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.

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India must adapt to maintain its position as the world’s largest supplier of generic drugs. COVID-19 underlines India’s importance to developing countries when it comes to drug access. Healthcare providers can help patients make informed medication decisions by offering personalized care and professional insights on cost and effectiveness. With tools like EHR systems and patient portals, they can easily track preferences, share resources, set up payment plans, and discuss treatment options. Balancing affordability with individual needs helps providers deliver patient-centered care that builds trust and improves health outcomes. One of the top reasons Americans choose generic medications is the potential for savings.

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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. Some brands of antibiotics are found to be more effective as compared to their generic counterparts. For example, augmentin brand gives effective and quick results as compared to its simple generic amoxicillin clavulanate version. But generic medicines for diabetes and hypertension are very good and cost effective for the patients for chronic illnesses.” (PuP3).

EVALUATION OF PRICE DISPARITY AMONG GENERIC MEDICINES IN INDIA

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.

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The Indian Pharmaceutical Alliance (IPA) represents 23 research-based national pharmaceutical companies focused on patient health and safety with a commitment to provide quality drugs to patients throughout the world. Even more surprising is the fact that more than a third of these drugs were likely manufactured in India. This country’s ability to produce affordable, generic drugs has led to its reputation of being the “pharmacy of the world.” By export volume, India is currently the largest provider of generic medicines globally, supplying 18 percent of global generic medicines. Recently, in March 2024, the Indian Government constituted a five-member Committee to oversee reform efforts for the pricing of drugs and medical devices and supervise the drafting of a new Drugs and Medical Devices (Control) Order. The primary task of the Committee is to strike a balance between pricing and availability of essential medicines while offering incentives to the industry to foster growth and exports.

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The regulatory framework in India for pharmaceutical pricing and reimbursement aims to ensure fair pricing of essential drugs and provision of adequate reimbursement mechanisms to facilitate patient access and simultaneously also promote innovation and enhancement of production capacity of epclusa price philippines healthcare providers. Lack of access to essential medicines is a major health policy concern globally, even more so in the low-and middle-income countries. According to the World Health Organisation, a whopping 2 billion people worldwide are not having access to essential medicines [1].

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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.

NICE may be ‘systematically undervaluing’ medicines for severe conditions, says ABPI

Chinese pharma has also placed much emphasis on using AI and genetics for developing new drugs. This enables firms like XtaIPi to identify thousands of molecules which could be used to treat a disease with fewer resources and time. Jean Lee is a content expert with a background in journalism and marketing, driven by a passion for storytelling that inspires and informs. 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. For many Americans, the decision between generic and brand-name medications often comes down to cost.

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• We conducted a total of 16 in-depth interviews (IDIs) – 10 with pharmacists and 6 with physicians.
• 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.
• Food and Drug Administration (FDA) guidelines that include regular and rigorous inspections to ensure compliance.
• 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%).
• 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.
• From a theoretical point of view, the contribution of intellectual capital to the financial stability and economic prosperity of the pharmaceutical industry, most of all due to patents as immaterial assets deriving from human, structural and/or relational capital, seems indispensable (Festa et al., 2020).

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 informed consent, the interviews were audiotaped while the first author also took notes. Recordings were translated from the local languages such as Marathi and Hindi in English, and then transcribed verbatim. We used thematic analysis [21], which warranted reading and rereading the transcripts in order to generate the potential themes.

PALENO (Palbociclib) Generic Online in India

The price the NHS pays for some generic cancer drugs has risen by between 100% and more than 1,200% over the past five years, according to research presented at the European Cancer Conference held in Amsterdam. Consider that the receipt of an FDA “warning letter” often results in staff changes at the most senior levels of leadership at Indian generic companies. This accountability occurs even in incidences where the FDA has come down hard on companies for even the smallest of deviations.

Teva Announces Strong Financial Results for the Third Quarter of 2024, led by Generics Performance a…

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.

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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.

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.

