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

As hospitals and insurers seek to drive down the price of generic drugs, the process has pushed generic manufacturing into the hands of fewer and fewer companies, with an ever-larger percentage of them in India and China. The offshoring of production to China and India has put the U.S. in a dangerous position, dependent on unreliable suppliers. Chinese and Indian manufacturers have demonstrated a pattern of repeatedly violating FDA regulations. FDA inspections are ineffective at controlling quality standards at Chinese and Indian facilities.

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

Generic Aadhaar is giving identity to the old medical stores and making it easy for them who are dealing with huge competition and online Pharmacy in the Market. Earlier these medical stores were earning 5-10% profit margins but now they can earn 40% profit margins from Generic Aadhaar’ Franchise Outlets. What’s more, Indian manufacturers are being audited by inspectors from every market they export to — UK, Germany, South Korea, Japan, Brazil, to name a few — who regularly visit and evaluate Indian pharmaceutical factories.

Worth the price? Push for cheaper generic drugs has Canadians buying questionable medicines from India

Thus, manufacturers have the freedom to set prices for their own drugs on the basis of various market forces, unless corrective measures are warranted. 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. The NPPA is responsible to fix, revise and monitor the pricing of such ‘controlled drugs’, which are listed by the Government in the dynamic National List of Essential Medicines (NLEM). The list is revised from time to time and some examples of essential medicines included in the NLEM are paracetamol, insulin, antibiotics, etc.

• 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].
• With over 165,000 providers and 190 million patient records, Tebra is redefining healthcare through innovation and a commitment to customer success.
• 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.
• 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.
• India, meanwhile, has developed a $15-billion generic-pharmaceutical industry, with labour costs about one-tenth of those in Canada.
• Despite the changing dynamics across the global industry, there is a lot to be positive about.
• She has represented the firm at national and international conferences and conclaves in India and Dubai.

Buy generic Cazanat (Cabozantinib) in India

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.

PALENO (Palbociclib) price in India

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.

Scope for costsavings on medicine and affordability of PMBJP medicines

• The marginal price adjustment is expected to affect 923 scheduled formulations listed in the NLEM, including antibiotics, cardiovascular medicines, tuberculosis drugs, and Parkinson’s and dementia medicines, among others; the small scale of the adjustment renders it meaningless compared to previous price adjustments.
• The availability of such generic formulations plays a crucial role in enhancing the accessibility and affordability of essential cancer treatments.
• In other words, the overall coverage of essential drugs in PMBJP list is just 57%, when compared to the total number of essential medicines included in NLEM.
• That job falls to state-level officials, who have a reputation for being under-trained and corrupt.
• For example, heart attacks and cardiac arrests are increasing in India, and treatments for these newly emerging diseases are very expensive.
• The price ceiling policy has been in place for more than 20 years, but it has neither been very successful nor free of consequences for pharma companies.
• Typically, a claim for reimbursement of a new pharmaceutical product requires a valid prescription from a registered medical practitioner.

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).

Diversity Fuels Innovation in Teva’s R&D Management Team

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].

Cabozantinib Generic Price in India

In fact, AYUSH represents a mass-niche market, requiring peculiar attention mostly in terms of competitive strategies that would have a focus orientation. 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. The most relevant contribution of the research relies on the shift to innovative production that Indian companies must adopt (after years of focusing only on generic drugs), and in this vein, appropriate industrial marketing solutions are indispensable. In order to collect data in an accurate and reliable manner, one of the researchers personally visited the selected PMBJP outlets to check the availability of generic medicines. The researcher cum field investigator is trained in both pharmacy and public health with previous experience of conducting primary data collection for health systems research.

• 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.
• There is a concrete risk of confusion in the minds of patients/consumers regarding which drug should be considered due to this price variation.
• The European Parliament has similarly recognized the importance of medicines as global public goods, and it has repeatedly called on the Commission to exclude TRIPS-plus requirements in trade negotiations — much like in its 2021 resolution to ensure all HIV antiretroviral treatments are affordable.
• There are increased expectations regarding both the production amount and the trade balance value.
• For scheduled medicines, the NPPA pricing formula sets the 8% mark-up for wholesalers and 16% for retailers.

How can I get generic drugs?

• Among the medicines included in the survey, 22 are universal medicines, which are supposed to be available at all levels.
• 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.
• The pharmaceutical business function of R&D has been significantly affected by the DPCO.
• The government must take up generic promotional schemes, general awareness programs on quality of generics to build confidence among prescribers, pharmacists, and consumers.
• This is the first limitation of the research, thus, further investigations expanding the range of the data under examination would improve the reliability of the results.
• Adequate infrastructure is one of the prerequisites for efficient storage and distribution of medicines.

