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Industry raises alarm as pharma, nutra brands of methylcobalamin flood market due to ambiguous regulations
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Shardul Nautiyal, Mumbai
December 18 , 2020
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Even as the notification to revoke the ban on methylcobalamin is awaited following Centre’s scientific panel nod, industry has once again raised alarm as pharmaceutical and nutraceutical products of methylcobalamin have flooded the Indian market due to ambiguous nature of regulations which as of today neither regulate drugs nor nutraceuticals effectively.
The main reason for the present situation is that the Centre is yet to come out with guidelines on the recommended dietary allowance (RDA) and tolerable upper limit (TUL) of the products containing methylcobalamin.
Questions have been raised about the ambiguous RDA value and TUL of methylcobalamin which till today Food Safety and Standards Authority of India (FSSAI) is unclear about and has been taking refuge of Indian Council of Medical Research (ICMR) due to lack of scientific evidence despite Centre’s scientific panel approved new RDA values, industry sources have alleged.
The Central Drugs Standard Control Organisation (CDSCO) has also been following with FSSAI to take action against Gujarat based manufacturers for production and sale of methylcobalamin meant for therapeutic intervention in contravention to norms.
In a recent representation made to union ministry of chemicals and fertilizers, industry had recommended Drugs Controller General of India (DCGI) to be given the sole authority for implementation of nutraceutical policies and regulations citing FSSAI and ICMR as toothless bodies giving reference that ten years back nutraceuticals was under DCGI only and was properly regulated.
Gujarat based manufacturers have alleged that the dual standards of FSSAI is very much evident with the presence of already FSSAI approved brands available with 1500 microgram (mcg) quantity/per serving. 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. There are more than half a dozen other brands with the same formula. Rejunex CD3 of Intas is a FSSAI approved product containing 1500 mcg methylcobalamin.
Industry has been questioning how the ban on methylcobalamin pan-India is justified when it is still awaiting notification based on the state licensing authorities (SLAs) argument and stand that the states need to follow it as per Centre’s directive as per the law of the land.
In a letter to the 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.
Nutraceutical and drug industry have alleged that FSSAI and CDSCO have been turning a blind eye to the contentious issues raised with reference to RDA values of vitamin C and other micro-nutrients like methylcobalamin which are vital for boosting immunity, mental health and other co-morbid chronic ailments in the crucial juncture of COVID-19 pandemic.
The Central government has also recommended 1000 mcg of vitamin C as prophylactic use against COVID-19 whereas its RDA is 40 mcg due to poor regulatory and policy interventions from apex and responsible authorities like ICMR, FSSAI and DCGI.
Methylcobalamin is an essential nutrient and is required to treat vitamin B12 deficiency, in people with pernicious anaemia, diabetes and other conditions as well. It is important for the brain, nerves and for the production of red blood cells (RBCs).
FSSAI and CDSCO have been drawing flak from the industry as there is no clarity on TUL and RDA values of many micronutrients including vitamin C and methylcobalamin.
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