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].

Sun Pharmaceutical: PALENO (Palbociclib)

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.

Evolution of PMBJP

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.

Availability of essential generic medicines at pmbjp pharmacies/ kendras across mumbai and palghar region

Hence, the critical issues that affect the quality of generic drugs are purity, potency, stability, and drug release, and these should be controlled within an appropriate limit, range, or distribution to ensure the desired drug quality. EHR systems with e-prescribing capabilities help providers identify cost-saving Abiraterone price philippines opportunities, such as more affordable generic or therapeutic alternatives. With additional tools like coupon finders, EHR systems can locate the best local prescription prices and provide real-time data for drug-specific directions, enabling providers to offer more personalized and budget-friendly care.

A Cost Analysis of the Jan Aushadhi Scheme in India

India’s healthcare market is dynamic and rapidly expanding, driven by economic growth, demographic changes and government initiatives. While significant challenges remain, particularly in terms of infrastructure and workforce distribution, the opportunities for growth and improvement are substantial. The datasets, including the qualitative dataset concern the implementation of a government scheme related with specific places and actors, making anonymising and removing any potentially sensitive observations, especially from interview transcripts difficult. Some physicians reported that they face difficulties in prescribing generics as patients have negative attitudes towards cheaper medicines.

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

• The Indian pharmaceutical industry has been living a situation of constant growth in recent years, as shown by statistical analyses of the field at the descriptive and inferential levels.
• The latter models face relatively more constraints to meet district- level demands, often resulting in delays and disproportionate local purchases.
• 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.
• The ASHP considers regional and local shortages too, a measure that doctors and health economists consider more relevant to the quality of care provided to patients.
• 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.
• A sustained, affordable supply of generic medicines is essential for health — as well as for preventing the next pandemic.
• EHR systems with e-prescribing capabilities help providers identify cost-saving opportunities, such as more affordable generic or therapeutic alternatives.

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.

Successful market access

• Qyobo is a software startup that collects pharmaceutical data from dozens of national and international databases to provide a picture of the drug supply chain that is not only superior to what the patient or the doctor sees, it is probably superior to the knowledge of the FDA.
• 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.
• For scheduled medicines, the NPPA pricing formula sets the 8% mark-up for wholesalers and 16% for retailers.
• There are increased expectations regarding both the production amount and the trade balance value.
• There is a concrete risk of confusion in the minds of patients/consumers regarding which drug should be considered due to this price variation.
• Data from the American Society of Health System Pharmacists (ASHP) shows that the number of drugs in shortage reached 301 at the end of 2023, one of the highest figures since data began.

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 low-down on health insurance ads during open season

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.

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Further, the healthcare professionals stated that generics do not yield good results while treating for acute conditions like bacterial infections, but they expressed confidence in generic medicines for chronic illnesses. Apart from the limited coverage of essential medicines and the significant presence of Fixed dose combinations (FDCs) in the PMBJP medicine list, the availability of surveyed essential drugs was also found to be low (47%) in PMBJP outlets. Across Mumbai and Palghar districts, around 50% and 42% of medicines were found to be out of stock for the period of 3–6 months respectively.

PALENO (Palbociclib) Generic Online in India

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 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].

Medicine pricing in India

• Also, a formulary containing the details of therapeutically interchangeable products is available for reference [36].
• The country was the single largest supplier of pharmaceutical products to Africa in 2018, and accounted for a fifth of the continent’s pharmaceutical imports.
• The analysis of marketed AMLO containing FPPs was exercised using a validated analytical method.
• 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%).
• The implementation of market-based price ceilings on a set of essential medicines, including on-patent and generic drugs, is a form of pharmaceutical price control applied by the Indian Government and intended to make drugs accessible to people at an affordable price and address drug shortages.
• For example, augmentin brand gives effective and quick results as compared to its simple generic amoxicillin clavulanate version.
• These three pharmaceutical categories alone are worth approximately 60% of the entire Indian pharmaceutical production.
• Since then, through global partnerships and country-led efforts, about 19 million people living with HIV in resource-constrained settings are now receiving TLD, according to the Clinton Health Access Initiative.

The quotes are being sought for generic drugs, although they are also allowed for imported or combination drugs by their trade or brand names. Cipla’s introduction of Cabotres when it launch is constantly making cancer treatments more accessible and affordable. The brand’s commitment to quality ensures that Cabotres is a reliable option for patients. “Now what happens is most of the time we don’t get adequate supply of these Jan Aushadhi products in definite time. Hence, government can increase number of wholesalers, distributors in the scheme to improve availability of medicines at the stores.” (P9). The survey was undertaken to find out the extent of availability and stock-out of medicines at PMBJP outlets.

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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.

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.

PREVALENT STATE MECHANISMS FOR PROCUREMENT OF MEDICINES

For the industry to retain its position as the largest generic drug supplier, it must continue improving regulatory compliance of manufacturing sites, as well as developing cost-effective and high-quality manufacturing processes. Reducing the industry’s dependence on the imports of APIs, key intermediates and starting materials will be key to sustaining its global leadership position. Despite the changing dynamics across the global industry, there is a lot to be positive about. India’s export growth for FY 2019 was one of its highest growth rates in the last decade. While margins may be reducing due to the extra costs and regulatory fees, on average, Indian drugs cost 33% less in comparison to their U.S. counterparts, bringing much needed relief to the notoriously high healthcare prices in the United States and elsewhere.

