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Indian pharmaceutical industry leads global market with record regulatory approvals & ambitious growth plans
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Shardul Nautiyal, Greater Noida
September 02 , 2024
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The Indian pharmaceutical industry is making headlines with its remarkable achievements in regulatory approvals and strategic growth plans, positioning itself as a key player on the global stage, said K Raja Bhanu, director general of the Pharmaceuticals Export Promotion Council of India (Pharmexcil).
"India's pharmaceutical sector has consistently demonstrated its commitment to quality and regulatory compliance, securing a significant share of market authorizations globally," he said.
India boasts of the highest number of US FDA-approved manufacturing sites outside the United States, encompassing both finished dosage form (FDF) and active pharmaceutical ingredient (API) facilities. Bhanu emphasized the industry's prowess, noting, "Our ability to maintain such high standards of production and quality has enabled us to capture over 30% of US FDA market authorizations in the past five years."
In the first ten months of 2023 alone, Indian pharmaceutical companies and their wholly-owned subsidiaries received nearly 44% of US FDA market authorizations. This achievement not only underscores India's critical role in the global pharmaceutical supply chain but also highlights its growing influence in international markets. "The recognition from the US FDA and other regulatory bodies is a testament to India's stringent adherence to global quality standards," Bhanu added.
Further solidifying its leadership, Indian pharmaceutical firms have garnered substantial accreditations from other major regulatory agencies worldwide. As of November 2023, 748 manufacturing sites in India have been registered with the US FDA. Additionally, the industry has filed 5,637 Type II Active Drug Master Files (DMFs) with the US FDA, reinforcing India's dominance in the API segment.
In Europe, Indian companies have secured 2,371 Certificates of Suitability (CEPs) and registered 348 sites under the European Union's Good Manufacturing Practices (GMP). These certifications ensure compliance with the high standards required for the European market. Moreover, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted market authorizations to 1,943 Indian companies, while approximately 2,050 have received recognition from Ethiopia's Drug Administration and Control Authority (DACA).
Looking to the future, the Indian pharmaceutical industry has set ambitious goals, aiming to double its current exports from USD 50 billion to USD 120-130 billion by 2030. The strategy includes leveraging India's expertise in generic drugs while expanding into biosimilars, gene therapies, and specialty medicines. Bhanu highlighted the importance of innovation and investment, saying, "With support from initiatives like the production linked incentive (PLI) scheme, we anticipate significant contributions from APIs, potentially adding an extra USD 10 billion in exports by the end of the decade."
The Covid-19 pandemic has further underscored the need for self-sufficiency in pharmaceutical production, prompting India to focus on the indigenous manufacturing of essential medicines. "By enhancing our production capabilities, India is not only ensuring self-reliance but also strengthening its position as a key player in the global pharmaceutical industry," Bhanu remarked.
As the industry moves forward, collaboration between the government, industry stakeholders, and regulatory bodies will be crucial to sustaining India's growth momentum and achieving its ambitious targets.
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