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Indian excipient market poised to expand significantly

Komal Saini & Vandita Kakkar
Thursday, November 24, 2022, 08:00 Hrs  [IST]

Excipients are part of a completed pharmaceutical product that are introduced during formulation but are not the active medicinal ingredient. One of the most popular buzzwords now used in the pharmaceutical industry is excipient functionality. Excipients don’t function as active medicinal ingredients and don’t treat illnesses. The therapeutic revolution of the last 50–60 years, however, would not have been possible without them.

It is no secret that active pharmaceutical components are emerging as a key impetus in the growth of the global market thanks to ground-breaking research advances, unique medication formulations, drug development approaches, and availability of advanced technology.

Excipients are now more frequently regarded as “Active Substances,” rather than just fillers and carriers for active ingredients. Excipients, as mentioned earlier, are the inactive parts of a drug other than the active pharmaceutical ingredients to help with the process of making drugs for particular reasons. They can be employed as lubricants, glidants, binders, coatings, disintegrants, fillers, anti-adherents, preservatives, adsorbents, sweeteners, and more.

Excipients are utilised in the creation of precise and practical dosage, as well as to bulk up formulations in order to stabilise the active ingredient and ensure simple administration and absorption by humans. Excipients are employed based on the medication form and administration route. They are helpful in the production of drugs because they can: Assist in the manufacturing process of the drug delivery system, protect, support, or improve product identification, bioavailability, or patient acceptance and improve any other aspect of the drug’s overall safety, efficiency, or delivery while it is being stored or used.

Excipients have received the title of “Active Ingredients” due to their use in creating more practical dosage forms, which has seen a significant increase in the use of non-functional additions. Most of the major pharmaceutical companies today devote a sizable sum of money in research and development in order to create high-quality formulations. In order to create new formulations from outdated medicinal compounds that would boost their therapeutic effects, these businesses have started looking for fresh, value-added, and well-approved excipients.

Parenteral excipients such tonicity modifiers, surfactants like tweens, lipids for liposomal drug delivery systems, solid-lipid nanoparticles, and so on are some of the most widely utilised excipients. Excipients are currently the most important components of formulations because they improve drug efficacy, reduce discomfort and irritability during injection, and ensure storage, stability, and safety.

Regulatory requirements
It is important for those involved in the supply chain to be aware that an excipient can only be considered pharmaceutical grade if it complies with excipient GMPs during manufacturing, repackaging, and handling, meets pharmacopoeia specifications, and/or meets applicable regulatory requirements (if any exist for the specific excipient) (e.g., IPEC PQG GMP, WHO Excipient GMP).

Customers can rest easy knowing that excipients produced in accordance with the Joint IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients 2006 will adhere to generally recognised good manufacturing practise (GMP) standards. For a new excipient, unlike active pharmaceutical components, there are no regulatory processes in place, and there is no adequate regulatory protection for “know-how” or any other forms of intellectual property.

Almost every part of a medicine, from the packaging to the active medicinal ingredient, must follow good manufacturing practices. For excipients, there isn’t a global regulatory standard, though. Excipient GMP conformance certification could benefit the pharmaceutical and excipient industries beyond the current International Pharmaceutical Excipient Auditing (IPEA) programme, according to a 2008 USFDA statement. This statement marked the beginning of the path to accredited certification for excipients.

IPEA and ANSI had created an accreditation methodology and plan by the end of August 2009. The plant where Silicon Dioxide NF - Syloid® FP excipient is produced by W. R. Grace & Co. in Baltimore, Maryland, USA, underwent the first-ever ANSI recognised excipient GMP certification of a quality management system in February 2010. This certification has several advantages since it assures the pharmaceutical business that the excipient producer is adhering to GMPs and because it
eliminates the hassle and expense of conducting individual company audits at the excipient site.   

Excipients filing strategy
It makes sense that many pharmaceutical companies are apprehensive of risking their applications should a new excipient be shown to be harmful, or they are unwilling to allow the approval process for a new drug to take longer because of the inclusion of a novel excipient. The requirement for the creation of innovative excipients for enhanced drug delivery systems is a topic of intense research and controversy.

Novel excipients may appear to be the ideal solution in many ways. However, given that the existing regulatory framework has historically discouraged their usage, which frequently results in limiting excipient choices to those that have already been approved, they remain a risk that most are unwilling to take.

In contrast to the more time-consuming and riskier road of developing innovative excipients, utilising the multi-functional benefits of currently approved excipients can be a simple and secure alternate route. Pharmaceutical firms can learn about an excipient’s entire beneficial features and increase their confidence in its quality, origin, and performance by engaging directly with the excipient maker.

Excipients can play a very crucial part in the success of a drug’s formulation, which is something that drug manufacturers are beginning to recognise. In order to boost R&D innovation, enhance production, and shorten time to market, they are turning to excipient producers and contract formulators.

Excipients have never shared the spotlight with active pharmaceutical substances and have never historically received the recognition they merit in the creation, production, and administration of medications. Tradition has it that an excipient serves just as a filler or binder that stabilises the final product. It’s common to underestimate, overlook, misunderstand, or ignore the entire value that a formulation can add to a final dosage form or the true significance of guaranteeing an excipient’s quality and performance. Actually, whether or not a medicine is successful depends on how well the excipient performs.

Future outlook
Despite these obstacles, the excipient market is anticipated to expand significantly in the near future. All thanks to India’s consistent economic growth, healthcare reforms, and regulations pertaining to patents, which is attracting the attention of the world’s largest pharmaceutical companies to begin their operations here.

Other established stepping stones in the development of the Indian pharmaceutical industry include the doubling of disposable incomes, the increase in middle-class households, the expansion of medical infrastructure, increased use of health insurance, the rise in chronic disease prevalence, the adoption of product patents, and aggressive market penetration by relatively smaller companies.

In short, the route of globalisation is rich of potential but also rife with risks, since it necessitates a significant shift in perspective and transformation to draw in foreign investment and expertise.

(Komal Saini is Research Scholar and Dr. Vandita Kakkar is Assistant Professor of Pharmaceutics, UIPS, Panjab University, Chandigarh)


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