The Gujarat Food and Drug Control Administration (FDCA) has referred a total of 626 cases to the National Pharmaceutical Pricing Authority (NPPA) for violation of ceiling prices from January 1, 2020 till date out of which 202 cases were reported during C-19 lockdown period.
These cases for violation of ceiling prices were shared with the NPPA at a recent webinar in which 160 plus representatives and officials from NPPA and Gujarat Price Monitoring and Research Unit (PMRU) deliberated on the role of PMRU and Gujarat FDCA during C-19.
It had referred 202 cases of ceiling price violations alone during the lockdown period of March, April and May through its PMRU at the state FDCA headquarters in Gandhinagar.
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 to keep an oversight on pharmaceutical companies for any kind of drug price violation.
The state Gujarat PMRU is equipped with a team of three field investigators which is led by a project co-ordinator having a Pharm D qualification which is supported by an information technology (IT) division to effectively monitor price violations in the state in real time.
PMRUs have also already been set up in 15 states including Kerala, Gujarat, Odisha, Rajasthan, Punjab, Haryana, Tripura, Uttar Pradesh, Nagaland, Mizoram, Jammu and Kashmir, Andhra Pradesh, Telangana and Karnataka.
Gujarat, Maharashtra, Karnataka, Andhra Pradesh are among the states which fall under the category of A states. NPPA has categorised the states based on three categories, i.e. based on maximum, minimum and least number of pharma companies in the state for better division of work.
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 Drug Price Control Order (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 through initiating a Central scheme of assistance at state level and UTs.
A total of 21 states had given their consent for the formation of the PMRU in the past two years. 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.
“Each unit will function under the direct supervision of the state drug controller (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.
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).
