Reservation or allocation of land for the health-care sector will boost the growth and development of the industry, resulting in employment and self-employment of health-care staff, even at the pharmaceutical level. 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. Consider that the Indian pharmaceutical industry has significantly reduced the burden on the U.S. public health system by making much needed medicines affordable and readily available.
business advice for growth
Regulations to support mandatory generic prescribing and generic substitution by pharmacists are needed. The cardiovascular disease (CVD) treatment market is one of the leading pharmaceutical markets in India, as the country accounts for one-fifth of all cardiovascular-related deaths worldwide. According to national statistics, India’s cardiovascular market was worth $2.52bn in 2022 and is forecast to reach $4.26bn by 2030. Consequentially, there is a strong emphasis on generic CVD drugs over branded drugs due to their affordability.
Five Years into the Product Patent Regime: India’s Response
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.
Pharma’s new age of longevity
An in-depth exploration of the global healthcare ecosystem with timely research, insightful analysis, and scientific expertise. Nevertheless, India has a massive population with low per capita income, and stricter patent rules would probably mean less access to medicine for a significant part of the population. The affordability of pharmaceuticals is a critical challenge in India and South Asia in general, raising questions of life and death. DPCO is a blessing for those who use medicine and has boosted their hopes of the availability of cheaper and better medicines, leading to a great psychological impact on consumers (Venkiteswaran, 2013). For example, heart attacks and cardiac arrests are increasing in India, and treatments for these newly emerging diseases are very expensive.
Evolution of PMBJP
The average price increase of generic cardiovascular medicines from 2019 to 2024 was 44.19%, compared to the 59.97% average price increase of branded cardiovascular medicines, according to GlobalData’s POLI database. For manufacturers of branded/originator CVD drugs, the price changes authorised by the NPPA over the years have likely benefitted them. Branded medications typically command higher prices due to factors such as high R&D costs, patent protection, post-marketing surveillance, and marketing expenses, which generally grant them monopolistic control over the market. As a result, the upward revision of their prices helps maintain profitability, but this may not be the case with this year’s price increase of essentially zero per cent. Thus, from a practical point of view, Indian pharmaceutical companies are somehow forced to continue to leverage their expertise in generic drugs, considering the positive financial impact of these productions. At the same time, according to an ambidextrous perspective, they should try to invest in R&D for innovative drugs to capture new opportunities arising from the demands for good health from the growing income classes.
PALENO (Palbociclib) price in India
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 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.
Thalix (Thalidomide) price in India
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.
Indian pharma is being squeezed – and it’s bad news for drug access in developing countries
Andrea Curry is an award-winning journalist with over 15 years of storytelling under her belt. She has won multiple awards for her work and is now the head of editorial at The Intake, where she puts her passion for helping independent healthcare practices into action. Inspired by “vertebrae,” our name embodies our mission to be the backbone of healthcare success. With over 165,000 providers and 190 million patient records, Tebra is redefining healthcare through innovation and a commitment to customer success. Electronic health records (EHR) and patient portals make it easier for providers to track patient preferences, allergies, and past prescriptions.
Generic drug prescribing experience
This chapter has been written by a member of GLI’s international panel of experts, who has been exclusively appointed for this task as a leading professional in their field by Global Legal Group, GLI’s publisher. GLI’s in-house editorial team carefully reviews and edits each chapter, updated annually, and audits each one for originality, relevance and style, including anti-plagiarism and AI-detection tools. All methods were performed in accordance with the relevant guidelines and regulations. The study protocol was approved by the School of Health Systems Studies, Tata Institute of Social Sciences, Mumbai. Besides, the permission to conduct the study was obtained from Bureau of Public Pharmaceutical Undertakings (BPPI), Department of Pharmaceuticals, Government of India. The informed written consent of study participants’ including the pharmacists of surveyed PMBJP outlets was obtained prior to conducting interviews and reviewing stock records.
