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

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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

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India set the agenda of self-reliance in the pharma sector by declaring 2015 as the “Year of APIs”. Since then, the country  has been trying to reduce external dependence for its Active Pharmaceutical Ingredients (APIs)requirement. In 2019, India still imported 68% of its APIs from outside the country, mostly from China.1[1]What does this tell us? The contour of self-reliant India will take its time to unveil and we need to strengthen domestic manufacturing before “promising big”. Today, the manufacturing hubs in the pharmacy of the world that India is, are taking a hit. Take, for instance Vitamin C; there has been a steep rise in the cost of raw materials used to manufacture this immunity boosting medicine.

Digging deeper into India’s story of Vitamin-C tablets

The Vitamin-C supplement is available under two categories— as an essential medicine and a food supplement. Hence, the difference in the prices of brands available in the market. Let’s understand this with an example. Take, for instance, the much-in-demand Limcee and Celin; these are medicines that are recognized as essential medicines, therefore classified under National List of Essential Medicines (NLEM) under price control. They fall under the purview of Drugs Controller General of India (DGCI) and the National Pharmaceuticals Pricing Authority. Currently, the price of Limcee stands at Rs.1.67 per tablet.

The other side of the coin are the Vitamin C supplements that fall under the purview of Food Safety and Standards Authority of India (FSSAI), where the drug is treated like a supplement and the manufacturers enjoy the liberty of unregulated pricing and can freely increase their prices. Many new companies have also launched their brands in the last few months as food supplements, given the increased demand during the current pandemic, and these are priced multiple times that of the NLEM brands (up to Rs.12.25 per tablet in some cases).

Now this move has impacted the cost of production of Vitamin C produced by pharmaceuticals companies in India. With the result, the companies under the purview of FSSAI can possibly afford these raw materials and subsequently  charge any amount of money they want from consumers because they are not subject to price control. On the other hand, the manufacturers of Vitamin C under price control are facing issues in producing abundant affordable medicines for the consumers because of this enhanced cost of raw materials by domestic suppliers.

To add to that, with the increase in demand, domestic companies are anyway not able to supply adequate amounts of the raw material. It must be noted that the manufacturers of low cost NLEM drugs are obligated under laws to make the drugs available to consumers unlike the manufacturers of food supplements. The pricing structure and inadequate supplies from the domestic raw material providers however, has hit the production capacity of companies manufacturing affordable versions.

With the result, the patients have little access to the more affordable medicines as companies are unable to cater to the demand because of inadequate supplies. The patients end up buying the costlier version of Vitamin C that comes under the purview of FSSAI.  The next question is—if Make in India was about affordable solutions, why are the rising costs of these APIs not regulated? How is it fair to regulate the price of the end product, when raw material price hikes are at the discretion of the suppliers?

When the idea of a self-reliant India rests on the grounds of affordability and accessibility, why are the patients denied access to something as basic as a Vitamin C tablet? Importantly, the domestic industry has had 22 years to get its act together as that is when the anti-dumping law came into force. In today’s era of globalization, such a draconian law does not serve well for the country. A topic worth considering.

Cannot achieve patient interest  without accessibility

For India to lead its people into a safe healthcare paradigm, we will have to create policies that foster accessibility and affordability. Make in India should not restrict our patients’ access to medicines that are otherwise available at affordable prices. The focus should be to address the issues that we have, instead of imposing restrictive policies.

Issues such as improving the healthcare infrastructure, building a strong primary healthcare system, having facilities to bring more doctors and healthcare workers into the system, investment into research and development, and digital health. These are the real issues to be addressed. The pandemic has exposed many realities of India’s pharmaceutical industry. From underlining the serious fault line in the global pharmaceutical supply chain, to revealing our increased costs of APIs, and  inadequate supplies of reasonably priced medicines to patients.

Isn’t it counterproductive to the entire purpose of providing affordable healthcare to the people of India? Therefore, there is a dire need of policy intervention, where imposing anti-dumping duty is not a solution. It is more important to set things right internally first.

Dr. Gajendra Singh
Public Health Expert

[1]https://timesofindia.indiatimes.com/business/india-business/68-of-apis-comes-from-china-govt-data/articleshow/76521046.cms

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While discussions around food hygiene and safety has always had prominence, the ongoing Covid-19 crisis has once again thrown open and emphasized the importance of addressing the issue and heightening awareness around it. This has also highlighted the importance of global standards processed foods that are hygienically prepared, well stored and well packaged, and nutritious as well, making it the need of the hour. The government is also enhancing its initiatives for making food safety and hygienic practices the new normal from farm to fork.

Food products should be healthy and nutritious:

The Food Safety and Standards Authority of India (FSSAI) in an observation on COVID-19 has stated that the importance of food safety and hygiene has never been more important as we navigate through unprecedented times. The pandemic has changed consumer perceptions about food safety and there is a new awareness and demand for food products that are not just convenient and easy to store, but are also healthy and nutritious. We will also witness more demand of technologically-driven, automated manufacturing processes for food production. Such foods, for example, include well-crafted protein rich cold-cuts, and other nutrient rich processed foods that are hygienic and definitely value-add to the meal every day and are a healthy choice for the discerning modern consumer, who nowadays is willing to pay much more for high-quality products.

With growing health awareness among consumers, the result can be seen in the increasing demand of such processed foods. The advantages of quality processed food products enables us to enjoy a varied diet that fits with the fast pace and pressures of our modern-day society. People have been travelling abroad for their holidays and are exposed to a wider, global selection of flavours and styles of foods. To meet such consumer expectations, manufacturers here are producing sophisticated processed foods that are gluten-free and comply with guideline at every stage of food production, storage and transportation. Hence, these are products that meet international quality standards and stand a class apart purely based on their flavour and quality of ingredients and are a healthy alternative for the modern consumer.

Food hygiene and safety is the need:

Related to the issues of food hygiene and safety is the need to ensure contactless or minimal human intervention in different phases of food production & delivery processes. Therefore, food delivery via drones could soon become a reality in India with the Director General of Civil Aviation (DGCA) giving a nod to multiple food start-ups to start testing. The approval of drone delivery can prove to be a game-changer at a time when the world is looking for new ways of contactless delivery. Also, restaurants have strict guidelines to follow while preparing food and delivering parcels.

While the government has a major role in ensuring that all guidelines are followed with regard to food hygiene and safety, the society at large too has great responsibility in this to ensure that there is compliance with global food standards and greater power for consumers to make healthy food choices. The pandemic has also highlighted the need to establish stringent food safety systems that can respond instantly to disruptions in supply chains and ensure continued access to safe and secure food to the consumers.

This new demand for better food hygiene and increase in awareness to build immunity will definitely prompt companies to be innovative in this emerging trend to stay ahead of the curve. There are companies that have a vision to link their past, present and future aimed at creating a valued food product true to their high standards. Food safety is everyone’s responsibility and all of us must work together and devise collective strategies to ensure that the best practices are implemented in the interest of the consumers.

Also Read: DO SOME SMART CHANGES FOR HEALTHY LIFE

Lindsay Bernard Rodrigues
Co-Founder and Director
Bennet & Bernard Group

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