Date: 13-Mar-2020

Industry Experts Raise Concern About RDA Specified By FSSAI For Methylcobalamin At 1 Mcg For Neurological Disease Management

Industry experts have raised concern about recommended daily allowance (RDA) for methylcobalamin currently set at 1microgram (mcg) for neurological disease management by Food Safety And Standards Authority of India (FSSAI) based on old Indian Council of Medical Research (ICMR) data. It has been learnt 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.

Methylcobalamin is widely marketed in the country as a drug for chronic neurological disorders with an RDA of 2000 mcg intramasucular but as per FSSAI it is detrimental for patients when used above 1 mcg for prevention and disease management.

Name of some widely sold brands are Locopen capsule, Neugaba M 75 capsule, Nervup 500 mcg injection, Nuroz Forte, Nurofine-2500 injection, Actovis 2500 injection etc.

In a recent correspondence with the FSSAI, industry has urged to share the technical details on which 1mcg is specified as RDA for methylcobalamin.

“Drug authority has allowed 2000 mcg intramuscular as upper limit but nutraceuticals may be allowed atleast 500 mcg RDA for prophalytic use in the interest of patients. One mcg of methylcobalamin to manufacture is of no use.” explains leading pharma consultant Dr Sanjay Agrawal.

Also industry demands to have different RDAs for all four Vitamin B12 i.e. methylcobalamin, adenosylcobalamin, hydroxycobalamin, cyanocobalamin to clear the confusion around its use and consumption since it is a prescription product.

“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,” explains leading pharma consultant Dr. Sanjay Agrawal.

“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 Indians are basically vegetarian and source of methylcobalamin is more from non vegetarian food, that is why authorities should consider and evaluate the methylcobalamin concentration again,”explains pharma consultant Anshu Yadav.