The ban on manufacturing methylcobalamin in Gujarat would soon be revoked as it has been approved by the Food Safety and Standards Authority of India (FSSAI) scientific panel as a nutraceutical ingredient.
In June 2019, a letter was issued by Food and Drug Control Administration (FDCA) commissioner, Gujarat to ban methylcobalamin.
Last week, the Central Drugs Standard Control Organisation (CDSCO) had urged FSSAI to take action against Gujarat based companies for manufacture and sale of methylcobalamin meant for therapeutic intervention in contravention of norms.
In a letter to FSSAI, CDSCO had brought to the notice that various brands of product containing methylcobalamin are manufactured and sold having therapeutic intervention under the FSSAI license.
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.
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“Repeated correspondences by industry experts since June 2019 when the ban was invoked has finally yielded the desired outcome from CDSCO, FSSAI and Gujarat state drug control department,” says pharma consultant Dr Sanjay Agrawal.
“FSSAI’s Scientific Panel after risk assessment based on secondary data has finally approved methylcobalamin (vitamin B12) as a nutraceutical ingredient,” as per a letter shared from Pawan Agarwal, chief executive officer, FSSAI’s office to pharma consultant Dr Sanjay Agrawal.
The letter further states that such decisions are taken by FSSAI’s scientific panel after risk assessment based on secondary data which also goes through a process of approval through scientific the committee and the union ministry of health.