How To Get Generic Drugs and Low-Cost Prescriptions

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.

Pharmaceutical pricing and reimbursement

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.

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There is a robust low-cost manufacturing setup available in India, where the industry can produce drugs at a cost that is 40%–50% lower than the rest of the world and sometimes even as much as 90%. There is also a presence of good technical and technological expertise together with the availability of low-cost skilled human resources. The growth of the middle-class population is leading to a new lifestyle, providing a huge market for lifestyle drugs, which are currently the lowest contributor to revenues from the sector.

Tools & Resources for Caregivers

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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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].

A Cost Analysis of the Jan Aushadhi Scheme in India

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.

• 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%).
• Haiti’s plight is a reminder of the international community’s wider and longer-term responsibilities to the country.
• These savings are a driving factor for many, particularly as medication prices continue to rise in the US.
• Professor Schondelmeyer favors creating what he calls “concentric circles” starting with the most at-risk drugs, which start with drugs produced in at-risk countries in only one factory, then move out to include those produced at multiple facilities or multiple countries and those in current shortage.
• Thus, not granting a patent for Glivec really hasn’t prevented patients from getting this life-saving medication.

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The sale of PMBJP medicines is mainly dependent on the prescription of generic drugs by the physicians. But doctors from private health care facilities hardly mention the generic or chemical names of drugs on the prescription slips and only 60 percent of the prescriptions from public health facilities contain generic names [27]. 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. In low-income and middle-income countries (LMICs) such as India, patients and healthcare providers (both public and private) often struggle with high and increasing pharmaceutical prices due to low and weak health insurance coverage, which restricts patient access.

Generic drug

The study findings show that PMBJP’s unbranded generics offer great opportunities for substantial cost savings. But, in order to fully realise the potential of this scheme, some policy actions are urgently required. Fourth, PMBJP’s medicine procurement and distribution policies must be reviewed to address the supply chain issues. Moreover, there is a need for major pharmaceutical policy reforms to promote generic medicines in a big way.

Drug Price List: Generics and Matching Brands

Indian industry and government have also suggested manufacturers are being unfairly attacked and subjected to overly stringent oversight by the Americans. 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. Dhiraj Singh/BloombergAbout one in 20 of Canada’s finished drugs are now made in India – roughly 20 million prescriptions a year. When Health Canada launched a new “Inspection Tracker” website this month listing concerns about standards at pharmaceutical factories, 11 of the 15 plants on the list were in India, seven of them now subject to import restrictions. As a sign of the shift, Canadian generic giant Apotex Inc. locates about 10% of its production at two Indian factories.

CONVERGENCE OF NATIONAL HEALTH PROGRAMMES

Moreover, the margins that Indian suppliers can earn in the United States are higher than those they can achieve in the more saturated Indian market. There are also ample opportunities presenting themselves across Asia for India’s pharma players, especially as talks of a free-trade agreement (FTA) with the Eurasian Economic Union and Regional Comprehensive Economic Partnership in Asia progress. Although the market continues to diversify with new players springing up from within India as well as internationally, a handful of national players continue to have a sizeable footprint in the domestic and international generics industry. Piramal, Torrent, Cipla, Sun Pharma, Aurobindo, Dr. Reddy’s and Glenmark, to name a few, represent a number of the success stories in India’s pharma industry landscape. With the biopharmaceutical industry rapidly evolving across the globe, inorganic growth has been an important part of company strategy for expanding footprints, retaining market share and moving into new areas of the value chain. For example, Torrent acquired Bio-Pharma Inc. (BPI) in early 2018 – its first acquisition of a manufacturing site outside of India – to diversify and strengthen its product pipeline.

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.

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.

Indian pharma is being squeezed – and it’s bad news for drug access in developing countries

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.

• However, caution must be exercised while interpreting affordability because of the following reasons.
• Andrew Hill, senior research fellow in pharmacology and therapeutics at the University of Liverpool, told the conference on 27 January 2017 that these data provide a “reliable indicator of the amount of money which the UK NHS pays for drugs”.
• Lack of access to essential medicines is a major health policy concern globally, even more so in the low-and middle-income countries.
• 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.
• 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].
• The qualitative data was collected to understand the perception of the doctors and pharmacists on generic medicine as well as their views on PMBJP scheme.

Following this, we picked the essential drugs from the PMBJP product basket, which were found on all the above-mentioned lists. Of the 35 surveyed medicines, 22 were from the first (for global burden of disease) and second (specific to Southeast Asia) core medicine lists recommended by WHO/HAI methodology and 13 were drawn from the NLEM, 2015. Information was obtained on the availability of essential medicines at PMBJP outlets across primary, secondary and tertiary levels of health care delivery system against the basket of 22, 28 and 35 medicines respectively selected according to therapeutic category. Among the medicines included in the survey, 22 are universal medicines, which are supposed to be available at all levels. Apart from the universal medicines, 6 more medicines were considered at the secondary level, while, in addition to the medicines at the primary and secondary levels, 7 other medicines were assessed for availability at the tertiary level. The list of medicines and consumables has been provided as an additional file (Additional file 1).

A narrative strengths, weaknesses, opportunities and threats analysis of the Indian pharmaceutical industry

With these tools, providers can offer personalized recommendations, share cost comparisons, and provide educational materials through secure messaging. This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. Haiti’s plight is a reminder of the international community’s wider and longer-term responsibilities to the country. India’s negotiators note they’ve “firmly communicated” that data exclusivity and patent term extensions are “redlines” for them in these negotiations. Last year, the FDA allowed the cancer drug cisplatin to be sold in the U.S. from an uninspected lab in China.

