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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. Expenditure incurred for freight charges also led to a price rise.
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.
Domestic market for indigenous excipients
Indigenous excipients – a few of them like starch or gelatin, are produced in quantities enough for the domestic needs. The Indian advantage is with low cost of production but only a very low fraction (10 per cent) of Indian products are exported. MCC and croscarmellose sodium are being exported.
Secondly, Pharma MNC’s show a trend of employing smart and advanced functional excipients which are sourced from US/ Europe since India is yet to grow into. It can also be observed that for the same investment, returns on excipient manufacturing is relatively lesser than that of bulk drug of finished pharmaceuticals. Smart excipients and speciality chemicals would be priced higher as against traditional excipients.
Scope for excipient manufacturing in India
Technology and resource availability
With infrastructure and resource availability India has tremendous scope to increase and expand its current excipient base. India already has an established bulk drug facility, agrochemical industry, petrochemical industry, food and herbal product manufacturing. There would be an overlap of principle and technology in the manufacture of excipients and other chemicals. It is well known that production costs in India and China are lesser due to availability of resources and labour.
Excipient research and innovation
Development of novel excipients and manufacturing of the same has thrown open unseen possibilities of therapy. The trending areas of research are for biologics and 3D printed medicinal products which demand newer and multifunctional excipients. mRNA based vaccine delivery is one the best examples where a cationic lipid and a PEGylated cationic lipid aided in covid vaccine. Nancomposites, new herbal and polymeric materials are being explored for excipient resources. This calls for companies to manufacture such products for domestic as well as exports.
Safety and regulatory considerations
The incident of fatalities due to cough syrup in Gambia in 2022 and earlier such reports stress the importance of safety of medicines due to excipients. Some more concerns of safety due to excipients are for paediatric and neonatal health, gastroenteric issues, drug excipients incompatibility, Transmissible Spongiform Encephalopathies (TSEs) and Bovine Spongiform Encephalopathy (BSE), allergens, carcinogens (nitrosamines, ethylene oxide, etc. compounds and genotoxic impurities, and hazardous colourants. Thus, excipient use calls for stringent regulations.
Each country has its Pharmacopeial standards for the excipient to be incorporated in the drug product. Similarly, global regulations/guidelines of WHO, ICH and IPEC aid in standardization of excipients. Excipient and vendor qualification is a vital component in regulation.
In a recent development the Drug Technical Advisory Board DTAB suggested that the names of excipients be mentioned on the label with regard to excipients that cause high sensitivity. In the case of approvals for ‘new’ and ‘novel’ excipients the approval pathway for respective regulatory body has to be made as specific as possible.
Collaborations & expansions
Companies in India could collaborate or expand their facilities. To cite two examples JRS Pharma India established a new facility (2022). Similarly, Ingredion in 2022 acquired Amishi Drugs & Chemicals and with Mannitab Pharma Specialities, it acquired majority stake.
Government support
The Government of India’s production-linked incentive (PLI) schemes and regional partnerships are lucrative. Like Bulk drug parks and biotech parks, there could be establish excipient hubs as well. Incentives via tax should promote excipient industries so as to facilitate availability of good quality excipients at rightful price.
IPEC India initiatives
The International Pharmaceutical Excipients Council of India is one of the organizations aimed and promoting right use of excipients and ensuring growth of the industry.
They involve in offering training, advice on supply chain management, creation of standards and procedures for excipients and work with other regulatory bodies. Education of all stakeholders about excipient science would definitely help in their best use and improvement via research.
Conclusion
Any excipient catalogue would present innumerable excipients and within an excipient multiple grades or specifications. Manufacturing each specification type, testing for the specifications, and selection of right excipient grade based on the product and therapeutic use is an art and a science. Excipient industry in India thus has an enormous potential for growth.
The pharma eco system in India is already well established especially with India being the pharmacy of the world due to its generic medicines. Support from local and central governments in setting up of manufacturing units, and helping throughout development pathway would be ideal.
In the recent past India has seen a rise in prices of a few medicines which was attributed to increased production cost owing to raw material costs. Strengthening domestic manufacture would markedly aid in timely supply of raw materials, reduced production costs, and more affordable medicines. India would also expand itself as global excipient player.
Secondary outcomes would be creation of employment and specialized courses related to excipient science. Lastly, MNC and MSME pharma finished product manufacturers must adhere to quality regarding excipients used in dosage forms to avoid health issues arising from them.
Acknowledgement
The author is grateful to the faculty and management of Dhanwantari College of Pharmacy, Bengaluru for their support.
(The author is Professor and Principal, Dhanwantari College of Pharmacy, Bengaluru)
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