Products

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 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.

A SURVEY BASED STUDY IN CURRENT SCENARIO OF GENERIC AND BRANDED MEDICINES

A sustained, affordable supply of generic medicines is essential for health — as well as for preventing the next pandemic. Yet, the stricter intellectual property rules EU negotiators propose for India and Indonesia would undermine — and even thwart — access to affordable medicines in developing countries. The production of pharmaceuticals, medicinal chemicals and botanicals for health-care has been growing yearly in India.

• It is another reason why India’s position as pharmacy of the world has a value far beyond its borders.
• These prices can fluctuate based on the pharmacy and specific dosage requirements like Cabozantinib 20mg, 40mg and 60mg.
• Cabotres is the medicine by the Cipla brand that harnesses the therapeutic benefits of cabozantinib.
• In the past few years, expectations of regulatory organizations around the world have increased.
• 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.

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 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.

But India’s thriving generics industry could only do this because these medicines were developed before it had to implement the 1995 World Trade Organization (WTO) agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). But just to begin to pursue that objective requires more information than the FDA has today. The FDA has pretty much admitted that it is ineffective at managing America’s generic drug shortage problem, pointing the finger at the drug and medical device makers. In May 2022, FDA Director Dr. Robert Califf admitted in congressional testimony that supply chains are too narrow and too dependent on single sources. Another example is in contrast dyes, which are administered to patients before CT scans to improve health care professionals’ visibility of the circulatory system and help identify blood clots in cancer patients.

The current regulations are not yet designed to promote patent filings (Chaudhuri, 2019), and this situation strongly impacts the internationalization perspective. The Indian pharmaceutical industry is among the top producers in the world, supplying over 50% of the global demand for various vaccines, 40% of generic demand in the USA and 25% of all medicines in the UK (IBEF, 2020). Although the sector still shows more relevant values concerning production quantity than production turnover, pharmaceutical exports are expected to reach US$16.28bn in FY20 (ibidem).

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.

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.

The customer will have to present a medical prescription (legal) prescribed from a doctor. Contrast this with China, which is reportedly using its own vaccine projects as a commercial negotiating tool with countries who stand to benefit. It is another reason why India’s position as pharmacy of the world has a value far beyond its borders. SII is also partnering with US firm Novavax to develop and distribute the NVX-CoV2373 vaccine in collaboration with CEPI and COVAX.

• The result is that Ireland is the number one source by dollar value for U.S. pharmaceutical imports (Table 2).
• In fact, we did carry out prescription audit as part of the overall study, but its findings are not included here.
• System leaders, we supported a 2016 report acknowledging governments’ limited policy space to enact actions regarding access to medicines due to TRIPS-plus measures in trade deals, which undermines their ability to protect the human right to health.
• India must adapt to maintain its position as the world’s largest supplier of generic drugs.
• 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).
• 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.
• However, JAS never really took off; there were only 99 JAS outlets across India which were selling 131 medicines till 2014.

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.

Because more than half of India’s pharmaceutical exports are to highly regulated markets such as the United States, Indian manufacturers must comply with strict U.S. Food and Drug Administration (FDA) guidelines that include regular and rigorous inspections to ensure compliance. However, some key obstacles remain to be addressed for the country to fully realise the remarkable growth potential of its healthcare market. These are limited resources, infrastructure deficits, shortage of health professionals, access and affordability of medicines in rural and semi-urban areas, as well as lack of public awareness about available healthcare benefits. Some reported that quality issues are hindering the uptake of unbranded generics, and asked for strong regulatory framework for quality control. “When we write any generic medicines and if it is not available in hospital pharmacy, patients have to go to other pharmacies to buy it.

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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.

The five medicines chosen were alprazolam, (0.25 mg), cetirizine (10 mg), ciprofloxacin (500 mg), fluoxetine (20 mg), and lansoprazole (30 mg). The lack of well-established linkages between procurement and logistics often results in inefficient inventory management practices (temperature control, storage space, adherence to stock movement protocols, IT- enabled inventory management). Additionally, poor quality assurance mechanisms (empaneled labs for testing, accreditation, timely reporting), and insufficient supply down to the district and peripheral level facilities were observed in some states. The analysis of marketed AMLO containing FPPs was exercised using a validated analytical method. For each selected brand of AMLO FPP, two strips containing 20–30 tablets (in total), were taken. Further, individual tablets were weighed, triturated followed by weigh equivalent to 2.0 mg of AMLO besylate was taken and diluted to 20 mL with selected diluent.

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. Nevertheless, they claimed that generic medicines are not as effective as branded medicines. They also believed poor bioavailability is the reason why the price of generic medicines is less than branded medicines. Most of the blockbuster drugs that fuelled Big-Pharma profits over the last two decades went off patent in the last few years, opening the market to generic copies.

So, what needs to be done beyond the practical steps being taken by Indian generic manufacturers to embrace a culture of quality? Importantly, beyond presenting an evidence-based case that generics manufactured in India are efficacious and safe, we must also demonstrate the enormous good these drugs provide to consumers. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition.

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.