India sees insignificant revision to price ceiling in 2024

That leads to widely differing standards across India, with the temptation to lower standards to attract more manufacturers. “The Indian drug industry is like the wild west on steroids,” Professor Schondelmeyer told us. There is less emphasis on R&D in pharmaceuticals, which have a major focus on generics.

• The generic landscape is rapidly changing with cost pressures slowing down domestic offtake, pricing pressures in developed markets such as the United States and Europe, as well as pricing pressures being introduced in India.
• Because the active chemical substance is the same, the medical profile of generics is believed to be equivalent in performance.
• Since reimbursement schemes do not have uniform formulary inclusions, patients do not have clear guidance on which drugs are covered under the scheme, leading to unanticipated out-of-pocket expenses.
• Starting in 2014 in India, a Ministry of AYUSH was established, indicating the extraordinary relevance in the country of these specific items.
• Besides affordability, we did cost comparison of unbranded and branded generic equivalents of some commonly used medicines.
• Transparency in fixing the MRP by the manufacturer and clear guidelines for mark-ups at least for branded-generics is required in pharmaceutical trade.
• The list of medicines and consumables has been provided as an additional file (Additional file 1).
• We will not dispense any prescription medicine without a valid prescription from a licensed/certified doctor physician.

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Therefore, it will be crucial to see the direction in which the pharmaceutical pricing policy of India is moving. Fluctuations in input costs (raw materials, manufacturing equipment, etc.) and inflationary pressures, which are unpredictable and beyond the purview of control of pharmaceutical companies, also pose a hurdle to the determination of price fixation of non-essential medicines. As a result, manufacturers often find it difficult to recuperate costs of research and development and costs of innovation. Drug pricing and reimbursement within India are shaped by a complex interplay of regulatory, economic and policy factors. The aim is to adopt a balanced approach that considers the needs of the patients, while simultaneously ensuring the creation of a sustainable healthcare system and incentivisation for pharmaceutical companies to innovate and create value. In this endeavour, the Government continuously evaluates and reforms existing policies relating to pharmaceutical pricing and reimbursement.

Creating Huge Little Moments for Patients

The website is regularly updated by the Trust with assistance from Ministry of Consumer Affairs, Government of India. Indeed, the United States – a key destination for India’s generic exports – has made it increasingly costly and time-consuming for sorafenib price in uae generic producers across the globe. This is in part due to the prescription drug user fee act (PDUFA), which requires pharmaceutical companies to pay fees ranging from US$1.5 million to US$2.7 million when submitting a candidate for approval.

Evolution of PMBJP

• For the experiment purpose, nine top-selling AMLO containing FPPs were purchased from local pharmacy outlets in Guwahati (Assam, India).
• In addition, at the level of corporate strategy, firms should establish collaborations and alliances and expand their industrial marketing vision.
• Paleno, which contains Palbociclib is a medicine used to treat breast cancer treatment.
• Unlike developed countries, people in developing countries pay the cost of medicines out-of-pocket.
• This provides an added advantage to the nation, which assists in developing processes that are cost-effective (Mahajan, 2019).
• 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.

Details of five “pairs” of medicines including their trade name as sold in the Indian market, strength, dosage form, and the pharmaceutical company that manufactures these products are given in Table 1. Price-to-patient (MRP) and price-to-retailer (PTR) found for all the five ‘pair’ of medicines is tabulated in Table 1. PTR for the branded product of cetirizine was 11 times the price for branded-generic by the same company. Retailer is earning INR 22.76 for 10 tablets of branded-generic cetirizine versus Rs 8.16 for the branded version from the same company. For ciprofloxacin, the MRP of both the branded and branded-generic product was same but the branded-generic was available to retailer at 3.6 times less price than branded medicine from the same company.

• 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.
• India sees the second most significant generic market penetration in the Asia-Pacific (APAC) region, just behind Malaysia.
• Efficient SCM practices are important to ensure the timely distribution of the right products in the right quantity at the right place.
• In the five years from 2017 to 2022, imports rose to $197.9 billion, worth almost one third (32.8%) of the cash spent by American patients, insurers, hospitals, and the government on pharmaceuticals (Figure 1).
• Together, we can help lead the future of healthcare with the extensive IQVIA network of assets, resources, clients, and partners.
• Moreover, complex reimbursement procedures, including documentation requirements and approval processes, can delay or deter patients from accessing timely reimbursements.
• Across Mumbai and Palghar districts, around 50% and 42% of medicines were found to be out of stock for the period of 3–6 months respectively.

Selection of medicines for the survey

The five medicines chosen were alprazolam, (0.25 mg), cetirizine (10 mg), ciprofloxacin (500 mg), fluoxetine (20 mg), and lansoprazole (30 mg). 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). Additionally, poor quality assurance mechanisms (empaneled labs for testing, accreditation, timely reporting), and insufficient supply down to the district and peripheral level facilities were observed in some states. The analysis of marketed AMLO containing FPPs was exercised using a validated analytical method. For each selected brand of AMLO FPP, two strips containing 20–30 tablets (in total), were taken. Further, individual tablets were weighed, triturated followed by weigh equivalent to 2.0 mg of AMLO besylate was taken and diluted to 20 mL with selected diluent.

