India's Contract Development and Manufacturing Organisation (CDMO) sector has rapidly emerged as a pivotal player in the global healthcare landscape. Renowned for its position as a leading generics medicines developer and producer and its ability to execute large scale operations with US-FDA approved facilities and processes, India's pharmaceutical industry has set ambitious targets for growth.
In 2020, the Indian pharmaceutical industry recorded a substantial market size of US$42 billion. India has a growth ambition to achieve a market size of US$130 billion by the year 2030. This goal likely represents India's total value of its pharmaceutical industry, including both domestic and export revenues.
India supplies almost 40% of the generic drugs to the United States. As of 2022, it boasts a remarkable milestone with a total of 603 US FDA approved manufacturing sites, making it the country with the largest number of such sites outside of the US. This signifies India's growing prominence and recognition in the global healthcare landscape.
According to the US Center for Drug Evaluation and Research, 2022 Report on the State of Pharmaceutical Quality, the US drug regulator witnessed a notable increase of 12% in manufacturing sites worldwide and India leads the pack with a remarkable 17% increase. This expansion reflects India's commitment to maintaining high-quality standards and regulatory compliance in pharmaceutical manufacturing.
India has confidently addressed 483 observations — the issues linked to quality manufacturing practices compliance — from the FDA, demonstrating a strong commitment to continuous improvement and driving the industry towards achieving world-class standards.
This article delves to India's transformation in the CDMO services ecosystem and explores how the sector's commitment to compliance, efficiency, and quality has positioned it on the global stage.
Investments in compliance and quality
The strength of India's regulatory capabilities and deeply ingrained quality culture makes it a reliable partner for delivering fully compliant products and services. The adoption of digital quality systems and automation by the pharmaceutical companies drive efficiency, speed, and easy access to audit trails, further enhancing regulatory compliance.
Indian government investments in compliance and quality
The Indian government has taken proactive steps to support the healthcare ecosystem and improve the quality of pharmaceutical products. Initiatives such as the launch of the Medical Device Act demonstrate India's commitment to ensure drug and device safety. The Directorate General of Foreign Trade (DGFT) has mandated quality checks in central labs before exporting drugs, bolstering confidence in Indian pharmaceutical exports.
As part of this mandate, drugs produced for export will be permitted only after rigorous testing at earmarked laboratories by the central government starting from June 1, 2023. The government has also increased surveillance to improve Good Manufacturing Practices (GMP) adherence to be on par with international standards set by the World Health Organization
Additionally, the new Promote Research in Pharma (PRIP) scheme is set to play a crucial role in fostering innovation and research within the pharmaceutical sector by upskilling the talent base available to the industry. Such moves from the government benefit the entire industry but specifically support the CRO-CDMO sector where innovative research is conducted.
Fostering self-sufficiency
The Production Linked Incentive (PLI) Scheme, 100% Foreign Direct Investment (FDI), Jan Aushadhi Yojana and Ayushman Bharat are among the measures aimed at enhancing medicinal drug production within the country. India currently relies on imports for approximately 95% of its Active Pharmaceutical Ingredients (APIs) from China.
To address this dependency and promote domestic production, the government introduced the PLI scheme, encouraging the production of 38 key bulk drugs domestically. Such a move has multiple benefits. It helps build self-reliance, adds more API capacity into India and develops a talent base. All of these help the pharma industry in India while also strengthening the CDMO sector.
Capabilities of Indian CDMO
Many Indian CDMOs have successfully cleared several significant regulatory inspections including those from the US FDA. This highlights India's commitment to regulatory excellence and adherence to global standards in the CDMO sector.
According to a recent market report, the U.S. drug regulator completed the good manufacturing practices and pre-approval inspection of Piramal Pharma’s Pithampur facility with no Form 483 observations. Similarly, another news on Ajanta Pharma shows that it recently cleared a USFDA inspection for their facility in Dahej and Cadila Pharmaceuticals’ manufacturing facility received zero 483 observations.
A 483 observation is issued when there are compliance issues in the current Good Manufacturing Practices (cGMP) regulations enforced by USFDA. Syngene received US FDA approval for its API plant in Mangalore, recently. Syngene has a state-of-the-art facility compliant with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP) quality systems.
These facilities have earned global accreditations, showcasing India's commitment to delivering quality services. This is possible through a strong commitment to patient safety, product quality and efficacy. Additionally, investments in the integration of digital quality systems and automation, such as a trackwise system, electronic documentation management system, electronic batch manufacturing record, electronic lab notebook, and enterprise management system has elevated the speed and rigor of operations, further increasing efficiency and accuracy.
Challenges and the road ahead
The positive progress made in regulatory norms suggests the need to continuously revisit and refine and strengthen regulations to ensure better quality, safety, and compliance in the pharmaceutical sector. As manufacturing technologies evolve and AI-ML (artificial intelligence and machine learning) gets embedded more strongly, the current regulatory framework may not be fully effective or comprehensive enough to address all emerging challenges and advancements in the industry.
There is a need for open dialogues between the pharmaceutical industry and regulatory authorities as the sector expands its scope beyond generics to novel APIs (Active Pharmaceutical Ingredients), addressing regulatory challenges will be essential to maintaining India’s competitive edge on the global stage.
This will propel the pharmaceutical and biopharmaceutical industry towards a future that not only meets the growing global healthcare needs but also enables transformative breakthroughs and delivers innovative therapies to patients.
—The author, Dr Mahesh Bhalgat, is COO at Syngene International. The views expressed are personal.
(Edited by : C H Unnikrishnan)
First Published: Oct 18, 2023 8:53 AM IST
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