FDA to set up DPCO violation cell

Total 21 states had given their consent for formation of State Price Monitoring and Resource Unit


In order to keep a tab on drug price violation in the state, the Rajasthan drug control department has formed the State Price Monitoring and Resource Unit (PMRU) Society with approval from medical education and drug department (MED).

This will pave the way for formally setting up a drug price ceiling violation cell in Rajasthan drug control department headquarters in Jaipur to regulate prices of medicines in all the 33 districts of the state.

Informs Rajasthan drug controller Raja Ram Sharma, “Besides forming the society, we have trained drug inspectors on the Drug Price Control Order (DPCO) – 2013 regulation and the actions to be taken upon its violation.”

“Training has also been given on how to conduct sample survey in the market of the respective drugs covered under and outside the DPCO. Drug inspectors are also technically equipped to implement modalities for recovery of the overcharged amount earned as a profit by manufacturer through overpricing of drugs,” assistant drug controller Manoj Tongra further explains.

This comes close on the heels of Gujarat Food and Drug Control Administration (FDCA) having set up the same and has kick started its operations across 33 districts to track price violations by the pharma companies from October 1, 2019 onwards.

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Gujarat FDCA 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 to check price violations in real time and seamless manner backed by an Information Technology (IT) set up.

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.

As of today, PMRUs have already been established in nine states including Rajasthan like Gujarat, Kerala, Odisha, Punjab, Haryana, Nagaland and Tripura with the latest entrant being Uttar Pradesh (UP).

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.

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.

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.