American consumers are often amazed to find out about the drugs prescribed to them. For example, numerous individuals are taken aback to discover that more than 90% of the medicines prescribed by specialists in the U.S. are generics.
Considerably more surprising is the fact that in excess of 33% of these drugs were likely manufactured in India. This country’s ability to manufacture cost-effective, generic drugs has led to its reputation of being the “pharmacy of the world.” By export volume, India is presently the biggest supplier of generic medicines globally, providing 18% of global generic medicines.
It makes sense that when the media raises concerns about the safety and scope of imported and exported generic medicines, consumers question the quality of medicines fundamental to their health. Ongoing stories have depicted an industry laden with quality issues. These concerns raise fears among patients that consuming medicines made in India may bring about unpredictable effects.
Luckily, the generic medicines manufactured in India are as safe and efficacious as those produced in the United States.
In the past few years, expectations of regulatory organizations around the globe have increased. With the number of companies and manufacturing facilities supplying to the regulated market growing fast, it is natural that the agencies are increasing their efforts. Since 50% of India’s pharmaceutical exports are too highly regulated markets such as the United States, Indian manufacturers must comply with severe U.S. Food and Drug Administration (FDA) guidelines that incorporate regular and rigorous inspections to guarantee compliance.
Also, Indian manufacturers are being examined by inspectors from every market they export to — Mexico, South Korea, Germany, Japan, Brazil, to name a few — who regularly visit and assess Indian pharmaceutical factories.
In response to this growing regulatory environment, pharmaceutical companies in India keep on reinforcing their processes, while improving operating procedures, automation, and quality management systems. This incorporates vigorously proficient quality control and quality assurance systems close by workshops and training programs, building an omnipresent culture of quality. The outcome is a focus on quality that begins at a shop-floor level for machine operators, guaranteeing compliance from the ground up.
Redefining India’s reputation
So, what should be done in order to the practical steps being taken by Indian generic manufacturers to grasp a culture of high-quality? Significantly, beyond presenting a proof-based case that generics manufactured in India are efficacious and safe, we should likewise show the huge great these drugs provide to consumers.
For instance, Indian generic drug manufacturers play an important role in bringing safe, new, affordable drugs to US consumers. In 2018 alone, the FDA affirmed a record of 741 generic drugs with Indian organizations, representing almost 50% of the approvals. (Indian companies got 73 tentative approvals and a total of 415 product approvals in 2018.)
Consider that the Indian pharmaceutical industry has altogether reduced the burden on the U.S. public health system by making genuinely necessary medicines affordable and readily accessible. Every third tablet sold in the U.S. comes straight from India. Generic drug savings added up to $292.6 billion in 2018, as per the AAM Access & Savings Report (2019). Of this, expected savings adding up to $80 billion in 2017 can be credited to the contributions from Indian generic companies.
Indeed, Indian pharmaceutical companies are presently turning into a key source of medication for the rest of the developing world.
India’s global reach
The worldwide 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 organizations and manufacturing facilities supplying to the U.S. market is growing too fast. The focus on improved healthcare infrastructure, growing regulatory necessities, and surge in research and development spend bodes well for the pharma business.
This growth isn’t exclusive to India. Indian generic manufacturers are additionally producing in the U.S. and in other countries at whatever point necessary. The Indian Pharmaceutical Alliance (IPA) accounts for 23 research-based national pharmaceutical companies centered with respect to patient health and safety with a pledge to give quality drugs to patients throughout the world.
To drive forward this commitment to give high-quality and safe drugs, IPA organizations have attempted a few focused steps towards excellence in quality. Over the past 4 years, IPA has worked towards:
- Benchmark Indian pharma drug quality with the rest of the world
- Create targeted guidelines and best practices in areas of significant, which are vetted by regulators over the world, including the FDA
- Expand the capabilities and skills of quality talent for Indian pharmaceutical companies
Moreover, between 2012 and 2016, IPA companies contributed $161 million to generic-drug user fees, subsequently offering more than half of the revenue under the Generic Drug User Fee Amendments, which empowers the FDA to bring more prominent predictability and timeliness to the review of generic drug applications, just as assists with funding the inspection of generic plants.
Indian companies will keep on expanding globally, enriching their manufacturing capabilities to fulfill the growing demand on the planet. The future will see a significant role in worldwide healthcare by Indian pharma, not only in making medicines affordable, yet in addition to reinforcing India’s position as a worldwide hub for making innovative and high-quality medicines.
By making key strategic moves in uncharted geographies, technologies, and products, Indian generic manufacturers look to recover their position as a world-class provider of affordable, excellent drugs. Guaranteeing we communicate this vision and quality-centric focus will be essential to the splendid future between manufacturers and those who depend on these medicines.
All things considered, a clear and concise understanding of our record of achievement and emphasis on quality supports the continuous efforts of Indian generic manufacturers to give quality solutions that eventually benefit consumers across the globe.
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