Episode Transcript
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Speaker 1 (00:00):
In this episode, we talk about an issue that can
impact the future of the Indian pharmaceutical industry. We also
talk about the Enforcement Directorate's efforts towards completing investigations and
speeding up trials under the Prevention of Money Laundering Act.
But we begin today by talking about a new definition
of the Aravali Hills proposed by a committee under the
(00:21):
Environment's Secretary and approved by the Supreme Court. Hi, I
am Aherrikananda and you are listening to three things in
an Express News show. Earlier this week, protests broke out
in several parts of Rajasthan, including Jodhpur, Odhirpur and Seeker
(00:44):
over a new uniform definition of the Aravali Hills, which
critics say could leave more than ninety percent of the
range vulnerable to mining and construction. This new definition was
proposed by a committee under the Environment Secretary and was
approved by the Supreme on the twentieth of November. Now,
the Aravali Range stretches from Delhi in the north to
(01:04):
good Shat in the south, passing through Haryana and Rajasthan,
with Rajasthan accounting for nearly two thirds of the range.
Despite its ecological importance. For decades, these hills have been
under severe pressure from both legal and illegal mining, as
well as other development activities such as construction. Now, even
(01:25):
as criticism and protests continue, the Environment Minister has maintained
that the new definition does not relax mining restrictions in
the range, saying mining would be permissible in only zero
point one nine percent of the Aravalis. So what exactly
is this new definition and how exactly would it affect
the Ravali Range. To find this out, Michaelleague Shashan Pargev
(01:47):
speaks to the Indian expresses jamazumdar Jab.
Speaker 2 (01:50):
Before we talk about this new definition and how it
will impact the Arablis, I wanted to ask you something basic,
which is that what makes this range so crucial for
this region? Why is it so important?
Speaker 3 (02:02):
Yeah, first thing is that it is an ancient landform,
so it's there for ages. It hosts a very wide
area of bio diversity. Many species which are found here
are endemic unique to this area, and there are a
number of National parks, tiger reserve, sanctuaries, wetland areas in
this stretch. And it also acts as a natural barrier
(02:27):
which stops from the eastward movement of the dust and
sand from the western desert areas, and which is very
crucial for the land east of Aravelli to stay green.
If you look at a natural map of India, you
will see clearly that along the line of the Araballi
which runs north to south, to the west of this line,
(02:49):
you will see the contier is in brown and on
the east it's green. So it's very critical for the
human health. Also given the pollution that we are going through.
Speaker 2 (02:59):
Right now, right, one of the things that people have
been pointing out is that the Rbly range actually prevents
a lot of pollutants from entering the capitol.
Speaker 3 (03:08):
Yeah, I mean that is obviously the one key function
of this hill range. And even hills which are as
low as twenty meters in height, even they perform a
critical function in blocking as wind breakers and PM two
point five may travel higher in the air, but PM
taming particular, they travel lower to the ground, and this
(03:32):
hill range in that sense has been a very effective
barrier to such dust particle movement and sent particle movement
is toward.
Speaker 2 (03:39):
And jen Now let's talk about this new definition, because
the fear is that it will put the majority of
the range under threat, So could you break down this
definition for us, especially considering that some of it can
seem a bit technical. Now it says that under the
new definition, any landform that is at an elevation of
one hundred meters or more or above the local relief
(04:02):
will be considered as part of Aravli Hills, along with
its slopes and adjacent land. So what does local relief
mean in this context?
Speaker 3 (04:13):
So if you have traveled in the hills of say
Himashal or count you have seen that sometimes when you
build a house on the slope, so from one side
you enter the house, your entrance is from the road.
Speaker 2 (04:25):
In the third floor.
Speaker 3 (04:26):
On the other side of the road, which is down
on the other side of the house, which runs down
the slope, your entrance would be probably from the ground
floor thirty feet below. So it all depends on your
reference point. So if you're measuring such a building, if
you measure the building from the upper road, it will
measure only one floor because that one floor is above
the upper road. But if you measured the same building
(04:46):
from the lower road, then you would get three floors.
