Entrepreneurship – A journey to change… for the better
“People who are crazy enough to think they can change the world, are the ones who do.”

-Rob Siltanen
The classical definition of Entrepreneurship is “The capacity and willingness to develop, organize and manage a business venture, along with any of its risks in order to make a profit (Read more: http://www.businessdictionary.com/definition/entrepreneurship.html). What definitions usually do not dive into, is the reason for this “capacity or willingness to develop and manage a business venture”. When we look into biographies and or autobiographies of great entrepreneurs and  successful businesses, the one thing that stands out is the intention to start a business venture.

In almost all cases the intention was to bring about a change ! change in the way business was being done, in the way customer needs were being met, in the way innovations were applied etc.,Although from a business perspective we can always say“that an existing opportunity was identified and harnessed to build a business and make profits” – this can also imply that a need to CHANGE was identified which brought about the existence of a business venture !

So, for us, an entrepreneur is a change agent ! She/he is that potential force which brings about a change leading to progress in their field of endeavour. Although bringing about this change is not for the mild at heart there is nothing stopping each one of us to change and become a change agent !

As entrepreneurs, quite often, we are forced to overcome(in innovative ways) quite a number of challenges before we realise our dream of building and managing a business venture. The only thing that helps us overcome these challenges are our passion, commitment and determination towards our goals and objectives.

In a large number of cases, these challenges exist due to availability of a large body of information leading to information overload on one hand and the non-availability of very specific, authentic information and useful knowledge to help the business on the other.
 

We have created this blog with a specific objective to help health and wellness businesses create high quality products through world class organisations. We would write and share blog posts, articles and other communication that wouldhelp entrepreneurs understand applicable laws & rules (regulations), procedures to attain compliance to these regulations and also provide latest updates applicable to specific product categories in this industry sector.

Since this is a very vast area to cover, we propose to focus at present on Medicine products, Medical devices, Food & Nutritionproducts, Cosmetics and Wellness products and organisations associated with these business ventures.
Enjoy !

PART  1
 

Legal requirements and the cost of compliance

Amongst the many day to day challenges, one of the main challenge faced by a micro or a small scale producer of health and wellness products is the question : “Since I produce in small quantities and sell my products locally, do I need to comply with various regulations required to legally start, run and establish a health and wellness product/s business ? “
This, in itself is a complicated question since we need to consider views, requirements, needs, responsibilities etc., of various factors/players in this environment. Some of these major factors/players/stakeholders in the business environment include customer/s, entrepreneur, government, people which have invested in your business, your employees, distributors, competitors, various central and state departments etc.,
Let’s try to understand different perspectives :
– From the perspective of a customer or end user, he or she would expect a product or service which they can be confident of, trust to be safe, provide the benefit for which it was purchased for and also have a higher value than the money spent.
– From a business perspective, as an entrepreneur, the focus will always be on sustaining and growing the business by producing or selling trustworthy products and or services (“Brand”) to the end customer, for a profit.
– From the perspective of the distribution or sales channel, they would prefer to distribute, market and ultimately sell a product which they are confident about from the safety, utility and sales volume perspective.
– From the government’s perspective, since one of its primary constitutional responsibility is the welfare of its people and country it has created various monitoring, controlling and taxation collection departments or agencies to ensure interests of everyone in the country and the country itself are taken care of. Although this is a primary constitutional objective, in reality, this is yet to be achieved in all spheres of activity.
– So, from the perspective of central and state government departments, their one and only mandate is to ensure all business and individuals comply or follow the procedures and or rules(regulations) set forth by the respective governments.
– The pride an employee and a business owner feels when he or she hears from an end user about a great product which his organisation produces, can only be experienced and not explained !

Although compliance to existing regulations is essential to start, conduct and maintain a business, don’t you think adhering or compliance to regulatory requirements will actually benefit your business ? Just think from your customer’s perspective. Does your brand command that authority from a “quality product” perspective ? Would you buy such a product if you are a customer ?
So, to create a trustworthy product or service (Brand), especially in the health and wellness sector, which all stakeholders are not only comfortable buying but also recommend to others, regulatory, legal compliance is one of the essential pillars’ on which your business should stand on.
Although legal, regulatory compliance is mandatory, the challenges in regulatory compliance are two to threefold. First, lack of awareness, second multitude of approvals required to start a business which span across multiple functional governmental departments, non-availability of specific procedural information, manual process/procedures to enable compliance and most important, inertia or aversion to interact with the government and or its various departments.
In summary, the cost of regulatory compliance is :
Being in business for a longer duration PLUS building a brand which your customers trust EQUALS to repeated purchases helping your business survive and grow !

Do you still think attaining regulatory compliance is an option ?

Can we actually attribute a cost to regulatory compliance ?

Come, let’s start building high quality products through world class organisations !

People who change AFTER change will Survive
People who change WITH change will survive
People who CAUSE the change will LEAD…

– Anonymous

PART  2

PART  3

Products regulated – Health & Wellness products
Applicable regulations
D & C Act
FSSAI
Cosmetics, Nutritional products, Ayurvedic products, Pharmaceuticals, Homeopathic,
Testing

PART  4

Manufacturing

PART  5

Distribution

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