Indian excipient manufacturers raise alarm over surging prices of excipients by 30% to 50% to impact pharma industry

The Indian excipient industry, which is majorly represented by MSMEs, has less than 1% market share in the 7 billion global excipient industry.

The Indian excipient market is growing at 10 to 12% as against the global growth rate of 5 to 7%.

The Indian excipient manufacturers have raised alarm over the surging prices of major excipients by 30% to 50% has impacted pharma industry negatively.

Major excipients like lactose, hydroxypropyl methyl cellulose (HPMC), micro-crystalline cellulose (MCC) and polyvinylpyrrolidone (PVP) among others are majorly imported from China.

In excipients like phthalates where solvents like acetic anhydride is used as a raw material input, the prices have exceptionally gone up by 100%.

Besides this, freight rates have also gone up which has also led to significant rise in excipient prices , according to a senior official from the industry. Most basic excipients are not manufactured in India. As of today, there are only 10 manufacturers of an excipient like MCC in the country. Therefore, manufacturers have urged the Government for timely policy interventions towards resolving the issue.

A pharmaceutical excipient is a substance-either natural or synthetically formulated-that serves multiple purposes in medicines and drugs. It is used as a bulking or stabilizing substance, as an agent to enhance the solubility of a drug, or as an ingredient that enhances the therapeutic effect of a drug.

Currently, excipients are clubbed with APIs under Drugs and Cosmetics (D&C) Act which requires a drug licence.

Experts have also speculated that the power crisis in China and India also has a compounding effect on the Pharma industry.

Excipients improve API stability including protection from degradation. Some of the excipients are Diluents like lactose and MCC. There are Disintegrants like sodium starch glycolate, croscarmellose sodium and Binders like PVP and HPMC.

The Indian excipient industry, which is majorly represented by MSMEs, has less than 1% market share in the 7 billion global excipient industry.

There is no effective regulation for excipients in India apart from monographs on excipients mentioned in Indian Pharmacopoeia (IP). India has less than 100 monographs close to what European Pharmacopoeia (EP) and British Pharmacopoeia (BP) has. It is fairly organized in terms of pharmacopoeial standards but needs to pragmatically work on manufacturing standards or guidelines.

Experts have recommended compliance to voluntary guidelines on excipients available with the International Pharmaceutical Excipients Council (IPEC).

The global pharmaceutical excipients market is projected to reach US$ 9.7 billion by 2025 from US$ 6.9 billion in 2019 at a CAGR of 5.8%. The Indian excipient market is growing at 10 to 12 per cent as against the global growth rate of 5 to 7%.

Factors such as the growing pharmaceuticals industry coupled with advancements in functional excipients, rising adoption of orphan drugs and increasing uptake of bio-pharmaceuticals are some of the driving factors for pharmaceutical excipients. The emergence of multi-functional excipients, shifting focus of pharmaceutical manufacturing to emerging markets and growing biosimilars industry also present significant growth prospects for the Indian market.

North America holds the largest share in the pharmaceutical excipient market due to rising demand for pharmaceutical and biopharmaceutical drugs and presence of a large number of excipient manufacturers in this region. Europe holds second major share followed by Asia-Pacific and Rest of the World.

Asia-Pacific is the fastest growing region for pharmaceutical excipients where emerging countries such as China and India are the major players due to low labour costs, increased outsourcing of inorganic and organic chemicals manufacturing.

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