Shardul Nautiyal, Mumbai
Tuesday, June 23, 2020, 08:00 Hrs [IST]
Further to experts trying to explain that the recommended daily intake and dosage values are two different things, peer reviewed studies on methylcobalamin for therapy and prophylactic use in neurological disorders contradict Indian Council of Medical Research (ICMR) recommended dietary allowance (RDA) values.
Scientific studies have concluded that methylcobalamin is recommended to be taken in the dose of 500 microgram (mcg) per day for an individual to lead normal life. In the acute cases of neuropathy, dose of 1,500 mcg per day can be safely taken. Dose of 1 mg per day is required to be taken for age related brain decay.
Contesting the claim of the ICMR RDA values, Ahmedabad-based pharma consultant Dr Sanjay Agrawal, who is closely following the issue, in his correspondence to the newly joined CEO of Food Safety and Standards Authority of India (FSSAI) Arun Singhal has also raised the alarm bell on the subject and urged it to be resolved at the earliest to help the industry manufacture quality product in the interest of patient safety.
“FSSAI has shared a notification on January 7, 2020 which says the RDA of methylcobalamin (vitamin B12) is 1 mcg. So if 1 mcg dose is prepared, a very small portion of methylcobalamin is absorbed. Not to forget that methylcobalamin is required for integrity of myelin, neuronal function, proper red blood cell formation and DNA synthesis. We are trying to explain that the recommended daily intake and dosage values are two different things. Dosage value is the value at which the drug is prepared. Therefore it should be some therapeutic dose even if it is taken as a preventive measure. So when a dose is taken only a portion is absorbed by the body,” explains Dr Agrawal in the letter addressed to FSSAI.
He further explains, “I only know two authorities Drugs Controller General of India (DCGI) and FSSAI who makes regulations for drug and nutraceutical. We have been informed about the said notification and regulation from FSSAI and whole fraternity is following the same administrative protocol. Therefore we are contacting FSSAI for solution. We have also been told by your office to contact ICMR directly for explanation and clarification. Since we only know FSSAI as regulatory authority for nutraceuticals, kindly solve our query and concern.”
The letter also states that the industry is in touch with FSSAI from June 2019 and mailing continuously to make everyone understand the importance of methylcobalamin. “We discussed the matter with the then FSSAI CEO Pawan Agrawal and it was confirmed by him in December 2019 that as methylcobalamin has been approved by the scientific committee therefore it will be included in the regulation as soon as possible. We have not seen the amended regulation yet due to which the local regulators are not accepting the manufacturing of methylcobalamin under nutraceuticals,” Dr Agrawal stated.
In a letter to the FSSAI earlier, DCGI had brought to the notice that various brands of product containing methylcobalamin are manufactured and sold having therapeutic intervention under the FSSAI license. Only two variants of vitamin B12 namely cynocobalamin and hydroxycobalamin which are covered under Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary use, Food for Special Medical Purpose, Functional Food And Novel Food Regulation 2016) (FSSAI-2016) but does not cover methylcobalamin.
A randomized, open labeled study comparing the serum levels of cobalamin after three doses of 500 mcg versus a single dose methylcobalamin of 1,500 mcg in patients with peripheral neuropathy concluded 500 µg methylcobalamin thrice weekly regime is more effective in increasing the serum cobalamin levels as compared to the 1,500 µg methylcobalamin once weekly regime.
Study of Dr. Schweikart on methylcobalamin also concluded that recommended dose of methylcobalamin depending on the individual is between 10 to 1,000 µg/day. Dr. Schweikart says there are different factors which increase the methylcobalamin requirement. Among the most important are pregnancy and lactation/exposure to toxins and radicals/stress/athletic sport/infections and malabsorbtion due to old age /inflammation of the stomach, intestines and/or pancreas/ intestinal surgery/ interactions with medicines or drugs/nutrient deficiencies (e.g. calcium)/fungal, parasite or bacterial infections in the intestine.