Indian excipient industry holds enormous growth potential-- Dr B L R Madhavi Thursday, November 28, 2024, 08:00 Hrs [IST] As per the International Pharmaceuticals Excipients Council “Pharmaceutical excipients are substances other than the active pharmaceutical ingredient (API) that have been appropriately evaluated for safety and are intentionally included in a drug delivery system to Aid in the processing of the drug delivery system during its manufacture Protect, support, or enhance stability, bioavailability, or patient acceptability, Assist in product identification, and enhance any attribute of the overall safety Assist in the effectiveness and/or delivery of the drug in use Assist in maintaining the integrity of the drug product during storage. Not just in pharmaceuticals but excipients are necessary in the cosmetic, cosmeceutical, herbal, phytopharmaceutical, nutraceutical, healthcare 3D printing, some traditional and alternate medicinal product industries as well. Their purpose in these areas would much overlap with the definition stated for pharmaceuticals. Thus, coming to the context of the excipient industry in India, the current market and future projections in the pharma and allied industries would govern excipient industry. It is vice versa as well. The pharma industry market value in India is predicted to reach US$ 130 billion by 2030. The cosmetic market shows a projected growth of US$18.4 billion by 2032. Nutraceuticals show a predicted growth of 3.5 per cent from 2024 to 2030. Certain ayurvedic products like churnas, tailas, tablets employ excipients. The Ayurveda market is expected to touch Rs 3.2 billion by 2032. The other rising field in therapeutics is biologics, herbals and phytopharmaceuticals. This overview of product market demand clearly indicates the huge demand for excipients that go into the preparation of the same. The excipients may be classified based on different criteria which is well known. Based on products e.g. pharmaceutical, cosmetic, nutraceuticals, biologic, etc. Based on the route of administration of the product they may be segregated into oral, topical, parenteral and miscellaneous. Based on functionality in the product, they are classified as organoleptic, solubilizing, stabilizing additives, coating agents, release rate modifiers etc. Based on the source they may be natural, semi synthetic or synthetic, inorganic, organic, polymeric etc. The other aspect of classification may be based on their chemical structure viz. polymers – linear, branched, co-polymers; proteinaceous, co-processed excipients, carbohydrate based e.g. Gums, starches; lipids, nanomaterials and the like. Fine chemicals / Speciality chemicals is another domain which covers excipients. It is important to know these classifications as they govern the specifications of the excipients that are approved for use in the respective products. Supply of excipients and factors To meet the needs of the product sector, the excipient manufactures and suppliers play the vital role that governs market scenario. Excipient market is predicted to be US$ 21.1 billion by 2030. Some companies at the global level dealing with excipients are Ashland Inc, Roquette Freres, BASF-SE, Merck KGaA, Lubrizol, DFE Pharma, etc. India being the pharmacy of the world, presents the highest demand for the excipients. Some excipient companies based in India include Miracle Ingredients, Nitika Pharmaceuticals, JRS Pharma Novo Excipients, Rettenmaier India, Roquette India, Sigachi Industries, Signet Excipients, SPI Pharma Inc, Sunil Healthcare, Indchem International, Ingredion India, Abitec Corporation, ACG Associated Capsules, Arihant Innochem etc. The Indian manufacturers’ contribution to the global market of excipients is barely one per cent. Imports and higher prices Though there are manufacturers of excipients in India, the country relies largely on imports for its excipients. India stands in the list of top three countries to import pharmaceutical excipients. USA, China and France export larger fraction of excipients to India. A report from Volza mentions that during the period of 2023 March till 2024 February 975 consignments of excipients were received from 98 countries. About 45 companies in India procured these products. The list of products, their quantity and country of import have been given in detail in the report. Owing to the lack of indigenous manufacturing when excipients are being imported, the prices have been high. Unethical practices The Economic Times report almost a year ago about brought to light about the use of industry grade excipients in pharmaceutical manufacturing after the CDSCO’s inspection and investigation. These chemicals are not meant for human use but unlicensed traders have committed to such punishable practices. Reports or statistics of such unlawful activities would help to reveal and curb such practices. for more information, please visit https://acplgroupindia.co.in