Indian pharma is being squeezed and its bad news for drug access in developing countries

Given the role of various interlinking factors, states need to establish robust procurement systems, strengthen the existing infrastructure, ensure adequate HRH backed with robust HRH policy, expand the range of services, and strengthen CPHC for supporting holistic efforts. An overall health system strengthening is the way forward to expedite the realization of universal access to free essential medicines at public health facilities. As previously mentioned, the AYUSH Ministry was formed in 2014 for the development and spread of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy treatments. Earlier, it was known as the Department of Indian System of Medicine and Homeopathy (ISM&H), founded in 1995.

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• 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.
• Our unique business model gives us an edge over any other players in the market currently as we are providing affordable healthcare to millions of households.
• USA, the first country to implement a generic drug implementation policy, achieved 89% share of generic drugs in 2016 and this reduced the medical insurance expenditure by US$ 67.7 billion [37].
• With medication costs rising, many are looking for ways to save money without compromising their well-being.
• According to a CNN report, about half the hospitals in the U.S. rely on GE Healthcare for the contrast dye.
• 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.
• In the case of other medicines, if the drug is under DPCO in India, it may be possible to sell it under price control domestically and to collect maximum revenue from exports, thus helping to enhance the country’s economy (Das, 2013).

For method development, method validation, and degradation sample analysis, an Agilent high-performance liquid chromatography Infinity 1260-II (Agilent Technologies company, Santa Clara, CA, USA) equipped with a quaternary pump, an online degasser, and a multiple wavelength or diode array ultraviolet detector was used. For data acquisition and processing, the OpenLabTM CDS software (version 2.6) (Agilent Technologies, Palo Alto, CA, USA) was used. Indian drugmaker Intas was making cancer drugs for the United States at the plant where, in a trash bin, inspectors found documents doused in acetic acid.

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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.

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• The three major medicines for breast cancer – Palbociclib, Ribociclib, and Abemaciclib are popular internationally.
• The figures came to light after academics collated the NHS price of 14 generic cancer drugs between 2011 and 2016 using information from the British National Formulary, the indicative NHS price and the Drugs Tariff and Prescription Cost Analysis data.
• In the USA substitution is allowed and patients accept generic substitution if physician approves of the same.
• However, some key obstacles remain to be addressed for the country to fully realise the remarkable growth potential of its healthcare market.
• 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.
• Patanjali, Himalaya, Vicco Laboratories and Dabur are the major companies manufacturing in the field (Mehrotra et al., 2017).
• 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?”).

“The two major reasons for the cost pressures are slowing down of the domestic offtake and pricing pressures in developed markets such as the United States and Europe, in addition to some of the pricing pressures also being introduced in India in the domestic markets,” commented Raisinghani. “This is further compounded by regulatory bodies demanding stricter compliance, which are leading to higher compliance costs,” he added. If sponsors, healthcare providers, and regulators work together effectively, then effective use of generic drugs will make medical costs cheaper and also ensure sound treatment options for the patients. Early issuance of guidance notes on the prescription of generic medicines, clarity in dispensing rights, state notification of FDSI, and mandated display of EML at the facilities heighten the awareness of both providers and community members. In line with this, irrational prescriptions and poor adherence to STPs/STGs and EML may be attributed to lack of awareness.

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“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. Given the interlinkages within various systemic processes, a move towards improving access to essential medicines must be subsumed under overall health systems strengthening across the states. Education curricular changes sensitizing providers on generic medicines, rational prescription, STGs/STPs, and continuum of care can mitigate undesirable practices. 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. Similarly, Guatemalans found themselves unable to access medicines readily available in most countries at affordable prices, as Guatemala is bound by data exclusivity clauses in its free trade agreement with the United States. This is a statin or blood-thinner used by millions of patients at risk of cardiovascular disease.

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On the other hand, Palghar is an economically backward district with a population of nearly 3 million and is primarily inhabited by the tribal people. Others are not so sure anything has happened to dramatically curb manufacturing shortcomings, and argue that far from being too strict, the FDA ensures only the minimum standards are maintained. India’s Ministry of Health and Family Welfare did not respond to a request for comment. The chief drug regulator, however, has said he plans to add hundreds more staff and promised more oversight of the manufacturing process, while signing a co-operation agreement with the FDA last year. Three years ago, an Indian parliamentary committee looking at the drug-approval process concluded regulators were often in bed with the companies they governed, putting consumers’ interests last.

