December 04 2023 0Comment

Big Pharma Benefits Indian Drug Manufacturer: A New Challenge Before Pharmaceutical Patent

Indian Drug Manufacturers Benefit From Big Pharma Interest Beyond China

According to an article published by the Hindu, based on interviews with ten industry officials and analysts, drugmakers are attempting to reduce their reliance on Chinese contractors. The reason is that they produce medications used in clinical trials and early-stage production. This move benefits rivals in India in the sector of pharmaceutical patent.

Due to the low cost and speed offered by contract drugmakers in China, China has been the favoured place for various pharmaceutical research and production services for nearly 20 years.

Despite the Trump administration’s trade battle with China and the supply chain disruption witnessed by other industries during the COVID-19 outbreak, that partnership has generally held steady. However, rising tensions with China have spurred many Western governments to advise businesses to “de-risk” supply chains from exposure to the Asian giant.

India desires to expand its presence in the pharmaceutical services sector to enhance sales and reputation in its $42 billion pharmaceutical business.

However, concerns about insufficient control remain. According to Nimgaonkar, Indian CDMOs must do more to guarantee their reputation for quality standards meets those of Western and Chinese counterparts.

In February, the US Food and Drug Administration (FDA) issued a warning against using an eye drop made in India that was related to a drug-resistant bacterium epidemic in the US that resulted in one death.

Mordor Intelligence, an India-based research organisation, expects revenue from India’s CDMO market to be $15.6 billion this year, compared to $27.1 billion in China. However, it expects India’s sector to develop at more than 11% per year on average over the next five years, compared to 9.6% in China.

According to DeYoung, Piramal Pharma has received requests from clients for “backward integration to India” this year. This means that even the most basic raw ingredients are supplied from India rather than China. Piramal sources roughly 15% of its raw materials from China, but it is working to minimise this figure.

According to Sai Life Sciences, it has nearly doubled its manufacturing capacity since 2019 and plans to add another 25% in the next year or two to satisfy demand.

India’s Potential To Be The Leading Manufacturer Of Generic Medicine

India has emerged as a global powerhouse in the pharmaceutical industry, particularly in producing generic medicines. A generic medicine is bioequivalent to a branded drug, offering the same therapeutic effects at a fraction of the cost. India’s prowess in this sector is rooted in a combination of factors that position the country as a frontrunner in the production and distribution of generic pharmaceuticals.

Its robust pharmaceutical infrastructure is one key factor driving India’s success in generic medicine manufacturing. The country boasts a vast network of pharmaceutical companies, both large and small, equipped with state-of-the-art facilities and adhering to stringent quality standards. These facilities can produce various generic drugs, from simple over-the-counter medications to complex formulations for treating chronic diseases.

India’s commitment to research and development is another catalyst for its burgeoning generic medicine industry. The country’s pharmaceutical companies invest significantly in research to develop cost-effective generic alternatives without compromising quality. This dedication has led to the creating of a vast portfolio of generic drugs that cater to diverse therapeutic areas, offering affordable healthcare solutions not only to its population but also to the global market.

Development Of the Indian Pharmaceutical Industry

Moreover, India’s regulatory framework plays a crucial role in ensuring the safety and efficacy of generic medicines. The regulatory authorities have implemented stringent quality control measures, aligning with international standards. This commitment to quality has garnered trust from global consumers and regulatory bodies, solidifying India’s reputation as a reliable source of high-quality generic medications.

The cost advantage offered by Indian pharmaceutical manufacturers is a global game-changer. The ability to produce high-quality generics at a fraction of the cost compared to their branded counterparts has positioned India as the world’s pharmacy, especially for developing nations facing healthcare budget constraints.

In conclusion, India’s potential to be the leading generic medicine manufacturer is underpinned by its robust infrastructure, commitment to research and development, stringent regulatory standards, and cost-effective production capabilities. As the world grapples with the challenges of ensuring access to affordable healthcare, India stands poised to play a pivotal role in meeting the global demand for high-quality, cost-effective generic medicines.

What Are The Backlog The Indian Pharma May Face During Their Upliftment

In pharmaceuticals, innovation and timely access to cutting-edge drugs are pivotal in advancing healthcare outcomes. India, known for its prowess in generic drug manufacturing, has encountered a challenge that threatens to hinder the speed of bringing new medicines to market: patent backlogs. As the Indian pharmaceutical sector strives to keep pace with global advancements, addressing this issue is crucial for fostering innovation and ensuring timely access to life-saving medications.

One of the primary reasons behind patent backlogs in India is the surge in patent applications, a testament to the growing significance of the pharmaceutical industry in the country. The sheer volume of applications has strained the capacity of the patent office, leading to delays in the examination and approval process. To cope with this, there is an urgent need for increased staffing, modernised infrastructure, and streamlined processes within the patent office.

TRIPS Agreement

Implementing the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement in 2005 marked a significant shift in India’s patent approach. It has facilitated intellectual property protection. Also contributed to a spike in pharmaceutical patent applications. The transition to a product patent regime has necessitated a more robust and efficient patent examination system to balance the interests of innovators. The imperative to make medicines accessible to the masses.

India must invest in bolstering its patent examination infrastructure to address patent backlogs. This includes recruiting and training additional patent examiners, leveraging technology for more efficient processes, and establishing specialised divisions within the patent office dedicated to pharmaceuticals. By doing so, India can expedite the examination of pharmaceutical patent applications, reducing the backlog and fostering a more conducive environment for innovation.

The Solution

Collaboration between the government, pharmaceutical industry, and research institutions is essential to resolving the patent backlog issue. Public-private partnerships can contribute to developing a more streamlined and responsive patent system. They are encouraging innovation while ensuring that the benefits of new medications reach patients promptly.

Moreover, encouraging a culture of innovation and research within the pharmaceutical industry is vital. Incentives for research and development and initiatives to support startups and small enterprises can contribute. This is to a more vibrant and dynamic ecosystem. This can alleviate the pressure on patent offices by fostering a more balanced distribution of patent applications.

In conclusion, addressing patent backlogs in India is critical for the pharmaceutical sector to keep pace with the speed of medicine and drug manufacturing. By investing in infrastructure, streamlining processes, fostering collaboration, and incentivising innovation, India can create a conducive environment that protects intellectual property and ensures timely access to innovative medications to benefit patients in the country and worldwide.


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