India seeks input on proposal to replace gelatin with cellulose in capsules

By Gareth Macdonald contact

- Last updated on GMT

iStock/Felipe Caparrós Cruz
iStock/Felipe Caparrós Cruz

Related tags: Bovine spongiform encephalopathy

Indian regulators have called for industry feedback on a proposal to replace gelatin in capsules with cellulose.

The Central Drugs Standards Control Organization (CDSCO) called for “science-based” suggestions and comments in a note​ posted on its website last week.

Specifics of the replacement plan, which products would be impacted or who put the idea forward were not provided. However, in the note CDSCO mentions safety considerations as a motivation.

A proposal has been received to replace gelatin capsules with cellulose based capsules which are of plant origin and are safe for use as compared to animals-based gelatine capsules.”

CDSCO did not respond to a request for more information.

Replacement

Gelatin replacement is not a new topic for the pharmaceutical industry.

Concerns gelatine derived from cows with bovine spongiform encephalopathy (BSE) could cause the human equivalent- Creutzfeldt-Jakob Disease (CJD) - in people who ingest the substance prompted the EMA​ to issue sourcing and processing guidelines.

In addition to advising against sourcing from countries in which BSE has been detected, the agency also says “when manufacturers have a choice the use of materials from ‘non TSE-relevant animal species’ or non-animal origin is preferred​.”

Cultural concerns are also a factor.

Cows and pigs are the main sources of the gelatin used in pharmaceuticals, which is a problem for people whose religions prohibit the consumption of products derived from such animals.

In Indian, more than 80 per cent of the population identify as Hindu - a religion to which the cow is a sacred animal.

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