Consent for publication
We further observed that the PMBJP drug (enalapril) used for the treatment of hypertension costs 725% lower per month than that of the reference branded-generic drug. WHO model list of essential medicines has total 37 FDCs, while NLEM, 2015 consists of 24 FDCs. As far as the NLEM list is concerned, majority of these FDCs are aimed at improving treatment adherence and preventing drug resistance in diseases of public health concerns such as malaria, TB and HIV-AIDS.
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. This scale has been essential in driving production efficiencies and achieving the lower sustainable pricing secured today, strengthening country-led efforts to reach all people living with HIV who need TLD. Empowering patients to personalize their healthcare and connecting them to caregivers has the potential to change the care delivery paradigm. Building on a rich history of developing AI for healthcare, IQVIA AI connects the right data, technology, and expertise to address the unique needs of healthcare. By submitting this form, I agree to receive logistics related news and marketing updates from A.
Drug Price List: Generics and Matching Brands
- Further, it is required to be covered under the reimbursement schemes, which are listed in formularies approved by the respective authorities.
- Faster decision making and reduced risk so you can deliver life-changing therapies faster.
- 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.
- At the bottom of the health services pyramid, there are primary health centres (PHC), sub-centres (SC) and health posts (HP), which focus on primary care.
- Recordings were translated from the local languages such as Marathi and Hindi in English, and then transcribed verbatim.
- The designed digital architecture of SCM should not only facilitate maximum utility but also prioritize interoperability, real- time data management, and monitoring through a centralized dashboard in each state.
- The Indian government believes that the prices of lifesaving drugs shouldn’t be set by market forces.
Both cabozantinib and sorafenib are multi-kinase inhibitors used to treat advanced cancers like RCC and HCC. Common side effects include gastrointestinal issues and fatigue for both drugs, but specific side effects and patient responses may vary. S&S was the first law firm in India to challenge the constitutional validity of the provisions of the Drugs (Price Control) Order, (DPCO) 2013, representing 15 pharmaceutical companies before the Delhi High Court in this groundbreaking case. In Mumbai region, among the surveyed medicines which were not available at the time of survey, around 50% were out of stock for the period of 3–6 months while about 38% of medicines were out of stock for the period of less than 1 month (Fig. 4). Around 50% of antimicrobials, antidiabetics, antiepileptics and consumables were out of stock for the period of 3–6 months.
In a nutshell, with Paleno making its way into Indian medicine markets, the availability of Palbociclib is manifolded. With these generic drug versions by Indian brands, Breast Cancer patients with HR +ve, HER –ve have hope as they have better access to affordable treatment opportunities. The Indian medicine market has recently witnessed the launch of Palbociclib’s generic version – Paleno.
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 lapatinib cost uk 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.
The rise and rise of the pharmaceutical supply chain in India
Unfortunately, access to medicine is mainly determined by socioeconomic status in low and middle income countries, with poor medicine access among disadvantaged populations []. Indians mainly rely on private purchases for healthcare including medicine, and the country’s low public spending on health at 1.3% of GDP coupled with majority of people being either uninsured or underinsured makes this especially unaffordable for the poor [25]. 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]. In response to poor medicine access and reduce the financial burden of medicine, Government of India has been promoting the use of unbranded generics by rebranding and expanding its generic medicine scheme (PMBJP).
Although the sector must tackle several issues concerning internal (fragmented) and external (innovative) competition, drug price controls and patent regimes have a significant influence on its effective functioning, which is why the Indian pharmaceutical industry is still mainly concentrated on generic drugs. Although some Indian companies have invested significantly in R&D initiatives, most of them prefer remaining in the business of generic drugs. Because it does not require huge efforts to invent new molecules, there are still numerous small companies that produce the same generic drugs, creating tough competition in the domestic market (Pardhe, 2019). The low availability of medicines at PMBJP outlets reflects the implementation issues faced by the scheme. Nevertheless, the study findings show that PMBJP’s unbranded generics offer great opportunities for substantial cost savings.
Teva’s Top Graduates: From Academic Learning to Business Leadership
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.
If anything, recent Indian policies are sending a signal that intellectual property is tenuous in this country and will be granted only in those cases where it can benefit India. But, when it comes to drug pricing and intellectual property, the plane is severely tilted in India’s favor. At Delightaid Health, we can help you to get high quality generic Cabozantinib 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.
