It meets 40% of the generic demand in the US and provides a quarter of all medicines in the UK. It has undergone a remarkable transformation, evolving into a dynamic powerhouse driving healthcare advancements worldwide. Interestingly, India is the biggest contributor to UNESCO, with a share of over 50-60%. The principal aim of this study is to conduct an explorative investigation of the current and future situation of the Indian pharmaceutical industry, with the development of a narrative SWOT analysis to generate an overall scenario analysis.

EVALUATION OF PRICE DISPARITY AMONG GENERIC MEDICINES IN INDIA

On top of all these problems is the large and growing national security risk as more and more drugs become dependent on suppliers from China. Even the common knowledge that we are becoming dependent on a small number of large drug companies for generic drugs understates the dependency on China. 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.

Diversity Fuels Innovation in Teva’s R&D Management Team

• 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).
• Empowering patients to personalize their healthcare and connecting them to caregivers has the potential to change the care delivery paradigm.
• Of the 10 drugs already on the market and recalled because of quality defects since New Year’s Eve, four were made in Indian factories, Health Canada says.
• Generic production has moved increasingly to India and China as the lowest-cost manufacturing centers in the world.
• 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.
• In response to this growing regulatory environment, pharmaceutical companies in India continue to strengthen their processes, while improving automation, operating procedures and quality management systems.

Furthermore, India’s Department of Pharmaceuticals (DoP) recently announced plans for a new pricing reform for pharmaceutical products and the induction of price control for medical devices, which would induce more stringent rules over pharmaceutical pricing. Such measures risk decreasing sales of price-controlled products, which in turn could discourage multinational pharmaceutical companies from launching new products in the Indian market. In India, a dispensing pharmacist is not authorized to substitute a branded medicine with a branded-generic (or generic) as per the provisions under Rule 65 of the Drugs and Cosmetics Act, 1940 and Rules, 1945, which also add to the patient’s burden.

Generic drug

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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• Indian pharmaceutical companies have been a critical partner in the supply of these drugs by providing affordable medicines for major health conditions that enhance patient access, improve management of health conditions, and bring savings and resilience to the overall health system.
• 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.
• Similarly, a defense strategy seems realistic when combining the experience with generic drug production with DPCO limits, thinking about a competitive strategy based on cost leadership, which may be sustainable considering the huge population of the country.
• “Established in 1992, BPI has a proven track record in the research & development and manufacturing of oral solutions, suspensions and suppositories,” underlined Jinesh Shah, director at Torrent Pharma.
• This enables firms like XtaIPi to identify thousands of molecules which could be used to treat a disease with fewer resources and time.

However, it must be noted that Novartis provides Glivec free of charge to 16,000 patients in India, roughly 95% of those who need it via the Novartis “Glivec International Patient Assistance Program”. The remaining 5% are either reimbursed, insured, or participate in a very generous co-pay program. Thus, not granting a patent for Glivec really hasn’t prevented patients from getting imbruvica cost mexico this life-saving medication. Dr. Reddy’s Laboratories, a well-known global pharmaceutical company, manufactures Cabzored as part of its oncology treatments. (launching link) It is designed to offer a cost-effective and accessible treatment option for patients with specific types of cancer. In fact, the physicians have also cited other reasons for not prescribing generic medicines.

• To maximize the outcome of this progress, the Global Fund, together with PEPFAR and the National Department of Health, Republic of South Africa, will host the annual ARV Buyer Seller Summit in Maputo, Mozambique, starting on 30 October.
• But branding and marketing cost makes the medicines expensive which leads customers to buy medicines at a higher price.
• According to national statistics, India’s cardiovascular market was worth $2.52bn in 2022 and is forecast to reach $4.26bn by 2030.
• Further, international pricing trends and regulations, as well as global supply chain disruptions, have immense influence on local drug pricing and availability in India, particularly for those drugs for which there is no local production and reliance is purely on exports.
• The USA represents a large pharmaceutical demand as companies obtain substantially higher prices for medicines sold in that market.
• 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.
• The principal aim of this study is to conduct an explorative investigation of the current and future situation of the Indian pharmaceutical industry, with the development of a narrative SWOT analysis to generate an overall scenario analysis.
• A “pair” of product from the same company was chosen to appreciate the price structure and mark-ups for the two versions.
• Financially poor people use India’s public health-care system and reserving land in cities for public facilities will serve the population’s low-income earners.
• 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.

How Can We Use AI to Make Medicines More Efficiently?

A challenge is also posed by the exponential growth in population, and epidemiological changes in the population resulting from shift in lifestyles. Thus, there is a continuous boost in the demand for pharmaceutical products and a consequent strain on the supply chain. The growth in population also affects reimbursement policies, since the Government has to allocate an increasing number of funds to public health insurance schemes and may be affected by budgetary constraints.

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The pharmaceutical company – Sun Pharma is one of the manufacturers of this generic drug for advanced metastatic breast cancer treatment. The USFDA has been more critical whilst carrying out inspections of manufacturing facilities, giving warnings to a number of Indian national players. Moreover, companies exporting to the United States and Europe will need to become fully compliant with the track and trace requirements being imposed by various regulatory agencies to ensure quality pharmaceutical imports by preventing counterfeiting. Drug Supply Chain Security Act (DSCSA) was enacted in Congress on November 27th 2013 with the aim of making drug products safer by creating a framework for enabling pharmaceutical product traceability, its implementation has been far slower than expected. Even though serialization has not been completely enforced yet, Indian players should be prepared for it in both the European and U.S. markets.

