Month: October 2020

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Bridging the Gap between Nutraceutical Regulations and Enforcement

India, well-known as World’s Pharma hub, finds its root of Traditional medicines in Ayurveda! This legacy of curative knowledge is far older than the modern medicines. With Covid-19, world has accepted the role of preventive measures, thus “alternative” medicine becomes “mainstream”.

As per research, there is surge in global demand for nutraceutical products. The European consumption is influenced by innovation and research, the USA demand is driven by growing health awareness, whereas, Asian preference is due to the trust in conventional medicines.

India, having an inherent advantage in this space, is poised to benefit. Hence, to tap this potential, multipronged approach is needed, such as increasing grants for R&D, Ensuring end-to-end supply chain and redefining the regulatory system.

Efforts are being put by regulators to give the industry the required boost and allow it to contribute substantially for the public healthcare. So, let us have a look at some of the reforms done in regulations in Corona times.

 

11th June 2020: FSS Act, 2006 permits use of nutrients in products such as health supplements, nutraceuticals, etc. in amount not exceeding Recommended dietary allowance (RDA) prescribed by ICMR. – all the central and state licencing authorities are advised to strictly implement the limitation of ‘Not more than one RDA’ for nutrients as per section-22 of FSS Act, 2006 while granting licenses to FBO except for Food for Special Medical Purposes and Food for Special Dietary Uses where use of more than one RDA is permitted (as per schedule III of Nutraceuticals Regulations). https://fssai.gov.in/upload/advisories/2020/06/5ee715f0cf8c7Letter_Compliance_RDA_License_15_06_2020.pdf

16th July 2020: Surveillance and enforcement to prohibit the sell of health supplements and nutraceutical products contains PABA- a banned ingredient-re. FSSAI has banned the use of PABA in the products covered under Nutraceutical regulations due to safety concern with immediate effect. No further manufacturing is allowed and products already manufactured and imported shall be withdrawn from the market. https://fssai.gov.in/upload/advisories/2020/07/5f1035178000aLetter_Surveillance_Enforcement_Sell_HealthSuppliments_16_07_2020.pdf

 11th Aug 2020: Products covered under FSS (food or health supplements, nutraceuticals, food for special dietary use, food for special medicinal purpose, functional food and novel food) are required to comply with the general labelling requirements under the FSS (Packaging and Labelling) Regulations, 2011. https://fssai.gov.in/upload/advisories/2020/08/5f3267e31a228Letter_FSS_Health_Supplements_11_08_2020.pdf

1 Oct 2020: The ministry of health and family welfare has framed Food Safety and Standards (Amendment) Bill 2020 and introduced 70 amendments in the 2006 Act to revamp FSSAI functioning and its jurisdiction.                                With the amendments, the government has proposed to bring regulation of animal feed industry under FSSAI.Government has also decided to specify standards for “food contact material”, which would mean specifying standards for food packaging material.
The government has also proposed to make the Act more stringent prescribing enhanced penalties for violations, including manufacture and sale of unsafe food, adulteration of food causing death, carrying out business without licence and repeat offences. The amendments propose enhancing maximum fine for manufacturing and sale of unsafe food from Rs 1 lakh to Rs 3 lakh.

https://economictimes.indiatimes.com/news/economy/policy/govt-moves-to-revamp-the-food-safety-and-standards-authority-of-india/articleshow/78434548.cms

8 Oct 2020: FSSAI invites EOIs (Expression of interest) for selection of Training Partners empanelled under FoSTaC for training of Food Handlers- working with MDM, Aanganwadi, Govt. Canteens and Place of Worship for FSSAI. Organization invites EOIs from experienced and well-established agencies with valid empanelment as Training Partners under FoSTaC launched by FSSAI and who are ready to provide their services with due care and guidance to the users so as to get maximum utilization of resources.

FSSAI will reimburse the amount with due verification, as deemed fit, considering the number of trainees per class. (EOI_TP_ FoSTaC pdf)

12 Oct 2020: The order on “Requirement of Non GM cum GM free certificate to accompany imported food consignments-reg” is presently applicable only to food crops mentioned in annexure I of the order and not to processed products in general. Comments received from different countries will be studied before order comes into effect. (Clarification_GM_Food pdf)

 

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Navigating Towards Future of Nutra Industry

As most of us are in lockdown at home we are wondering how the post- lockdown world would look like. Opening up economic production, even partially, has brought lot more challenges.

