A sample list of generic drugs available in India along with their indication is depicted in Table 1. Adequate infrastructure is one of the prerequisites for efficient storage and distribution of medicines. Progress in the direction of infrastructure expansion and strengthening improves both service delivery and availability of medicines for the end-users. When faced with challenges of infrastructural shortfall to store and dispense medicines, a few states reported adopting alternative measures to ensure the distribution of medicines. For instance, there were reports of users facing constraints in accessing medicines at these pharmacies due to stock out of generic medicines and distribution of near-expiry or expired medicines and branded medicines, which invariably resulted in OOPE.
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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].
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- The sale of PMBJP medicines is mainly dependent on the prescription of generic drugs by the physicians.
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- 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%.
- With the availability and usage of generic drugs, the experience with these drugs will increase and it will be possible to compare the real-time effectiveness of generic drugs vis-à -vis brand drugs.
- We used thematic analysis [21], which warranted reading and rereading the transcripts in order to generate the potential themes.
- We, therefore, critically looked at the selection criteria for medicines included in the PMBJP list.
- By making bolder strategic moves in uncharted geographies, products, and technologies, Indian generic manufacturers seek to reclaim their position as a world-class provider of affordable, high-quality drugs.
In addition, views of healthcare professionals regarding unbranded generic medicine were studied. PMBJP, originally called Jan Aushadhi Scheme (JAS), was initiated by the United Progressive Alliance (UPA) Government in 2008. JAS, as is argued, is an important government intervention in the pharmaceutical market which would make the supply side effective particularly for consumers who are relatively responsive to price changes in making their purchasing decisions of medicines [15].
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- These concerns raise fears among patients that taking drugs made in India may result in unpredictable effects.
- This has resulted in growing its access, particularly in regions where treatment costs are a huge barrier to healthcare.
- The NPPA’s revised ceiling prices are calculated based on the average retail price of the named formulation(s) having a market share of 1% or more and being in accordance with the Drug Price Control Orders (DPCO) 2013.
- Similarly, pharmaceutical research and development can be carried out in India by global pharmaceutical MNCs.
- Therefore, a better distribution of medicine in the middle-income groups, who need medicines for several treatments, has been observed.
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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Descriptive and inferential analyses have been based on empirical data extracted from authenticated data sources. Subsequently, a narrative strengths, weaknesses, opportunities and threats analysis was performed based on the results of prior investigations and on qualitative data that were retrieved from a marketing intelligence examination to generate an overall scenario analysis. For example, melphalan to treat ovarian cancer cost the UK £1.82 for 2mg but in India its generic cost is 8p, a rise of 2,171%, the findings show. And ethinylestradiol to treat breast cancer which has a cost of 3p, according to the Indian generics website, cost the NHS £7.14 per tablet, a rise of 26,197%.
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SII separately has a manufacturing agreement with AstraZeneca to produce one billion doses of the Covishield vaccine, which the UK company is developing with the University of Oxford. Another challenge to India is wealthy countries protecting their pharma industries to ensure drug security. In August, President Trump issued an executive order that called for the elimination of drug imports, both as active ingredients and formulations. The price ceiling policy has been in place for more than 20 years, but it has neither been very successful nor free of consequences for pharma companies. Generic drug manufacturers do not have to spend extra money for drug discovery and preclinical and clinical trials. Generics are available at a lower cost; they provide an opportunity for savings in drug expenditure in a country.
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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.
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Addressing these infrastructure gaps requires substantial investment and collaborative efforts between the public and private sectors. Several factors have an impact on pharmaceutical patents in India, such as an increasing level of income, a consistent growth rate of the domestic economy, and rapid growth in the diffusion of better economic conditions. In this respect, however, foreign companies, as well as national companies, have been reluctant to invest in R&D in India (Ghai, 2010). Indeed, compared to developed nations, Indian pharmaceutical companies concentrate less on innovation, where they allocate less budget. For all the above-described reasons, they find manufacturing generic drugs more lucrative, as the outcome is guaranteed. Taking into account the above considerations, from a narrative and then qualitative point of view, a positive scenario for the Indian pharmaceutical industry can be highlighted, thus providing a response to RQ3 (“What are the most relevant SWOT for the future?”).
