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LATEST NEWS UPDATES | Drug wrapper plan injects veg debate into medicines too -GS Mudur

Drug wrapper plan injects veg debate into medicines too -GS Mudur

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published Published on Jul 5, 2017   modified Modified on Jul 5, 2017
-The Telegraph

New Delhi: An industry body and medical experts have decried a government proposal to replace gelatin with cellulose to encapsulate drugs, calling it an impractical idea that needlessly injects the vegetarian-non-vegetarian debate into medicines.

The Punjab Haryana Delhi (PHD) Chamber of Commerce and Industry today said gelatin had been used for over a century and made up 95 per cent of capsule formulations worldwide, and cautioned that the proposal to shift to cellulose disregarded key technical issues and was impractical.

The Directorate General of Health Services, a unit of the Union health ministry, had last month invited views from "stakeholders to address technical issues" related to the replacement of gelatin with cellulose for the encapsulation of drugs.

Gelatin is made from naturally occurring collagen and has been used for over 125 years as an ingredient of certain foodstuffs and for many decades to encapsulate certain drugs. Regulatory authorities worldwide, including Indian drug regulators, view gelatin as safe.

"This proposal to replace gelatin capsules is totally misplaced and uncalled for - this is possibly a political move that unwisely brings the issue of vegetarian and non-vegetarian into drugs," said Vivek Seigell, director of the PHD chamber.

Pharmacology specialists say they are also puzzled by the proposal given that gelatin is routinely used to encapsulate drugs worldwide and a move to encapsulate drugs in cellulose would need to be preceded by pharmacokinetic studies on how such drugs behave in the body.

A pharmacokinetic study refers to the movement of drug into, through, and out of the body -the time taken for its absorption, bioavailability, distribution, metabolism and excretion.

"When you change any component of a drug formulation, you absolutely need to conduct pharmacokinetic studies," Bhagirath Patel, director of the SatKaival College of Pharmacy, Anand, Gujarat, told The Telegraph.

Although cellulose, like gelatin, has no therapeutic role, it ferries the drug into the body and needs to dissolve in the stomach for the release of the drug. The speed at which the cellulose dissolves will determine how quickly the drug is available for absorption into the bloodstream.

The PHD chamber has also in a representation to the government pointed out that cellulose capsules would need to undergo pharmacokinetic studies with each drug encapsulated into them to establish the equivalence of cellulose capsules with gelatin capsules.

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The Telegraph, 5 July, 2017, https://www.telegraphindia.com/1170705/jsp/frontpage/story_160294.jsp


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