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).

1 The scenario of the Indian pharmaceutical industry: descriptive and inferential analysis

Further, the private physicians underlined the need for developing strong regulatory mechanisms to ensure that generic drugs meet high standards of quality. “We are ready to prescribe low cost generics, but it becomes difficult for me to convince my patients to take such a low-cost generic medicine. Most of the time patients want relief from pain as quick as possible and thus they are ready to pay even high for medicines. We first examined the selected medicine list of PMBJP to assess the extent of coverage of essential medicines. NLEM, 2015 has 376 essential drugs whereas the PMBJP list contains 214 essential medicines.

The website you are about to access may be governed by different regional policies, regulations or advertising codes. Please be sure to read the privacy policy and terms of use of the websites that you visit. Cabotres is the medicine by the Cipla brand that harnesses the therapeutic benefits of cabozantinib. In addition to litigation, the firm advises clients on representations to be made to governmental regulatory bodies like the NPPA. The firm regularly attends hearings before forums such as the Ministry of Chemicals & Fertilisers and the Department of Pharmaceutics on behalf of its clients, providing strategic legal support in these highly regulated environments. Regarding her contributions in international conferences, Ms. Sharma has been elected as an executive member of AIPPI for the Indian Group, is an active member of the APAA and regularly participates and attends the INTA.

What is the process of securing reimbursement for a pharmaceutical product?

• The five medicines chosen were alprazolam, (0.25 mg), cetirizine (10 mg), ciprofloxacin (500 mg), fluoxetine (20 mg), and lansoprazole (30 mg).
• 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.
• The focus on growing regulatory requirements, improved healthcare infrastructure, and surge in research and development spend bodes well for the pharma industry.
• (2010), “Status of home based care provision to bedridden elderly in Chandigarh”, Journal of the Indian Academy of Geriatrics, Vol.
• The current study focuses on the availability, affordability and acceptability aspects of PMBJP essential medicines.
• 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.

In the present scenario, the changes in the patent regime may benefit MNCs, while domestic companies may face more challenges. Similarly, the threats possibly deriving from other low-cost countries – China above all – are real. The negotiations with MNCs, international rules and domestic regulations are imbalanced, while there are increasingly stringent regulations and nontariff barriers to generic drugs in developed countries (Dhar and Joseph, 2019). After the 1990s, India emerged harvoni cost uk 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. Similarly, pharmaceutical research and development can be carried out in India by global pharmaceutical MNCs. India has many pharmaceutical, bioscience and chemistry colleges that churn out huge amounts of high-quality graduates every year.

Drug Resources

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 government must take up generic promotional schemes, general awareness programs on quality of generics to build confidence among prescribers, pharmacists, and consumers. Availability of generics or branded-generics in the market with lower price tag and assured quality is essential to make the medicines affordable. Results of our study revealed that price-to-patient for the branded-generic version was not much less than to its branded counterpart; branded-generic was available at % cost of the branded product. Medicine prices are under the purview of Department of Pharmaceuticals which itself is under ministry of chemicals and fertilizers. The Drug Price Control Order (DPCO) identifies active pharmaceutical ingredients (APIs) for which a pricing formula is used to set the MRP.

Notable 2024 FDA decisions

• Not surprisingly, all of them, directly or indirectly, concern patents, which are central issues of debate in the national industry.
• For method development, method validation, and degradation sample analysis, an Agilent high-performance liquid chromatography Infinity 1260-II (Agilent Technologies company, Santa Clara, CA, USA) equipped with a quaternary pump, an online degasser, and a multiple wavelength or diode array ultraviolet detector was used.
• Further, we did not fully follow WHO-HAI methodology for calculating availability of essential medicines as the list of surveyed medicines was modified to meet the contextual requirements.
• The maximum number of fixed dose formulations listed in PMBJP is for vitamins and micronutrient deficiency followed by gastrointestinal complaints and cardiovascular disorders.
• The true causes are always somewhat obscure because pharmaceutical companies try to conceal the thinness of their supply chain and its exposure to single points of failure, such as unexpected decisions by foreign governments to shut a facility.
• In line with this, irrational prescriptions and poor adherence to STPs/STGs and EML may be attributed to lack of awareness.
• This push to make generics ever cheaper is saving the health-care system billions of dollars.

