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NPPA fast-tracks PMRU initiative after initial delay; facility to ensure drug pricing compliance goes operational in four states
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Arun Sreenivasan, New Delhi
February 23 , 2019
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After an initial delay, the National Pharmaceutical Pricing Authority
(NPPA) has fast-tracked its initiative to constitute price monitoring
and research units (PMRUs) in states and union territories to ensure
ground-level compliance of its orders on ceiling prices for essential
medicines. Within a month after taking the decision to implement the
scheme, the units are operational in four states.
According to
official sources, Odisha this week has become the fourth state in the
country to set up the regulatory mechanism in collaboration with the
health department and the state drug controller. Kerala was the first to
establish the facility followed by Punjab and Gujarat. Some other
states, such as Manipur and Maharashtra, are also ready to establish the
unit shortly.
Though the national pricing regulator has been
spotting thousands of cases of overcharging, it lacked field units to
develop necessary linkages with state licensing authorities to bring the
culprits to book. The NPPA had only an office in the national capital
with no state-level branches. The PMRUs were conceptualised to resolve
that problem and the draft was announced way back in 2015. However, the
scheme got stuck in the pipeline for a long time. The decision to roll
it out was taken at a meeting between the national price regulator and
state drug controllers last month.
The NPPA has been banking on
data provided by state authorities regarding pricing violations so far.
However, with various functions including licensing and quality control,
state officials have their hands full and checks on drug pricing often
takes back seat.
“State drug regulators face serious manpower
shortage. We have only 40-odd inspectors to keep an eye on drug
manufacturing and distribution in the entire state. With the setting up
of this unit, we have a dedicated team to monitor price movements,” says
Ravi S Menon, Drug Controller and Licensing Authority of Kerala, where
the first PMRU was established in January.
Each unit will
function under the direct supervision of the concerned state drug
controller and monitor the price movement of scheduled and non-scheduled
formulations based on periodical returns filed by the industry. PMRUs
would act as key partners of the NPPA with their information gathering
mechanism at the grassroots level.
For the purpose of providing
staff and infrastructure to PMRUs, states are divided into three
categories, based on population. States having more than 3 per cent of
total population fall in the first category, less than 3 per cent
population belong to category 2 and those with less than one per cent
are in the third category.
According to the proposal draft issued
by the government, “in the first year, 90 per cent of the non-recurring
expenses and six months’ advance for recurring expenses would be
released as first installment to those States/UTs that desire to set up
the PMRUs.”
It may be noted that the Parliamentary Standing
Committee on Chemicals and Fertilisers, in its 38th report, recommended
the creation of NPPA cells in all states to carry out the regulator’s
mandate. Back in 2005, a government task force for exploring options to
make life-saving drugs affordable also backed a similar mechanism for
live linkage of the national pricing regulator with state drug
controllers.
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