Why India’s pharma industry must prioritise quality and innovation to sustain momentum

The Indian pharmaceutical industry is undergoing significant transformation because of its unwavering commitment to quality and safety. The industry, which ranks third in the world in terms of production and currently exports to around 200 countries, though has the reputation as a trusted supplier of quality generic medicines, need to further prioritise patient safety.   

Despite ambitious target to reach $120-130 billion by 2030 — the country’s pharmaceutical exports have increased by 9.67% to $27.9 billion over the past year — the industry depends on quality standards to guarantee trust, reliability, and efficacy, especially for life-saving drugs.

Several factors are driving this progress, including a comprehensive quality system overhaul and an implementation of robust risk management strategies. As a result, millions of patients worldwide will be able to benefit from these developments, which not only enhance patient safety but also facilitate groundbreaking discoveries and a more efficient drug development process.

As the ‘Pharmacy of the World’ and a leading producer of generic drugs, India has gained international recognition for meeting its own needs and those of many other nations. India’s pharmaceutical industry believes that its goal to move up to the top 10 in terms of value by 2030 is achievable, given it currently 14th ranking the world. However, addressing the challenges of counterfeit and inferior pharmaceuticals is extremely difficult for the pharmaceutical sector and its regulators.

A Proactive Approach to Quality

Some of India’s pharma companies certainly deserve credit for regularly upgrading their quality standards through workforce upskilling, digitisation, and capability building. However, quality should not be solely the responsibility of a few companies.

Acknowledging this, the government has recently launched three critical schemes under the banner of ‘Strengthening Pharmaceuticals Industry’ (SPI) to enhance the quality standards of Micro, Small & Medium Enterprises. These schemes encourage MSMEs to adopt global best practices, upgrade technologies, and provide credit for facility improvements.

The Skill Development Council of India has initiated Good Manufacturing Practice Training Programs to improve quality control. With the most significant number of accredited manufacturing facilities outside the US, India, a major exporter of generic drugs and vaccines, must ensure that the quality of its products remains uncompromised. Sustaining the tag of the Pharmacy of the World relies on delivering high-quality and affordable products that enable maximum patient access, thereby reducing the global disease burden. 

To keep its position as the world’s pharmacy, India needs to emphasise R&D and prioritizing both affordable and quality production. Maintaining its competitiveness is essential to securing India’s place in the pharmaceutical business globally. Leaders in the industry should also provide thoughts on pricing, regulations, strategy, and policy. These observations will be considered for a thorough presentation directing future policy formulation and industrial growth.

Innovation for Patient Safety

In the country’s drug industry, innovation is essential to maintaining high standards of quality and ensuring high standards of quality and patient safety. Robust research and development (R&D) programs aimed at identifying new drugs and improving delivery methods are essential to this activity. These R&D efforts aim to develop cutting-edge treatments and ensure they are affordable and accessible, thus broadening their reach and impact. Maintaining strict quality control throughout the manufacturing process is necessary to ensure the efficacy and safety of these innovations.

Digital technologies are vital in this regard since they significantly enhance patient safety monitoring and pharmacovigilance. Pharmaceutical companies can reduce risks and ensure early interventions using digital tools to track and analyse adverse drug reactions more efficiently. Digital technologies facilitate real-time monitoring, and data analytics, and offer vital information about the efficacy and safety of drugs.

The sector is contributing to a safer, more efficient healthcare environment by combining cutting-edge R&D, strict quality assurance, and the integration of digital technologies. 

Challenges and Future Trends

The industry in India continues to have challenges with sustaining innovation, maintaining quality control, and complying with regulations, even with notable advancements. It is imperative to maintain a commitment to improvement, adapt to changing rules, and make constant investments. The outlook is promising with trends like personalised medicine, which tailor treatments to individual patient profiles, and the development of biosimilars, making advanced therapies more affordable and accessible. The Indian pharmaceutical industry may further strengthen its position as a global leader in quality and patient safety by tackling these issues and leveraging new trends.

Industry must prioritise quality and innovation to sustain momentum. Success depends on adherence to rigorous quality assurance processes and continuous improvement in manufacturing practices, global standards to combat spurious and substandard drugs. To address the changing healthcare demands of a diverse international population, India’s pharma industry must continue to invest primarily in research and development to pioneer new treatments and delivery methods.

—The author, Dr. Daya Krishan Mangal, is Adjunct Professor IIHMR University, Jaipur, and Honorary Senior Associate, Department of International Health, Division of Health Systems, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, USA. The views expressed are personal.

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