July 26, 2015 2:52:51 am
The scientific committee advising the Drug Controller General of India (DCGI) met Saturday and took an in-principle decision to switch over to gelatin alternatives in capsules pending a final report on the matter.
The committee, comprising drug experts, was discussing the matter in the wake of the Bureau of Indian Standards (BIS) laying down standards for non-gelatin based capsules last month.
“The committee considered in detail the issue of non-gelatin based capsules and resolved that alternative substances like cellulose and starch should replace gelatin wherever possible. The committee will now go back and look at the available evidence to make its technical recommendations. We expect a report in a couple of months but we cannot adopt the BIS standards in toto. We have to update the Indian Pharmacopoeia Commission,” said a source who was present in the meeting.
Gelatin, a colourless and brittle product, is obtained from the connective tissues, skin, bones, etc of animals, including pigs and cows, which are avoided by a majority of the country’s population because of religious reasons. It is the principal constituent of shells of capsules.
The Indian Express had reported about the BIS notification and the scheduled meeting of the scientific committee July 24.
The pharmaceutical industry, too, is positive about the replacement of gelatin, particularly because it had caused some issues for Indian pharma exports to the United States in the past.
A couple of years ago, the US had threatened to stop Indian drug imports because the bovine extracts used in them did not meet the standards laid down by the UDFDA.
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