The industry has once again alerted the Centre 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 evading Indian Council of Medical Research (ICMR) prescribed recommended dietary allowance (RDA) values.
These brands have been evading the defined arbitrary RDA values of ICMR and despite being approved under the Food Safety and Standards Authority of India (FSSAI) license are being used as drugs for therapy purposes.
Some of the noteworthy global brands available are GNC Vitamin B12 capsules (USA) – 1000 microgram (mcg), methylcobalamin B12 (Canada) – 1000 mcg, Life Extension (USA), methylcobalamin- 1000 mcg, Natural Factors (methylcobalamin) – 5000 mcg among others.
Indian Brands that are approved by FSSAI and available in the drug retail supply chain are health aid vitamin B12 (methylcobalamin) 1500 mcg, nature made vitamin B-12-1000 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 B-12-5000 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.
Some of the widely sold brands are Locopen capsule, Neugaba M 75 capsule, Nervup 500 mcg injection, Nuroz Forte, Nurofine-2500 injection, Actavis 2500 injection, etc.
The letter to DCGI and the union ministry of chemical and fertilisers also pointed out the ambiguities related to regulatory actions on manufacturers.
According to the letter, “Even if we consider methylcobalamin is banned but we have been continuously communicated in mails by the officials of FSSAI that its RDA value of methylcobalamin is 1 microgram (mcg). It has to be noted that researchers have claimed that the source of vitamin B12 is mostly non -vegetarian food. Globally, the RDA is 2.4 mcg. In India where the population is mostly vegetarian, on the contrary, RDA is defined as 1 mcg. We have the full right to know from the regulators where this scientific value has come. Also if methylcobalamin has not been included in the gazette notification, why FSSAI officials are talking about RDA value. However, FSSAI has asked us to question ICMR about this concern. It has been recommended that FSSAI must discuss with ICMR and explain to us the reason for keeping RDA value as 1 mcg.”
“Our continuous follow-ups with the FSSAI has yielded no positive and desired response makes it amply evident that nutraceuticals were well regulated when it was under DCGI ten years ago,” the letter further stated.
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