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.
“We spend a lot of time at work; we should enjoy it.”
However, it must be noted that Novartis provides Glivec free of charge to 16,000 patients in India, roughly 95% of those who need it via the Novartis “Glivec International Patient Assistance Program”. The remaining 5% are either reimbursed, insured, or participate in a very generous co-pay program. Thus, not granting a patent for Glivec really hasn’t prevented patients from getting this life-saving medication. Dr. Reddy’s Laboratories, a well-known global pharmaceutical company, manufactures Cabzored as part of its oncology treatments. (launching link) It is designed to offer a cost-effective and accessible treatment option for patients with specific types of cancer. In fact, the physicians have also cited other reasons for not prescribing generic medicines.
- According to a 2022 study released by GS1 India, a global supply chain standards organization, more than 50 per cent of Pharma and medical devices manufacturers lose 1 per cent of their sales due to expiry and pilferage.
- 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.
- The pharmacists, they claimed, will sell noneffective, or highly overpriced drugs once the authority to decide the drug for a given indication is bestowed upon the pharmacists through the policy of compulsory active ingredient prescribing.
- In India, many pharmaceutical companies manufacture two types of products for the same molecule, i.e. the branded product which they advertise and push through doctors and branded-generic which they expect retailers to push in the market.
- 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.
Pharmacists’ views on PMBJP
Drugs registered under DPCO must be sold within the price range, which is mandatory for the company and therefore, the break-even point is sometimes barely reached (Paul, 2018). Indian companies will continue to expand globally, enriching their manufacturing capabilities to meet the growing demand in the world. The future will see a major role in global healthcare by enzalutamide price in thailand Indian pharma, not only in making medicines affordable, but also in strengthening India’s position as a global hub for making innovative and high-quality medicines. These policy issues, along with market forces, drive the response of the public and private sectors to reimbursement policies, as well as determine the extent of price control on pharmaceutical products.
Beginning of Generics
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.
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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.
Do all drugs have generic versions?
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.
Buy generic Cazanat (Cabozantinib) in India
In the above, API stands for Active Pharmaceutical Ingredient and AYUSH stands for Ayurveda, Yoga, Unani, Siddha and Homeopathy. Starting in 2014 in India, a Ministry of AYUSH was established, indicating the extraordinary relevance in the country of these specific items. More focus on patents for innovative drugs is required, instead of concentrating primarily on generic drugs. There is a need for policymakers to work on the sustainability and development of the industry, while the companies must redesign their orientation toward enhancing innovation capabilities. In addition, at the level of corporate strategy, firms should establish collaborations and alliances and expand their industrial marketing vision.
- Additionally, barriers in communication and coordination between the states, districts, healthcare facilities, and procurement bodies cause duplication of purchases.
- 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.
- In many cases the generic drugs do not produce the desired effect in the expected time which branded ones do.
- The cost of generic medicines of PMBJP outlets for treating various conditions range from 0.01 days’ wages to 0.47 days’ wages for the lowest paid unskilled worker in Maharashtra.
- The medicine will be only for personal use and not more than 3 month supply at a time.
- An in-depth exploration of the global healthcare ecosystem with timely research, insightful analysis, and scientific expertise.
- Price-to-patient (MRP) and price-to-retailer (PTR) found for all the five ‘pair’ of medicines is tabulated in Table 1.
- These calculations, as emerging from Figures 2 and 3, allow us to respond positively to RQ2 (“Are the expectations about the trade balance positive or negative?”).
- Particularly, the country exports generic medicines on a large scale, with a major impact in the American and European markets.
A narrative strengths, weaknesses, opportunities and threats analysis of the Indian pharmaceutical industry
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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According to National Sample Survey Organisation, public facilities accounted for only 30% of the overall healthcare services in the year 2017–18 [4]. This means that majority of the people had to obtain healthcare including medicines from private providers. Moreover, even those who access healthcare from public facilities end up purchasing drugs from the market as the prescribed medicines are often not available in pharmacies of public hospitals. Currently, almost all medicines in India are sold under a brand (trade) name and medicines are called as branded medicines or branded-generic. In real sense, Indian market does not have branded medicines (a name commonly given to an innovator product) because till January 2005 product patent was not applicable in India.
