Industry is at crossroads as the Union Health Ministry is being misguided with reference to putting in place the right regulatory regime to control nutraceuticals and drugs. A silent and yet intense anger is also raging in the industry in the absence of a clear regulatory regime today.  Industry insiders and experts have upped their ante against the intense lobbying related to delegating power to regulate nutraceuticals to a toothless body like Food Safety and Standards Authority of India (FSSAI).

Besides this, the Union Health Ministry is also being misguided to approve an irrational move to bring about certain amendments in the provisions of the Drugs and Cosmetics (D&C) Act towards regulating nutraceuticals on the premise of recommended dietary allowance (RDA) value without even informing and consulting industry. This probably according to industry insiders is happening as a part of lobbying at the Centre towards appeasing a section of people in the industry and Ministry.

This is also very much evident as the state licensing authorities (SLAs) are trying to enforce the ban invoked by the Centre in June 2019. Drugs and nutraceutical manufacturers have since then been defying the one-year old arbitrary and draconian ban on methylcobalamin due to dubious nature of Indian Council of Medical Research (ICMR) and FSSAI recommended dietary allowance (RDA) values and tolerable upper limit (TUL) even in major micronutrients like vitamin C.

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 has also once again 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 were 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. In a letter to the FSSAI, CDSCO had brought to the notice that various brands of products 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.

Unmindful of the concerns regarding RDA for mental health conditions and neurological disorders, industry has dubbed FSSAI as white elephant and urged the centre that there is no need of FSSAI as the authority is not competent enough to talk on technical and scientific aspects and only relies on the dictates of ICMR. It is a sheer wastage of public money which has been pooled in to maintain an authority which is doing more harm than good.

Industry players have also voiced concern that methylcobalamin’s RDA value has been approved by CDSCO up till 2000 mcg but FSSAI is approving only 1 mcg which is of no use. DCGI has approved 2,000 mcg of methylcobalamin even in injectable form and brands are available as patients take methylcobalamin based on the medical condition. Until and unless, FSSAI does not inform the industry that methylcobalamin is approved, there is no value of prescribing RDA value for the same.

Surprisingly the mails which we have received from FSSAI on methylcobalamin and cyanocobalamin, both have the same RDA value for manufacturing. Please be advised we are talking about per serving usage value which the manufacturer can refer to and not the RDA value for a healthy person.

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. The issue has been festering due to missing exact information on TUL of vitamin B12 [methylcobalamin to be specific] from the public domain. No adverse effect has been associated with excess methylcobalamin intake from food or supplements in healthy individuals.

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. Additionally, we had received a letter in December 2019 from FSSAI about methylcobalamin’s approved RDA value for neurological disorders by the technical committee but industry is yet to see the notification on the same.

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). On January 7, 2020, FSSAI issued a notification regarding RDA of vitamin B12 which is specified as 1 mcg without mentioning type of vitamin B12 like methylcobalamin, adenosylcobalamin, hydroxycobalamin and cyanocobalamin.

Former CEO of FSSAI Pawan Agrawal had promised in December 2019 that methycobalamin has been approved by the scientific committee and will take due course of its time to be included in the gazette. Nevertheless, the industry has waited for almost 1 year without any progress for inclusion of methylcobalamin in the gazette.

Dr Sanjay Agrawal
Leading Pharmaceutical Consultant and Inventor
Editor-in Chief of IJM Today
6/146, Malviya Nagar ,
Jaipur, Rajasthan-302017
Phone : 0141 2550814

The post Industry is at crossroads as the Union Health Ministry is being misguided appeared first on Health Vision.

Methylcobalamin has been in clinical use since the 1990s. 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).

Methylcobalamin as a supplement is very essential specifically for Indians where the majority of the population is vegetarian as naturally it is present in nonvegetarian products. When a supplement is taken for prophylactic cause it must at least be of the therapeutic dose. Methylcobalamin is approved by CDSCO till 2000 mcg but FSSAI is approving only 1 mcg which is of no use to manufacture.

In a recent representation made to union ministry of chemicals and fertilizers, industry has once again recommended Drugs Controller General of India (DCGI) to be given the sole authority for implementation of nutraceutical policies and regulations citing Food Safety and Standards Authority of India (FSSAI) as a toothless body. Ten years back nutraceutical was under DCGI only.

A therapeutic dose for conditions requiring methylcobalamin would be a minimum of 1500 µg and a maximum of 6000 µg per day. No significant therapeu­tic advantage appears to occur from dosages exceeding this maximum dose; however, it is likely that beneficial physiological effects occur at dosages as low as 100 µg per day, especially if this dose is given for long time.