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.
- The mean drug availability at PMBJP stores located in the vicinity of PHCs and district/rural hospitals was 51% and 61% respectively.
- 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.
- Moreover, patented drugs are not immediately subject to price control and entitled to a five-year exemption from the date of marketing.[vi] Only essential and life-saving medicines, i.e. ‘controlled/scheduled drugs’ are subjected to price regulation by the NPPA as per the provisions of the DPCO.
- 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.
- GlobalData examined a similar price increase for 146 essential medicines in Pakistan under the hardship category to subsidise the rising cost of active pharmaceutical ingredients (APIs) and production, which led to an acute nationwide shortage of essential drugs.
- While the upward revision of drug prices is positive for their respective producers, patients must increase their out-of-pocket (OOP) spending to cover the increased prices.
For example, an attack strategy seems realistic when combining strengths such as the industry’s manufacturing ability and the rising economy of the country, thinking about a competitive strategy based on differentiation and/or niche orientation for innovative and patented drugs. 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. Consequently, domestic businesses will be hindered to some extent, and exports may blossom. For example, India has been universally considered the pioneer in the export market for generic drugs. 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). Nonetheless, DPCO policies had an adverse influence on the imports of medicines to India in the form of a fall in trade due to price regulations.
- 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.
- 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).
- Even among states with procurement bodies, their efficiency in achieving desirable outcomes is tied to state-specific customization of the procurement and distribution system.
- 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.
- The extensive scale and diversity of the Indian pharma industry offer resilience and adaptability to the demands of supply chain, enabling it to cater to diverse needs and maneuver through market fluctuations effectively.
- 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].
- 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.
Aurobindo has had numerous well-documented safety and quality issues, as well as instances of corruption and lack of transparency. At the same time, pharma imports from China and India increased their share of total pharma imports, reaching 58% by weight. While imports from those two countries dominate the $208 billion in total imports, their dominance is much greater in specific drugs and medicines, sometimes reaching 100%. In many cases, pharmaceuticals from India are dependent on ingredients or starting materials that come from China.
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.
The industry benefits from cost competitiveness, driven by factors such as lower labor costs, economies of scale, and efficient manufacturing processes. This cost advantage enables Indian pharmaceutical firms to provide competitively priced products both domestically and globally. The extensive scale and diversity of the Indian pharma industry offer resilience and adaptability to the demands of supply chain, enabling it to cater to diverse needs and maneuver through market fluctuations effectively. Such a widespread presence on the global stage underscores the importance of robust supply chain networks capable of meeting stringent regulatory mandates, ensuring high-quality standards, and overcoming logistical hurdles. According to DPCO, the trade margins in the pharmaceutical supply chain should be reduced to allow better penetration of medicines under DPCO and allow a larger population to obtain access. The first-line sellers will receive different percentages of margins to apply, including distributors, wholesalers, retailers (chemists) and hospitals.
Through the years, some SCM practices are identified to stand out as desirable and cost-effective. Additionally, the use of IT-based platforms for procurement and inventory management (i.e., storage, quality testing, tracking, monitoring, and allocation based on consumption patterns across the empaneled health facilities) are pivotal for a highly responsive and accountable system. The U.N. Special Rapporteur on the Right to Health proposed that “developed countries should not encourage developing countries to enter into” free trade agreements with TRIPS-plus measures, and that they should “be mindful of actions which may infringe upon the right to health.” In the same vein, as U.N. 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.
Generic drugs savings totaled $292.6 billion in 2018, according to the AAM Access & Savings Report (2019). Of this, an estimated savings totaling $80 billion in 2017 can be attributed to the contributions from Indian generic companies. The foremost challenge is ensuring a fair and just regulatory framework, which is stable and predictable. This uncertainty in the regulatory framework affects the ease of doing business for pharmaceutical companies, which has a detrimental impact on innovation and value creation. Besides, CDSO must ensure that generic medicines available in the Indian pharmaceutical market are bioequivalent and those qualifying bioequivalence tests should be listed along with their branded counterparts and price on a public or PMBJP portal.