Making the case for Indian generic drug manufacturing
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.
We are all infor better health
CPA is the leading national, bipartisan organization exclusively representing domestic producers and workers across many industries and sectors of the U.S. economy. Reimagine clinical development by intelligently connecting data, technology, and analytics to optimize your trials. Faster decision making and reduced risk so you can deliver life-changing therapies faster.
Mission is to Protect your Businesses & Much More
“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.
HEALTH SYSTEM FACTORS INFLUENCING SUPPLY CHAIN OF MEDICINES
Supply chain management (SCM) is the regulation of the flow of goods, finances, and information related to products or services spanning from procurement to distribution to the end-users. Efficient SCM practices are important to ensure the timely distribution of the right products in the right quantity at the right place. Furthermore, the Indian pharma supply chain grapples with issues related to counterfeit drugs and supply chain integrity.
Erlonat Erlotinib 150 mg Tablets Price in India
According to Qyobo’s data, atorvastatin is available from nine different drugmakers, including companies based in Germany, Bangladesh and Turkey. But all of those drugmakers depend on an Indian company, Ind-Swift Laboratories Ltd, for the active pharmaceutical ingredients (APIs) to make atorvastatin. And Ind-Swift depends on five companies, all of them Chinese, for the key starting materials (KSMs) to make the APIs. Unknown to American doctors or patients, the entire supply chain for this drug depends on China. The intense pressure to lower prices of generic pharmaceuticals has led to a different global structure. Generic production has moved increasingly to India and China as the lowest-cost manufacturing centers in the world.
Cabozantinib Generic Price in India
Hence, consumer awareness for the generics, variety of trade names available in the market, and price variation is very limited. Hence, there is need to conduct a study that can document the price structure and quality of the branded product and their branded-generic versions manufactured in India. Difference in price-to-patient was not as huge as it is expected for generics but margins for retailer were very high for branded-generics.
Buy generic Cazanat (Cabozantinib) in India
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].
- It indicates where Chinese pharma might be headed, and may drive up its production costs for formulations – thus potentially benefiting India.
- According to an estimate, medicines account for 69% of household out-of-pocket spending on health care.
- 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).
- The very high profit margins on branded drugs have enabled drugmakers to manufacture those products in the U.S. or Europe.
- Branded-generics, on the other hand, are not promoted or advertized by the manufacturer.
- By comparison, German biotech firm BioNTech’s deal with US involves a price of US$19.50 per dose, while the Moderna/US deal is set at between US$32 and US$37 per dose.
- The industry benefits from cost competitiveness, driven by factors such as lower labor costs, economies of scale, and efficient manufacturing processes.
What is the process of securing reimbursement for a pharmaceutical product?
There is a robust low-cost manufacturing setup available in India, where the industry can produce drugs at a cost that is 40%–50% lower than the rest of the world and sometimes even as much as 90%. There is also a presence of good technical and technological expertise together with the availability of low-cost skilled human resources. The growth of the middle-class population is leading to a new lifestyle, providing a huge market for lifestyle drugs, which are currently the lowest contributor to revenues from the sector.
Worth the price? Push for cheaper generic drugs has Canadians buying questionable medicines from India
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. We have sought to establish an ML link between the price and sample age of AMLO besylate containing FPPs and acceptable quality attributes of the same. The analysis of nine top-selling AMLO besylate-containing marketed FPPs was exercised using a validated analytical method.
RELATED PUBLICATION
(2016), “R&D, technology transfer and productivity in the Indian pharmaceutical industry”, International Journal of Innovation Management, Vol. The infrastructure of the industry and the R&D capabilities of domestic businesses have improved considerably in recent years, but many challenges remain, mainly related to pricing regulation, sector fragmentation and intellectual property. Not surprisingly, all of them, directly or indirectly, concern patents, which are central issues of debate in the national industry. Tiered pricing, also known as differential pricing , is often practised by pharmaceutical companies based on the ability of countries to pay, but Hill was unavailable to comment. Several factors have contributed to this significant growth of the healthcare industry in India – which includes a combination of public sector initiatives and expansion of private-sector enterprises.
India’s Solution To Drug Costs: Ignore Patents And Control Prices – Except For Home Grown Drugs
While India’s pharma exports grew by 11% in FY 2019 and appear to be promising, the industry is increasingly facing problems across its export markets. This has been underpinned by several changing global market dynamics as well as pressures faced at home in the domestic arena. 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. Furthermore, efforts by Governments to promote the development of their own national pharmaceutical industries in key markets across Latin America, Sub-Saharan Africa and Southeast Asia have made the playing field more challenging as exporters encounter increasingly rigid regulatory policies.
