After a long wait of two years, the National Pharmaceutical Pricing Authority (NPPA) has finally allocated Rs. 33.88 lakhs for Price Monitoring and Research Unit (PMRU) in Maharashtra Food and Drug Administration (Maharashtra FDA) to track price violations by pharmaceutical companies across the state.
The state FDA is all set to kickstart its operations across all the 34 districts to track price violations by the pharma companies. “We are in the process of recruiting manpower for the same,” according to a senior FDA official associated with the development.
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 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.
“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.
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.
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.