Content
- Why Not Regulate Prices?
- Teva’s Top Graduates: From Academic Learning to Business Leadership
- Buy generic Cazanat (Cabozantinib) in India
- Limitations of this study
- Indian pharma is being squeezed – and it’s bad news for drug access in developing countries
- RELATED PUBLICATION
- Sun Pharma PALENO (Palbociclib)
- Learning Essential Caregiver Communication Skills
- How to buy PALENO in India?
- Do you wish to stay updated on upcoming must-read industry trends?
- 2 The scenario of the Indian pharmaceutical industry: contextual analysis
- Product
- Harness the power to transform clinical development
- Successful market access
- Making the case for Indian generic drug manufacturing
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.
Why Not Regulate Prices?
“The two major reasons for the cost pressures are slowing down of the domestic offtake and pricing pressures in developed markets such as the United States and Europe, in addition to some of the pricing pressures also being introduced in India in the domestic markets,” commented Raisinghani. “This is further compounded by regulatory bodies demanding stricter compliance, which are leading to higher compliance costs,” he added. If sponsors, healthcare providers, and regulators work together effectively, then effective use of generic drugs will make medical costs cheaper and also ensure sound treatment options for the patients. Early issuance of guidance notes on the prescription of generic medicines, clarity in dispensing rights, state notification of FDSI, and mandated display of EML at the facilities heighten the awareness of both providers and community members. In line with this, irrational prescriptions and poor adherence to STPs/STGs and EML may be attributed to lack of awareness.
Teva’s Top Graduates: From Academic Learning to Business Leadership
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.
Buy generic Cazanat (Cabozantinib) in India
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.
Limitations of this study
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.
Indian pharma is being squeezed – and it’s bad news for drug access in developing countries
This transformation has enabled the implementation of on-demand delivery models, employing strategies like direct-to-patient approaches and B2B eCommerce platforms. In fact, Indian pharmaceutical companies are now also becoming a key source of medicine for the rest of the developing world. Of note, they are playing a pivotal role in bringing down the price of lifesaving, antiretroviral drugs that have helped contain the AIDS epidemic.
- We already know from previous experience that such proposals — known as TRIPS-plus — can have devastating consequences for access to medicines.
- 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.
- These calculations allow us to respond positively to RQ1 (“Are the expectations about the global value of the industry positive or negative?”).
- 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.
- 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.
- Another challenge to India is wealthy countries protecting their pharma industries to ensure drug security.
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Generic drugs savings totaled $292.6 billion in 2018, according to the AAM Access & Savings Report (2019). Of this, an estimated savings totaling $80 billion in 2017 can be attributed to the contributions from Indian generic companies. The foremost challenge is ensuring a fair and just regulatory framework, which is stable and predictable. 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. Besides, CDSO must ensure that generic medicines available in the Indian pharmaceutical market are bioequivalent and those qualifying bioequivalence tests should be listed along with their branded counterparts and price on a public or PMBJP portal.
Sun Pharma PALENO (Palbociclib)
In the USA substitution is allowed and patients accept generic substitution if physician approves of the same. 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. Studies involving comparative evaluation on quality of branded and their generic counterpart may be made mandatory for the generic (or branded-generic) manufacturer and their reports should be made public to promote generic use and prescriptions. Unlike developed countries, people in developing countries pay the cost of medicines out-of-pocket. Universal access to medicines, a critical component of Sustainable Development Goals, is intended to ‘ensure access to safe, effective, quality and affordable essential medicines for all [24].
Learning Essential Caregiver Communication Skills
In the present scenario, the changes in the patent regime may benefit MNCs, while domestic companies may face more challenges. Similarly, the threats possibly deriving from other low-cost countries – China above all – are real. The negotiations with MNCs, international rules and domestic regulations are imbalanced, while there are increasingly stringent regulations and nontariff barriers to generic drugs in developed countries (Dhar and Joseph, 2019). After the 1990s, India emerged as an information technology and information technology-enabled services hub for the world due to trained manpower, a very high number of computer engineers, and a cheaper workforce that could speak foreign languages, mostly English. Similarly, pharmaceutical research and development can be carried out in India by global pharmaceutical MNCs. India has many pharmaceutical, bioscience and chemistry colleges that churn out huge amounts of high-quality graduates every year.
- Furthermore, the Indian pharma supply chain grapples with issues related to counterfeit drugs and supply chain integrity.
- The challenges are reportedly more pronounced in North-Eastern states and for facilities under the National Urban Health Mission (NUHM).
- “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.
- FDA Commissioner Robert Califf admitted as much last year, when he warned that “there’s not enough reserve and supply” of generic drugs in the United States.
- Doctors did not seem to be very much confident about the effectiveness of generic medicines.
How to buy PALENO in India?
- 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.
- The Indian medicine market has recently witnessed the launch of Palbociclib’s generic version – Paleno.
- 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.
- Patients’ and doctors’ perception for all branded-generics irrespective of company is the same.
- This includes vigorously efficient quality control and quality assurance systems alongside training programs and workshops, building an omnipresent culture of quality.
- 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.
A sustained, affordable supply of generic medicines is essential for health — as well as for preventing the next pandemic. Yet, the stricter intellectual property rules EU negotiators propose for India and Indonesia would undermine — and even thwart — access to affordable medicines in developing countries. The production of pharmaceuticals, medicinal chemicals and botanicals for health-care has been growing yearly in India.
India’s challenges
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.
Aurobindo has had numerous well-documented safety and quality issues, as well as instances of corruption and lack of transparency. At the same time, pharma imports from China and India increased their share of total pharma imports, reaching 58% by weight. While imports from those two countries dominate the $208 billion in total imports, their dominance is much greater in specific drugs and medicines, sometimes reaching 100%. In many cases, pharmaceuticals from India are dependent on ingredients or starting materials that come from China.
- 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.
- And while the Republicans generally favor more market-based solutions—including the importation of drugs from other countries and increased price transparency—reducing drug costs in the U.S. has become one of the few bi-partisan issues.
- Reducing the industry’s dependence on the imports of APIs, key intermediates and starting materials will be key to sustaining its global leadership position.
- Early issuance of guidance notes on the prescription of generic medicines, clarity in dispensing rights, state notification of FDSI, and mandated display of EML at the facilities heighten the awareness of both providers and community members.
- With additional tools like coupon finders, EHR systems can locate the best local prescription prices and provide real-time data for drug-specific directions, enabling providers to offer more personalized and budget-friendly care.
- COVID-19 underlines India’s importance to developing countries when it comes to drug access.
- In India, the public health-care system is not strong, and most of the middle class and above prefer to visit private hospitals for treatment.
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2 The scenario of the Indian pharmaceutical industry: contextual analysis
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.
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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.
Harness the power to transform clinical development
- Only qualified allopathic doctors and the pharmacists registered under the state or central pharmacy council were considered for IDIs.
- 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 survey was undertaken to find out the extent of availability and stock-out of medicines at PMBJP outlets.
- 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.
- 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.
- FDA approvals are considered benchmarks across many countries; therefore, these authorizations are very important for Indian pharmaceutical industries for the access, export, presence and profit they represent at the global level.
- In fact, the physicians have also cited other reasons for not prescribing generic medicines.
- In the present scenario, the changes in the patent regime may benefit MNCs, while domestic companies may face more challenges.
- The world’s supply of generic medicines is a lifeline for the Global South — and this is more important than the profits of a handful of companies.
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 lapatinib cost uk 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.
Successful market access
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.
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.