NPPA Fast-Tracks PMRU Initiative After Initial Delay

NPPA Fast-Tracks PMRU Initiative After Initial Delay

New Delhi, 22 Feb 2019: 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. Pharmabiz