Maha FDA to launch PMRU to track drug price violations

Gujarat, Karnataka, Andhra Pradesh are among other states which fall under A category.


Last Updated on January 17, 2021 by The Health Master

The Maharashtra Food and Drug Administration (FDA) is all set to kickstart operations of its Price Monitoring and Research Unit (PMRU) with a team of seven people in Mumbai headquarters to track price violations by pharmaceutical companies across the state.

“A team of seven people are in the process of being recruited for the successful implementation of the PMRU for all the 36 districts of Maharashtra as National Pharmaceutical Pricing Authority (NPPA) has recently allocated Rs. 33.88 lakhs for the same”, according to a senior official associated with the development.

Picture: Pixabay

With the setting up of PMRUs, violations of drug ceiling pricing reported will be dealt timely with the help of the state NPPA cell in coordination with the NPPA in cases of contraventions to the provisions of Drug Price Control Order (DPCO-2013).

Under the proposed scheme, the cell is to be headed by one person along with a team of NPPA officials whose strength will vary as per the size of the pharma industry in the respective states.

Maharashtra falls under the category of A states and NPPA has accordingly sanctioned the budget as per the categorization. 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.

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Gujarat, Karnataka, Andhra Pradesh are among other states which fall under A category.

PMRUs have also already been set up in 15 states including Kerala, Gujarat, Odisha , Rajasthan, Punjab, Haryana, Tripura, Uttar Pradesh, Nagaland, Mizoram, Union Territory of Jammu and Kashmir , Andhra Pradesh, Telangana and Karnataka.

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).

To read or download the notification of NPPA / DPCO, click here

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 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.

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.

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“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 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 notification stated.

Through the price monitoring cells, NPPA will closely work with the state drug regulators to find out any discrepancies that affect the consumers.

The officials heading the cell will report their findings to the NPPA directly in case they find any pharma company violating the law by selling the drugs above the ceiling price.

NPPA held a meeting with all the state drug controllers in 2016 in Delhi to set up price monitoring cells in all the states across the country.

While the expenditure related to manpower, amenities and other infrastructural cost will be borne by the Centre, state government will have to provide the space for setting up the office within the state drug regulatory office, as per the plan.

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