Pharmaceutical

Why India is a hub for pharma manufacturing worldwide?

The pharmaceutical industry’s main markets are under serious pressure. Europe, Japan and North America jointly account for 82% of audited and unaudited drug sales; overall sales reached US$773 billion in 2008, as per IMS Health. Yearly growth in the European Union (EU) has decreased to 5.8%, and sales are increasing at a much progressively sluggish rate in Japan (2.1%) and North America (1.4%). Impending policy changes, promoting the utilization of generics in these key markets are required to additionally dent the top- and bottom-line of global pharma majors. The industry is preparing itself for some fundamental changes in the marketplace and is looking at newer approaches to drive growth. Thus, at JoinHub Pharma, we bring better wellness for people and progress in medicine by implementing latest quality parameters and developing superior pharmaceutical products.

From the centuries-old centre for silk brocade to the world’s biggest hub for polishing and cutting diamonds, there are industrial clusters spread in various parts of India. Rising hi-tech centres to some which are thinking about many problems, there are very few surprises on India’s manufacturing map.

India’s pharmaceuticals industry looks set for strong long-term growth. With the near sales of US$19 billion in March 2009.10, it ranks 14th in the worldwide league table. However, PwC estimates that it will rise to around US$50 billion by 2020 – 163% over the course of about 11 years.

In response to this growing regulatory environment, best pharmaceutical companies in India continue to reinforce their processes, while improving automation, operating processes and quality management systems. This incorporates vigorously efficient quality control and quality assurance systems alongside workshops and training programs, fabricating an omnipresent culture of quality. The result is a focus on quality that begins at a shop-floor level for machine operators, guaranteeing compliance starting from the earliest stage.

Because of these actions, FDA review outcomes for the top 10 pharmaceutical manufacturers in India have not only improved, yet are in line with results from other worldwide manufacturers. Former FDA Commissioner Scott Gottlieb said to media about the report reports questioning the quality of Indian products, “…the FDA labs tested 323 products from around the globe — including at least 100 from India — to decide whether foreign manufacturers had a higher incidence of product failure. All 323 samples met U.S. market quality standards utilizing testing standards submitted in marketing applications or set by the United States Pharmacopeia (USP).”

Accountability is additionally intrinsic to this focus on quality. Consider that the receipt of an FDA “warning letter” often brings about staff changes at the most senior levels of leadership at Indian generic companies. This accountability happens even in incidences where the FDA has come down hard on organizations for even the smallest of deviations.

Redefining India’s reputation

For instance, Indian generic manufacturers play an important role in bringing safe, new, affordable drugs to US customers. In 2018 alone, the FDA approved a record 741 generic drugs with Indian companies, representing almost 50% of the approvals.

Consider that the Indian pharmaceutical industry has essentially reduced the burden on the U.S. public health system by making genuinely necessary medicines affordable and promptly available. Each third tablet sold in the U.S. comes from India. Generic drugs savings totalled $292.6 billion in 2018, as indicated by the AAM Access & Savings Report (2019). Of this, surprising savings totalling around $80 billion in 2017 credited to the contributions from Indian generic companies.

Moreover, Indian pharmaceutical companies are presently turning into a key source of medication for many countries. Of note, they are playing a significant role in bringing down the price of lifesaving, antiretroviral drugs that have contained the AIDS pandemic.

India’s global reach

The global demand for medication from India will keep on going up. India’s share of the US generic market is growing quickly, and the number of companies and manufacturing facilities providing to the U.S. market is growing fast. The emphasis on growing regulatory requirements, improved healthcare infrastructure, and flood in research and development spend looks good for the pharma industry.

This growth isn’t exclusive to India. Indian generic manufacturers are likewise producing in the U.S. what’s more, in other countries whenever necessary. The Indian Pharmaceutical Alliance (IPA) has 23 research-based pharmaceutical organizations centred around patient safety and health with a commitment to give quality drugs to patients throughout the world.