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%). More than 70% of PMBJP pharmacies across all levels of care had the medicines in categories of cardiovascular, analgesics, antacids and vitamins. On the other hand, the availability of antiasthmatic and antipsychotic medicines was very low-only a third of the PMBJP pharmacies had them. Anticancer and electrolyte balancer were not available in more than four-fifth of PMBJP stores, while half of the pharmacies had antimicrobial, antidiabetics, palliative care medicines, anti-epileptics.

Evolution of PMBJP

Against a group of these units, if 03 antimicrobials medicines were available in a PMBJP store and 04 antimicrobials medicines were available in another store, then the overall availability of anti-microbials in PMBJP pharmacies at primary level facilities of Palghar was 50% [((3X1) + (4X1)) X100/14]. In addition to streamlined procurement and communication channels, systematic reporting across the programmes is pivotal in aligning the demand for medicines with the state’s disease burden. For chronic conditions, the pace of NCD services uptake, especially at primary level healthcare facilities significantly influences demand-driven access to NCD-specific essential medicines. For example, in negotiations with Indonesia, the bloc proposed an extensive intellectual property enforcement regime that could adversely impact access to medicines. It has also sought to extend the duration a pharmaceutical producer is granted a patent monopoly and expand exclusive rights to data, both of which would delay the marketing of affordable generic versions.

The customer will have to present a medical prescription (legal) prescribed from a doctor. Contrast this with China, which is reportedly using its own vaccine projects as a commercial negotiating tool with countries who stand to benefit. It is another reason why India’s position as pharmacy of the world has a value far beyond its borders. SII is also partnering with US firm Novavax to develop and distribute the NVX-CoV2373 vaccine in collaboration with CEPI and COVAX.

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.

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. The so-called branded medicines in India are manufactured and promoted by multinationals or by reputed Indian manufacturers. Branded-generics, on the other hand, are not promoted or advertized by the manufacturer. Patients’ and doctors’ perception for all branded-generics irrespective of company is the same. The Common Review Missions serve as a platform to not only highlight various state level experiences but also signal the way forward to overcome systemic challenges in access to essential medicines.

Drug reimbursement policy has a substantial impact on the pharmaceutical industry, since it affects the incentives and outcomes of pharmaceutical research and development. Further, a robust drug reimbursement policy is equally important to ensure access and affordability for patients, since out-of-pocket expenses contribute to more than 45% of healthcare expenditure in India,[vii] despite the presence of price-control regulation. Although India’s case is lot more complex than most countries given the dominating presence of ‘branded’ generics in the Indian pharmaceutical market, it is worth learning from countries which achieved reasonable success in promoting the utilisation of generics. 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]. Japan, Canada, Australia, European countries as well as LMICs such as Philippines had similar experience regarding generic drug use [38, 39]. All these countries have either made it compulsory to prescribe drugs with active substance names or passed laws for mandatory generic substitution.

Capacity building of skilled cadres across the levels of care like facility-in-charge, store-keepers, ANMs and pharmacists in inventory/ material management, demand estimation, and indenting is required to support their state-specific practices. Professor Schondelmeyer told us that the U.S. is now dependent on India for 45% of the generic medicines we buy. One key reason generic drug production moved (and is still moving) to India is the high level of subsidies offered by the Indian government to drug manufacturers and exporters. Another reason is that India has not joined the International Council for Harmonization, a body that sets global standards for drug production. It also does not have national standards for drug production, instead leaving pharmaceutical regulation to its 38 states.

This is the first limitation of the research, thus, further investigations expanding the range of the data under examination would improve the reliability of the results. In value terms, the sector, considering the total manufacturing of pharmaceuticals, medicinal chemicals and botanicals (Table 1), is worth Rs. 145,841.1m in 2018–2019. The largest market share concerns ayurvedic and homeopathic medicaments (AYUSH medicines) with 24.37%, followed by antibiotics (API and formulations) with 18.82%, and anti-retroviral drugs for HIV (Human Immunodeficiency Virus) treatment with 15.89%. These three pharmaceutical categories alone are worth approximately 60% of the entire Indian pharmaceutical production.

One challenge is coming from China, which has increasingly been exporting active pharmaceutical ingredients in recent years. 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. In India, generic substitution is legally not allowed so patients’ awareness about generics is limited and doctors and patients do not want pharmacist to change the trade name written by doctor.

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].

The three major medicines for breast cancer – Palbociclib, Ribociclib, and Abemaciclib are popular internationally. Despite India’s contribution to global access to medicines, the government has never tried to use this as an instrument of foreign policy. One silver lining is that China is proposing a new regulation that would give its firms exclusive control over their clinical test data.