Advice You - Business

A parasite is medically defined as an organism that lives on within another organism at the expense of the host. Bureaucracy is an administrative system, which places undue emphas

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

is on adherence to complex procedures and inflexible rules of operation. It is an administration characterised by excessive red tape and routine. This impedes effective action, sl

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

Examples of combination products may in

ws down decision-making and adds unnecessary layers of costs. Bureaucracy is sometimes described as the tail wagging the dog and is a parasite to productivity. It is also like the

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

millstone around one’s neck, limiting mobility.

Most of the large organisations have some form of bureaucracy. It is a given, inherent structure created largely by Alfred P. Sloan,

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

who became president and CEO of General Motors (GM) in 1923. He recognised the need for coherence and unifying order when he confronted GM, a sprawling corporation that was in dir

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

Combination pro

e need of organisation. It was Sloan who transformed GM’s loosely configured, far-flung divisions into a coherent corporation. But while that organisational form worked well for m

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

ny years, it had begun to become too restrictive as business became more demanding and more global in the 1980s.

Jack Welch told his people to “fight it, kick it.” Welch fought a

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

two-decade war against bureaucracy with initiatives like “ boundaryless” and “Work-Out”. GE’s list of values specifically addressed the company’s intolerance for bureaucracy and i

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

was at the top of this list for many years. Welch recognised the adverse effects of bureaucracy and knew that unless he rid the organisation of the worst of it, GE would never be

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

come a legitimate global competitor. He called bureaucracy “the Dracula of institutional behaviour,” meaning that it kept rising from the dead after being driven with a stake into

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

it. He was concerned that bureaucracy was creeping back into the organisation. He hated bureaucracy, knowing that layers slow down decision-making. He delayered the organisation

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

Following aspects would a

and removed the use of headquarters in order to help GE become more nimble and competitive. By waging “war” on bureaucracy and the old ways one movement at a time, Welch establish

dd to the challenges in developing combination products:

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

d a solid foundation on which he eventually built GE’s famed learning organisation

Margaret Thatcher, the former Prime Minister of United Kingdom (1979 – 1990) who privatised Bri

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

tain Inc, the state-owned enterprises, did not support bureaucracy and consensus. She said: “To me consensus seems to be: the process of abandoning all beliefs, principles, values

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

and policies in search of something in which no one believes, but to which no one objects; the process of avoiding the very issues that have to be solved, merely because you canno

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

get agreement on the way ahead. What great cause would have been fought and won under the ‘I stand for consensus’ banner?”

With privatisation, Britain Inc was able to cut back on

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

Professional from academic institutions, pharmaceutical industries, health care indust

ureaucracy and re-gain its natural corporate wellness. Many countries have followed Britain’s footsteps to privatise its government sector thereby minimising bureaucracy and boost

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

ing productivity.

If you desire speed and quick response to market changes, then the command-and-control bureaucracy is not the best way to run a business. It is more important to

.

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

et everyone involved than adhering to a rigid hierarchy. Many companies are cutting down on headquarters’ bureaucracy as they are bogging companies down, stifling the units’ abili

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

y to reason and quickly decide. Business was moving too quickly and bureaucracy was strangling creativity and innovation. Gun down bureaucracy as it is the enemy of productivity

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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A tremendous amount has been written about Executive Compensation, and lately, most of this information has been extremely unflattering. Much of the criticism has resulted from the gross excesses, misinterpretations of regulations, and the rash of criminal cases brought against the top management of a number of large firms, such as WorldCom, Tyco, Enron, and a host of others. Virtually every day another egregious example of corporate greed has come to light. The effect has been a huge increase in media attention, which in turn has acted as the stimulus for new government regulations aimed at curbing these abuses.

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Advice You - Bureaucracy is the Parasite to Productivity

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