FDA refers 202 cases of DPCO to NPPA

At present NPPA is reviewing the cases of violations and will get back with details of the amount to be recovered from the offending companies

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FDA

The Gujarat Food and Drug Control Administration (FDCA) has referred 202 cases of ceiling price violations to the National Pharmaceutical Pricing Authority (NPPA) during the lockdown period of March, April and May through its Price Monitoring and Research Unit (PMRU).

The state drug regulator had kick-started PMRU operations across all the 33 districts of the state from October 1, 2019 onwards to track price violations by the pharma companies. This is part of NPPA policy to keep an oversight on pharma companies for any kind of drug price violation.

H G Koshia
Hemant Koshia, SDC, Gujarat

“Having manned with information technology (IT) staff, the PMRU which is led by a project co-ordinator having a Pharm D qualification is assisted by three field investigators to bring in insights about price violations in real time,” informed Gujarat FDCA Commissioner Dr H G Koshia. “At present NPPA is reviewing the cases of violations and will get back with details of the amount to be recovered from the offending companies,” Dr Koshia further said.

As of today, PMRUs have already been established in 12 states including Gujarat like Kerala, Odisha, Rajasthan, Punjab, Haryana, Nagaland and Tripura with the latest entrant being Uttar Pradesh (UP). NPPA has recently set up PMRU in Jammu & Kashmir Union Territory (UT).

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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 UTs to support state drug controllers (SDCs) and itself through initiating a central scheme of assistance at state level and UTs.

“Each unit will function under the direct supervision of the SDC. 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.

As per NPPA policy, PMRU shall be funded by NPPA for its recurring and non-recurring expenses. The PMRU shall help NPPA and SDC in ensuring availability and accessibility of medicines at affordable prices. It is also expected to organise seminars, training programmes and other information, education and communication (IEC) activities in the areas of availability and affordability of medicines for all. 

PMRU will also collect samples of medicines, collect and analyse data and make reports with respect to availability and over-pricing of medicines for taking action under the provisions of Drug Price Control Order (DPCO-2013). 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.

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