Empowering people to take better care of themselves

Many of the Global Fund’s major pharmaceutical suppliers are based in India and are also critical partners in efforts to scale up regional manufacturing sustainably, particularly in Africa. This improved pricing – a 25% reduction – will allow governments in resource-limited settings to expand access to critical HIV services. 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. The FDA produces smaller figures because they count only shortages at the national level. 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.

Quality Issues

• The increased inclination toward the health insurance sector and the growth of per capita income have expanded the purchasing capacity of patients/consumers, providing a long-term perspective for the development of the pharmaceutical sector.
• Of note, they are playing a pivotal role in bringing down the price of lifesaving, antiretroviral drugs that have helped contain the AIDS epidemic.
• Further, she has also conducted workshops on IP law for university students and has been invited as a judge for several prestigious moot court and negotiation competitions at the university level.
• In Jordan, for instance, between 2002 and 2006, the less expensive generic alternatives of 79 percent of medicines were delayed by data exclusivity, threatening the financial sustainability of government public health programs.
• PMBJP pharmacy’s proximity to the public health facilities was assessed using google maps (Fig. 1).
• 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].
• However, intrinsic systemic factors contributing to delays, inaccurate demand estimation and supply of short- expiry medicines cause shortages and stock-out of medicines under the vertical programmes too.

This transformation has enabled the implementation of on-demand delivery models, employing strategies like direct-to-patient approaches and B2B eCommerce platforms. In fact, Indian pharmaceutical companies are now also becoming a key source of medicine for the rest of the developing world. Of note, they are playing a pivotal role in bringing down the price of lifesaving, antiretroviral drugs that have helped contain the AIDS epidemic.

Navigating the supply chain roadblocks

The profiles of the physicians and pharmacists are provided as additional files (Additional files 2 and 3). The fact anyone is paying attention to the quality of Indian-made medicines is arguably because of Mr. Thakur. In 2004, he noticed a generic antibiotic produced for the Indian market failed to curb his son’s severe ear infection; a switch to the brand-name version knocked down the boy’s worrying high fever overnight.

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.

In comparison, Gen X was the most likely to prefer generic medications, mainly due to cost (95%), previous experience (28%), availability (26%), and higher trust (15%). When patients choose between brand-name and generic medications, cost, trust, and availability all come into play. These factors and others revealed below influence how people decide which option is best for their needs.

Over the years, it has been noted that states with autonomous bodies for procurement demonstrate relatively improved governance, decreased wastage, improved availability of quality medicines and less burden on end-users in terms of out-of-pocket expenditure (OOPE). The latter models face relatively more constraints to meet district- level demands, often resulting in delays and disproportionate local purchases. Even among states with procurement bodies, their efficiency in achieving desirable outcomes is tied to state-specific customization of the procurement and distribution system. Interestingly, the European Commission does appear to recognize that overly restrictive intellectual property rules can be harmful. It recently proposed a seismic package of reforms to pharmaceutical and intellectual property regulations — seemingly an attempt to wrestle back some balance between such restrictions and access to medicines in Europe. Whatever the cause of the benzathine shortage, Professor Stephen Schondelmeyer says that it has led to more outbreaks of syphilis in the U.S. than were expected.

• Paleno, which contains Palbociclib is a medicine used to treat breast cancer treatment.
• This provides an added advantage to the nation, which assists in developing processes that are cost-effective (Mahajan, 2019).
• 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.
• In addition, at the level of corporate strategy, firms should establish collaborations and alliances and expand their industrial marketing vision.
• Purchase of medicine contributes the most (60.6%) to the OOP health payments by households, and pushes more than 3% Indians into poverty every year [3, 25].
• Unlike developed countries, people in developing countries pay the cost of medicines out-of-pocket.

Go deeper with GlobalData

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.

In most of the states, free medicines were restricted to targeted beneficiaries like BPL families, beneficiaries of JSSK, Janani Suraksha Yojana (JSY), and enrollees of state-specific insurance schemes. Even among the beneficiaries, the range of medicines given free of cost was not as per the EML nor based on epidemiological load. In Colombia, data exclusivity increased the public health system’s costs by $396 million between 2003 and 2011. Meanwhile, in 2006, the Korean National Health Insurance Corporation calculated that a four-year patent term extension would cost 722.5 billion won — the equivalent of $757 million at the time. This issue came to a head during the COVID-19 pandemic when, after relentless pharmaceutical industry lobbying, the EU and other wealthy countries blocked India and South Africa’s proposal to temporarily waive some TRIPS obligations for COVID-19 medical products. It was the influx of affordable generics from India that helped drive down the price of treatment from over $10,000 to under $100 per year, saving countless lives.

• For example, India has been universally considered the pioneer in the export market for generic drugs.
• Drug pricing and reimbursement within India are shaped by a complex interplay of regulatory, economic and policy factors.
• Diverse systemic determinants of access to quality and affordable medicines have been documented through CRMs.
• Generic drug manufacturers do not have to spend extra money for drug discovery and preclinical and clinical trials.
• Gilead licensed 11 Indian companies to make generic versions, and they sealed marketing deals with others.

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.

Why Does an $84,000 Drug in the U.S. Cost Less Than $1,000 in India

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 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.