Gujarat FDCA Sets Up Drug Price Monitoring Cell To Track Prices
Mumbai, 9 Sept 2019:
In order to effectively track drug price violations by pharma companies, Gujarat Food and Drug Control Administration (FDCA) has finally started a Price Monitoring and Research Unit (PMRU) at its headquarters in Gujarat.
This is in accordance to the national drug pricing regulator National Pharmaceutical Pricing Authority (NPPA) policy mandate to keep an oversight on pharma companies for any kind of drug price violation.
Technical and monitoring staff has been recruited at Gujarat FDCA for which in-house training is also currently being given to 7 personnel followed by week long field training. The staff includes a senior scientist having a Pharm D degree assisted with 3 more professionals having pharmacy degree along with 3 data operators.
“This will bring about a radical change in the way we monitor drug prices to ensure with clarity that Drug Prices Control Order (DPCO) is not violated,” informs Gujarat FDCA Commissioner Dr H G Koshia.
As of today, PMRUs have already been established in 9 states including Gujarat like Kerala, Odisha, Rajasthan, Punjab, Haryana, Nagaland and Tripura with the latest entrant being Uttar Pradesh (UP).
Uttar Pradesh Food Safety and Drug Administration Department (UP FSDA) has recently set -up the PMRU in the state.
PMRU is aimed at keeping a tab on drug price ceiling violation and to ensure that the purpose of the DPCO-2013 is achieved effectively and in a proper manner.
As per NPPA officials, process is also ongoing to set up PMRUs in other states.
Total 21 states had given their consent for formation of PMRU. These were Assam, Gujarat, Haryana, Maharashtra, Manipur, Odisha, Punjab, Tripura, Mizoram, Rajasthan, Chhattisgarh, Bihar, Nagaland, Goa, Delhi, Tamil Nadu, Madhya Pradesh, Uttarakhand, Puducherry, Andhra Pradesh and Kerala.
The NPPA has only an office in the national capital with no state level branches. The PMRUs were conceptualised to resolve this problem and the draft was announced way back in 2015.
Maharashtra Food and Drug Control Administration (FDA) has also sent a proposal for the formation of Maharashtra State PMRU Society to the state medical education and drug department (MED) for approval. PMRU is required to be run by a registered society in compliance with the norms under the society law.
NPPA had in 2016 proposed a plan to set up a ceiling price violation cell in each state to take action for any contravention to the provisions of DPCO-2013.
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. Pharmabiz