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.
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- After determining the most relevant coordinates of the field, specific reports and issues from other governmental and corporate institutions have been purposively retrieved and analyzed through a content analysis for generating a narrative SWOT analysis, particularly to respond to RQ3.
- Therefore, price controls were effective at analyzing this price variation and are attempting to decrease the difference even more (Jhanwar and Sharma, 2018).
- The offshoring of production to China and India has put the U.S. in a dangerous position, dependent on unreliable suppliers.
- Moreover, companies exporting to the United States and Europe will need to become fully compliant with the track and trace requirements being imposed by various regulatory agencies to ensure quality pharmaceutical imports by preventing counterfeiting.
- Learnings from states indicate that the ability of the community health workers to deliver community-based services (e.g., HBNC) is dependent on timely and adequate supply of medicine kits.
- If these Jan Aushadhi stores are available in Government hospital premises, patient can get those medicines easily.”(PuP2).
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.
The low-down on health insurance ads during open season
While in a few, they are observed to be efficient (e.g., Tamil Nadu, Kerala, Rajasthan, Andhra Pradesh), challenges reported in many states are largely due to implementation gaps confounded by other systemic challenges. We have sought to establish an ML link between the price and sample age of AMLO besylate containing FPPs and acceptable quality attributes of the same. The analysis of nine top-selling AMLO besylate-containing marketed FPPs was exercised using a validated analytical method.
- Indeed, compared to developed nations, Indian pharmaceutical companies concentrate less on innovation, where they allocate less budget.
- The inclusion of FDCs of antimicrobials, FDCs for CVDs and other diseases pose a public health concern.
- But just to begin to pursue that objective requires more information than the FDA has today.
- Regulatory authorities need to provide more emphasis on quality control of generic medicines.” (P4).
- 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.
- Addressing patient concerns and misconceptions about medication quality and effectiveness starts with clear communication and easy access to resources.
Cabozantinib Brands in India
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.
India’s challenges
The following were identified as the key focus areas to bolster the Indian pharmaceutical and healthcare sectors. Thus, from a practical point of view, Indian pharmaceutical companies should invest more in R&D, attempting to attract talented human capital. Otherwise, they will lose the highly qualified national workforce that will favor MNCs in the field.
GENERIC DRUG: PRESCRIBER’S PERSPECTIVE
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.
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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.
- Faster decision making and reduced risk so you can deliver life-changing therapies faster.
- Further, it is required to be covered under the reimbursement schemes, which are listed in formularies approved by the respective authorities.
- Recordings were translated from the local languages such as Marathi and Hindi in English, and then transcribed verbatim.
- 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.
- The Indian government believes that the prices of lifesaving drugs shouldn’t be set by market forces.
- At the bottom of the health services pyramid, there are primary health centres (PHC), sub-centres (SC) and health posts (HP), which focus on primary care.
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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.
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State- level autonomous bodies and state government- owned agencies are empowered to procure and distribute 80 per cent to 100 per cent of medicines and diagnostic products of the total requirement. Additionally, existing resources like untied funds or funds from rural/urban local governing bodies support the facilities to undertake local purchases to meet emergency demand or shortages. 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. EU negotiators should drop TRIPS-plus proposals, and entirely avoid them in future negotiations with developing countries. 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.
Choosing the best option: Balancing cost and care
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.
How can I get generic drugs?
A 3-tiered public healthcare delivery system is catering to the needs of the population of these two districts. At the bottom of the health services pyramid, there are primary health centres (PHC), sub-centres (SC) and health posts (HP), which focus on primary care. The mid-level of the pyramid, which is the secondary care level, includes rural hospitals and municipal general hospitals, and at the top level, tertiary care institutions like medical colleges are there. According to the PBBJP portal, 29 PMBJP pharmacies are currently functional across these two districts.
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- (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].
- As the managing editor of The Intake, she is committed to supporting independent practices with content, insights, and resources tailored to help them navigate challenges and succeed in today’s evolving healthcare landscape.
- To make the sample representative and consistent with the distribution of PMBJP outlets in Mumbai and Palghar, 11 pharmacies were selected for the study covering all levels of health care delivery system.
- 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.
- These operations need huge amounts of capital, but DPCO measures, which limit drug prices, do not contribute to establishing a favorable scenario concerning capital budgeting for R&D.
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.
Key drugs losing patent protection in 2025
Furthermore, India’s Department of Pharmaceuticals (DoP) recently announced plans for a new pricing reform for pharmaceutical products and the induction of price control for medical devices, which would induce more stringent rules over pharmaceutical pricing. Such measures risk decreasing sales of price-controlled products, which in turn could discourage sunitinib price in malaysia multinational pharmaceutical companies from launching new products in the Indian market. 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.
- 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.
- 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.
- Indian companies will continue to expand globally, enriching their manufacturing capabilities to meet the growing demand in the world.
- 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.
- Consequently, domestic businesses will be hindered to some extent, and exports may blossom.
- Quality and price of medicines were studied to evaluate the two versions of the same therapeutic molecule.
- Progress in the direction of infrastructure expansion and strengthening improves both service delivery and availability of medicines for the end-users.
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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.
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In the fourth edition of the Re-Pharma Summit 2024, panelist Sabina Sawliwala highlighted the differences in costs and logistical difficulties between companies operating in India and more developed economies like the US and Europe. “Our logistics and transportation costs are literally double-digit, whereas if go to America or Europe, these are single-digit costs,” she added. Poor road connectivity, congested ports, and limited cold chain facilities impede the timely and safe delivery of pharmaceutical products, particularly to remote and rural areas.
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.
There are only 74 bulk drugs which are under price control[15]and are called scheduled medicines. For scheduled medicines, the NPPA pricing formula sets the 8% mark-up for wholesalers and 16% for retailers. For non-scheduled medicines, these markups are not set, but it is agreed by the partners of the trade that for branded medicines average mark-up would be around 10% and 20% for wholesalers and retailers, respectively. Diverse systemic determinants of access to quality and affordable medicines have been documented through CRMs. Though not an exhaustive list, state-specific experiences over the years highlight the determinants of access, and pertinent systemic challenges needing redressal.
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.
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. According to an estimate, medicines account for 69% of household out-of-pocket spending on health care. To make quality generic medicine affordable, India’s People’s Medicine Scheme (Jan Aushadhi) was launched in 2008 and then revamped and rebranded as Pradhan Mantri Bhartiya Jan Ausadhi Pariyojana (PMBJP) in 2015. The current study focuses on the availability, affordability and acceptability aspects of PMBJP essential medicines. Infrastructure constraints present another significant hurdle for the Indian pharma supply chain. Despite substantial progress in recent years, inadequate transportation and logistics infrastructure continue to hamper the efficient movement of goods within the country.