Worth the price? Push for cheaper generic drugs has Canadians buying questionable medicines from India
The company ignored tests showing unknown impurities in some drugs, and inspectors came across samples with bacteria and mould that were “TNTC,” too numerous to count. What that patient is unlikely to know is the drug’s active ingredients come from a company called Dr. Reddy’s Laboratories Ltd. in India — or that U.S. inspectors made some eye-opening discoveries recently at the plant that produces them. The medicine will be only for personal use and not more than 3 month supply at a time. Quality and price of medicines were studied to evaluate the two versions of the same therapeutic molecule.
Authors would like to thank the pharmacists, PMBJP pharmacy owners and physicians who participated in the study. The survey was conducted in two districts of Maharashtra, namely Mumbai metropolitan region and Palghar. In terms of per capita income, Maharashtra is one of the richer states in India and Mumbai is its capital city. With a population of more than 20 million, the city is one of the most populous urban centres in the world. It has the distinction of being home to the largest slum population in any city in the world, displaying a high level of income inequality.
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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. To compare and evaluate the price and quality of “branded” and branded-generic equivalents of some commonly used medicines manufactured by the same pharmaceutical company in India. Prior to that, the state level commitment for free medicine policy had been differential. Fund shortages pushed states to appropriate budget heads under benefit schemes (e.g., Janani Shishu Suraksha Karyakaram- JSSK) or use revenue from services like diagnostics to ensure the provision of free medicines, thereby shifting the burden to other determinants of OOPE.
- 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.
- 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.
- In terms of per capita income, Maharashtra is one of the richer states in India and Mumbai is its capital city.
- 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.
- 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.
Any medicine information provided on this website is for informational purposes only and is not a substitute for specific or medical advice. That’s why the launch of this drug will make it more affordable for breast cancer patients to manage the disease. For treatment of breast cancer, Palbociclib is administered with hormone (endocrine) therapy. By our calculations, China’s global share of formulations exports trebled from 0.4% in 2009 to 1.2% in 2018, while India’s doubled over the same period from 1.5% to 3.6%.
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.
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Regulatory authorities need to provide more emphasis on quality control of generic medicines.” (P4). “We are ready to prescribe generic only, but there is no mechanism to ensure that private pharmacy shop chemists would dispense right and cost-effective generic medicines. Because there are hundreds of generics with different prices are available in the market, chemists can substitute for prescribed medicine as per their wish and earn high profit margins. Clinicians working in the public sector said that they prescribe 99% medicines in generic form as the government supplies only generic medicines to public health facilities.
This is the first limitation of the research, thus, further investigations expanding the range of the data under examination would improve the reliability of the results. In value terms, the sector, considering the total manufacturing of pharmaceuticals, medicinal chemicals and botanicals (Table 1), is worth Rs. 145,841.1m in 2018–2019. The largest market share concerns ayurvedic and homeopathic medicaments (AYUSH medicines) with 24.37%, followed by antibiotics (API and formulations) with 18.82%, and anti-retroviral drugs for HIV (Human Immunodeficiency Virus) treatment with 15.89%. These three pharmaceutical categories alone are worth approximately 60% of the entire Indian pharmaceutical production.
However, as shown in Table 2, PMBJP medicine list has as many as 130 FDCs in different therapeutic categories. The maximum number of fixed dose formulations listed in PMBJP is for vitamins and micronutrient deficiency followed by gastrointestinal complaints and cardiovascular disorders. As a protectionist tide sweeps across the globe, the Indian pharmaceutical industry needs to continue evolving.
