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Industry asks FSSAI to specify tolerable upper limit for methylcobalamin similar to permitted in drug

Shardul Nautiyal, Mumbai
Tuesday, February 18, 2020, 08:00 Hrs  [IST]

The pharmaceutical industry has demanded to the Food Safety Standards Authority of India (FSSAI) to specify the tolerable upper limit for each type of vitamin B12 similar to what has been permitted in drug at 2000 micro gram (mcg) methylcobalamin intramuscular.

As per the clinical studies conducted, the methylcobalamin is very safe at 2000 micro gram (mcg) intramuscular.

Industry experts have contested that that when gazette notification is talking about Vitamin B12, it refers to which type of vitamin B12 as all four vitamin B12 like methylcobalamin, cyanocobalamin, hydroxycobalamin and adenocylcobalamin are different and have different level of absorption in the body therefore recommended dietary allowance (RDA) and upper limit for each type of B12 must be different.

Pharmaceutical industry, however, is not satisfied with the RDA value defined for vitamin B12 in particular.

“If I presume that you are talking about methylcobalamin and the given RDA value is 1 mcg which is at very lower side, the upper limit should be at least 500 mcg. FSSAI has not identified any tolerable upper limit for methylcobalamin. Industry has therefore written to the FSSAI to specify the tolerable upper limit for each type of methylcobalamin,” explains leading pharma consultant Dr Sanjay Agrawal.

Experts have been raising concern over lack of clarity in FSSAI RDA values for Vitamin- B12 in neurological disorders based on Indian Council of Medical Research (ICMR) data. This according to them lacks scientific evidence and rationale.

Experts inform that the FSSAI scientific panel and scientific committee has recommended RDA values in vitamins and minerals for various micro-nutrients using reference from ICMR and Codex in this context.

Codex is a collection of internationally adopted food standards and related texts presented in a uniform manner. These food standards and related texts aim at protecting consumers' health and ensuring fair practices in the food trade.

“The contention is that scientific panel and scientific committee has recommended RDA value of 1 micro gram per day for vitamin B12. The technical team must understand that vitamin B12 is not a single component. There are four types of vitamin B12 and the human body reacts differently to all four B12 vitamins,” Agrawal argues.

Methylcobalamin is used for the neuro-protection and maintenance of it. RDA should be revised and should not be prescribed based on old data or studies. Indian environment is different where we are more vegetarian and source of methylcobalamin is more from non vegetarian food, that is why FSSAI should consider and evaluate the methylcobalamin concentration again.

“For example, when one type of Vitamin B12 - methylcobalamin is consumed, it is directly absorbed whereas when another type of vitamin B12 - cynocobalamin is consumed, only one tenth of its part is converted into methylcobalamin and absorbed by the body. So, if 1 microgram methylcobalamin is taken, the body will react differently as compared to 1 microgram of cynocobalamin,” Pharma Expert Anshu Yadav further explains.


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