Gujarat FDCA To Kickstart Operations Of PMRU From Oct 1

Mumbai, 23 Sept 2019:

Having set up the drug price violations cell in the state, the Gujarat Food and Drug Control Administration (FDCA) is all set to kickstart its operations across all the 33 districts to track price violations by the pharma companies from October 1, 2019 onwards.

The state drug regulator had launched a full fledged state of the art Price Monitoring and Research Unit (PMRU) to track price violations in the month of September this year at its headquarters in Gujarat.

“We have appointed a project co-ordinator having a Pharm D qualification for the first time in the country. The project co-ordinator will be assisted by three field investigators. Equipped with the knowledge about drug quality and price, the PMRU staff will bring in insights about price violations in real time and seamless manner for which we have an Information Technology (IT) staff in place,” informed Gujarat FDCA Commissioner Dr H G Koshia.

This is a welcome change as National Pharmaceutical Pricing Authority (NPPA) policy has mandated to keep an oversight on pharma companies for any kind of drug price violation.

“A phase wise approach will be in place towards detecting price violation in all the four zones of Gujarat FDCA,” Dr Koshia added.

Recruitment of technical and monitoring staff at Gujarat FDCA is currently being followed with in-house training and field training to 7 personnel.

This will ensure that drug prices are being monitored to ensure with clarity that Drug Prices Control Order (DPCO) is not violated.

As of today, PMRUs have already been established in nine 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.

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. Pharmabiz