If these Jan Aushadhi stores are available in Government hospital premises, patient can get those medicines easily.”(PuP2). If government wants us to prescribe drug through their molecule names, why do they allow so many brand names and why are there such wide price variations? By doing so, the brand has presented a cost-effective treatment for many patients of (HR+) (HER2-) advanced or metastatic breast cancer patients. Learn more about the Indian generic versions of Palbociclib and how it is a breakthrough in breast cancer treatment.
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.
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.
We found that switching from branded-generic medicine to unbranded generic medicines would lead to substantial cost savings for medicine consumers. Our estimates suggest that unbranded generic substitution would reduce pharmaceutical expenditure by 6–1129% of patient’s spending. However, caution must be exercised while interpreting affordability because of the following reasons. First, affordability might differ depending upon the compliance of the minimum wages act of the Maharashtra government. 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.
One of the reasons for this decrease was the transition of the pricing strategy from cost-based to market-based policies, a noticeable cause due to the implications deriving from DPCO (PTI, 2013). The legal framework for intellectual property rights, i.e. the law and policy relating to patent protection and/or compulsory licensing, also affects the availability and pricing of pharmaceuticals, especially innovative and biologic drugs. Further, international pricing trends and regulations, as well as global supply chain disruptions, have immense influence on local drug pricing and availability in India, particularly for those drugs for which there is no local production and reliance is purely on exports.
The mean drug availability at PMBJP stores located in the vicinity of PHCs and district/rural hospitals was 51% and 61% respectively. 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%). Aside from collecting primary data, secondary data such as the price information of some PMBJP medicines and their leading brand name counterparts (in terms of market share) were gathered from the web portals of PMBJP and MedGuideIndia.com respectively. The website provides information on a wide range of drugs available in the Indian pharmaceutical market including their prices.
Regulations to support mandatory generic prescribing and generic substitution by pharmacists are needed. The cardiovascular disease (CVD) treatment market is one of the leading pharmaceutical markets in India, as the country accounts for one-fifth of all cardiovascular-related deaths worldwide. According to national statistics, India’s cardiovascular market was worth $2.52bn in 2022 and is forecast to reach $4.26bn by 2030. Consequentially, there is a strong emphasis on generic CVD drugs over branded drugs due to their affordability.
Hence, consumer awareness for the generics, variety of trade names available in the market, and price variation is very limited. Hence, there is need to conduct a study that can document the price structure and quality of the branded product and their branded-generic versions manufactured in India. Difference in price-to-patient was not as huge as it is expected for generics but margins for retailer were very high for branded-generics.
There are a large number of drugs that went off patents, providing many pharmaceutical companies with huge opportunities to enter the market. The increased inclination toward the health insurance sector and the growth of per capita income have expanded the purchasing capacity of patients/consumers, providing a long-term perspective for the development of the pharmaceutical sector. Hence, India can become a global outsourcing hub for pharmaceutical products due to its low-cost production ability combined with FDA-approved manufacturing plants (Vaidya et al., 2018). While drug pricing control on essential medicines is critical to ensure affordability and access to pharmaceutical products, it may have an adverse effect on value creation and innovation in pharmaceutical products. Therefore, another key policy aspect which ought to operate in tandem with drug pricing is drug reimbursement, i.e. rules and processes that determine the amount and conditions under which healthcare payers will pay for pharmaceutical products.
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.
(2016), “R&D, technology transfer and productivity in the Indian pharmaceutical industry”, International Journal of Innovation Management, Vol. The infrastructure of the industry and the R&D capabilities of domestic businesses have improved considerably in recent years, but many challenges remain, mainly related to pricing regulation, sector fragmentation and intellectual property. Not surprisingly, all of them, directly or indirectly, concern patents, which are central issues of debate in the national industry. Tiered pricing, also known as differential pricing , is often practised by pharmaceutical companies based on the ability of countries to pay, but Hill was unavailable to comment. Several factors have contributed to this significant growth of the healthcare industry in India – which includes a combination of public sector initiatives and expansion of private-sector enterprises.