Global Business Reports The Worlds Pharmacy: Indias Generic Drug Industry

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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.

Browse the Drugs alphabetically

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.

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

Company

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 harvoni price in singapore 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.

Apigat (Apixaban) 5 mg Tablet 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].

Sun Pharmaceutical: PALENO (Palbociclib)

In India, the pharmaceutical market is majorly dominated by generics, accounting for 78.33% of all drugs in the Indian market, while patent-protected drugs account for 21.67% of the market share, according to GlobalData’s Price Intelligence (POLI) database. India sees the second most significant generic market penetration in the Asia-Pacific (APAC) region, just behind Malaysia. One reason could be that the country’s pharmaceutical price controls measures generally disincentivise pharma companies from developing novel originator medicines while incentivising the production of generics. This policy works in India’s favour, however, as the country is one of the leading producers and exporters of generics globally. The use of generic drugs is steadily increasing internationally as a result of economic pressure on drug budgets.

• Thus, not granting a patent for Glivec really hasn’t prevented patients from getting this life-saving medication.
• 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 market is dominated by generic products with 71% of the total market share and 20% of global exports in terms of volume, which makes India the largest supplier of generics globally (IBEF, 2016), with particular importance in the field of vaccines (Chattopadhyay and Bercovitz, 2020).
• Haiti’s plight is a reminder of the international community’s wider and longer-term responsibilities to the country.
• 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.
• These savings are a driving factor for many, particularly as medication prices continue to rise in the US.
• For each selected brand of AMLO FPP, two strips containing 20–30 tablets (in total), were taken.

Scope for costsavings on medicine and affordability of PMBJP medicines

Further, in order to generate demand for unbranded generic medicines, in 2017, the erstwhile Medical Council of India issued a circular to the medical fraternity to comply with its regulation for prescribing medicines by generic names [14]. Besides, since April 2017, bioequivalence studies have become an essential requirement for the manufacture of a generic medicine in India [14]. While the idea of popularising non-branded generic drugs is a robust policy response to improve access and reduce pharmaceutical spending, little is known about how far these initiatives have been effective in making generic drugs accessible at affordable prices. The NPPA’s revised ceiling prices are calculated based on the average retail price of the named formulation(s) having a market share of 1% or more and being in accordance with the Drug Price Control Orders (DPCO) 2013.

• Interestingly, 1 in 10 Gen Z and Millennial Americans said they base their preference for brand names on the packaging alone — that’s some pretty effective product design at work.
• While each of these cost reduction initiatives has some merit, the challenge will be to reign in prescription drug costs without removing all of the financial incentives that have helped to make our domestic pharmaceutical industry a world leader and critical part of the U.S. economy.
• Now, the advantages that have enabled India to play this role are in danger of being eroded.
• However, trust in brand names and appealing product packaging, especially among younger generations like Gen Z, are affecting purchasing decisions.
• Third, the unemployment rate is quite high (6.5%) and absolute poverty is widespread in the country (23%) [33].

The World’s Pharmacy: India’s Generic Drug Industry

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.

India’s global reach

Among the antidiabetics, cardiovascular and consumables not available on the survey day, 44% and 33% respectively were out of stock for the period of 3–6 months. 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. The pharmaceutical industry was once concentrated in Europe and North America, but has spread increasingly into the developing world, where low costs cater to a growing Western pressure. No wonder Palbociclib suppliers in India are looked upon as major game changers for Breast Cancer treatment. As Sun Pharmaceutical has introduced cheap medicines in India, addressing breast cancer has become accessible and affordable.

“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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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.

• Price erosion has made it more difficult for low-cost manufacturers in India to justify their margins as the price of generics formulations falls globally.
• For example, Torrent acquired Bio-Pharma Inc. (BPI) in early 2018 – its first acquisition of a manufacturing site outside of India – to diversify and strengthen its product pipeline.
• 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.
• In a country where very few people have health insurance, 70% of Indians pay for healthcare expenses out of their own pockets.
• This transformation has enabled the implementation of on-demand delivery models, employing strategies like direct-to-patient approaches and B2B eCommerce platforms.
• The researchers had also compared the prices in the UK, a developed economy, with the prices listed on a generics medicines website in India, an emerging market.
• Most of the physicians argued that generic and branded medicines have the same active substance(s).

Life Effects Stories from Patients and Caregivers

The Bureau of Pharma Sector Undertakings (BPSU) working under the Department of Pharmaceuticals, Government of India, was entrusted with the responsibility of implementing JAS, i.e., to coordinate procurement, supply and marketing of generic drugs through JAS outlets. The scheme envisaged to sell generic medicines at affordable prices through exclusive outlets namely JAS stores across the country, starting from the district to sub-divisional headquarters and to towns and villages. However, JAS never really took off; there were only 99 JAS outlets across India which were selling 131 medicines till 2014. According to a study, the availability of medicines in JAS was abysmally low (33%) [13, 14]. Against this backdrop, in September 2015, the union government decided to expand its generic drug scheme called “Pradhan Mantri Bhartiya Jan Aushadhi Pariyojna (PMBJP)”, which envisaged making unbranded quality-assured generic medicinesFootnote 4 available at affordable prices to all people and especially the poor.

