Mumbai : Even as the industry is confused over the blurred line between nutraceuticals and drugs, industry sources have lately revealed that leading Indian companies are selling vegetarian capsules with vitamin B12 as the main ingredient in dosage of 500 milligram (mg) and more for neurological disorders, pernicious anaemia, among others.
This is the latest in the series of cases of companies evading defined arbitrary recommended dietary allowance (RDA) values of Indian Council of Medical Research (ICMR) and despite being approved under the Food Safety and Standards Authority of India (FSSAI) license are being used as drugs for therapy purposes.
This comes close on the heels of several industry representations to the Union ministry of chemicals and fertilizers towards streamlining the drug regulatory regime related to regulating nutraceuticals as several brands containing ingredients above permissible limits have entered the drug retail supply chain.
The latest in the series of Indian brands which have been evading the defined arbitrary RDA values of ICMR is vitamin B12 which is being sold in dosage of 500 milligram (mg) and despite being approved under the FSSAI license being used as drugs for therapy purposes.
Some of the widely sold brands approved by FSSAI and available in the drug retail supply chain are Health Aid Vitamin B12 (methylcobalamin) 1500 mcg, Nature Made Vitamin B12-1000 mcg, B-12 dots by Twinlab-500 mcg, Jarrow Formulas, Methyl B-12-1000 mcg, Nature’s Bounty Vitamin B-12 1000 mcg, Source naturals methylcobalamin Vitamin B12-5000 mcg, solgar sublingual methylcobalamin supplement-1000 mcg, Cobaforte CD3 plus tablet-1500 mcg, nocob methylcobalamin 1500mcg, unived methylcobalamin 1500mcg, Bhumija Lifesciences vitamin B12 1500 mcg, bluebonnet liquid methylcobalamin – vitamin B12 1000 mcg, EZ Melts B12 as methylcobalamin, 2,500 mcg and Garden of Life Vitamin Code vitamin B12-1000 mcg among others.
In a recent letter issued to the Union ministry of chemicals and fertilisers, the industry has drawn the attention to the industry’s consistent efforts of also seeking clarity on the ban on methylcobalamin (the most important B12) and about defining its arbitrary RDA values by ICMR and approved by FSSAI as mentioned in correspondences or emails shared with the concerned divisions of ICMR and FSSAI dated December 17, 2020, dated November 2, 2020, dated October 7, 2020, dated September 26, 2020, and dated September 16, 2020.
The industry had earlier also cautioned about the blatant violation of administrative protocols in the regulatory regime in the country citing the FSSAI directive to state drug controllers (SDCs) to take action against manufacturers for the production and sale of methylcobalamin meant for therapy in cases of diabetes and neurological disorders.
Methylcobalamin is also widely marketed in the country as a drug for chronic neurological disorders with a recommended dietary allowance (RDA) of 2000 mcg intramuscular but as per FSSAI, it is detrimental for patients when used above 1 mcg for prevention and disease management.
The letter to DCGI and the union ministry of chemical and fertilizers also pointed out the ambiguities related to regulatory actions on manufacturers.