Quality Issues

Our increased reliance on very few suppliers who ultimately depend on ingredients from China for many life-critical products is a huge risk to the health and safety of the American people. The first chapter of this report summarizes data on the importance of affordable medicines. The second chapter highlights the role that Indian companies play in the supply of drugs to the U.S. in terms prescriptions, patient access, resilience, and savings. The last two chapters discuss the state of the overall supply chain of affordable medicines, concerns raised by U.S., EU and India, and possible opportunities for partnering to address these concerns. Nonetheless, despite being a global market leader in generic drug formulations, the Indian pharmaceutical industry is highly dependent on China for raw material supply to produce pharmaceutical formulations and even medicines.

Generic drugs – The Indian scenario

The mean drug availability at PMBJP stores located in the vicinity of PHCs and district/rural hospitals was 51% and 61% respectively. 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%). Aside from collecting primary data, secondary data such as the price information of some PMBJP medicines and their leading brand name counterparts (in terms of market share) were gathered from the web portals of PMBJP and MedGuideIndia.com respectively. The website provides information on a wide range of drugs available in the Indian pharmaceutical market including their prices.

• 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).
• 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.
• 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.
• Nearly 30% of palliative care medicines and vitamins, about 17% of antiasthmatics and consumables were out of stock for a period of 1–3 months.
• 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.

Selection of rational, affordable essential medicines and quality assurance criteria for PMBJP medicine list

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.

• According to the study, “over 80 per cent of the Pharmaceutical and Medical Devices Manufacturers do not have product visibility till point of care.
• For example, the development of a range of long-acting HIV prevention and treatment medicines could be transformative in advancing the end of AIDS — but this can only happen if those medicines are made widely available at low prices through large-scale generic production.
• Thus, the Indian government should take effective measures to better balance the positive and negative effects of DPCO.
• 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.
• And Ind-Swift depends on five companies, all of them Chinese, for the key starting materials (KSMs) to make the APIs.

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In the home market, drug prices are controlled by the drug price control order; therefore, there is strong pressure on revenues and subsequently on costs. In the international market, threats derived from pharmaceutical multinational companies are emerging as tough obstacles to overcome. Indian generic manufacturers are also producing in the U.S. and in other countries whenever necessary.

We appreciate the cooperation of retail pharmacists and distributors who helped us in collection of the data.

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But your income and the cost of the drugs you need may affect your ability to qualify for discounts. Information about these programs is free and available from your doctor, pharmacists, and the government. We already know from previous experience that such proposals — known as TRIPS-plus — can have devastating consequences for access to medicines. The disproportionate intellectual property protections the bloc proposes could threaten the affordability of generics that countries like India and Indonesia export to poorer nations. 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.

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Particularly, the country exports generic medicines on a large scale, with a major impact in the American and European markets. Assessing the availability and affordability of generic medicine at PMBJP outlets is important, but perhaps it is even more important to know the physicians’ attitude towards generic drugs and PMBJP scheme, as they play a key role in prescribing generic medicines. Most of the physicians argued that generic and branded medicines have the same active substance(s). Table 6 shows the cost of standard treatments, as recommended by WHO, with surveyed medicines at PMBJP price and at branded generic price for a number of health conditions [22, 23]. We find that for all selected disease conditions, the drug cost of the thirty-day treatment reduce by 6–1129% if PMBJP’s unbranded medicines are used instead of their largest selling branded-generic counterparts. For the treatment of Type 2 diabetes, the monthly expenditure on the PMBJP medicine (Glimepiride) was estimated to be almost 50% lower compared to its equivalent branded-generic counterpart.

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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.

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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.

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.

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.

Manufacturers and pharmaceutical companies may revise the prices of the product following the routine annual change in the Wholesale Price Index (WPI) of the preceding calendar year. This policy is not applicable to patented drugs or fixed-dose combination (FDC) drugs. However, this year’s price increase is so marginal as to be almost equivalent to zero, especially compared to the significantly higher price increases observed in the last three years. In 2021, the NPPA approved a 10.7% increase to the MRP of drugs enlisted in the NLEM and a 12.1% increase in 2023. Therefore, the insignificant price increase for the new fiscal year (FY 2024–2025) will come as a huge blow to pharmaceutical developers as they grapple with the global tightening of price control mechanisms alongside the rising costs of raw materials, shipping, and production.

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.

