Methylcobalamin manufacturers have once again raked up the contentious issue of arbitrarily fixing of Recommended Dietary Allowance (RDA) value for methylcobalamin by Food Safety and Standards Authority of India (FSSAI) which they claim is not based on scientific rationale with reference to a government notification dated January 7, 2020.
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.
RDA for methylcobalamin is currently set at 1microgram (mcg) for neurological disease management by FSSAI based on data provided by Indian Council of Medical Research (ICMR).
Based on the industry correspondence to share technical details on which 1mcg is specified as RDA for methylcobalamin, FSSAI has maintained that RDA for different essential nutrients for Indians are specified by ICMR which also specifies RDA for vitamin B12 (irrespective of its sources such as methylcobalamine or cyanocobalamine) as 1 microgram (mcg).
“Since revision of RDA does not fall under the scope of FSSAI and any such request may be taken up with ICMR rather than with FSSAI. Moreover, it is to mention that usage of single vitamin B12 (methylcobalamin) at higher doses for patients requires diagnosis by a physician and therefore falls under the scope of CDSCO and not FSSAI,” it stated.
“Drug authority has allowed 2000 mcg intramuscular as upper limit but nutraceuticals may be allowed at least 500 mcg RDA for prophalytic use in the interest of patients. One mcg of methylcobalamin to manufacture is of no use,” explains Ahmedabad based leading pharma consultant Dr Sanjay Agrawal.
A notification was issued on Recommended Dietary Intake on January 7, 2020 where vitamin B12 RDA was considered as 1 mcg without clarifying the tolerable upper limit (TUL) of each vitamin B12 and individual RDA of each type of vitamin B12. The nutraceutical regulations mention that the quantity of nutrients added to the articles of food shall not exceed the RDA as specified by the ICMR and in case such standards are not specified, the standards laid down by international food standards body, namely, Codex Alimentarius Commission, shall apply. This means that manufacturer of methylcobalamim can manufacture it in 1mcg strength only.
The issue has been festering due to missing information on tolerable upper limit (TUL) of methylcobalamin from the public domain. Methylcobalamin has a history of safe long term use as a therapeutic agent given in high dosage or via intramuscular injection for the treatment of disorders associated with impaired vitamin B12 absorption. Oral or intramuscular dosages between 1-5 mg are used with no supportive evidence of adverse effect. The usual treatment in PA patient is 1 mg administered intramuscular once every 1-3 month and oral dosages of 300 mcg to 1000 mcg daily could also provide adequate treatment.
“One aspect is body requirement and other is the dose which is to be manufactured. The regulatory authority has considered both as one without giving consideration that only a portion of same will be absorbed. 1mcg methylcobalamin to manufacture is nothing for Indian public which is already suffering from malnutrition. The FSSAI must take into account that when cynocobalamin is taken only in 1/10 portion, it is absorbed by the body therefore RDA value for each type of vitamin B12 must be different. For prophylactic use atleast 500 mcg methylcobalamin must be allowed to manufacture” elaborated Dr Agrawal.
The FSSAI spokesperson said the differences in the bioavailability of two forms namely, cyanocobalamin and methylcobalamin are also insignificant and may not affect RDA which is very surprising, If that is the truth why water and fat soluble vitamins are given different RDA value,” pharma consultant Anshu Yadav argued.
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 a form of vitamin B12. It can be used to replace levels in patients who don't have enough and may also be used to treat certain conditions such as neuropathy, ALS and certain types of anemia