IDMA writes to DCGI against Celluloid based capsules
New Delhi: In a recent development to the vegetarian capsules proposal of DCGI, IDMA( Indian Drug Manufacturer's Association) is reported to have written to the authority asking them to not replace gelatin based capsules with cellulose based ones.
The primary reason for IDMA ‘s reinforcement in this direction being that cellulose based capsules do not have time tested data to back them ( no research), whereas, gelatin based capsules are the mainstay of drug delivery systems. IDMA has pointed out towards these gelatin based capsules as being guaranteed for their safety, convenience, patient acceptance, economy etc.
"Then why the need to replace them?" sources at the organisation asked.
The association has heeded the drug controller that it would not be possible to switch over without looking into the scientific, technical, techno-commercial availability, and affordability issues. It has cautioned the DCGI saying that the switch over could impact all citizens of the country, as also globally, since most countries were dependent on India's quality, affordable generic drugs.
Speaking about global approvals, the IDMA has named USFDA, MHRA, EU TGA and DCGI as the international and national labels, that vouch for the credibility of the 185 year old gelatin base. Emphasizing further, the manufacturers have highlighted the fact that gelatin products have undergone extensive BA/BE studies and have been under consumption for decades, without any adverse impact. Whereas, the cellulose based capsules , they say are merely a fraction in number.
Elaborating further on consumption, the IDMA has emphasized the fact that less that 2 % of cellulose based capsules are consumed in India; and all of these are concentrated in herbal applications. According to the manufacturer’s association, 95 percent of capsule production in the world is gelatin based. Talking about the advantages of gelatin based products, the association has brought to light the fact those their shelf life is 5 years, whereas in comparison, cellulose products have a mere three year shelf life.
The DCGI has been advised by the manufacturers to consult industry and eminent medical personalities before taking a decision on the same.
The primary reason for IDMA ‘s reinforcement in this direction being that cellulose based capsules do not have time tested data to back them ( no research), whereas, gelatin based capsules are the mainstay of drug delivery systems. IDMA has pointed out towards these gelatin based capsules as being guaranteed for their safety, convenience, patient acceptance, economy etc.
"Then why the need to replace them?" sources at the organisation asked.
The association has heeded the drug controller that it would not be possible to switch over without looking into the scientific, technical, techno-commercial availability, and affordability issues. It has cautioned the DCGI saying that the switch over could impact all citizens of the country, as also globally, since most countries were dependent on India's quality, affordable generic drugs.
Speaking about global approvals, the IDMA has named USFDA, MHRA, EU TGA and DCGI as the international and national labels, that vouch for the credibility of the 185 year old gelatin base. Emphasizing further, the manufacturers have highlighted the fact that gelatin products have undergone extensive BA/BE studies and have been under consumption for decades, without any adverse impact. Whereas, the cellulose based capsules , they say are merely a fraction in number.
Elaborating further on consumption, the IDMA has emphasized the fact that less that 2 % of cellulose based capsules are consumed in India; and all of these are concentrated in herbal applications. According to the manufacturer’s association, 95 percent of capsule production in the world is gelatin based. Talking about the advantages of gelatin based products, the association has brought to light the fact those their shelf life is 5 years, whereas in comparison, cellulose products have a mere three year shelf life.
The DCGI has been advised by the manufacturers to consult industry and eminent medical personalities before taking a decision on the same.
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