Experts call for policy push to boost excipients production

PHARMACEUTICAL experts and industry veterans are sounding the alarm over India's heavy reliance on imported excipients, which are key substances used in drug formulation, highlighting the need for domestic research, advanced technology, and skilled manpower.

- SHARDUL NAUTIYAL, MUMBAI

Excipients form 90% of the dosage forms available in the market. The role of excipients is very important as they impart a lot of physical characteristics to the drug product in terms of flowability, compressibility, disintegration and controlling the drug release in the product. In some cases, they also influence the organoleptic properties like taste and texture among others.

Despite being hailed as the “pharmacy of the world” for its robust generic drug production, India finds itself in a precarious position when it comes to the critical yet often overlooked component of drug formulation—excipients. These serve as the vehicle for active pharmaceutical ingredients (APIs), ensuring stability, bioavailability, and efficacy.

An alarming 90% of India’s excipients are still imported, mainly from USA, China, Taiwan, Japan and Europe, while only 10% are manufactured domestically. This imbalance has created what experts describe as a vicious cycle of dependency, stalling the growth of a robust excipient ecosystem within the country.

Vital role of Excipients in Drug Formulation

While APIs often take the limelight in pharmaceutical discussions, excipients—such as lactose, hydroxypropyl methyl cellulose (HPMC), microcrystalline cellulose (MCC), and polyvinylpyrrolidone (PVP)—play a silent yet vital role in ensuring a drug’s functionality, safety, and efficacy.

According to industry estimates, over 90 different excipients may be used in formulating solid dosage forms, spanning categories such as binders, disintegrants, diluents, lubricants, glidants, coating agents, sweeteners, and more. Magnesium Stearate, for example, is used in more than 90% of all oral dosage forms, making its quality and availability critical.

Yet, India has a less than 1% share in the US$7 billion global excipient market, a statistic that experts say is unacceptable for a country that aspires to be a global pharma leader.