The units
PMRUs will provide technical assistance to state drug controllers and NPPA in monitoring notified prices, violation of provisions in DPCO, pricing compliance and availability of drugs.
It will also help the regulator in monitoring price movement of scheduled and non-scheduled formulations, based on periodical returns filed by the industry, price revision of scheduled formulations by manufacturers on annual increase in wholesale price index, as per provisions contained in the DPCO and in overseeing the prices of non-scheduled formulations.
The National Pharmaceutical Pricing Authority (NPPA) proposes to set up price monitoring and resource units (PMRUs) in states and Union territories to support state drug controllers and itself.
In a recent notification, NPPA said it required constant liaison with state drug control departments to carry out its mandate.
The support of state drug controllers is vital for sharing information on shortages of medicines and to ensure that pharma companies are fully complying with NPPA directives.
NPPA also needs support for verification of pharma company documents, field investigation and testing medicine samples.
At present, NPPA does not have any field unit to liaise with state drug controllers and inspectors.
The regulator has, therefore, proposed to initiate a central scheme of assistance for setting up PMRUs at states and UTs.
“Each unit will function under the direct supervision of the state drug controller. PMRUs will be the key collaborating partners of NPPA, with information-gathering mechanism at the grassroots level. PMRUs will also ensure that the benefits of the Drug Pricing Control Order (DPCO - revised from time to time) trickles down to the grassroots level. The central funding will be for an initial period of five years, subject to a mid-term review after 12th Plan period,” the notification said.
PMRUs will provide technical assistance to state drug controllers and NPPA in monitoring notified prices, violation of provisions in DPCO, pricing compliance and availability of drugs.
It will also help the regulator in monitoring price movement of scheduled and non-scheduled formulations, based on periodical returns filed by the industry, price revision of scheduled formulations by manufacturers on annual increase in wholesale price index, as per provisions contained in the DPCO and in overseeing the prices of non-scheduled formulations.
Co-ordination with PMRUs will help NPPA ensure that that the prices of such formulations, even if they are increased, do not go beyond 10% annually.
Sujay Shetty, executive director and leader, pharma life sciences, PricewaterhouseCoopers India, said: “If the objective is to forge linkage with state FDAs, these units will not function independently. So anything that is going to help NPPA function more efficiently is always welcome.”
The objectives also include collection and compilation of market-based data of scheduled as well as non-scheduled formulations, collection of medicine samples from retail markets, conducting training, seminars and workshops at the state and district levels and publicity.
The notification also said these tasks require constant interaction with various stakeholders – state departments, drug controllers, consumer groups, etc.
Also, each PMRU will have to submit a quarterly return to NPPA and principal secretary/ secretary (health) of the state on targets and other pre-determined parameters in the prescribed proforma, which would form technical inputs to the government for effective policy formulation and implementation. Each PMRU will have online systems compatible with centralised online systems installed in NPPA to facilitate online linkage with the NPPA.
The scheme is proposed to be implemented during the 12th Five Year Plan period and commencing from the financial year 2015-16. The continuation of the scheme in the succeeding Five Year Plans would depend upon mid-term evaluation.
It has been also proposed to release the entire non-recurring and recurring grants, which is Rs 20.73 crore in the first year of its implementation -- that is, during 2015-16. From the second year, only the recurring grants would be released. The total outlay required for five years, from 2015-16 to 2019-20, works out at Rs 96.85 crore.
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