• India, meanwhile, has developed a $15-billion generic-pharmaceutical industry, with labour costs about one-tenth of those in Canada.
• Despite the changing dynamics across the global industry, there is a lot to be positive about.
• 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.
• The production of pharmaceuticals, medicinal chemicals and botanicals for health-care has been growing yearly in India.
• With over 165,000 providers and 190 million patient records, Tebra is redefining healthcare through innovation and a commitment to customer success.

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 second reason for not regulating prices is that the pharmaceutical industry is a major part of the U.S. economy, generating more than $700 billion in annual sales ($600 billion more than the pharmaceutical industry in the second-ranked country) and supporting more than 4 million jobs. In addition, prescription drugs are a significant export category, representing percent of all U.S. exports while showcasing America’s innovative capabilities in ways that save and improve lives globally. While it is essential to prioritize streamlining procurement mechanisms, it is equally important that such provisions effectively translate to better access and availability of medicines across all levels of care. The state experiences underscore the need towards establishing robust tracking mechanisms for the efficient utilization of resources.

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.

Schondelmeyer, a professor of pharmaceutical management and economics at the University of Minnesota, testified on drug shortages before the House Ways and Means Committee in February, urging the Congress to take action to address the growing problem of generic drug shortages. After developing the above topics, it is possible to implement a potential framework to oversee the current and future conditions of the Indian pharmaceutical industry. Naturally, the peculiar situation is considered due to the COVID-19 pandemic, whose impact in the near and far future may greatly influence scenario analysis. For these reasons, we opted for a narrative SWOT analysis, similar to other studies (Vandevelde and Halleux, 2017; Septinaningrum and Nugraha, 2019; Cowx et al., 2010). Special economic zones (SEZs) are popular because they provide tax benefits for companies. To create new business opportunities for the pharmaceutical industry, SEZs can be a powerful option, especially if established near airports, stations and ports.

Third, the unemployment rate is quite high (6.5%) and absolute poverty is widespread in the country (23%) [33]. As a large section of the population continues to live in hand to mouth condition, the PMBJP medicines may still be unaffordable to many people. Findings of the present study indicate that both the branded and branded-generic versions of the five “paired” medicines had identical quality and they fulfilled all the criteria prescribed by the statutory standards. Hence, the general notion and doubt regarding the quality of the branded-generic version of medicines needs to be erased conducting more such studies and publishing them widely.Suitable changes in the drug price policy may be made to have lower prices for branded-generic versions.

Both cabozantinib and sorafenib are multi-kinase inhibitors used to treat advanced cancers like RCC and HCC. Common side effects include gastrointestinal issues and fatigue for both drugs, but specific side effects and patient responses may vary. S&S was the first law firm in India to challenge the constitutional validity of the provisions of the Drugs (Price Control) Order, (DPCO) 2013, representing 15 pharmaceutical companies before the Delhi High Court in this groundbreaking case. In Mumbai region, among the surveyed medicines which were not available at the time of survey, around 50% were out of stock for the period of 3–6 months while about 38% of medicines were out of stock for the period of less than 1 month (Fig. 4). Around 50% of antimicrobials, antidiabetics, antiepileptics and consumables were out of stock for the period of 3–6 months.

An in-depth exploration of the global healthcare ecosystem with timely research, insightful analysis, and scientific expertise. Nevertheless, India has a massive population with low per capita income, and stricter patent rules would probably mean less access to medicine for a significant part of the population. The affordability of pharmaceuticals is a critical challenge in India and South Asia in general, raising questions of life and death. DPCO is a blessing for those who use medicine and has boosted their hopes of the availability of cheaper and better medicines, leading to a great psychological impact on consumers (Venkiteswaran, 2013). For example, heart attacks and cardiac arrests are increasing in India, and treatments for these newly emerging diseases are very expensive.

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. Professor Schondelmeyer told us that the U.S. is now dependent on India for 45% of the generic medicines we buy. One key reason generic drug production moved (and is still moving) to India is the high level of subsidies offered by the Indian government to drug manufacturers and exporters. Another reason is that India has not joined the International Council for Harmonization, a body that sets global standards for drug production. It also does not have national standards for drug production, instead leaving pharmaceutical regulation to its 38 states.