| |DECEMBER 20249INDIA'S PHARMA SECTOR FACES DECLINE IN LICENSING AND TECHNOLOGY TRANSFERSMARKSANS PHARMA SECURES USFDA APPROVAL FOR GENERIC VERSION OF CLARINEXThe Indian pharmaceutical industry, known as the `pharmacy of the world', has faced a trend of negative net voluntary licensing and technology transfers ­ constructive for medicine access in LMICs, according to the 2024 Access to Medicine Index. Released every two years by the Access to Medicine Foundation, a non-profit organization, the report receives backing from the UK Foreign, Commonwealth, and Development Office as well as the Dutch Ministry.India has always been an important source of cost-effective generic drugs, supporting healthcare systems worldwide. Yet, worries have arisen about healthcare provision in countries reliant on such agreements due to a decrease in licensing deals for patented medications. The index assesses 20 leading pharmaceutical companies, indicating a decrease in non-exclusive voluntary licensing agreements crucial for the generic manufacturing of vital drugs.Five out of the 20 pharmaceutical companies evaluated have established manufacturing plants in the nation, cutting expenses and enhancing distribution networks. Moreover, India has been involved in 11 out of the 47 worldwide technology transfer initiatives, which involve complete production capabilities. Partnerships between Indian and international pharmaceutical companies highlight the opportunity to meet urgent healthcare requirements. A partnership exists between Takeda and Biological E. Limited to produce the dengue vaccine QDENGA® (TAK-003), with the goal of reducing India's substantial dengue problem. By 2030, this program aims to produce 50 million doses per year to tackle India's dengue disease burden, which causes 59.5 disability-adjusted life years (DALYs)per 100,000 people. Collaborations such as this illustrate how technology transfers play a crucial role in enhancing medicine accessibility and reducing supply chain risks. POMarksans Pharma Limited has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Loratadine Tablets USP 10 mg. These tablets are intended for over-the-counter (OTC) use to treat allergic rhinitis caused by pollen and upper respiratory tract allergies. Loratadine, an antihistamine, relieves symptoms such as itching, runny nose, watery eyes, and sneezing caused by "hay fever" and other allergies.This product is the generic version of the Clarinex tablet manufactured by Bayer Healthcare in the same strength. The approval enables Marksans Pharma to expand its presence in the allergy medication market in the United States.Marksans Pharma, headquartered in Mumbai, India, specializes in the research, manufacturing, and marketing of generic pharmaceutical formulations across global markets. The company operates manufacturing facilities in India, the United States, and the United Kingdom, which leading regulatory agencies, including the USFDA, UKMHRA, and Australian TGA approve.The company boasts a robust product portfolio encompassing several major therapeutic areas such as cardiovascular (CVS), central nervous system (CNS), anti-diabetics, pain management, upper respiratory, and gastroenterology. Marksans Pharma markets its products in diverse international markets, affirming its global reach and commitment to providing high-quality, affordable pharmaceuticals.PO
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