To drive forward this promise to give safe and quality drugs, IPA organization have undertaken a few focused steps towards excellence in quality. In the past 4 years, IPA has focused on:

  • Benchmark & measure Indian pharma quality with the other countries rules
  • Create focused guidelines and best practices in areas of relevance, which are verified by regulators over the world, including the FDA
  • Expand the skills and abilities of quality talent for Indian pharmaceutical companies

Furthermore, IPA companies gave $161 million to generic-drug user expenses between 2012 and 2016, along these lines contributing the greater part of the income under the Generic Drug User Fee Amendments, which helps the FDA to carry more prominent consistency and timeliness to the review of generic drug applications, just as assists to fund the inspection of generic plants.

In conclusion

Indian companies will keep on expanding globally, enriching their manufacturing capabilities to satisfy the growing demand in the world. The future will see a significant role in global healthcare by Indian pharma, not only in making medicines affordable, yet additionally in fortifying India’s position as a global hub for making innovative and high-quality medications.

By making bolder vital strategies in uncharted countries, technologies, and products, Indian generic manufacturers look to set their position as a world-class provider of high-quality, affordable drugs. Guaranteeing we communicate this vision and quality-centric focus will be basic to the bright future between manufacturers and those who depend on these medicines.

All things considered, a clear understanding of achievement and emphasis on quality supports the progressing endeavours of Indian generic manufacturers to give quality solutions that at last benefit consumers over the globe.

Looking for the best pharmaceutical manufacturer in India? Then, contact our experts today.

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Pharmaceutical

Which are the precautions that must be taken to avoid Corona in lockdown?

India is closely monitoring the danger posed by a new flu-like virus (2019 Novel Coronavirus, or COVID-19) that has killed hundreds in China, and has asked its citizens not to go there.

While the Food and Drug Administration reported that testing in the United States would be enormously expanded, health experts have been warning that the virus’s spread in the country is unavoidable. That implies it’s time to prepare your home and family in case your community is influenced.

Started at now, a vaccine has not been formulated for the novel Coronavirus. Considering this reality, prevention appears to be the best cure accessible so far.

The World Health Organisation has a list of suggestion for protection against a few illnesses, including the new strain of coronavirus. Here is a helpful infographic from the UN body.

Pharmaceutical

What will be the effect on pharma industry post Corona?

The effect of the Coronavirus pandemic and the lockdown, it triggered is unmistakably obvious in financial markets. Yet, there is still no clarity on the more profound effect that it is having across businesses and industrial sectors. Being a WHO, FDA, ISO 9001:2008, and GMP certified company, we at JoinHub Pharma helping and supporting healthcare experts by offering face masks, hand sanitizers, N95 masks, surgical masks, tablets, drops, capsules etc covering everything of healthcare.

Based on assessments made by different analysts and industry body FICCI, here is an impact analysis on the pharma sector.

The impact of China and India
Among the problems for pharmaceutical supply chains during this pandemic are the restrictions and impact of COVID-19 on two of the largest global producers of active pharmaceutical ingredients (APIs) and generics: China and India.

Since the outbreak started in China and lockdowns were imposed, ¬supply from their manufacturing facilities has reduced. The true extent has been difficult to quantify as limited numbers of the typical workforce have been able to return to work. A recent letter sent by Medicines for Europe revealed that the Chinese powers expect large manufacturing facilities to be fully operational soon, although smaller producers may continue to struggle for some time J.P. Duffy, a Reed Smith Partner stated that “most companies feel that they are relatively well-positioned to weather short-term disruption. This is because many publicly traded companies have six months to a year of stockpiles; however, if restrictions continue for an extended period, especially if people in China cannot get back into the factories to work, eventually supply chain shortages will start to disrupt everyone.”