Nutraceutical and drug industry have alleged that FSSAI has 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.

Prime Minister Narendra Modi has also recommended 1000 mcg of Vitamin C as prophylactic use against COVID-19 whereas its RDA is 40 mcg due to poor interventions from apex and responsible authorities like ICMR, FSSAI and DCGI. Manufacturers of methylcobalamin have also been defying the arbitrary and draconian ban on methylcobalamin in Gujarat due to dubious nature of Indian Council of Medical Research and FSSAI recommended RDA value and upper tolerance limits in major micronutrients.

Unmindful of the concerns regarding RDA for mental health conditions and neurological disorders, industry has dubbed FSSAI as white elephant and urged the Centre that there is no need of FSSAI as the authority is not competent enough to talk on technical and scientific aspects and rely on the dictates of Indian Council of Medical Research (ICMR). It is a sheer wastage of public money which have been pooled in to maintain an authority which is doing more harm than good.

FSSAI has been drawing flak from the industry as there is no clarity on tolerable upper limit (TUL) and RDA value. There is a nationwide ban on the methylcobalamin with state drug regulators citing that FSSAI has imposed the ban based on ICMR recommendation.

This is all the more contradictory considering that ICMR and National Institute of Nutrition (NIN) has recently issued another report which have different stipulated RDA values of methylcobalamin and estimated average nutrient requirements for Indians.

According to an industry expert, “The dual standards of FSSAI can also be seen by the presence of already FSSAI approved brands available with 1500 mcg qty/per serving. Rejunex CD3 of Intas is a FSSAI approved product containing 1500 mcg methylcobalamin. 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.”

According to Gujarat FDCA Commissioner Dr H G Koshia, “There is a ban on methylcobalamin pan-India and the states need to follow it as per FSSAI directive.” The Central Drugs Standard Control Organisation (CDSCO) had earlier urged the FSSAI to take action against Gujarat-based manufacturers for manufacture and sale of methylcobalamin meant for therapeutic intervention in contravention of norms.

Industry can’t comprehend that under which policies CDSCO and FSSAI are directing each other. Both are two autonomous regulatory body with their independent domain expertise. Specifically a letter was addressed to Dr H. G Koshia by Deputy Director RCD Shri Sanjeev Kumar to investigate the issue having higher Methylcocbalamin concentration without intimating FSSAI Delhi office and the Ministry of Chemical and Fertilizer. In another letter Gujarat FDA office has informed FSSAI regarding manufacturing of methylcobalamin in Gujarat.

In a letter to the FSSAI, CDSCO has brought to the notice that various brands of product containing methylcobalamin are manufactured and sold having therapeutic intervention under the FSSAI license.

In view of the same, it has been recommended on priority basis to instruct drug inspectors and food safety officers to launch surveillance drives against various brands of products containing methylcobalamin being manufactured and sold under FSSAI license, the letter further stated.

Industry players have also voiced concern that methylcobalamin RDA value has been approved by Central Drugs Standard Control Organisation (CDSCO) uptill 2000 mcg but FSSAI is approving only 1 mcg which is of no use. Drugs Controller General of India (DCGI) recommended 2,000 mcg of methylcobalamin even in injectable form and brands are available as patients take methylcobalamin based on the medical condition.

“Until and unless, FSSAI does not inform the industry that methylcobalamin is approved, there is no value of prescribing RDA value for the same. Surprisingly the mails which we have received from FSSAI on methylcobalamin and cyanocobalamin, both have the same RDA value for manufacturing. Please be advised we are talking about per serving usage value which the manufacturer can refer to and not the RDA value for a healthy person,” Ahmedabad based pharma consultant Dr Sanjay Agrawal argued.

On January 7, 2020, FSSAI issued a notification regarding RDA of vitamin B12 which is specified as 1 mcg without mentioning type of vitamin B12 like methylcobalamin, adenosylcobalamin, hydroxocobalamin and cyanocobalamin.

Former CEO of FSSAI Pawan Agrawal had promised in December 2019 that methylcobalamin has been approved by the scientific committee and will take due course of its time to be included in the gazette. Nevertheless, the industry has waited for almost 10 months without any progress for inclusion of the methylcobalamin in the gazette, an industry expert remarked.

RDA for methylcobalamin in the US is 2.4 mcg where most of the population is vegetarian whereas India with a vegetarian population mcg is set as 1mcg. I would like to apprise you that Vitamin B12 is present in non vegetarian sources only. Also other countries have kept RDA and per serving usage value as a separate entity that is being goofed up by FSSAI in India.