So it all actually boils down to your reference point
from where you will be measuring the height.
Speaker 2 (04:54):
Okay, son this example, if I'm trying to measure the
elevation of this building, it will change based on which
side I'm measuring it from. Right. But if I truly
wanted to know the elevation of the building, shouldn't I
be looking at the area's lowest elevation point. Shouldn't that
be the baseline?
Speaker 3 (05:14):
Yeah, you have to find one standard baseline for this
measurement to be objective uniform. So when FSI realized that
this one hundred meters elevation formula was being pushed through,
then they recommended that at least this standard baseline should
be defined as the lowest elevation of a state above
(05:36):
sea level. So in case of Rajasthan, that is one
hundred and fifteen meters. So decide that if you take
that as a benchmark, and then you can measure all
hills the peaks at xoisl and then you know that
what is our one hundred meters or not. But if
you go from the local elevation that is the land
area basically the deep between two hills, so that deep
(05:56):
itself could be an elevation of two hundred meters and
on that the hill would be fifty meters, So the
hill is actually to fifty meters, but you were measuring
only fifty and that hell would be excluded from under
the new definition of Ali.
Speaker 2 (06:07):
And could you talk about how this new definition came
about and how the Aravli range was defined earlier.
Speaker 3 (06:14):
Yeah, so there was no definition of Arabli the way
we are seeking now because for centuries and even in
the recent times, Arabli has been defined as it is,
So there was never a need really to define Arably.
It's a hill range and it's visible where it is
not rising too high. Even there you can tell that
(06:34):
you were on the rocks. So in that sense, it
was never felt necessary. And the four states where this
range spans Rajasthan, Haryana and Daily. Out of these four states,
only Rajasthan ever had any year stick and that to
us from the perspective of mining. They used to allow
mining leases in areas under one hundred meter elevation. So
(06:57):
that was going on for more than twenty years. And
in twenty ten when this was presented before the Supreme Court,
and the Court felt that there should be an uniform
benchmark for rably in all four states. And then it
asked the Supreme Court empowered Committee, which in turn engaged
the Forest Survey of India for the job and Forest
(07:17):
sy of India. They bought the Survey of India topos
sheets and from there they did detailed survey in fifteen
districts of Rajasthan, which is the key arravally zoned because
bulk up the range is in Rajasthan. And in those
fifteen districts they found that if they go by three
degree slope or higher, then that part shows the characteristics
(07:39):
of Arabi and those areas should be identified as alvalue.
So going by that benchmark, they identified roughly forty thousand
square kilometers in these fifteen districts of prajaisthan as Arai.
Speaker 2 (07:50):
So this three degrees benchmark, this is what the Forest
Survey of India identified.
Speaker 3 (07:56):
Yeah, three degrees are more. That benchmark was proposed and
then the po was to identify the ravly range in
these fifteen districts and then on that they wanted to
superimpose the ongoing mining leases to find out how much
is legal and what is not legal. That process was
never really completed because the state of Rajasthan they were
quite reluctant over the years to hand over the mining coordinates,
(08:20):
so the mining cod units were they came in installments.
So eventually in twenty eighteen, the Court observed that from
the data available it was clear that a lot of
mining is going on illegally and in areas where it
should not be allowed. Then again this came up last
year when the Supreme Court thought that there should be
(08:41):
a common benchmark for four states. So again FSI came
in the picture. They stood by their three degrees or
more slope formula. But for some reason, the Ministry consulted
the four states and then they decided that the old
benchmark of one hundred meters, which was already being used
by Rajasthan for mining and which was not accepted by
(09:01):
the Supreme Court in twenty ten, that benchmark would be appropriate.
Speaker 2 (09:05):
And now based on this new definition, where we looking
at one hundred meters of elevation based on the local relief,
how much of the arab Leis would not be counted
as part of the range.
