Underlining that unlike food, drug is taken not out of choice but prescribed by doctors to save life and making them vegetarian or non-vegetarian is not desirable, Health Ministry’s highest decision making body on technical matters has rejected a proposal to replace commonly used animal-based gelatin capsules with ‘veg’ cellulose.
The Drug Technical Advisory Committee (DTAB) had received a proposal seeking introduction of a provision under the Drugs and Cosmetic Rules, 1945 for introduction for labeling of cellulose based capsules with a green dot to indicate their vegetarian origin to distinguish them from normally available gelatin based capsules.
However, the DTAB members in a meeting recently opined that “unlike food, drugs are not taken by choice but are prescribed by the doctors to save lives and marking them as vegetarian or non vegetarian origin is not desirable. Some members also pointed out that HPMC capsules are basically synthetic origin and as such cannot be considered as purely of vegetarian orign as in case of food preparations.”
Soon after receiving the proposal to ‘mark’ the veg-based capsules, the DCGI had sought public opinion in the matter before taking the final decision.
The Confederation of Indian Pharmaceutical Industry (CIPI) and Indian Drug Manufacturing Drug Association (IDMA) has opposed the proposed move.
“Gelatin based capsules are cost effective, time tested, safe and recognised by regulatory bodies across the world. It has been used by pharma industries over a century, said CIPI executive secretary Sudesh Kumar.
He had also said in countries like USA and EU, 95 per cent of the capsules used for drug formulations are gelatin based. In India the ratio is around 98 per cent.
Raising concern over the safety of cellulose based capsules, Kumar said the Hydroxypropyl Methycellulose (HPMC), a form of cellulose is used in manufacturing cellulose based capsules. HPMC is derived from plant fiber such as wood from tree trunks and then treated with a number of harsh chemicals to get synthetic gelatin.
The IDMA, in its representation to the Drug Controller General of India (DCGI) said 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.
It also said that the cellulose based capsules should not be considered without considering in-depth the scientific, technical, techno-commercial, availability, affordability issues , the IDMA added.
However, those in the favour of cellulose based capsules allege that gelatine derived from animals with bovine spongiform encephalopathy (BSE) could cause the human equivalent — Creutzfeldt-Jakob Disease (CJD) — in people who ingest the substance.