India Solicits Price QuotesFor More Than 500 Generic Drugs

In the USA substitution is allowed and patients accept generic substitution if physician approves of the same. Generic substitution rates have increased remarkably there, probably due to greater acceptance by physicians and pharmacists as well as encouragement from the third party payers.[20]Cheaper generics are one of the important factors to reduce health-care cost. Studies involving comparative evaluation on quality of branded and their generic counterpart may be made mandatory for the generic (or branded-generic) manufacturer and their reports should be made public to promote generic use and prescriptions. Unlike developed countries, people in developing countries pay the cost of medicines out-of-pocket. Universal access to medicines, a critical component of Sustainable Development Goals, is intended to ‘ensure access to safe, effective, quality and affordable essential medicines for all [24].

India

If these Jan Aushadhi stores are available in Government hospital premises, patient can get those medicines easily.”(PuP2). If government wants us to prescribe drug through their molecule names, why do they allow so many brand names and why are there such wide price variations? By doing so, the brand has presented a cost-effective treatment for many patients of (HR+) (HER2-) advanced or metastatic breast cancer patients. Learn more about the Indian generic versions of Palbociclib and how it is a breakthrough in breast cancer treatment.

• According to National Sample Survey Organisation, public facilities accounted for only 30% of the overall healthcare services in the year 2017–18 [4].
• 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.
• (2010), “Status of home based care provision to bedridden elderly in Chandigarh”, Journal of the Indian Academy of Geriatrics, Vol.
• The focus on growing regulatory requirements, improved healthcare infrastructure, and surge in research and development spend bodes well for the pharma industry.
• The Drug Price Control Order (DPCO) identifies active pharmaceutical ingredients (APIs) for which a pricing formula is used to set the MRP.
• But, in order to fully realise the potential of this scheme, some policy actions are urgently required.
• The maximum price differential was observed for atorvastatin and clopidogrel, used for treating hypocholesteraemia and clopidogrel respectively, indicating that the unbranded medicines can be fairly affordable.

Key drugs losing patent protection in 2025

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.

• There was social and economic injustice because the low- and middle-income classes could not afford costly medicines, and DPCO resulted in socioeconomic justice for many poor people in India, a developing country.
• 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).
• 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.

Successful market access

Remarkably, 36% of China’s exports are to the EU and North America, where regulations are the most stringent, compared to 19% in 2009. Beijing’s “Made in China 2025” policy has identified pharmaceuticals as one of its strategic industries. Now, the advantages that have enabled India to play this role are in danger of being eroded.

How to buy Cabozantinib online in India

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. Since reimbursement schemes do not have uniform formulary inclusions, patients do not have clear guidance on which drugs are covered under the scheme, leading to unanticipated out-of-pocket expenses. Moreover, complex reimbursement procedures, including documentation requirements and approval processes, can delay or deter patients from accessing timely reimbursements. One of the key findings of our study is that PMBJP list included only 214 essential drugs, implying that it excluded more than 50% of drugs listed under NLEM, 2015. The inclusion of FDCs of antimicrobials, FDCs for CVDs and other diseases pose a public health concern. It is worth noting that though considerable research showed issues with some antibiotic FDCs, these FDCs still find their way to the Indian market [28].

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However, as shown in Table 2, PMBJP medicine list has as many as 130 FDCs in different therapeutic categories. The maximum number of fixed dose formulations listed in PMBJP is for vitamins and micronutrient deficiency followed by gastrointestinal complaints and cardiovascular disorders. As a protectionist tide sweeps across the globe, the Indian pharmaceutical industry needs to continue evolving.

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.

Costs and affordability

Furthermore, the physicians expressed the need for developing a regulatory framework to contain the proliferation of brands by the firms operating in the Indian pharmaceutical market, which, according to them, pose a barrier in prescribing generic medicines. Some brands of antibiotics are found to be more effective as compared to their generic counterparts. For example, augmentin brand gives effective and quick results as compared to its simple generic amoxicillin clavulanate version. But generic medicines for diabetes and hypertension are very good and cost effective for the patients for chronic illnesses.” (PuP3).

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The following were identified as the key focus areas to bolster the Indian pharmaceutical and healthcare sectors. Thus, from a practical point of view, Indian pharmaceutical companies should invest more in R&D, attempting to attract talented human capital. Otherwise, they will lose the highly qualified national workforce that will favor MNCs in the field.

To make the sample representative and consistent with the distribution of PMBJP outlets in Mumbai and Palghar, 11 pharmacies were selected for the study covering all levels of health care delivery system. The PMBJP pharmacies were purposively selected based on their proximity to public health facilities such as medical college (Tertiary level), Municipal General Hospital (Secondary Level) and PHCs and HPs (Primary level). PMBJP pharmacy’s proximity to the public health facilities was assessed using google maps (Fig. 1). All the selected PMBJP outlets agreed to participate in the study; and a written consent form was signed before data collection.

Here’s a breakdown of the cost differences between generics and brand names for over-the-counter and prescription drugs. To better understand the factors shaping these decisions, Tebra surveyed over 1,000 Americans and compared the costs of popular medications in five major US cities. This report explores how patient preferences, medication types, and healthcare tools like EHR systems shape the way Americans approach their healthcare choices. New drugs are protected by patents, so only the company that came up with the drug can sell it. Once the patent expires, other companies can get a generic version of the drug approved by the FDA and start selling it.

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The Indian pharmaceutical industry has been living a situation of constant growth in recent years, as shown by statistical analyses of the field at the descriptive and inferential levels. There are increased expectations regarding both the production amount and the trade balance value. There was an enormous effect of price policies on brands and drugs that had similar contents. These branded drugs showed a variation in pricing, also known as inter-brand price variation. There was ample availability of multiple brands for identical drugs in India, and therefore, after DPCO was revised in 2013, a so-called tug of war between these branded drugs began.

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.