Speaker 3 (09:16):
So simple answer is we don't know yet. What FSI
told the ministry that of all the hills, some one
like seventeen to eighteen thousand hills that they found in
the fifteen district's Arawly hills, of only about thousand of
those or above hundred meters, so ninety nine percent of
the hills will be excluded. But that doesn't necessarily mean
that nineteen nine percent of the Arabi area would be excluded.
(09:38):
Because different hills spent differently, the bigger hills will have
larger areas. One can safely assume that at least eighty
eighty five percent areas would be excluded if this new
formula is applied compared to if you apply that three
degree slope formula.
Speaker 2 (09:53):
And yeah, one of the big concerns, of course is minding,
but are there any other concerns beside it that are
what is some.
Speaker 3 (10:01):
Yeah, this figure of zero point one nine percent of
Arably areas would be undermining. This is again very misleading
because this zero point one nine percent of the entire
area of thirty four Raly districts, which comes to some
one point four to one point five lack squaculimeter, So
(10:21):
this is about two eighty s curriculumet So that is
the total area currently under mining leases. So this is
the area where mining is already taking place. It has
nothing to do with what will happen in future once
arably is redefined under the new definition. This has nothing
to do with that question. So the point is that
(10:43):
this two eighty s curriculumeters is where already mining is happening,
and this is in Arabi. So when arably is redefined
and a large area is excluded, how much of those
excluded areas will go under mining or other forms of development?
That question the Ministry hasn't at rest at all. And
nobody in their real sense would go for mining in
(11:03):
Arabi in Daily and cire in Gurga because it's a
lot more lucrative to develop housing estates there. So at
one hand, the future scope of mining is not addressed
by the Ministry, and on the other hand, by helping
on about mining alone, they're not addressing this possibility of
opening up arably areas for other forms of development. We
(11:25):
all know the pressure these gars are in Gurga Dabad
and they're all prime real estate. I mean, if under
the new definition they are not identified as anymore, then
nothing stops anyone from developing those ideas.
Speaker 2 (11:40):
And it's interesting that FSI itself has been flagging some
of these concerns to the Ministry. Do we know how
the Ministry responded to its concerns.
Speaker 3 (11:50):
The effect of it that they submitted to the Supreme
Court that doesn't really justify this new definition other than
citing some arguments which are faulty. To put it mildly,
because they said that the average slope of some ten
to twelve districts in Aravali zone is under three degrees,
so they claimed that if you apply SI slow formula,
(12:13):
then those districts would be excluded. This very conveniently ignored
the fact that if you take the entire districts, much
of which is planes, then the average would obviously be
much lower and the slope rises only when only where
the hills are so using that logic that the average
slope of a district is below three degrees, they tried
(12:33):
to push it through and for some reason they succeeded.
And they also claimed before the Supreme Court that this
new definition will cover more areas as will identify more
areas as rably compared to FSIS three person slow formula. However,
when the Ministry held repress conference yesterday and this question
(12:54):
was put to them that if they can quantify how
much area would be covered as under the new definition,
then the answer of was, we can't tell. When we
do the ground demarcation district by district, we will get
to know. So it's inexplicable. Without having any knowledge of
how much this new definition would cover, they give the
code that assurance that it will cover more than f
(13:15):
SI is formula and JA.
Speaker 2 (13:16):
You also write that large tracks which were earlier identified
as part of the range have now been left out.
Could you give some examples of that?
Speaker 3 (13:27):
Yeah, I mean there are very famous stretches of Arabli
which we all know. For example, the Chithor fort, it's
the Unis Socite, it's Arabaly, so it is the district
is altogether missing in the list. So Imauru, where the
Ranthamburg Fort is also Adably, it's like the junction of
the wind range and the Aravly range, so that district
is altogether gone. In Nagar also, if SI measured some
(13:49):
thousand square kilometer under Arably, that district is also missing.
So if you go to the extreme, then some government documents,
I think they identify more than fifty districts under Arably,
and now we have only thirty four in the list
that the Ministry gave to the Subpreme Court.