In recently published manual, The Union Health Ministry has addressed the preventive measures that cover all types of workplaces including manufacturing plants and corporate offices.

The Covid 19 situation is disrupting and challenging the entire world like never before. I believe, it will help in making companies the world over more humane than alone profit oriented. The social distancing will in fact help in bringing the people more closer.

The present crisis will make a new difference in the human kind’s equation to 3ps i.e. People, Planet and Profits. It will help in making each of us more humble, caring, empathetic and self-sufficient; create more awareness about the importance of preserving and protecting our planet and its air, water and food resources; there will be a corporate behavioural shift where more importance will be given to people and planet over profits.

New workplace Norms:

Some of the highlights of the new workplace norms are like gap of one hour between shifts, staggered lunch breaks to ensure social distancing, sanitization of workplaces between shifts, frequent cleaning of common surfaces and hand washing. Thermal screening will be there for all those entering and leaving the work premises is mandatory and a list of COVID-19 dedicated hospitals in the vicinity should be available at the workplace.

One of the biggest consequences of the Covid-19 pandemic has been the workplace transition to the home front, i.e., work from home (WFH). WFH has radically changed traditional work arrangements.

Essentials of WFH style:

The WFH has become survivor of for many industries including Nutraceutical as it has opened a window for physical and virtual collaboration. This has accelerated the workplace transformation and digitally transformed environments.
But to successfully navigate through this new way of working, organisations need to address it differently. The people strategy and business strategy need to be reframed in a manner that the focus need to be shifted from business-first to people-first, that is, be employee-focused and client-centric in operations.
With remote work environments becoming the new norm it is necessary that workforce is reskilled and relevant for the times ahead. Hence organisations need to ensure continuous training and learning programmes for employees

Even assistance with healthcare support (doctor on call, fitness sessions), stress management (counselling and meditation) and social connections (virtual coffee meets) can be provided by the organisations.

 

Essentials to Make Progress Nutra Industry in Near Future:

Amongst the industries in this COVID-19 crises health has become very precious industry and being at home everybody is consuming home food and looking for how to fight with COVID-19 infection by improving immunity.

 

By and large immunity has become a focus and everybody is trying to improve immunity to fight with any viral load is confronted. Absence of vaccines and presence of tests increasing new number of suspected and infected patients. Although the mortality rate is very low in India, community has engulfed in lot of fear of life.

 

As long as community remains in fear, for few who do not fear at all and disobey social distancing as well as other provided norms you would find the situation would remain same with mixed feelings as well as plethora of concerns attached to this crisis issue.

 

As a result it is important to bring hope in community from fear which will perhaps provide discipline on one hand by improving one’s immunity and also hope and on the other hand align them to be work forward to make industry more profitable.

 

It is a reality that WFH is going to be new work culture and even in the offices as they open the same remote working culture would always remain in future. It is a matter of balancing on the spot working and remote working for variety of businesses. As this proportion will vary from industry to industry, industries like IT, would have more component of remote working while construction, travel will have more focus on the spot working. Considering this kind of scenario industries are taking innovative approaches.

As a result it is important to bring hope in community from fear which will perhaps provide discipline on one hand by improving one’s immunity and also hope and on the other hand align them to be work forward to make industry more profitable.

It is a reality that WFH is going to be new work culture and even in the offices as they open the same remote working culture would always remain in future. It is a matter of balancing on the spot working and remote working for variety of businesses. As this proportion will vary from industry to industry, industries like IT, would have more component of remote working while construction, travel will have more focus on the spot working. Considering this kind of scenario industries are taking innovative approaches.

For any business or basically health business following essential functions need to, progress in a profitable way

  1. Decision making: Business progresses on day to day decisions based on articulated plans. Here management has to manage with right proportion of On the job and remote working
  2. Business development is an important activity and companies have different strategies to implement ,in the-right proportion
  3. Manufacturing, logistics, trading and availability depends on which way it progresses with technology.
  4. Communication in physical or digital way and on line business is becoming a fulcrum of business model
  5. Performance Management is a crucial piece of all activities and our HR professional will make it happen

For Nutra industry to grow further it is necessary to leverage its strengths and opportunities.in future .In given environment ,challenges are many and the Industry leaders will have to adapt the new ways to manage their businesses.

 

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