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.
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.
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