Govt allows import of life-saving drugs from India

[padamchen]

Dozens. Hundreds. Doubtless India has many more.

Just look up Pakistan Journal of Pharmacology. (last issue here http://www.pjps.pk/?page_id=13), where by my count there are publication of at least three. Synthesising new molecules is literally the easiest thing in the field. So you isolated or developed a new molecule. Congratulations. You have accomplished about 2% of the work needed to bring a medicine to the market.

Once you have made a new molecule you need to

1) Check if it has any effects against pathogens in the dish
2) If so check (on mice, then eventually humans) if it does so on humans with the disease
3) Then see if it does not have adverse events (as the saying goes even a pistol will kill pathogens in a petri dish, what you need is something that will kill them in your body while not harming the rest of you).
4) If so can it be produced on an industrial scale economically?

A new substance can fall at any of these hurdles. Moreover the each of these has various sub tests and milestones within them a drug has to clear. Maybe it has excellent results in humans, but horrid side effects. Maybe the costs are too great to cheaply make. Maybe its effects are sp easily countered so as to be useless practically.

Sigh.

 

[AsifIjaz]

Dozens. Hundreds. Doubtless India has many more.

Just look up Pakistan Journal of Pharmacology. (last issue here http://www.pjps.pk/?page_id=13), where by my count there are publication of at least three. Synthesising new molecules is literally the easiest thing in the field. So you isolated or developed a new molecule. Congratulations. You have accomplished about 2% of the work needed to bring a medicine to the market.

Once you have made a new molecule you need to

1) Check if it has any effects against pathogens in the dish
2) If so check (on mice, then eventually humans) if it does so on humans with the disease
3) Then see if it does not have adverse events (as the saying goes even a pistol will kill pathogens in a petri dish, what you need is something that will kill them in your body while not harming the rest of you).
4) If so can it be produced on an industrial scale economically?

A new substance can fall at any of these hurdles. Moreover the each of these has various sub tests and milestones within them a drug has to clear. Maybe it has excellent results in humans, but horrid side effects. Maybe the costs are too great to cheaply make. Maybe its effects are sp easily countered so as to be useless practically.

In the interest of not derailing the thread I would only say ...
I wish it was this simple. Please google pre-clinical trials and phase 1, 2 & phase 3 clinical trials.

 

[padamchen]

In the interest of not derailing the thread I would only say ...
I wish it was this simple. Please google pre-clinical trials and phase 1, 2 & phase 3 clinical trials.

High throughput screening labs (virtually IT process outsourcing units) are a dime a dozen. Lead optimisation. Modeling. Data crunching. More so in poorer countries with good IT infrastructure and skills and cheap trained manpower.

Every half baked university lab with post doc students can churn out hundred of "novel molecules" and "leads".

How many of them actually make it to filing of an IND. How many actually come to the market.

 

[sparten]

In the interest of not derailing the thread I would only say ...
I wish it was this simple. Please google pre-clinical trials and phase 1, 2 & phase 3 clinical trials.

:Confused:?
Thats exactly what I said. Making a new molecule is not that hard. Making a drug that is useable by the public in a commercially viable sense is very hard.

Every half baked university lab with post doc students can churn out hundred of "novel molecules" and "leads".

How many of them actually make it to filing of an IND. How many actually come to the market.

Changed your tune have we? You earlier asked for ONE unique molecule from Pakstan and now its a dime a dozen.
On a serious note.

While not exactly something any "half baked university" can do, making molecule is not the main hurdle as you say(FTR Pakistan has about perhaps a dozen research labs, divided between academic and commercial).

You are also right that very few actually result in a new drug; for a variety of reason. One number that I have read is that perhaps about 500-1000 new molecules are developed a year (worldwide), of which perhaps 10-50 will one day end up in commercial use. (As an interesting aside, look up penecillin development, long story short had it not been for WW2, it would never have been developed)




Source: https://defence.pk/threads/govt-all...-drugs-from-india.465882/page-4#ixzz4SbOKLoGl

 

[AsifIjaz]

Well, let me tell you a fact...
Over the last one decade I have worked on phase 2b/3 of over a dozen molecules... only one out of them made it to the market.
Now remember that most compounds/projects are cancelled or abandoned during preclinical or phase 1 or phase 2a... Few make it to phase 2b and even fewer to phase 3.

On topic
In order for Pakistan to succeed as a pharmaceutical production hub we need the following
1) deregulate drug pricing.. DRA should approve a compound and set its highest price level. afterwards it's a free market for all.
2) DRA should make a written procedure for drug application, evaluation, assessment and decision... All applications must have a bioequivalence report attached...
All this should be time bound and decisions.... whether positive or negative should be communicated in writing and in case of negative answer, a quantifiable answer should be given.
3) we need a few or at least half a dozen GCP compliant and WHO certified bioequivalenace centres... currently we have none.
4) Pakistan needs to target to get production facilities validated or certified by fda and Emea. This is going to take time but encourage this till you develop your own production and quality control standards which are implemented and you have trained manpower to certify them as well.
There is a limit to what you can earn from within pakistan and from other countries with cut throat competition.
5) announce today that after a decade all new compounds registered in Pakistan will require at least a local phase 3 clinical trial data from Pakistan that should at least involve 200 - 250 local patients and for special cases or rare or life threatening diseases... data from100 patients can be sufficienct provided it is approved/ agreed in advance.... in writing from DRA.
5) all IRBs / ERCs from across Pakistan should be registered with PMRC. All should have written sops. Currently few have them.
6) an independent, non government and non industry related inspection body should be formed to inspect factories, production houses, clinical sites, bioequivalence centres and irbs/ercs. inspection can be held without notice and the team can suspend, cancel or fine the concerned party. All decisions made should be given in a pre decided timeline and should be in writing and backed by quantifiable proof.

Get the above done and we can beat any pharmaceutical king country. Avoid any point and you will remain a possible force living below its potential.
No one wants to invest in a country with ambiguous and non business friendly policies. Give these companies a level playing field, with strict quality control and the option for a decent profit and they would be willing to do wonders for your health sector and your local industry. If you avoid these then you will end up with what we have in Pakistan today .. a looli langri pharmaceutical industry

 

[Imran Khan]

there must be no politics on human lives . get the medics and support to save every human life .

 

[Chhatrapati]

What's the big deal!? These are just casual things. Appreciate at least some thing is shared between India-Pakistan than trading insults.