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Just Other Articles - An Outsourcer's Passage to India: How to Do It, part II
Part I of this article listed all the things that you, an outsourcer, must do in preparation for a trip to India. It saw you up to the airport on your day of departure.
Now you’re on the plane and you’ve had dinner; your eyes close as you drift into sleep, to dream of maharajas, elephants and co
Now you’re on the plane and you’ve had dinner; your eyes close as you drift into sleep, to dream of maharajas, elephants and co
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
mputer geeks…
After sailing the skies for an interminably long time, you finally arrive in the Indian subcontinent. Hot, humid air surrounds you as you disembark from the aircraft; flocks of parrots and other exotic birds streak by overhead.
Immigration takes anything between 10 and 90 minutes
After sailing the skies for an interminably long time, you finally arrive in the Indian subcontinent. Hot, humid air surrounds you as you disembark from the aircraft; flocks of parrots and other exotic birds streak by overhead.
Immigration takes anything between 10 and 90 minutes
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
depending on the inflow of passengers... it pays to move fast and get a good position in the line.
Customs is usually a breeze, since the officers are only after the big offenders (and hopefully you’re not one of them!). They usually wave foreign citizens right by since they know these visitors
Customs is usually a breeze, since the officers are only after the big offenders (and hopefully you’re not one of them!). They usually wave foreign citizens right by since they know these visitors
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
are potential customers.
Incidentally, from the moment you entered the terminal, surveillance has been on, but since it's hidden, you've no idea it's in place.
If you now walk straight out of the terminal, voracious taxi drivers will descend upon you en masse, much like vultures on an African k
Incidentally, from the moment you entered the terminal, surveillance has been on, but since it's hidden, you've no idea it's in place.
If you now walk straight out of the terminal, voracious taxi drivers will descend upon you en masse, much like vultures on an African k
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ll, after which they will proceed to confuse and destroy your thinking process in their attempt to sell you a ride.
So don't venture outside unprotected. Buy a controlled-rate coupon inside the terminal at the 'prepaid taxi' counter for a taxi ride to your hotel. The salesperson will also assign
So don't venture outside unprotected. Buy a controlled-rate coupon inside the terminal at the 'prepaid taxi' counter for a taxi ride to your hotel. The salesperson will also assign
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
a taxi and driver to you.
The prepaid taxi coupon is your body armor against those unregulated taxi-drivers... they will not come near you when they see that slip of paper in your hands. You can walk to your taxi without fear of attack.
Once you're at your hotel, you're in safe hands, because
The prepaid taxi coupon is your body armor against those unregulated taxi-drivers... they will not come near you when they see that slip of paper in your hands. You can walk to your taxi without fear of attack.
Once you're at your hotel, you're in safe hands, because
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
indeed, Indian business hotels are havens for travellers. Their managements are seriously concerned about guests' well-being and comfort; their environs are restful and healing.
Knock back your welcome drink and decompress. Once that’s done, gently channel your thoughts towards acquiring a vital
Knock back your welcome drink and decompress. Once that’s done, gently channel your thoughts towards acquiring a vital
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
necessity: a mobile phone with GSM connectivity.
If you are a seasoned traveller, you will have a 'tri-band' mobile, in which case all you have to do is buy a SIM card and a prepaid connection, which will cost you about US$35 (as of 2005) including nearly 250 minutes of talk time.
If you don't
If you are a seasoned traveller, you will have a 'tri-band' mobile, in which case all you have to do is buy a SIM card and a prepaid connection, which will cost you about US$35 (as of 2005) including nearly 250 minutes of talk time.
If you don't
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
have a tri-band, buy an inexpensive GSM mobile for about $45 in addition to a SIM card. SIM cards and phones are available at any of the myriad phone shops in any Indian metropolis; your concierge will tell you where the nearest one is.
Take this advice on mobiles very seriously... one cannot st
Take this advice on mobiles very seriously... one cannot st
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
ress how important it is... I’ll be you $10 you’ll thank me for it later!
