Manufacturing of methylcobalamin badly impacted in Gujarat due to ambiguous nature of notification on its ban

Manufacturing of methylcobalamin badly impacted in Gujarat due to ambiguous nature of notification on its ban

Shardul Nautiyal, Mumbai
Monday, September 30, 2019, 08:00 Hrs [IST]

Manufacturing of methylcobalamin has been badly impacted due to the ambiguous nature of Food Safety and Standards Authority of India (FSSAI) ban on methylcobalamin in Gujarat. Methylcobalamine is an important pharmacopoeial ingredient used in drugs as well as in food supplements.

It is prescribed to treat vitamin B12 deficiency in people with pernicious anemia.

Gujarat manufacturers have stopped manufacturing methylcobalamin which is a form of vitamin B12 taken to regulate certain vital bodily functions like cell multiplication, blood formation, and protein synthesis.

While state drug regulator maintains that it has been done to dissuade unscrupulous people to use it irrationally as a food supplement, the industry feels that the notification banning it is not justified more so as it is wrongly interpreted and need further amendment to achieve the desired purpose.

Giving clarity on the issue, Gujarat Food and Drug Control Administration (FDCA) Commissioner Dr H G Koshia said, “Methylcobalamine can be used for manufacturing medicines but not for food supplements as per the notification.”

A controversy began with whether methylcobalamin can be used in health supplements, nutraceuticals, food for special dietary use, food for special medical purpose, functional food and novel food after the notification passed in 2016 under the subject of direction under section 16[5] of Food Safety and Standards Act 2006 regarding operationalisation of standards of health supplements, nutraceuticals, food for special dietary use, food for special medical purpose, functional food and novel food.

Experts have even gone on to say that methylcobalamin would be considered as a better option compared to cyanocobalamin because it exhibits many neuroprotective effects like improving brain cognition back to normal levels.

Cyanocobalamin a form of vitamin B12 is cheap, synthetic, mild toxic and an inactive form of B12 not absorbed well orally and is converted to methylcobalamin after 48 hours of entering into body where only a small amount is converted.

Methylcobalamin is a naturally found ingredient in food sources like fish, meat, eggs and milk. It bypasses several phases of absorption cycle and helps reverse symptoms.

Cyanocobalamin takes a lot of effort to reduce it to the active form; hence cyanocobalamin absorption varies greatly between individuals.

Methylcobalamin is better utilized and is direct active form.

Vitamin B12 (named as cobalamin) is considered to be the largest vitamin, involved in the synthesis of red blood cells, neuronal protection and DNA synthesis which are the vital functions of the body. Around 99 per cent people in the world are in need of extra vitamin B12.

“FSSAI released a regulation in 2017 which is an extension to the Gazette of 2016 and spells out that “suitable esters, derivatives and salts of vitamins and chelates of minerals may be used,” Pharma Consultant Dr Sanjay Agrawal pinpoints.

After the 2016 notification, manufacturers continued to manufacture, use and market methylcobalamin with confidence until the FSSAI notification issued on 11 June 2019 stating that Vitamin B12 namely cynocobalamine and hydroxycobalamine 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)Act 2016 and do not cover Methylcobalamine.

This created a confusion and havoc in the industry manufacturing essential medicinal product using methylcobalamin, industry experts rue.