New drug capsule shells offer new choice: veg or non-veg

Expert panel to meet tomorrow to decide on gelatin versus cellulose

Veg or non-veg? Not too far in the future, the person asking you that question might just be your neighbourhood chemist.

For, a scientific committee advising the Drug Controller General of India (DCGI) may take the next step on Saturday to letting drug manufacturers choose between capsule shells made of cellulose, which is derived from plants, instead of gelatin, an animal product.

The advisory panel will take a call on whether the newly notified standards on cellulose capsule shells should be included in the Indian Pharmacopoeia Commission, which is considered as the Bible for all drugs manufactured in India.

Last month, the Bureau of Indian Standards (BIS) wrote in a foreword to its “standards document” for capsules with a hydroxypropyl methyl cellulose (HPMC) shell that the “search for a gelatin replacement” was necessitated by a combination of factors.

They include “strict regulations regarding the use of animal-derived gelatin requiring the absence of bovine spongiform encephalopathy (BSE)”, or mad cow disease, and the fact that “several HPMC capsules for powdered herbs and dietary supplements have come up in recent years”.

It added: “Religious, cultural and personal issues may affect patients’ preference towards the medications presented in capsule dosage forms.”

Gelatin is a colourless and brittle product obtained from the connective tissues, skin, bones, etc., of fish and a range of animals from pigs to cows.

Sources in the DGCI told The Indian Express that gelatin has been the norm in capsule shells for decades but “now that the BIS standards have come, we will need to look into them”.

“However it will be optional. Drug manufacturers will have to decide what to use for the shell. It is not within our mandate to make it mandatory though there is a thinking that it is time for the gradual phasing out of gelatin,” the sources said.

For cellulose to become mandatory in capsules, it would require an amendment in the Drugs and Cosmetics Bill.

The Bill been slated for discussion during the ongoing Monsoon Session, but no proposal for an amendment along these lines is currently before the Health Ministry, said a senior official.

“We will look into it when the matter comes to us. We will decide once the DCGI has taken a call on this,’’ the official said.

celluloseDCGIIndian Pharmacopoeia Commission