Pharma industry seeks health ministry intervention on notifying methylcobalamin for neurological disorders, anemia, diabetes
Methylcobalamin is an essential nutrient and ingredient required to treat vitamin B12 deficiency, in people with anemia, diabetes and neurological disorders.
By: Shardul Nautiyal
November 2, 2021 12:57 PM
Methylcobalamin as a supplement is very essential specifically for Indians where the majority of population is vegetarian as naturally it is present in non-vegetarian products.
Drug and nutraceutical industry have sought health ministry intervention on notifying methylcobalamin for neurological disorders, anemia and diabetes.
In order to seek clarity on methylcobalamin different stipulated recommended dietary allowance (RDA) values, the industry experts have written to the union minister of health, chemicals and fertilizers Mansukh Mandaviya to urgently notify methylcobalamin for therapeutic use in neurological disorders, anemia and diabetes.
Drug and nutraceutical industry experts have raised concern that methylcobalamin RDA value has been approved by the Central Drugs Standard Control Organisation (CDSCO) uptill 2000 microgram (mcg) but Food Safety and Standards Authority of India (FSSAI) has approved a different RDA value of only 2.2 mcg which is of no prophylactic and therapeutic use.
Methylcobalamin is an essential nutrient and ingredient required to treat vitamin B12 deficiency, in people with anemia, diabetes and neurological disorders. It is important for the brain, nerves and for the production of red blood cells (RBCs). Methylcobalamin as a supplement is very essential specifically for Indians where the majority of population is vegetarian as naturally it is present in non-vegetarian products.
Drugs Controller General of India (DCGI) has recommended 2,000 mcg of methylcobalamin even in injectable form and brands are available in the market today as patients take methylcobalamin based on their medical condition. However, FSSAI has issued a notification regarding RDA of vitamin B12 which is specified as 2.2 mcg without mentioning type of vitamin B12 like methylcobalamin, adenosylcobalamin, hydroxycobalamin and cyanocobalamin.
Regulatory actions cannot also be taken against those who are manufacturing methylcobalamin based formulations in the absence of scientifically defined efficacious RDA value due to delay in notification.
Once notified, approved RDA value can be defined in a scientific way based on evidence. The issue, however, has been festering due to missing information on tolerable upper limit (TUL) of vitamin B12 or methylcobalamin for neurological disorders and immunity boosters from the public domain.
The pending notification which is being sought for is based on former FSSAI CEO Pawan Agrawal’s confirmation that methylcobalamin has been approved by its scientific committee in December 2019.
“Methylcobalamin has a history of safe long term use as a therapeutic agent given in high dosage or via intramuscular injection for the treatment of disorders associated with impaired vitamin B12 absorption but industry is yet to see the much awaited notification on the same. No adverse effect has been related to excess methylcobalamin intake from food or supplements in healthy individuals,” said Anshu Yadav in her letter to the union health minister further adding that we are pursuing the issue of methylcobalamin ban by FSSAI for more than two years.
“On the contrary, FSSAI has allowed usage of cyanocobalamin which has cyanide content but banned methylcobalamin which is a superior form of vitamin B12. There is no point of prescribing RDA value for the same until and unless FSSAI does not inform the industry that methylcobalamin has been approved. Surprisingly, the mails which we have received from FSSAI, methylcobalamin and cyanocobalamin both have the same RDA value for the manufacturer. We are talking about per serving usage value which the manufacturer can refer to and not the RDA value to be recommended for a healthy person,” Ahmedabad based pharma consultant Dr Sanjay Agrawal further explained.
Link : https://www.financialexpress.com/healthcare/pharma-healthcare/pharma-industry-seeks-health-ministry-intervention-on-notifying-methylcobalamin-for-neurological-disorders-anemia-diabetes/2361724/