Concerns have been raised by the industry on the recent ban on methylcobalamin only in Gujarat. In other states, there is no such ban on methylcobalamin which is an important pharmacopoeial ingredient used in drugs and food supplements.
Industry experts have pinpointed that ban on methylcobalamin warrants scrutiny in the wake of dual standards followed in such case by the regulatory authorities. Methylcobalamin is also approved all over the world in nutraceutical and food use.
Repeated correspondences by industry experts on the issue have yielded no responses from Food Safety and Standards Authority of India (FSSAI) and Drugs Controller General of India (DCGI) and Gujarat state drug controller since June 2019 when the ban was invoked.
Rues pharma consultant Dr Sanjay Agrawal, “What is the need of two authorities in India – Central Drugs Standard Control Organisation (CDSCO) and FSSAI and why a product is approved by one authority and banned by the other.”
FSSAI in its Food Safety and Standards (health supplements, nutraceuticals, food for special dietary use, food for special medical purpose, functional food and novel food Regulation 2016 [Available on website of FSSAI] has approved only cynocobalamin and hydroxycobalamin. Cynocobalamin which when enters the human body leaves the cyanide group and takes methyl group from 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.
In June 2019, the manufacturers of Gujarat were taken by surprise when a letter was issued by Food and Drug Control Administration (FDCA) Gujarat stating ban on methylcobalamin.
“FSSAI is an autonomous body but Gujarat FDCA is reporting to both drug authority and food authority. So in such case there is conflict of interest as the Commissioner FDCA Gujarat has approved the product methylcobalamin under drug regulation while banned it under food regulation,” Dr Sanjay Agrawal pinpoints.
He further informed, “Gujarat FDCA office had received a letter from Deputy Director FSSAI Delhi which is copied only to DCGI.”
It is contradictory that methylcobalamin is in the approved list by DCGI and is been manufactured under drug regulation whereas FSSAI has put a ban on same, experts conclude.