the details of therapeutically interchangeable products is available for reference [36].
- Neither IPCA nor Dr. Reddy’s responded to requests for comment, but Amir Attaran, a health-policy expert at the University of Ottawa who tracks the industry, said the findings are troubling.
Selection of medicines for the survey
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 Abiraterone price philippines 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.
- 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.
- The most relevant contribution of the research relies on the shift to innovative production that Indian companies must adopt (after years of focusing only on generic drugs), and in this vein, appropriate industrial marketing solutions are indispensable.
- Ms. Chawla has authorised and contributed to various academic articles and journals on topics relating to cyber laws and copyright laws.
- The so-called branded medicines in India are manufactured and promoted by multinationals or by reputed Indian manufacturers.
- 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).
She used the structured schedule to collect data on availability and stock-out of selected medicines and consumables. Those medicines not found in stock on the day of survey, the number of days of stock-outs in the last 6 months were recorded through manual checking of registers. We first reviewed the WHO-HAI core list of medicines, medicines that are listed on India’s Essential Medicine List and drugs listed under various national health programmes [18, 19].
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- Similarly, pharmaceutical research and development can be carried out in India by global pharmaceutical MNCs.
- The industry operates within a complex regulatory landscape characterized by stringent quality standards and evolving regulations.
- These concerns raise fears among patients that taking drugs made in India may result in unpredictable effects.
- Therefore, a better distribution of medicine in the middle-income groups, who need medicines for several treatments, has been observed.
- This has resulted in growing its access, particularly in regions where treatment costs are a huge barrier to healthcare.
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.
- With a population of more than 20 million, the city is one of the most populous urban centres in the world.
- In terms of per capita income, Maharashtra is one of the richer states in India and Mumbai is its capital city.
- Faced with shortages and a limited number of suppliers, almost all of them overseas, the FDA is actually being forced to relax its standards, just to find any supplier of certain badly-needed drugs.
- Capacity building of skilled cadres across the levels of care like facility-in-charge, store-keepers, ANMs and pharmacists in inventory/ material management, demand estimation, and indenting is required to support their state-specific practices.
- Currently, almost all medicines in India are sold under a brand (trade) name and medicines are called as branded medicines or branded-generic.
- In spite of being the ‘pharmacy of the world’, access to essential medicines for a large majority of Indians is constrained by both physical and financial reasons.
- Interestingly, India is the biggest contributor to UNESCO, with a share of over 50-60%.
- 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.
- There is also a presence of good technical and technological expertise together with the availability of low-cost skilled human resources.
- 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.
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.
3 Human capital in the patent-based regime
Although the sector must tackle several issues concerning internal (fragmented) and external (innovative) competition, drug price controls and patent regimes have a significant influence on its effective functioning, which is why the Indian pharmaceutical industry is still mainly concentrated on generic drugs. Although some Indian companies have invested significantly in R&D initiatives, most of them prefer remaining in the business of generic drugs. Because it does not require huge efforts to invent new molecules, there are still numerous small companies that produce the same generic drugs, creating tough competition in the domestic market (Pardhe, 2019). The low availability of medicines at PMBJP outlets reflects the implementation issues faced by the scheme. Nevertheless, the study findings show that PMBJP’s unbranded generics offer great opportunities for substantial cost savings.
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.
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.
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.
Remarkably, 36% of China’s exports are to the EU and North America, where regulations are the most stringent, compared to 19% in 2009. Beijing’s “Made in China 2025” policy has identified pharmaceuticals as one of its strategic industries. Now, the advantages that have enabled India to play this role are in danger of being eroded.
Some of these practices reportedly originated as ad-hoc measures in the service delivery chain and continued in the absence of root-cause mitigation efforts; while some continue to exist due to the lack of capacity building measures. They are relatively more prevalent in primary healthcare facilities and community health centers than in district hospitals. Given this as background, we are presenting a study, in that linear discrimination analysis (LDA) models for deducing the correlations between acceptable quality attributes of AMLO FPPs and independent variables would be helpful in establishing outcome effects.