Furthermore, as reported in Table 4, the positive trade balance trend appears to be confirmed for the future, most likely by virtue of renewed attention of the global economies on India’s pharmaceutical industry due to the COVID-19 pandemic. The Indian federal Department of Health Jan. 28 is soliciting price quotes on 504 drugs including painkillers, antibiotics and medicines to treat respiratory, cardiovascular and gastroenterological diseases for a program to improve access to generic drugs. A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by patents. Because the active chemical substance is the same, the medical profile of generics is believed to be equivalent in performance. As per statistics, about 60% of Indians cannot afford to buy their daily medicines because of unnecessary high prices of medicines in the Indian pharmaceutical market.

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.

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.

However, pharmaceutical companies may lose interest in the Indian market due to the fixation of prices, which can lead to economic uncertainty since the Indian market is under rigorous pricing laws (Kumar et al., 2020). Another major concern is that medicines are not available where needed due to an inadequate supply chain and to the absence of potential producers that may not be attracted by these restrictions. If there is a lack of proper supply of medicine to the needy, this would be in contradiction with the objectives of social justice (Mrinali, 2013). Thus, the Indian government should take effective measures to better balance the positive and negative effects of DPCO. This study reported the availability, stock-outs and affordability of a basket of essential medicines (unbranded) and consumables in selected PMBJP stores in the districts of Palghar and Mumbai in Maharashtra. Besides affordability, we did cost comparison of unbranded and branded generic equivalents of some commonly used medicines.

There are only 74 bulk drugs which are under price control[15]and are called scheduled medicines. For scheduled medicines, the NPPA pricing formula sets the 8% mark-up for wholesalers and 16% for retailers. 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. Diverse systemic determinants of access to quality and affordable medicines have been documented through CRMs. Though not an exhaustive list, state-specific experiences over the years highlight the determinants of access, and pertinent systemic challenges needing redressal.

The challenges are reportedly more pronounced in North-Eastern states and for facilities under the National Urban Health Mission (NUHM). Given the objective to understand the determinants of access to medicines in the Indian public health system, the CRM reports between 2007 and 2021 were reviewed. Core themes pertaining to medicines were identified and each theme was analysed to deduce the context-specific determinants influencing their availability and accessibility in the public health system. The findings were appraised for relevance and validated for aptness by comparing the recent reports with the former ones to ascertain their contextual underpinnings. Core themes in the Indian Public Health System, their interlinkages and key determinants for ensuring access to medicines are discussed below. As part of its NextGen market-shaping approach, the Global Fund will continue to work with manufacturers to secure a sustainable supply of affordable HIV treatment.

Almost 70% of antibiotic FDCs available on the market are not registered with Central Drugs Standard Control Organisation (CDSO) [29]. In view of growing antibiotic resistance and concerns regarding safety and efficacy of FDCs manufactured in India, it is worrying to find that the use of FDCs is being promoted by PMBJP. The FDCs, except the ones of proven quality, should be removed from the PMBJP’s list of medicines to safeguard public health. Pharmaceutical companies market their brands by branding their bioavailability results.

The International Criminal Court has become part of a global justice system feared by those who commit crimes against humanity. Food and Drug Administration were far from home, investigating a pharmaceutical factory in western India. 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. The event is a large forum to facilitate exchanges between partners across the antiretroviral supply ecosystem.

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.

Further, the private physicians underlined the need for developing strong regulatory mechanisms to ensure that generic drugs meet high standards of quality. “We are ready to prescribe low cost generics, but it becomes difficult for me to convince my patients to take such a low-cost generic medicine. Most of the time patients want relief from pain as quick as possible and thus they are ready to pay even high for medicines. We first examined the selected medicine list of PMBJP to assess the extent of coverage of essential medicines. NLEM, 2015 has 376 essential drugs whereas the PMBJP list contains 214 essential medicines.

• 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.
• Nevertheless, the study findings show that PMBJP’s unbranded generics offer great opportunities for substantial cost savings.
• This would not only contribute to increased demand generation but also mitigate the burden of accessing quality medicines and consequent financial hardship.
• Inspired by “vertebrae,” our name embodies our mission to be the backbone of healthcare success.
• At the same time, pharma imports from China and India increased their share of total pharma imports, reaching 58% by weight.
• Price-to-patient, retailer mark-up and qualitative analysis of branded and branded-generic medicines.

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. revolade price in singapore 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.