India’s Solution To Drug Costs: Ignore Patents And Control Prices Except For Home Grown Drugs

Indian Generic Price

In the fourth edition of the Re-Pharma Summit 2024, panelist Sabina Sawliwala highlighted the differences in costs and logistical difficulties between companies operating in India and more developed economies like the US and Europe. “Our logistics and transportation costs are literally double-digit, whereas if go to America or Europe, these are single-digit costs,” she added. Poor road connectivity, congested ports, and limited cold chain facilities impede the timely and safe delivery of pharmaceutical products, particularly to remote and rural areas.

3 Human capital in the patent-based regime

Although 62% of Americans trust brand-name medications more, nearly 2 in 3 (63%) said they prefer to buy generic drugs. Cost is the primary reason, with 91% citing it as the driving factor, followed by availability (34%). Additionally, 60% said they would prefer to buy brand-name medications but opt for generics because of the lower price. Price-to-patient, retailer mark-up and qualitative analysis of branded aromasin price in uk and branded-generic medicines. However, intrinsic systemic factors contributing to delays, inaccurate demand estimation and supply of short- expiry medicines cause shortages and stock-out of medicines under the vertical programmes too. Additionally, barriers in communication and coordination between the states, districts, healthcare facilities, and procurement bodies cause duplication of purchases.

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  • We conducted a total of 16 in-depth interviews (IDIs) – 10 with pharmacists and 6 with physicians.
  • However, it instead tipped the balance in favor of the pharmaceutical industry’s commercial interests, and away from access to affordable medicines.
  • Table 1 shows America’s top ten sources of pharmaceutical products last year by weight.
  • Food and Drug Administration (FDA) guidelines that include regular and rigorous inspections to ensure compliance.
  • 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).
  • 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.
  • 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%).

(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.

Surge in Pharmaceutical Imports Threatens U.S. National Security as India/China Dominance Grows

  • Further, she has also conducted workshops on IP law for university students and has been invited as a judge for several prestigious moot court and negotiation competitions at the university level.
  • 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].
  • India has many pharmaceutical, bioscience and chemistry colleges that churn out huge amounts of high-quality graduates every year.
  • 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.
  • However, intrinsic systemic factors contributing to delays, inaccurate demand estimation and supply of short- expiry medicines cause shortages and stock-out of medicines under the vertical programmes too.
  • 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.
  • Of note, they are playing a pivotal role in bringing down the price of lifesaving, antiretroviral drugs that have helped contain the AIDS epidemic.

There is a concrete risk of confusion in the minds of patients/consumers regarding which drug should be considered due to this price variation. Therefore, price controls were effective at analyzing this price variation and are attempting to decrease the difference even more (Jhanwar and Sharma, 2018). With specific reference to single commercial relationships, the USA and other developed countries are major trade partners as far as exports are concerned, while India depends significantly on imports of APIs from China (Rbi.org.in). More broadly, the Indian pharmaceutical industry has major exports to North America and Europe and major imports from Asia and Europe.

CONVERGENCE OF NATIONAL HEALTH PROGRAMMES

  • India has long been known as the “pharmacy of the world,” producing generic medicines at prices that other developing countries and global institutions can afford.
  • In the above, API stands for Active Pharmaceutical Ingredient and AYUSH stands for Ayurveda, Yoga, Unani, Siddha and Homeopathy.
  • Indian companies have managed to turn this into an opportunity by using these ingredients to supply medicines at reasonable prices while reducing their production costs and R&D spend.
  • Reddy’s Laboratories is accused of ignoring tests showing unknown impurities in some of its drugs.
  • Under the NCD control programme, medicines were first made available free of cost in the states like Kerala and Tamil Nadu.
  • This report explores how patient preferences, medication types, and healthcare tools like EHR systems shape the way Americans approach their healthcare choices.

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.

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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.

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Indian Generic Price

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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.

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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].

The Same Pill That Costs $1,000 in America Sells for $4 in India

Canadian, Australian and European regulators also gave passing grades to Ranbaxy, despite the company’s guilty plea to seven offences in the U.S., notes Dinkar Saran, a pharmaceutical-industry consultant with PriceWaterhouseCoopers in Boston. 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. That job falls to state-level officials, who have a reputation for being under-trained and corrupt. We will not dispense any prescription medicine without a valid prescription from a licensed/certified doctor physician. A bottle of 21 capsules costs between 5000 and 6000 Indian Rupees, depending on the strength of the medicine, making it very affordable.