Reports suggest a range of possible effects, including:
• Generic drug producers who source APIs from China are likely to face supply chain issues if the outbreak continues
• Short-term scarcities affecting certain products – one such shortage has already been announced by the US Food and Drug Administration (FDA)1
• Manufacturers of branded pharmaceuticals may see a shift in their demand, both as antiviral use rises and as other chronic conditions are left untreated by patients due to concerns over exposure to COVID-19.

India pharma’s global standing:
The Indian pharma industry has been a world leader in generics both globally and domestic markets contributing significantly to the global demand for generics in terms of volume. Made-in-India drugs supplied to the developed economies such as the US, EU and Japan is known for their safety and quality. In recent years, India has seen increasing competition from China, which it has been able to leverage due to its inherent cost advantage, manufacturing intermediates and APIs at a cost much lower than those in India which has resulted in a gradual increase in API imports from China to India and this, in turn, has led to the killing of domestic manufacturing capacity for certain key APIs and their advanced intermediates.

Supply chain disruption for India pharma:
Any disruption in the supply chain of APIs can result in significant shortages in the supply of essential drugs in India. Some of the critical APIs for high-burden disease categories such as cardiovascular diseases, diabetes and tuberculosis are listed in the National List of Essential Medicines (NLEM). In fact, the current market is largely dependent on China for many antibiotic APIs manufactured by the fermentation route such as penicillin, cephalosporins and macrolides.

The increased dependency of low-cost API is mainly attributed to China’s extensive efforts towards developing economies of scale, easing regulations for bulk drug manufacturers, availability of low-cost utilities, building process efficiencies and supporting manufacturers in the form of subsidy, low taxes and fiscal incentives. India has significantly lost out on the API manufacturing owing to the inadequate government support and API focused infrastructure coupled with complexity in getting approvals for setting up a manufacturing plant, delayed pollution clearances, the high cost with low availability of utilities, regulatory and price control regime are some of the key challenges faced by the bulk drug industry.

Relative stability, reasonable valuations:
HDFC Securities says Pharmaceutical manufacturer in India has been relatively resilient to the COVID disruption and is poised to gain from favourable currency tailwinds and stable outlook for India and US business. India growth has picked up (~10% growth for IPM as of MAT Mar’20). It forecast 11% growth for covered companies over the next two years. US pricing environment continues to remain benign and the regulatory challenges are well understood. The pharma sector is up ~1% YTD and has outperformed the Nifty Index by 28%. Some prefer stocks with high India exposure as it offers greater earnings visibility, supported by reasonable valuations.

Valuation and Risks:
The sector trades at ~23x one year forward, 10% below its 5-year historical average. The sector premium to Nifty is at 35% vs. (5-year avg of 38%). Key risks: a) extended lockdown can impact demand and manufacturing; b) Delay in US FDA plant resolution due to travel advisory; c) EM markets currency risks and subdued demand; d) delay in key approvals.

Major earnings cuts ahead for pharma firms:
Edelweiss Securities says the novel coronavirus or COVID-19, the pandemic has caused severe supply-side disruptions in various sectors, earnings will be cut by 10-15%. Pharma as a sector has emerged as a strong contender to drive the next leg of the rally, whenever it comes. In expectation, pharma stocks have seen a huge run-up in the last 10 days. This isn’t simply true for India, yet globally too best pharma companies have performed well. While for the time being, most companies will bounce back from the most recent 5 years of underperformance, this time around, the leader will be unique.

Conclusion
While drug shortages due to COVID-19 are so far limited and expected to remain this way in the short term, if the pandemic continues then stockpiles of pharmaceuticals, APIs and other chemicals may decrease, resulting in shortages. A further effect is the added complications for distribution, particularly with population movement restrictions across Europe.
Duffy advises medicine exporter from India and other countries to monitor the evolving situation and ensure enterprises are aware of the clauses of their contracts that may become problematic in the longer term.
Looking for the best pharma product exporter from India? Then, contact JoinHub Pharma today!

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