Medicine pricing in India
This provides an added advantage to the nation, which assists in developing processes that are cost-effective (Mahajan, 2019). DPCO has been a drawback for drug companies because it caused a decrease in their profit margins. Developing a medicine involves many aspects and is quite costly; hence, reducing their prices and profit margins has generated complex situations for pharmaceutical companies.
Generic drug prescribing experience
- 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.
- Faster decision making and reduced risk so you can deliver life-changing therapies faster.
- Recordings were translated from the local languages such as Marathi and Hindi in English, and then transcribed verbatim.
- 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 Indian government believes that the prices of lifesaving drugs shouldn’t be set by market forces.
Previous studies suggest that doctors’ negative perceptions regarding generics was a major constraint faced by JAS leading to its poor success [15,]. PMBJP’s stated objective is to gain the confidence of the medical community and consumers in unbranded generics by generating awareness through education and publicity. In this study, we have assessed the acceptability of PMBJP’s unbranded generics It is worth noting that the Indian pharmaceutical market is flooded with irrational or non-essential drugs. For example, majority of fixed dose combinations (FDC) that are marketed in India are therapeutically non-beneficial and unsafe for use [16, 17]. Notwithstanding, such FDCs account for more than 50% of the pharmaceutical formulations in India [17]. We, therefore, critically looked at the selection criteria for medicines included in the PMBJP list.
Availability of essential generic medicines at pmbjp pharmacies/ kendras across mumbai and palghar region
Our all-in-one EHR and billing platform delivers everything you need to attract and engage your patients, including online scheduling, reputation management, and digital communications. On average, generic medications cost approximately 79% less than their brand-name counterparts, offering substantial savings for consumers. For more commonly used medications, such as allergy relief, patients can save up to 83% per prescription by choosing the generic alternative. These savings are a driving factor for many, particularly as medication prices continue to rise in the US. State experiences highlight the importance of an established IT- enabled supply chain management system. 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.
Not only would this be bad news for India’s economy, it could make it harder for developing countries to access the medicines they need – threatening the UN Sustainable Development Goals in the process. In my last two articles, I discussed the recent surge in prescription drug costs, the reasons for the surge, and possible solutions. In this article, I’ll discuss why drugs frequently cost so much more in the U.S. than they do in other countries, why this disparity may be justified, and where we go from here. The government should ensure uniform quality across all the generics, and experts in the field of medicine say only then will doctors prescribe them willingly and with confidence.
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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.
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- 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.
- 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.
- The findings were appraised for relevance and validated for aptness by comparing the recent reports with the former ones to ascertain their contextual underpinnings.
- We further observed that the PMBJP drug (enalapril) used for the treatment of hypertension costs 725% lower per month than that of the reference branded-generic drug.
- In-depth interviews were intended to capture the perspectives of physicians and pharmacists on generic medicine in general and PMBJP scheme in particular.
- 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].
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.
Doctors regularly write angry letters to newspapers complaining that they cannot find the drugs their patients need. The heart of the problem is that we have driven prices too low, moved supply of generic medicines to a small number of the cheapest-of-the-cheap offshore suppliers, and sacrificed resiliency, manufacturing quality, and backup supply to chase the false god of low prices. Often hailed as the ‘pharmacy of the world,’ the Indian pharmaceutical industry is booming. It jumped from $40 billion in 2021 to an expected $130 billion in 2030, with projections hitting $450 billion by 2047. Beyond just keeping up with the demand at home, the Indian pharma industry commands over 20% of the global pharma supply chain and addresses approximately 60% of the worldwide demand for vaccines.