There is an urgent need for inclusion of methylcobalamin in the gazette and reviewing the RDA for nutraceutical manufacturers by not forgetting that products are already available at higher concentrations, informed pharma expert Anshu Yadav adding that until and unless FSSAI does not inform the industry that methylcobalamin is approved, there is no value of prescribing RDA value for the same. Surprisingly the mails which we have received from FSSAI regarding methylcobalamin and cyanocobalamin both have the same RDA value to manufacture. We are talking about per serving usage value which the manufacturer can refer to and not the RDA value for a healthy person.

Dr. Sanjay Agrawal
Leading Pharmaceutical Consultant
Editor- in Chief of IJMToday
Email: drsanjay@drsanjayagrawal.com
Mob: 98253 81729

The post FSSAI red faced as Industry lambasts authority for denigrating science by subscribing to ICMR arbitrary RDA values appeared first on Health Vision.

• Last 5 crores sample testing was achieved in a record time of 45 days.
• Number of Covid-19 testing laboratories reaching 2000.

Indian Council of Medical Research [ICMR], the apex body at the forefront of formulating COVID-19 testing strategy in India has achieved milestone of conducting 10 crores testing on 22^nd October 2020. With average testing of more than 10 lakhs per day in last 17 days. Till now, 74000 tests per million population have been conducted.

India has conducted last five crores sample testing in only 45 days. As on 8^th September, 2020 India had tested 5 Crores COVID-19 samples, and in less than 50 days it has reached 10 crores mark on 23^rd October, 2020. This has been enabled by rapidly increasing testing infrastructure and capacity across the country. ICMR has been enhancing COVID-19 testing capability across the country by expanding and diversifying testing capacity by leveraging technology and facilitating innovation in affordable diagnostic kits.

Prof (Dr.)Balram Bhargava, Director General, ICMR said, “We have effectively responded to the evolving epidemic through focused and collaborative efforts of the Centre, State/UTs government. Exponential increase in testing has led to early identification, prompt isolation & effective treatment of Covid-19 cases along with effective contact tracing. These have eventually resulted in a sustained low fatality rate.This testing milestone is testimony to the fact that India has been successful in implementing strategy of 5T approach “Test, Track, Trace, Treat and use of Technology” efficiently, which will enable us to contain the spread of the pandemic.’’

Ramping up of testing facility across India was at the core of increased testing per day. Through our ardent efforts, it was ensured that a specific testing platform is made available addressing general testing (RT-PCR), High-throughput testing (COBAS), testing at remotest places and PHCs (TrueNAT, CBNAAT), in containment areas (rapid antigen testing) and for large number & migrant population testing (pooled sample testing). The total number of diagnostic laboratory has reach 1989. Of which dedicated government laboratories are 1122 and private laboratories number stands at 867.

The post India achieves the milestone of 10 crores COVID-19 sample testing appeared first on Health Vision.

New Delhi 8th September 2020: Indian Council of Medical Research [ICMR], the apex body at forefront of formulating COVID-19 testing strategy in India has crossed 5 crores testing mark on 7^th September 2020. With average testing of more than 10 lakhs per day, India has tested 5,06,50,128 samples across the country till 7^th September 2020. The last one crores sample testing was achieved in only 10 days.

Rapidly increasing testing samples was made possible as daily testing average had been on a continuous rise from around 7 lakh tests being conducted per day in the 3rd week of August to more than 10 lakh tests per day in the 1st week of September. Which was achieved because of ramped up COVID-19 specific diagnostic labs across India with active support of Central and State/UT governments.

ICMR has effectively responded to the evolving epidemic through focused and collaborative efforts of the Centre, State/UT government. Recently India achieved milestone of conducting 10 lakhs tests per day. These milestones are testimony to the fact that India has been successful in implementing Testing, Tracking & Treating strategy efficiently, which will enable us to contain the pandemic.

ICMR has been responding to the situation by regularly revising its strategy for testing. In its latest advisory on COVID-19 testing strategy ‘Testing on Demand’ for individuals has been allowed. The State/UT governments can simplify the modalities to facilitate testing on demand.

The existing recommendations related to testing for COVID-19 have been extended, elaborated and divided into four parts – routine surveillance in containment zones and screening at points of entry, routine surveillance in non-containment areas, hospital settings and testing on demand – and choice of test (RT-PCR, TrueNat or CBNAAT and rapid antigen tests) in order of the priority.

India has been ramping up the testing facility across the country. The total number Covid-19 specific testing laboratories count has reach 1668. Of which dedicated government laboratories are 1035 and private laboratories number stands at 633.

 For more information, please visit https://www.icmr.gov.in/

The post COVID test – India crosses 5 crores sample testing. appeared first on Health Vision.