Mumbai: Maharashtra Food and Drug Administration (FDA) has submitted a proposal to the state government to form a registered society for setting up price monitoring and resource unit (PMRU) at its headquarters in Mumbai. PMRU is aimed at keeping a tab on drug price ceiling violation and to ensure that the purpose of the Drug Price Control Order (DPCO) is achieved effectively and in a proper manner.
As per the proposed plan which was discussed with drug pricing regulator National Pharmaceutical Pricing Authority (NPPA) in 2016, the Maharashtra FDA will provide office space for the PMRU at its headquarters in Mumbai and NPPA will provide financial assistance to run PMRU.
With the implementation of the plan, violations of drug ceiling pricing reported will be dealt timely with the help of the state PMRU in coordination with the NPPA in cases of contraventions to the provisions of DPCO.
Maharashtra FDA Commissioner Dr Pallavi Darade said,“Maharashtra has been identified as one of the states for setting up of PMRU. We had already accepted and submitted the plan based on the NPPA proposed PMRU two years ago. Based on the policy changes, now the PMRU is required to be run by a registered society in compliance to the norms under the society law.”
Accordingly, a proposal to form registered society has been submitted to the state government, she added.
As per a notification, NPPA had proposed to set up PMRUs in states and Union territories (UTs) to support state drug controllers and itself through initiating a central scheme of assistance at state level 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 DPCO percolate down to the grassroots level. The central funding will be for an initial period of five years subject to a mid-term review,” the notification stated.
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 support of state drug controllers is vital for sharing information on shortages of medicines and to ensure that pharmaceutical companies are fully complying with NPPA directives. This will also support NPPA for verification of pharmaceutical company documents, field investigation and testing medicine samples.