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Urgent need for stringent adherence to international quality standards to boost exports: Shivani Wagh
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Shardul Nautiyal, Mumbai
July 23 , 2024
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There is an urgent need for stringent adherence to international quality standards to manage pharmaceutical exports effectively as a part of implementing robust policy and regulatory measures, states Shivani Wagh, director, Supriya Lifescience Ltd.
Supriya Lifescience contributes to the industry's growth with its robust API manufacturing capabilities across diverse therapeutic areas, including antihistamines, anti-allergic, vitamins, anaesthetics, and anti-asthmatics. With a global presence in 120 countries and 80% of revenue derived from exports, the company maintains strong market positions in Latin America, North America, and Europe.
The growth strategy includes investments in R&D, biotech APIs, digital technology integration, and adherence to global standards. Strategic mergers and expansion into new segments like anti-anxiety and anti-diabetes further enhance their product portfolio and market reach. "We aim to enter 7 to 8 new countries this year, ensuring sustained growth and market reach," noted Wagh.
India's pharmaceutical industry remains a global leader, particularly in the generic drugs segment. In the financial year 2024, India exported pharmaceuticals worth approximately 16 billion US dollars.
“Despite global export declines, the sector experienced a notable 12.2% increase in 2023. From January to March 2024, exports reached 6.3 billion dollars, driven by rising global demand and regulatory reforms,” Wagh informed.
With product registrations in over 35 countries and successful audits from major health bodies, Supriya Lifescience clientele spans innovators, generic giants, and multinational corporations, supported by numerous USDMFs and CEPs filed worldwide. Supriya Lifescience Ltd., adheres to current Good Manufacturing Practices (cGMP) and International Council for Harmonisation (ICH) guidelines, maintaining strict regulatory standards in line with authorities such as the USFDA, EDQM, and NMPA.
She further emphasized the importance of governmental support for research and development (R&D) and innovation in India's pharmaceutical sector. "We advocate for government focus on R&D and innovation in India's pharmaceutical sector, alongside infrastructure improvements," she said. She further noted that incentives such as tax breaks and easier access to imports can significantly reduce production costs. Emphasizing local active pharmaceutical ingredient (API) manufacturing will enhance production efficiency and value addition, strengthening India's position in global markets and addressing healthcare challenges effectively.
Supriya Lifescience is committed to expanding India's pharmaceutical export sector through strategic global partnerships, regulatory training for staff, and investments in cutting-edge manufacturing technologies. The company is proactive in industry forums, advocating for favorable trade policies and sustainable practices in pharmaceutical production. Their goal is to improve market access, uphold quality standards, and strengthen India's competitive position in the global pharmaceutical market.
With over 80% of revenue from exports and 40% from Europe alone, Supriya Lifescience prioritizes expanding into new markets. Europe and Latin America remain their main markets, with North America targeted for growth and diversification. The strategy includes broadening the product portfolio and registering products in regulated markets. A recent ANVISA audit clearance with zero observations boosts their confidence in these efforts.
The pharmaceutical export market is poised for robust growth, driven by increasing demand for innovative treatments globally. Projections indicate sustained expansion fueled by advancements in biotechnology, emerging markets' healthcare investments, and evolving regulatory landscapes favoring international trade.
Supriya Lifescience serves global markets with a strategic focus on higher-margin niche segments. They prioritize regulated markets in North America and Europe, where they are expanding their footprint. Their tailored approach includes filing for eight to ten new products in these regions, leveraging their existing portfolio through backward integration. This strategy aims to achieve gross margins exceeding 28 % to 30% as they stabilize new products and penetrate deeper into regulated sectors.
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