Inaugurate your new phone by calling the vendor you came to see. Get to the vendor's office by car (yours or theirs, as long as it has air conditioning); other means of transport like auto rickshaws may look exciting but w
Inaugurate your new phone by calling the vendor you came to see. Get to the vendor's office by car (yours or theirs, as long as it has air conditioning); other means of transport like auto rickshaws may look exciting but w
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ill likely result in a missed appointment...
When at the vendor's place, look for:
* Capacity: (workstations and people);
* Supervisory arrangements: (floor managers, project leaders, group heads);
* Security: (controlled physical access and password-protected network resources).
Most import
When at the vendor's place, look for:
* Capacity: (workstations and people);
* Supervisory arrangements: (floor managers, project leaders, group heads);
* Security: (controlled physical access and password-protected network resources).
Most import
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
antly, meet the person who will be in charge of the project you are thinking of giving the vendor. Is s/he articulate? Tech-savvy? Quality conscious? Deadline oriented? Easy to get along with? Is there a second line to take over if s/he is away?
You must of course also hand over a copy of your R
You must of course also hand over a copy of your R
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
P and discuss each point in fine detail.
Bear in mind that most often, Indians are formal to begin with. If you invite the key people to a meal, they will be very happy to relate to you on a personal level... this is better for all parties concerned.
Conclude each visit by asking for your quota
Bear in mind that most often, Indians are formal to begin with. If you invite the key people to a meal, they will be very happy to relate to you on a personal level... this is better for all parties concerned.
Conclude each visit by asking for your quota
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
tion within a specified timeframe; encourage the vendor to email you freely regarding any questions s/he may have.
At the end of a visit, ask yourself if you have a good feeling about the interaction. If the answer is an overwhelming “NO!”, you had better strike the vendor off the hopefuls list.
At the end of a visit, ask yourself if you have a good feeling about the interaction. If the answer is an overwhelming “NO!”, you had better strike the vendor off the hopefuls list.
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
For any other answer, keep them in the running.
Follow these steps for all the hopefuls, and do extensive Internet research on the final candidates from the broadband connection in your hotel room.
Great, the business part of your trip is over, it’s time for recreation!
There are many unusual
Follow these steps for all the hopefuls, and do extensive Internet research on the final candidates from the broadband connection in your hotel room.
Great, the business part of your trip is over, it’s time for recreation!
There are many unusual
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
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
things to see in any Indian city, and you’d best ask your mentor what these are. There’s no point seeing typical big-city sights… look for the ancient or the ethnic (Akbar’s tomb, Kerala waterways or the Hindu temple at Madurai, for instance).
Be careful when deciding what to eat or drink. Onl
Be careful when deciding what to eat or drink. Onl
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
eat in restaurants that are clean by your country's standards; stick to bottled water from reputed companies like Kinley or Aqua Fina. And no matter how badly you may be tempted, do not eat from those small roadside carts and kiosks!
If you want to buy souvenirs to take home, ask your mentor wh
If you want to buy souvenirs to take home, ask your mentor wh
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ere to shop, else you may very well end up paying twice what you should. Buy things that are not easy to come by in your home country: fine silks, carpets, and most importantly, Indian jewelry, of which only meagre selections are available outside the subcontinent.
So now, replete with silk, gol
So now, replete with silk, gol
.
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
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
d and an outsourcing vendor shortlist, you're at the end of a memorable journey. Get on a plane, push the seat back and wonder how it all went by so fast.
Dream about how much you’re going to save in costs, the quality improvements you will see, what a good thing you’ve done for your company, an
Dream about how much you’re going to save in costs, the quality improvements you will see, what a good thing you’ve done for your company, an
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
d how glad you were that you planned your trip carefully.
You now have valuable knowledge and experience about travelling to India, and might very well soon be recognized as an expert in the subject. Fare thee well, bold traveller, and fearlessly guide all those who may follow in your footsteps
You now have valuable knowledge and experience about travelling to India, and might very well soon be recognized as an expert in the subject. Fare thee well, bold traveller, and fearlessly guide all those who may follow in your footsteps
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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