I Advice - Health and Fitness

It’s now 9 O’clock in the morning and already the sun is high in the tropical sky. Heavy bulbous clouds herald the possibility of a rain shower later in the day, but then i

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

t has not rained here for several days and the luxuriant tropical plants in the garden that nestles down to the sea are looking in need of water. I am standing beside a ‘sa

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

a’, which is Thailand is an open sided wooden building and this one is no more than ten metres from the sea. The warm Gulf of Thailand is lapping on the beach as I stand an

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

d watch a yoga class of half a dozen participants energetically practising the poses or ‘asanas’ that the teacher is urging them to try. It all looks very energising to me

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

nd they still have another hour of this practice which seems to create a serene inner strength.

Glowing slightly from the exertion, Janca from Breda in Holland tells me sh

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

e has been coming to “The Health Oasis Resort’ in Koh Samui for the past two years. She comes to recharge her batteries and get fit and healthy for her career driven life b

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ck home. Every morning she joins several other guests in one and a half-hours of Hatha Yoga as part of her mental and spiritual de-tox programme. Before coming to Koh Samui

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

she would never have dreamed of embracing this oriental exercise system. Now she participates in a class in her hometown and feels the regimen gets easier each time she re

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

urns to Thailand.

Yoga is a ‘Sanskrit’ word and it means ‘joining or uniting’. But joining or uniting with what? Gavin Flood defines the practice as “technologies or disci

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

plines of asceticism and meditation which are thought to lead to spiritual experience…..” However, outside of India Yoga has become associated as a form of stretching exer

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ise and the philosophical aspect leading to spiritual enlightenment is oft times ignored. Certainly it is the exercise element of the philosophy that I have been witnessing

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

in the wooden house beside the beach at Bang Po in Koh Samui.

Patanjeali is credited with the 196 aphorisms c

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

mpiled somewhere between 200 BC and 300AD that have gone to formulate the creed that has become. ‘Yoga’ and his vision known as Raja Yoga embraces eight life areas that pro

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

vide a template for leading a good and virtuous earthly existence. These tenets are similar to the laws and observances of all great spiritual traditions. The devotee esche

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

s lying, violence, theft, illicit sex and the need for possessions. Through the five observances he surrenders to God. The ‘asanas’ or postures were adopted as poses suitab

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

le for meditation that again like in many other traditions was a part of the discipline.

The mediation positions have evolved into the exercise postures that make up Hatha

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

Yoga which came into being in fifteenth century India under the guidance of Yogi Swatmarama. The emphasis here dwells on enlightenment of the mind (ha) via purification on

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

the physical plane through the medium of exercise, which leads to the increase of ‘prana’ or life force energy (tha).

“Prana’ is the key because as we increase the life fo

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

ce health and wellness and ultimately emotional well being come to the fore. People like Janca flock to 'spa’ type location such as theelopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

althoasisresort.org"> Health Oasis Resort in Thailand’s Koh Samui to achieve this increase in energy and well being, and yoga is one of the means of achieving that end

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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