Last Updated on January 21, 2024 by The Health Master
The Gujarat Food and Drug Control Administration (FDCA) has recovered Rs. 80.59 crores in 311 cases of ceiling price violations since 2013 to date.
It referred the following cases of ceiling price violations to the national pricing regulator National Pharmaceutical Pricing Authority (NPPA):
- 25 cases in 2022
- 47 cases in 2021,
- 30 cases in 2020,
- 37 cases in 2019,
- 17 cases in 2018,
- 49 cases in 2017,
- 37 cases in 2016,
- 28 cases in 2015,
- 37 cases in 2014,
- 4 cases in 2013.
As part of NPPA policy to keep an eye on pharmaceutical companies for drug pricing violations, the state drug regulator kicked off PMRU operations across all 33 districts of the state from October 1, 2019, onwards.
PMRU collects samples of medicines, analyzes the data, and makes reports with respect to the availability and overpricing of medicines for taking action under the provisions of the Drug Price Control Order (DPCO-2013).
“A dedicated team of three field investigators and three information technology (IT) professionals, led by a project coordinator with a Pharm. D. qualification, is currently working in Gujarat PMRU to keep an eye on price violations in the state in real-time,” Gujarat FDCA Commissioner Dr. HG Koshia informed.
Gujarat, Maharashtra, Karnataka, and Andhra Pradesh are among the states that fall under the category of “A” states.
NPPA has categorized the states based on three categories, i.e. based on the maximum, minimum, and least number of pharma companies in the state for better division of work.
NPPA had proposed a plan in 2016 to set up a ceiling price violation cell in each state to take action for any contravention to the provisions of the Drug Price Control Order (DPCO-2013).
As per a notification, the NPPA had proposed to set up PMRUs in states and Union territories (UTs) to support state drug controllers and to initiate a central scheme of assistance at the state level and UTs.
PMRUs have also already been set up in 16 states and one union territory, including:
- Kerala,
- Gujarat,
- Odisha,
- Rajasthan,
- Punjab,
- Haryana,
- Tripura,
- Uttar Pradesh,
- Nagaland,
- Mizoram,
- Jammu and Kashmir,
- Himachal Pradesh,
- Andhra Pradesh,
- Telangana,
- Goa,
- Karnataka,
- Union Territory of Ladakh.
PMRUs are in the process of being set up in states like:
- Bihar,
- West Bengal,
- Uttarakhand,
- Jharkhand,
- Puducherry,
- Chhattisgarh
- Madhya Pradesh.
The NPPA has only an office in the national capital and no state-level branches. The PMRUs was conceptualized to resolve this problem, and the draft was announced way back in 2015.
Each unit will function under the direct supervision of the state drug controller (SDC). PMRUs will be the key collaborating partners of the NPPA, with information-gathering mechanisms 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 NPPA 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 state drug controllers (SDCs) in ensuring the availability and accessibility of medicines at affordable prices.
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