Speaker 2 (14:04):
And now that the ministry has been facing this pushback,
do we know how they will be proceeding forward with this?
Speaker 3 (14:11):
One can't really tell because in the last two three days,
what they have avoid again and again is that Arabli
is not under threat. Everything will be protected, nothing will
be open to development or mining. But if it is so,
then if every corner of the range is under protection,
then what is the need for this new definition and
what is the scope for this sustainable mining plan that
(14:33):
will be now choked up across the range? So these
two realities their contradictory. I mean, if you are not
planning to open up new areas to mines and development,
then this exercise is unnecessary. And also technically speaking, if
the ministry or the government says that arably areas will
be protected, they may be telling you that the new
(14:55):
arably areas under the new definition will be protected. We
haven't heard anything clear about the areas which are likely
to be excluded under the new definition.
Speaker 1 (15:08):
And next we talk about an issue that could impact
the future of India's pharmaceutical industry. In the recent weeks,
Indian government officials have been holding multiple meetings with the
pharmaceutical industry stakeholders. These meetings have been about how the
government can implement something called data exclusivity in the pharmaceutical
drugs sector.
Speaker 4 (15:29):
So data exclusivity, in addition to patents, protects the interest
of an innovator company.
Speaker 1 (15:39):
That's the indine expresses anon Ada who reports on health
for the paper.
Speaker 4 (15:44):
Essentially the data that company submits to a drug regulator,
you know, on safety, efficacy, effectiveness of medicine. They say
that under data exclusivity they hold the exclusive rights to it,
which which means that the regulator cannot use this data
(16:04):
to sort of approve other generic products during this window period. Essentially,
what happens is the first company does a complete set
of trials to get their product approved, but when a
subsequent generic version of the drug wants to enter the market,
they can conduct a smaller trial which is known as
(16:25):
a bioequivalence trial, which essentially demonstrates that their drug works
in the same way as the innovator product within the body,
and based on that they can get an approval. And
what the generic companies do is they have everything in
place for when the patent expires and they can launch
their products immediately. But if there is a data exclusivity
(16:48):
in place, then the regulator would not be able to
approve their products before this data exclusivity period runs out.
Speaker 1 (16:57):
So this means even if the patent of a drug exits,
the regulator would not be able to approve a generic
drug if the data exclusivity is in place.
Speaker 4 (17:07):
Or the companies would not be able to get and
approval ahead you know, in preparation for a patent expiry
if there is a data exclusivity in place.
Speaker 1 (17:19):
So data exclusivity essentially delays the entry of cheaper generic
drugs into the market and area where India has a
significant advantage over many other countries.
Speaker 2 (17:29):
Now.
Speaker 1 (17:29):
Interestingly, data exclusivity was also discussed during the negotiations with
the UK and the European Free Trade Association. Back then,
India had rejected the idea.
Speaker 4 (17:41):
So see, data exclusivity has been a topic which has
been discussed in the past when there are international trade
deals because all the developed countries which are sort of
the originators of the drugs, do not want you know,
the generic versions to come in so easily have been
previously also demands from the Indian government to put in
(18:04):
place these you know, protective measures, but it hasn't happened
so far. This is one of the first times that
India is actually considering this, seeing that there have been
meetings that have happened between the Commerce Ministry and the
industry as well as you know stakeholders like the Health
Ministry and the Farma Department. So all of these meetings
(18:27):
have happened last month and what I have heard from
people who are present in some of these meetings is
that there is a push towards, you know, implementing data exclusivity.
And the question that was raised in the meeting was
not whether it should be done or not, but how
it can be done. So of course these are very
initial stages and we still don't know whether it would
(18:49):
actually happen, whether the government will actually push for it,
but certainly there has been a serious consideration about it.
Speaker 1 (18:57):
But Anona, why does the Indian government to bring in
data exclusivity for drugs and why did it change its
mind after rejecting the idea during the trade negotiations with
UK and e FDA.
