European group responds to Indian proposal to replace gelatin in capsules

By Gareth Macdonald contact

- Last updated on GMT

European group responds to Indian proposal to replace gelatin in capsules

Related tags: Gelatin

A European chemical industry group has reiterated that gelatin is safe after Indian regulators called for feedback on a plan to replace the excipient with cellulose in pharmaceutical capsules.

Last week the Central Drugs Standards Control Organization (CDSCO) asked for feedback​ on a proposal “to replace gelatin capsules with cellulose based capsules which are of plant origin and are safe for use as compared to animals-based gelatin capsules."

The organisation did not provide more information or respond to requests for details.

The Indian media​ attributed the proposal to an “advisory group looking into the drug and pharmaceutical matters."

Some reports ​suggested it was prompted by safety concerns and demand for capsules suitable for vegetarians.

Drug controller general of India G N Singh told the Times of India "A proposal has been received for plant cellulose-based capsules which are also safer for use than animal-based gelatin ones.​"

Industry response

The European chemical industry council - CEFIC - told us it is analyzing CDSCO's note and that it will provide detailed comments to Indian authorities.

It also stressed there are “no scientific reason to substitute gelatine with HPMC​.”

Gelatin is a natural and safe product with GRAS status in pharmaceuticals and food applications. It is manufactured by gentle extraction from collagenous raw materials without heavy chemical modification​.”

It is easily dissolved in the human body allowing a rapid release of medicinal products in the stomach. It is GMO free, completely natural, sustainable and non-allergenic.  In addition gelatin requires no E number and is therefore an ideal ingredient for today’s consumer needs for clean label. 

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