CDSCO asks FSSAI to take action against manufacturers for sale of methylcobalamin having therapeutic value

CDSCO asks FSSAI to take action against manufacturers for sale of methylcobalamin having therapeutic value

Shardul Nautiyal, Mumbai
Thursday, December 12, 2019, 08:00 Hrs  [IST]

The Central Drugs Standard Control Organisation (CDSCO) has urged the Food Safety and Standards Authority of India (FSSAI) to take action against Gujarat-based manufacturers for manufacture and sale of methylcobalamin meant for therapeutic intervention in contravention of norms.

In a letter to the FSSAI, CDSCO has brought to the notice that various brands of product containing methylcobalamin are manufactured and sold having therapeutic intervention under the FSSAI license.

According to the letter, it is pertinent to mention here that there are 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.

In view of the above consideration, it has been recommended on priority basis to instruct drug inspectors and food safety officers to launch surveillance drive against various brands of products containing methylcobalamin being manufactured and sold under FSSAI license.

Therefore, this warrants an apt action as per the provisions of FSSAI act 2006 Rules and Regulations made thereunder against the defaulting food business operators (FBOs) under intimation to FSSAI and CDSCO, the letter states.

Methylcobalamin also known as mecobalamin or methyl B12 plays a key role in maintaining good health. It is the only form of vitamin B12 that can cross the blood brain barrier without bio-transformation. Its methyl group stimulates serotonin secretion, a neuro-transmitter which is responsible for mood enhancement and protects brain from damage against excitatory neurotransmitters.

Industry experts have pinpointed that ban on methylcobalamin warrants scrutiny in the wake of dual standards followed in such case by the regulatory authorities-CDSCO and FSSAI.

Repeated correspondences by industry experts on the issue have yielded no responses from FSSAI, CDSCO and Gujarat state drug control department since June 2019 when the ban was invoked.

Rues pharma consultant Dr Sanjay Agrawal, “Industry is also discouraged with the ambiguous nature of ban and concerns have been raised by the industry on the ban on methylcobalamin only in Gujarat. There is no such ban on methylcobalamin in other states.”

Cynocobalamin which when enters the body leaves the cyanide group and takes methyl group from the human body to form methylcobalamin as methylcobalamin is the active form of vitamin B12 in the human body.

In a draft guideline issued in 2017 which is also considered as extension of regulation 2016, FSSAI added the word derivatives of Vitamins to the approved list. Manufacturers continued to manufacture methylcobalamin considering it as a derivative of methylcobalamin.

However, in June 2019, the manufacturers of Gujarat were taken aback when a letter was issued by Food and Drug Control Administration (FDCA) commissioner, Gujarat to ban methylcobalamin.

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