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.

ARTICLES FROM THIS PUBLICATION

The challenges are reportedly more pronounced in North-Eastern states and for facilities under the National Urban Health Mission (NUHM). Given the objective to understand the determinants of access to medicines in the Indian public health system, the CRM reports between 2007 and 2021 were reviewed. Core themes pertaining to medicines were identified and each theme was analysed to deduce the context-specific determinants influencing their availability and accessibility in the public health system. The findings were appraised for relevance and validated for aptness by comparing the recent reports with the former ones to ascertain their contextual underpinnings. Core themes in the Indian Public Health System, their interlinkages and key determinants for ensuring access to medicines are discussed below. As part of its NextGen market-shaping approach, the Global Fund will continue to work with manufacturers to secure a sustainable supply of affordable HIV treatment.

Empowering people to take better care of themselves

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.

Views on PMBJP scheme

“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.

Company

The Indian Pharmaceutical Alliance (IPA) represents 23 research-based national pharmaceutical companies focused on patient health and safety with a commitment to provide quality drugs to patients throughout the world. Even more surprising is the fact that more than a third of these drugs were likely manufactured in India. This country’s ability to produce affordable, generic drugs has led to its reputation of being the “pharmacy of the world.” By export volume, India is currently the largest provider of generic medicines globally, supplying 18 percent of global generic medicines. Recently, in March 2024, the Indian Government constituted a five-member Committee to oversee reform efforts for the pricing of drugs and medical devices and supervise the drafting of a new Drugs and Medical Devices (Control) Order. The primary task of the Committee is to strike a balance between pricing and availability of essential medicines while offering incentives to the industry to foster growth and exports.

HEALTH SYSTEM FACTORS INFLUENCING SUPPLY CHAIN OF MEDICINES

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.

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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.

• 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.
• The growth in population also affects reimbursement policies, since the Government has to allocate an increasing number of funds to public health insurance schemes and may be affected by budgetary constraints.
• For many Americans, the decision between generic and brand-name medications often comes down to cost.
• 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.
• 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.
• 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.

Indian pharma is being squeezed – and it’s bad news for drug access in developing countries

Thus, the Indian government should establish ongoing support to small- and medium-sized Indian companies in training and implementing FDA standards, as it provides easy global access to those and similar international markets. India has witnessed rapid population and economic growth in the past two decades, and this expansion has created a demand for larger and better infrastructure in cities and industrial parks. India’s limited development of service platforms is a result of the scarce functioning of the bureaucracy, but conditions have improved in recent years. There is a need to reserve appropriate sizes of land for the health-care sector in cities and for pharmaceutical companies in industrial belts during the planning process. In India, the public health-care system is not strong, and most of the middle class and above prefer to visit private hospitals for treatment.

• The fact anyone is paying attention to the quality of Indian-made medicines is arguably because of Mr. Thakur.
• There are only 74 bulk drugs which are under price control[15]and are called scheduled medicines.
• The Indian pharmaceutical industry is among the top producers in the world, supplying over 50% of the global demand for various vaccines, 40% of generic demand in the USA and 25% of all medicines in the UK (IBEF, 2020).
• 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.
• 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.
• 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.
• A 3-tiered public healthcare delivery system is catering to the needs of the population of these two districts.

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I was in the range of 1–3, where 1,2,3 represented three different health care facility levels such as primary (Health Post in urban area /PHC in rural area), secondary (District Hospital/Peripheral Hospital) and tertiary (Medical college & hospital). 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. Similarly, stock-out of medicines was calculated for the reference period of six months.

Palbociclib other generic alternatives brands in India

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.

Hence, the critical issues that affect the quality of generic drugs are purity, potency, stability, and drug release, and these should be controlled within an appropriate limit, range, or distribution to ensure the desired drug quality. EHR systems with e-prescribing capabilities help providers identify cost-saving opportunities, such as more affordable generic or therapeutic alternatives. With additional tools like coupon finders, EHR systems can locate the best local prescription prices and provide real-time data for drug-specific directions, enabling providers to offer more personalized and budget-friendly care.

Mission is to Protect your Businesses & Much More

A challenge is also posed by the exponential growth in population, and epidemiological changes in the population resulting from shift in lifestyles. Thus, there is a continuous boost in the demand for pharmaceutical products and a consequent strain on the supply chain. The growth in population also affects reimbursement policies, since the Government has to allocate an increasing number of funds to public health insurance schemes and may be affected by budgetary constraints.

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.

Again, this involves a minimum of one billion doses for India and other low to middle income countries. This is the lowest quoted price in the world for a COVID vaccine, and will see them distributed in low and middle-income countries. 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. You can share this content on Americans’ preferences for generic versus brand-name medications for noncommercial purposes as long as you provide a link to this source page. Exploring cost savings, perceived effectiveness, and the role of medication type in American buying habits. Generic medications go through testing for quality, strength, purity, and potency to show effectiveness before being approved by the FDA.

In fact, we did carry out prescription audit as part of the overall study, but its findings are not included here. The present study adopted descriptive cross sectional research design to assess the current situation of PMBJP scheme in two districts of Maharashtra. However, to fully understand whether rebranding of JAS as PMBJP improved the accessibility of essential medicines, a pre/post evaluation study would have provided better insights but that could not be performed due to the non-availability of comparable baseline survey data. Hence, N X P gave the total number of drugs in that therapeutic category which were surveyed at all PMBJP pharmacies at PHC level in Palghar. For instance, if availability of 7 (N) antimicrobials medicines in 02 PMBJP pharmacies (P) at PHC level in Palghar was evaluated, then overall 14 units (PXN) would be examined.

• Pharmaceutical price control is a popular technique that has been used by other countries to address the shortages of medicines following the Covid-19 pandemic and relieve pharma companies that are suffering from high production costs.
• This means about one in 20 of this country’s finished drugs are now made in India – roughly 20 million prescriptions a year.
• When patients choose between brand-name and generic medications, cost, trust, and availability all come into play.
• Before sending the shipment, the prescription will be fully checked by our qualified Pharmacist.
• Regulations to support mandatory generic prescribing and generic substitution by pharmacists are needed.
• 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.
• Further, inadequate healthcare infrastructure, particularly in rural areas, affects the distribution and accessibility of pharmaceuticals, impacting both pricing and reimbursement effectiveness.
• More focus on patents for innovative drugs is required, instead of concentrating primarily on generic drugs.

Sun Pharmaceutical: PALENO (Palbociclib)

In response to this growing regulatory environment, pharmaceutical companies in India continue to strengthen their processes, while improving automation, operating procedures and quality management systems. This includes vigorously efficient quality control and quality assurance systems alongside training programs and workshops, building an omnipresent culture of quality. The result harvoni price in singapore is a focus on quality that starts at a shop-floor level for machine operators, ensuring compliance from the ground up. In the past few years, expectations of regulatory organizations around the world have increased. With the number of companies and manufacturing facilities supplying to the regulated market growing fast, it is natural that the agencies are intensifying their efforts.

Consent for publication

Pharmaceutical price control is a popular technique that has been used by other countries to address the shortages of medicines following the Covid-19 pandemic and relieve pharma companies that are suffering from high production costs. The implementation of market-based price ceilings on a set of essential medicines, including on-patent and generic drugs, is a form of pharmaceutical price control applied by the Indian Government and intended to make drugs accessible to people at an affordable price and address drug shortages. 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.