NPPA Directs State Drug Controllers To Expedite Setting Up Of PMRUs

Mumbai, 22 April 2019: The national drug pricing regulator, National Pharmaceutical Pricing Authority (NPPA), has asked the state drug controllers to expedite setting up of Price Monitoring and Resource Units (PMRUs) in their respective states for effectively tracking drug price violations by the pharma companies. The primary function of PMRUs is to assist NPPA in price monitoring and drug availability.

Each PMRU will function under the direct supervision of the concerned state drug controller and monitor the price movement of scheduled and non-scheduled formulations based on periodic returns filed by the industry. 

As per the drug pricing regulator, total 21 states have given their consent for formation of PMRU. These are 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. First PMRU was established in Kerala on January 3, 2019. According to official sources, Odisha, Rajasthan Maharashtra, Punjab and Gujarat have started the process of its formation.

The NPPA has only an office in the national capital with no state-level branches. The PMRUs were conceptualised to resolve that problem and the draft was announced way back in 2015. However, the scheme got stuck in the pipeline for a long time. 

As a step towards achieving it, NPPA has directed state drug controllers to check price compliance by pharma companies in their respective jurisdiction. They have also been told to collect samples and provide references along with supporting documents such as invoices related to purchase of medicine, price declaration of retailers and photo copy of samples for effective monitoring of price compliance.

As of today, NPPA has also observed that references are received from the offices of only 12 drug controllers. 

NPPA has noticed that some of the manufacturers do not furnish production and sales data of the subject formulation even after issue of show cause notice.

NPPA has been following the price compliance agenda with state drug controllers. Letters of the copy to the Principal Secretary and Secretary (Health) in the state where the manufacturers’ headquarters is situated have been sent pressing upon the manufacturers to furnish required information within a period of 30 days and also to verify their credentials through inspection of their offices and factory premises by the state drug controllers.

However, it has been noticed that even after reminders, the manufacturers and marketing companies are not submitting the requisite data. Pharmabiz