Speaker 4 (19:10):
So yes, you're absolutely correct, India did reject data exclusivity,
especially when the FTA deal happened, and actually for the
EFDA there was this demand raised at the time, and
the deal does say that, you know, in one year
there should be some sort of discussion on the provisions
(19:30):
of data exclusivity. But from what I hear, it's mainly
about bringing in more foreign direct investment into India. So
as part of the EFTA negotiations, there is a hope
that more money would come into India as FDI if
these protectionist measures are taken. However, so far, India has
(19:53):
been against implementing data exclusivity, especially when it comes to
its farmer industry, because more than ninety percent of the
industry sustains on you know, making cheaper generic versions of
new drugs, and if such measures are brought in, India
might lose its edge in the global market. And at
(20:14):
the moment, India is recognized as one of the biggest
suppliers of these generic drugs, which could be hampered with
these sort of measures.
Speaker 1 (20:23):
And can you tell us how data exclusivity works in
combination with patents and how the two can affect a
drugs availability in the market.
Speaker 4 (20:33):
So there are a couple of complications here. Data exclusivity
and patent period is not the same. Data exclusivity is
granted at the time when a drug enters the market. Now,
what happens with patent's patents usually cover a period of
about twenty years, whereas data exclusivity is usually for a
maximum period of say ten years. Now, if this data
(20:56):
exclusivity period comes within the patent period, not so much
of a problem, you know. So, for example, if a
drug which you know, enters the market in the fifth
year of its patent, the data exclusivity period would be
within the patent period, and that is fine. But if
say a drug enters the market in the seventeenth year
(21:18):
of its twenty year patent period, then the data exclusivity
period actually goes beyond the patent period, during which time
the generic drug companies will not be able to come
into the market simply because they cannot get approvals based
on the data from the origin data company. They can
enter the market if they conduct all the trial from scratch.
(21:40):
The second is, like I mentioned previously, a lot of
these companies would in India actually get ready for a
patent expiring. So, for example, if a patent is expiring
in say two years, they would start conducting their bioequialance
trials before and they would have all this data to
be present to the regulator and usually they get these
(22:03):
approvals as well before the patent period is over, so
that they can enter the market right as the patent expires.
Speaker 1 (22:10):
Right and anona. We also understand that data exclusivity then
also hampers the ability to challenge a patent.
Speaker 4 (22:18):
Right yes, So when companies are able to get this
approval before a patent period, they can then reach out
to the courts and challenge the patent saying that you know,
we can make it more accessible, we can make it
for a cheaper. So there are certain provisions in which
case patents can be challenged. So for example, if a
(22:40):
company has a patent on a drug and does not
bring it to India at all, or if the drug
is exorbitantly priced, if the access is very little, So
there are several different provisions under which the patent can
be challenged. And I mean, in the twenty years that
we've had pharmaceutical patents, it hasn't happened too many times,
(23:04):
but there was I think once in twenty twelve that
a patent was successfully challenged and granted to a company
other than the originator. And it has happened recently where
the court has actually allowed a generic manufacturer to continue
manufacturing its product even though the company states that its
(23:24):
patent hasn't expired because of certain technicalities. And also the
cost was very high for this product which was meant
for rare diseases. So that sort of challenge cannot happen
if there is say data exclusivity, because then the companies
would not have the resource to do such huge trials,
(23:45):
especially say in case of rare diseases where it is
more time consuming because there are very few patients living
with that kind of condition.
Speaker 1 (23:54):
And India's APEX drug regulator, the cd SEO, issued a
notice recently before these meetings began. What was that about?
Speaker 4 (24:02):
So, yes, that's what activists working in the field of
drug access say. There was a notification from CDSCO in
October where they have talked about, you know, consulting with
stakeholders to have discussions to ensure a level playing field.
That is what they're saying. So what the notice goes
(24:24):
on to say is that you know a lot of companies.
