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.