- Furthermore, the physicians expressed the need for developing a regulatory framework to contain the proliferation of brands by the firms operating in the Indian pharmaceutical market, which, according to them, pose a barrier in prescribing generic medicines.
- Although India’s case is lot more complex than most countries given the dominating presence of ‘branded’ generics in the Indian pharmaceutical market, it is worth learning from countries which achieved reasonable success in promoting the utilisation of generics.
- 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.
- 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.
- Beyond just keeping up with the demand at home, the Indian pharma industry commands over 20% of the global pharma supply chain and addresses approximately 60% of the worldwide demand for vaccines.
- But your income and the cost of the drugs you need may affect your ability to qualify for discounts.
- Making medicine accessible at affordable prices to the masses will require more than the somewhat piecemeal approach to generic drug promotion that currently exists in the form of PMBJP scheme.
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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 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.
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This would not only contribute to increased demand generation but also mitigate the burden of accessing quality medicines and consequent financial hardship. In the years of NRHM ( ), a few states like Kerala, Assam, and Jharkhand already had state policies for free services and medicines for BPL families. Under lenalidomide cost australia the NCD control programme, medicines were first made available free of cost in the states like Kerala and Tamil Nadu. 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.
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.
In a nutshell, with Paleno making its way into Indian medicine markets, the availability of Palbociclib is manifolded. With these generic drug versions by Indian brands, Breast Cancer patients with HR +ve, HER –ve have hope as they have better access to affordable treatment opportunities. The Indian medicine market has recently witnessed the launch of Palbociclib’s generic version – Paleno.
The purpose of this research is to anchor the debate on the relationship between the cost of medicine and the availability and affordability of quality generic medicines in mid to low-income countries. 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. Califf admitted that the stakes are too high (i.e. patients are sicker for longer and some are even dying due to drug shortages) he said the economics of the industry need to be altered to boost domestic production of generic drugs. Finally, the study has revealed in a current and future scenario analysis that the overall situation of the Indian pharmaceutical industry is positive at the economic, business and commercial levels, even though with many concerns. Most likely, however, the real challenge of the sector will entail a sustainable compromise between the legitimate expectations of innovative growth from the business point of view and the fundamental exigencies of affordable health from a social point of view.
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 scheme envisaged to sell generic medicines at affordable prices through exclusive outlets namely JAS stores across the country, starting from the district to sub-divisional headquarters and to towns and villages. However, JAS never really took off; there were only 99 JAS outlets across India which were selling 131 medicines till 2014. According to a study, the availability of medicines in JAS was abysmally low (33%) [13, 14]. Against this backdrop, in September 2015, the union government decided to expand its generic drug scheme called “Pradhan Mantri Bhartiya Jan Aushadhi Pariyojna (PMBJP)”, which envisaged making unbranded quality-assured generic medicinesFootnote 4 available at affordable prices to all people and especially the poor.
This study aims to access, analyze and highlight opportunities and problems of the Indian pharmaceutical sector in the broader national health-care industry. The recent changes in the field, at the institutional and corporate levels, have placed India in the spotlight of the global pharmaceutical market, but several threats and weaknesses could limit this expansion. It stands to reason that when the media raises concerns about the safety and scope of imported generic medicines, consumers question the quality of medicines essential to their health. These concerns raise fears among patients that taking drugs made in India may result in unpredictable effects.
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. 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. Though it is expected that both the versions should have the same quality but perception for any branded-generic is same among doctors and patients. 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.
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.
It was argued that, in case of market based ceiling price, medicines would be way too expensive than under the cost-based pricing approach followed by DPCO, 1995 [12]. That the prices of drugs fixed by NPPA remained high and majority of medicines including several essential and lifesaving drugs were kept out of DPCO posed a challenge in terms of making the drugs affordable and accessible to the people [12, 13]. The issue of access to medicine is a primary cause of the skewed healthcare utilisation pattern in India.