The first company, whether it's the Novata company or whether
it's the company that brings in a drug to the
country for the first time, they actually end up doing
rigorous trials and then the others just immediately submit a
bioequivalence trial study and they get approvals. So they noticed
(24:45):
that that the subsequent applicants who obtain approval for the
same new drug based on bio equivalents data do not
have as much burden of cost and regulatory compliance as
the first person to do it. So there should be
some sort of level playing field for the first person
to bring in the drug to India. Now, this notification
(25:06):
does not talk about any method to implement it or
what would be the incentive for the person to bring
in the drug first to India. This was just sort
of meant to be a discussion with stakeholders, but there
were activists who have written to the Health Ministry saying
that this is not transparent and this could actually lead
(25:27):
to evergreening of patents, which means that you know, companies
could keep extending their patent period. It could delay the
entry of cheaper generic drugs into the market, and it
could also lead to companies just unnecessarily doing clinical trials
on supposed new drugs or even newer combinations of drugs
(25:49):
just to get these incentives. So these were some of
the concerns that were raised by activists in the field
of medicine access.
Speaker 1 (25:58):
And an on which can degory of drugs are likely
to be affected if data exclusivity is implemented.
Speaker 4 (26:05):
So you know, this would mainly affect newer molecules which
may be very much in demand. So for example, it
could be semagluetide, whose patent is supposed to expire in
twenty twenty six. Or you know, there are these new
drugs men for Alzheimer's, new drugs for cancers which are
still under patent and are very expensive in India, and
(26:29):
if data exclusivity provisions are brought in, these drugs might
make harder for generic companies to bring in their version
of these newer drugs.
Speaker 1 (26:44):
And in the end we talk about the Enforcement Director Rate, which,
after facing sustained criticism over the slow pace of its cases,
is now shifting its focus towards completing investigations and speeding
up trials under the Prevention of Money Laundering Act. Over
the past two decades, only a little over fifty money
laundering cases have reached the end of trial, even as
(27:06):
thousands of cases have been registered against this backdrop, the
agency's leadership has asked the officials to prioritize finishing investigations
and filing prosecution complaints instead of merely opening fresh cases.
Sources have told The Indian Expresses Deepti Mantivari that Enforcement
Directorate Director Rahul Navin has instructed officers to strike a better.
Speaker 4 (27:28):
Balance in their work.
Speaker 1 (27:29):
Officials have been asked not to concentrate exclusively on politically
sensitive cases, but to also focus on emerging contemporary crimes,
including cyber fraud, cryptocurrency related offenses, and terror financing. At
the same time, the agency is engaging with the judiciary
to increase the number of special courts dedicated to handling
money laundry cases with the aim of clearing the growing
(27:52):
backlog of trials. Deep demand rights that delays in investigations
and trials have long been cited as one of the
ed's major shortcomings. Since the money laundering law came into
force in two thousand and five, the agency has registered
more than eight thousand cases, attached assets worth nearly repease
one point nine lack carole, and arrested over one thousand individuals. However,
(28:16):
investigations have been completed and prosecution complaints filed in fewer
than one fourth of these cases. He points out that
the situation is even more stark when it comes to trials.
So far, trials have been concluded in just fifty six cases,
while most of these resulted in convictions, Charges have been
framed in fewer than four hundred cases overall. Sources within
(28:38):
the agency point out that ed's conviction rate stands at
around ninety five percent, which they say compares favorably with
other central agencies.
Speaker 4 (28:47):
However, they also acknowledge.
Speaker 1 (28:49):
That prolonged investigations and pending trials undermine the justice process,
is inconvenient for both the agency and the accused, and
have contributed to public criticism.
Speaker 4 (28:59):
Officials say that while.
Speaker 1 (29:00):
Trials are ultimately decided by the quotes, the agency can
add faster at its own end. This has led to
clear directions for quicker investigations, timely filling of prosecution complaints,
and more consistent follow up in quote proceedings. Alongside this,
the agency is also sharpening its focus on recovering assets
and returning them to banks and other victims. So far
(29:22):
as it's worth repeat, thirty six thousand koror have been
recovered with Recovery target or repease fifteen thousand karors set
for the next financial ear. You were listening to Three
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(29:44):
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