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Palbociclib is a targeted or biological therapy drug, that is USFDA, EMA, and CDSCO approved. Paleno, which contains Palbociclib is a medicine used to treat breast cancer treatment. Baladol, developed by PNB Vesper Life Sciences, has become the first new drug for treating COVID to enter phase II clinical trials around the world. Studies so far have shown that it reduces death rates by 80% – whereas WHO-approved medication dexamethasone reduces them by 20%.

• 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 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.
• On the other hand, the availability of antiasthmatic and antipsychotic medicines was very low-only a third of the PMBJP pharmacies had them.
• 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%).
• 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.
• 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.

Almost 70% of antipsychotics and antiasthmatics, more than 85% of anticancer and electrolyte balancing medicines were found to be out of stock for 3–6 months. The IPCA factory in Pithampur, for instance, chose not to reject drug products that failed to meet specifications in initial “trial” tests, the FDA reported. Inspectors said these negative results at the plant , which makes an anti-psychotic, an opioid pain drug and an anti-nausea medicine for Canada, were not documented, reported or investigated.

• Likewise, cost-effective, affordable, and quality services are linked to mechanisms promoting rational and scientific prescription practices of authorized providers.
• The informed written consent of study participants’ including the pharmacists of surveyed PMBJP outlets was obtained prior to conducting interviews and reviewing stock records.
• Cost is the primary reason, with 91% citing it as the driving factor, followed by availability (34%).
• As a sign of the shift, Canadian generic giant Apotex Inc. locates about 10% of its production at two Indian factories.
• 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.
• While significant challenges remain, particularly in terms of infrastructure and workforce distribution, the opportunities for growth and improvement are substantial.

ARTICLES FROM THIS PUBLICATION

The bottom line is that India’s manufacturers are seeing slimmer margins and losing their global cost-competitiveness. Further to that, the challenges faced by Indian pharma companies in the United States are growing in other aspects as well. The United States recently ended India’s Generalized System of Preferences Status (GSP) – a tariff reduction on imports – after President Trump determined that India did not adequately meet his trade demands.

In the above, API stands for Active Pharmaceutical Ingredient and AYUSH stands for Ayurveda, Yoga, Unani, Siddha and Homeopathy. Starting in 2014 in India, a Ministry of AYUSH was established, indicating the extraordinary relevance in the country of these specific items. More focus on patents for innovative drugs is required, instead of concentrating primarily on generic drugs. There is a need for policymakers to work on the sustainability and development of the industry, while the companies must redesign their orientation toward enhancing innovation capabilities. In addition, at the level of corporate strategy, firms should establish collaborations and alliances and expand their industrial marketing vision.

Maria Rosaria Carli was formerly Director of the Institute of Research on Mediterranean Economies of Italian CNR. Her research interests are focused on Economics of Development and she was Adjunct Professor of Economics of Developing Countries at the “Parthenope” University of Naples, Italy. She was Italian member of the Core Group and Standing Committee for the Social Sciences – European Science Foundation. She is scientific coordinator for the CNR on R&D projects and has published articles on national and international journals, as well as essays on collective volumes. After all, a clear understanding of our record of accomplishment and emphasis on quality supports the ongoing efforts of Indian generic manufacturers to provide quality solutions that ultimately benefit consumers across the globe. This medication is administered under the guidance of an oncologist and has specific dosing instructions to ensure effectiveness and minimize side effects.

Interview guides were used to conduct in-depth interviews of physicians and pharmacists. We conducted a total of 16 in-depth interviews (IDIs) – 10 with pharmacists and 6 with physicians. Physicians working in public or private sector and practicing in the periphery of PMBJP pharmacies were selected for the study. Only qualified allopathic doctors and the pharmacists registered under the state or central pharmacy council were considered for IDIs. Both quantitative and qualitative data were collected concurrently between January, 2019 and June, 2019. 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.

A sample list of generic drugs available in India along with their indication is depicted in Table 1. Adequate infrastructure is one of the prerequisites for efficient storage and distribution of medicines. Progress in the direction of infrastructure expansion and strengthening improves both service delivery and availability of medicines for the end-users. When faced with challenges of infrastructural shortfall to store and dispense medicines, a few states reported adopting alternative measures to ensure the distribution of medicines. 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.

To exploit that “patent cliff,” governments and insurers in Canada have pushed for lower and lower prices on the copies, and often mandate that patients’ prescriptions be filled with generics. India’s pharmaceutical industry is renowned for selling medicines to the world at reasonable prices, especially developing countries. To find out if there’s a generic drug that will work just as well for you as a brand-name drug you’re taking, talk to your doctor or pharmacist. Tell them you want the most effective drug at the best price, and that you want prescriptions for generic drugs when possible. In India, procurement of medicines is coordinated through various mechanisms such as state- level autonomous bodies, state government- owned agencies, procurement division/cell of the state government, and public-private partnership arrangements.

As a result of Covid-related factory shutdowns in Shanghai, China in early 2022, GE Healthcare was unable to produce enough contrast dye to supply the American market. According to a CNN report, about half the hospitals in the U.S. rely on GE Healthcare for the contrast dye. Vital scans were postponed or denied to patients at many hospitals as doctors and radiologists scrambled to find dye, used only in the most critical cases. “In the case of generic medicines used in hospitals, it is important to distinguish between the actual price paid by trusts and the much higher list prices often quoted,” he concludes.

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.