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. Reducing the industry’s dependence on the imports of APIs, key intermediates and starting materials will be key to sustaining its global leadership position. Despite the changing dynamics across the global industry, there is a lot to be positive about. India’s export growth for FY 2019 was one of its highest growth rates in the last decade. While margins may be reducing due to the extra costs and regulatory fees, on average, Indian drugs cost 33% less in comparison to their U.S. counterparts, bringing much needed relief to the notoriously high healthcare prices in the United States and elsewhere.

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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].

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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.

Sun Pharma PALENO (Palbociclib) 100, 125 mg price in India

With these tools, providers can offer personalized recommendations, share cost comparisons, and provide educational materials through secure messaging. This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. Haiti’s plight is a reminder of the international community’s wider and longer-term responsibilities to the country. India’s negotiators note they’ve “firmly communicated” that data exclusivity and patent term extensions are “redlines” for them in these negotiations. Last year, the FDA allowed the cancer drug cisplatin to be sold in the U.S. from an uninspected lab in China.

Generic drug

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).

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.

  • 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.
  • In India, many pharmaceutical companies manufacture two types of products for the same molecule, i.e. the branded product which they advertise and push through doctors and branded-generic which they expect retailers to push in the market.
  • Doctors regularly write angry letters to newspapers complaining that they cannot find the drugs their patients need.
  • Under the DPCO, manufacturers are required to be aware of price fixation and revision by the NPPA since it is mandatory to follow the ceiling prices fixed and notified by the NPPA.
  • The pharmacists, they claimed, will sell noneffective, or highly overpriced drugs once the authority to decide the drug for a given indication is bestowed upon the pharmacists through the policy of compulsory active ingredient prescribing.
  • Although we reported availability, stock-outs and affordability of medicines in the PMBJP pharmacy outlets, a more comprehensive assessment of the accessibility of essential medicines may have included measurement of medicine prices, prescription pattern and out-of-pocket payments on medicines.
  • This study provides a global overview of the potential growth and development of the Indian pharmaceutical sector, comparing it with internal trends and external competition.

According to a 2022 study released by GS1 India, a global supply chain standards organization, more than 50 per cent of Pharma and medical devices manufacturers lose 1 per cent of their sales due to expiry and pilferage. Counterfeit medications not only pose a significant threat to public health but also erode consumer trust in the pharmaceutical industry. The study also found that “best-in-class pharma companies globally have an inventory period of 64 days as compared to Indian counterparts that have 98 days. Along with that, the overall supply chain, logistics and warehousing costs in India is 15 per cent higher compared to other countries,” the report added. Healthcare expenditure continues to rise in countries where healthcare is not a priority. Generic drugs offer an important tool for reducing the overall healthcare expenditure.[17] As more and more patents expire, the generic versions of the pharmaceutical market are expected to continue for increased sales.

Indian Generic Price

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 availability of the above-mentioned generic versions of Cabozantinib enhances the affordability. This has resulted in growing its access, particularly in regions where treatment costs are a huge barrier to healthcare. In conclusion, it is clear that the evolving landscape of the healthcare and pharmaceutical industry in India offers an exceptional opportunity for new entrants to expand and diversify in the market. However, players who aspire to be successful must be ready to innovate, evolve new healthcare delivery models, be open to adapting to changing patient needs and expectations, and be willing to invest in talent, technology and expert legal and regulatory advice.

She used the structured schedule to collect data on availability and stock-out of selected medicines and consumables. Those medicines not found in stock on the day of survey, the number of days of stock-outs in the last 6 months were recorded through manual checking of registers. We first reviewed the WHO-HAI core list of medicines, medicines that are listed on India’s Essential Medicine List and drugs listed under various national health programmes [18, 19].

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%.

However, some policy issues continue to persist and present complex challenges for the legislature, as well as all other public and private stakeholders. Pharmaceutical pricing and reimbursement are critical components of the Indian healthcare policy. The interplay of pricing and reimbursement policies is aimed at ensuring affordability of pharmaceutical products for patients, as well as continuous innovation and value creation in the industry. The regulatory landscape is constantly evolving and new initiatives by the Government and the private sector, as well as by public–private partnerships, are paving the way for an overhaul of old policies. In many cases the generic drugs do not produce the desired effect in the expected time which branded ones do.

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