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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.

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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.

More papers with manufacturing and drug testing data were shredded and tucked away in plastic bags under a stairwell, indicating that Intas executives had manipulated data and tried to cover it up. This scale has been essential in driving production efficiencies and achieving the lower sustainable pricing secured today, strengthening country-led efforts to reach all people living with HIV who need TLD. Empowering patients to personalize their healthcare and connecting them to caregivers has the potential to change the care delivery paradigm. Building on a rich history of developing AI for healthcare, IQVIA AI connects the right data, technology, and expertise to address the unique needs of healthcare. By submitting this form, I agree to receive logistics related news and marketing updates from A.

Generics cost less on average and often prove just as effective, making them a practical choice for budget-conscious consumers. However, trust in brand names and appealing product packaging, especially among younger generations like Gen Z, are affecting purchasing decisions. When choosing between generic and brand-name medications, Americans face decisions influenced by both their wallets and their health needs. With medication costs rising, many are looking for ways to save money without compromising their well-being.

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.

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.

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.

As mentioned earlier, overall, mean drug availability was found to be around 51% with highest at PMBJP pharmacies at secondary level of care i.e., at peripheral hospitals (52.5%), followed by tertiary level i.e. medical college (50.8%) and primary level i.e. health post (48.7%). More than 70% of PMBJP pharmacies across all levels of care had the medicines in categories of cardiovascular, analgesics, antacids and vitamins. On the other hand, the availability of antiasthmatic and antipsychotic medicines was very low-only a third of the PMBJP pharmacies had them. Anticancer and electrolyte balancer were not available in more than four-fifth of PMBJP stores, while half of the pharmacies had antimicrobial, antidiabetics, palliative care medicines, anti-epileptics.

The prepared sample was filtered using a 0.45 μm membrane filter and injected into a chromatograph in duplicate. The chromatographic achievements and relationship models were developed using a licensed version of SPSS 28.0 (SPSS Inc., Chicago, IL, USA). Sequentially, the assay result biasness was ± 5%, and the quantitative value of genotoxic impurities equal to or more than threshold of toxicological concern limit was counted as acceptable quality attributes for AMLO besylate-containing FPPs. The European Parliament has similarly recognized the importance of medicines as global public goods, and it has repeatedly called on the Commission to exclude TRIPS-plus requirements in trade negotiations — much like in its 2021 resolution to ensure all HIV antiretroviral treatments are affordable.

Affordability was calculated on the basis of number of days of wages that an unskilled worker requires to expend for a standard course of treatment for common acute and chronic conditions [22, 23]. 5, the cost of the treatment with PMBJP medicines was between 0.01 days’ wages and 0.48 days’ wages, suggesting that unbranded generic medicines at PMBJP pharmacies were relatively affordable than their branded counterparts. At 0.01 and 0.5 day’s wage, diazepam for treating anxiety and diclofenac for treating arthritis respectively were the cheapest generic medicines at PMBJP stores. The maximum price differential was observed for atorvastatin and clopidogrel, used for treating hypocholesteraemia and clopidogrel respectively, indicating that the unbranded medicines can be fairly affordable.

All these factors are making the larger Indian players conscious of how best to evolve from their current offering. “I would also advise to focus strongly on reliable quality and being ahead of the curve on FDA requirements, to rapidly establish yourself,” he continued. The price ceiling policy has been in place for more than two decades, but it has neither been very successful nor free of consequences for pharma companies. Instead of the existing price controls, other mechanisms such as promoting competition among local manufacturers and increasing public healthcare spending should be focused on. 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. India’s independent drug pricing regulator, the National Pharmaceutical Pricing Authority (NPPA), has issued a marginal increase of 0.0055% to the maximum retail price (MRP) of medicines included in India’s national list of essential medicines (NLEM), which took effect on 1 April 2024.

The Indian Government in its interim Budget for financial year 2024–2025 has allocated an amount of Rs 90,658.63 crores to the Ministry of Health, which constitutes a 12.59% increase from last year, reflecting the Government’s prioritisation of development of the Indian healthcare system. That’s what they call hepatitis C, which is so common in parts of India’s Punjab state that the tailor-shop gossips might not be off base in their estimate. Drugmakers have made the village of Lande Rode one of the theaters in a battle to grab market share for sofosbuvir, a miracle cure that Gilead Sciences Inc. sells in the U.S. as Sovaldi at a retail price of $1,000 a pill. Gilead licensed 11 Indian companies to make generic versions, and they sealed marketing deals with others.

Effective systems are those which are not only apprised of local and aggregate demands for medicines but also have commensurate capacities to meet the demands. In this regard, the government of India has revised the national list of essential medicine to also include a newer range of services to ensure that healthcare facilities are equipped to provide services aligned with changing health needs.5 Likewise, states need to update their EMLs customized to their needs. Besides adequate HRH being one of the prime determinants for ensuring services and medicines, the plurality of job roles across the cadres brings out additional aspects for inspection and redressal. 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. Likewise, cost-effective, affordable, and quality services are linked to mechanisms promoting rational and scientific prescription practices of authorized providers.

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 velcade price in mexico 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.