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IDMA urges DCGI not to replace gelatin based capsules with cellulose based capsules
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Swati Rana, Mumbai
May 31 , 2016
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The Indian Drug Manufacturers' Association (IDMA) has urged the DCGI not
to replace gelatin based capsules with cellulose based capsule as
cellulose based capsules of plant origin do not have time tested data
whereas gelatin based capsules continue to be the mainstay of drug
delivery systems for its safety, convenience, patient acceptance,
economy and pharmacokinetic parameters.
The association has
emphasized that usage of gelatin capsules is in practice for more than
185 years and thereby has stood the test of time. Global pharmaceutical
products worldwide including the leading brands and products are
delivered in gelatin capsules and are approved by the US FDA, MHRA, EU,
TGA and DCGI. These products have gone through extensive clinical trial,
BA/BE studies etc. and have been consumed for decades with no adverse
reaction. On the contrary, the number of products approved in cellulose
capsules are a fraction in number.
In a recent submission to
DCGI, the association has explained that gelatin based capsules have
been in use in the pharmaceutical industry globally for over a century
and is one of the most popular and widely used dosage forms, by which
medications and supplements are formulated for oral consumption. More
than 95 per cent of all capsules in the world are gelatin based
capsules. In India gelatin capsules have been in wide usage since
pre-independence for their safety and have been approved by several
agencies across the world.
Meanwhile, the production and
consumption of cellulose capsules in India form less than 2 per cent of
total capsules and are mostly used in herbal applications. None of the
pharmacopoeias have published monographs or standards on cellulose based
capsules.
Explaining the safety and efficacy of gelatin based
capsules scientifically, the association said gelatin capsules have a
higher shelf life of 5 years thereby presenting itself as a viable media
to fill drugs compared to cellulose capsules which have a shelf life of
3 years.
Replacing gelatin based capsules with cellulose based
capsules in pharma industry would require major reviews of existing
formulations including fresh stability studies to demonstrate the
compliance requirement.
The association has recommended that
such a drastic move to replace gelatin based capsules with cellulose
based capsules is not necessary at present. Also it should not be
considered casually, based on just a proposal without considering
in-depth the scientific, technical, techno-commercial, availability,
affordability issues. This could impact all the citizens of this
country, as also globally as most countries are dependent on India's
quality, affordable generic drugs.
They have also suggested that
industry and eminent personalities should be extensively consulted
before arriving at any decision.
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