Last Updated on September 18, 2020 by The Health Master
The pharmaceutical industry has recently led a delegation to Union minister of chemicals and fertilizers D V Sadananda Gowda to urgently notify methylcobalamin for neurological disorders as regulatory action can’t be taken against those that are manufacturing methylcobalamin based formulations without scientifically defined efficacious recommended dietary allowance (RDA) value thanks to delay in notification.
Once notified, approved RDA value are often defined during a scientific way supported evidence. The issue, however, has been festering thanks to missing exact information on tolerable upper limit (TUL) of vitamin B12 or methylcobalamin for neurological disorders and immunity booster from the general public domain.
The pending notification which is being looked for is additionally supported former Food Safety and Standards Authority of India (FSSAI) CEO Pawan Agrawal’s confirmation that methylcobalamin has been approved by its scientific committee in December 2019. Mail correspondences shared on the difficulty are reviewed by Pharmabiz.
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Drug and nutraceutical industry players have voiced concern that methylcobalamin RDA value has been approved by Central Drugs Standard Control Organisation (CDSCO) uptill 2000 mcg but FSSAI is approving just one mcg which is of no use. Drugs Controller General of India (DCGI) recommended 2,000 mcg of methylcobalamin even in injectable form and makes are available as patients take methylcobalamin supported the medical condition. However, on January 7, 2020, FSSAI issued a notification regarding RDA of vitamin B12 which is specified as 1 mcg without mentioning sort of vitamin B12 like methylcobalamin, adenosylcobalamin, hydroxycobalamin and cyanocobalamin.
“No adverse effect has been related to excess methylcobalamin intake from food or supplements in healthy individuals. Methylcobalamin features a history of safe future use as a therapeutic agent given in high dosage or via injection for the treatment of disorders related to impaired vitamin B12 absorption but industry is yet to ascertain the much awaited notification on an equivalent ,” informed Anshu Yadav who led the delegation to the govt further adding that we are pursuing the difficulty of banning methylcobalamin by FSSAI for quite a year without a logical conclusion. On the contrary, FSSAI has allowed usage of cyanocobalamin which has cyanide content within but banned methylcobalamin which may be a superior sort of vitamin B12 .
“Until and unless FSSAI doesn’t inform the industry that methylcobalamin is approved, there’s no value of prescribing RDA value for an equivalent . Surprisingly the mails which we’ve received from FSSAI methylcobalamin and cyanocobalamin both have an equivalent RDA value to manufacture. Please be advised we are talking about per serving usage value which the manufacturer can ask and not the RDA value for a healthy person,” Pharma consultant Dr Sanjay Agrawal argued.
Methylcobalamin is an important nutrient and is required to treat vitamin B12 deficiency, in people with pernicious anaemia , diabetes and other conditions also . it’s important for the brain, nerves and for the assembly of red blood cells (RBCs). Methylcobalamin as a supplement is extremely essential specifically for Indians where the bulk of the population is vegetarian as naturally it’s present in nonvegetarian products. When a supplement is taken for prophylactic cause it must a minimum of be of the therapeutic dose.
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