However, the LDA had revealed the most acceptable quality attributes for the price range of 1–2 rupees and alike higher money value medicine, i.e., 2–3 rupees. The Commission is right to do this for its citizens’ health, and the lesson applies to other parts of the world too. However, in trade agreements, the bloc has continued to pressure developing countries to include disproportionate intellectual property protections that go far beyond the TRIPS agreement. Table 1 shows America’s top ten sources of pharmaceutical products last year by weight. China led the rankings, with 217.2 million kilograms (kg) or 477.8 million lbs of pharmaceutical imports. The IQVIA Human Data Science Cloud is our unique capability designed to enable healthcare-grade analytics, tools, and data management solutions to deliver fit-for-purpose global data at scale.
See markets more clearly. Opportunities more often.
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.
- This policy is not applicable to patented drugs or fixed-dose combination (FDC) drugs.
- A second policy challenge that affects pricing and reimbursement is lack of patient affordability for drugs that are not subject to the DPCO price control, particularly in the case of non-essential or newer drugs which do not form a part of the formularies.
- The NHS prices that trusts are actually charged can be found on the Department of Health’s electronic market information database (eMIT), says a spokesperson.
- Adopting smaller, more efficient packaging not only cuts down on storage and shipping expenses but also promotes sustainability and economic benefits.
- Both cabozantinib and sorafenib are multi-kinase inhibitors used to treat advanced cancers like RCC and HCC.
- The following were identified as the key focus areas to bolster the Indian pharmaceutical and healthcare sectors.
- To create new business opportunities for the pharmaceutical industry, SEZs can be a powerful option, especially if established near airports, stations and ports.
- 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.
- From a theoretical point of view, the contribution of intellectual capital to the financial stability and economic prosperity of the pharmaceutical industry, most of all due to patents as immaterial assets deriving from human, structural and/or relational capital, seems indispensable (Festa et al., 2020).
- One silver lining is that China is proposing a new regulation that would give its firms exclusive control over their clinical test data.
- 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.
- We conducted a total of 16 in-depth interviews (IDIs) – 10 with pharmacists and 6 with physicians.
The study highlights the need to modify the drug price policy, regulate the mark-ups in generic supply chain, conduct and widely publicize the quality testing of generics for awareness of all stakeholders. Supply chain management practices backed by IT-based platforms have shaped estimation, tracking, and monitoring practices for medicines, equipment, and consumables in the Indian health system. Early implementation of such platforms is identified as a key determinant to promote skill development and skill refinement among trained users, allowing the states to gradually saturate and establish them throughout.
- These objectives of the investigation highlight the essential explorative nature of the study, which has been finalized as a scenario analysis, adopting a mixed approach of quantitative and qualitative methods.
- That leads to widely differing standards across India, with the temptation to lower standards to attract more manufacturers.
- In this respect, however, foreign companies, as well as national companies, have been reluctant to invest in R&D in India (Ghai, 2010).
- One of the foremost challenges confronting the Indian pharma supply chain is regulatory compliance.
- Common side effects include gastrointestinal issues and fatigue for both drugs, but specific side effects and patient responses may vary.
- New drugs are protected by patents, so only the company that came up with the drug can sell it.
- Here, ni was the number of drugs from a specific therapeutic category available in a PMBJP pharmacy at a particular health care level and Pi was the number of facilities in that particular level of care and Ni was the total number of drugs listed in particular therapeutic category as per the survey medicine list.
- The national regulator reportedly has fewer than 400 staff to police more than 1,300 factories, and does not even oversee many of the drugs exported to places like Canada.
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.
Will my doctor automatically prescribe generic drugs?
- 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 USA represents a large pharmaceutical demand as companies obtain substantially higher prices for medicines sold in that market.
- 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.
- A “pair” of product from the same company was chosen to appreciate the price structure and mark-ups for the two versions.
- 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.
- But branding and marketing cost makes the medicines expensive which leads customers to buy medicines at a higher price.
- 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.
- According to national statistics, India’s cardiovascular market was worth $2.52bn in 2022 and is forecast to reach $4.26bn by 2030.
- 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.
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.
Healthy Future: Sustainability at Teva
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.
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.
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 abiraterone price in usa — 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.
At the time, this unprecedented pricing was a breakthrough toward ensuring the worldwide availability of high-quality treatment for HIV. 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 very high profit margins on branded drugs have enabled drugmakers to manufacture those products in the U.S. or Europe. European governments, especially the Irish government, have used subsidies and tax breaks to lure global pharmaceutical giants to manufacture there. The result is that Ireland is the number one source by dollar value for U.S. pharmaceutical imports (Table 2).