Gujarat Food and Drug Control Administration (FDCA) has referred 2044 cases of pharmaceutical products for non-compliance to new Drug Price Control Order (DPCO)– 2013 to the National Pharmaceutical Pricing Authority (NPPA). These products are either manufactured in Gujarat or in other states. In all such cases, manufacturers have violated the norms of the ceiling prices as per the new DPCO-2013.
The state drug regulator has also been able to recover Rs.20.33 crore based on the cases referred by Gujarat FDCA for non- compliance to DPCO-2013 spanning between 2013 and 2017. In 2013, 111 cases were referrred, in 2014, 629 cases were referred, in 2015, 370 cases were referred, in 2016, 767 cases were referred and in 2017, 157 cases were referred.
Once the case is referred to the NPPA, drug pricing regulator sends a recovery notice to the concerned manufacturer through the respective state drug controller for the recovery of the excess amount.
Meanwhile, Gujarat FDCA has submitted Utility Certificate (UC) for the funds to the NPPA for setting up the infrastructure for NPPA cell with an amount of Rs.7 lakh sanctioned for the purpose from the centre as a part of Central government’s mandate to set up price monitoring cell in all the states.
Meanwhile, Gujarat government has also formed a committee to oversee recruitment of manpower for the state NPPA cell for effective detection of ceiling price violations in drugs and devices. A total of seven personnel including a scientific officer will be deputed for the purpose of collection of data on price violations in the state based on the much awaited financial support from the Central Government.
Government has earmarked an amount of Rs.67 lakh for all category A states in the country of which Rs.7 lakh has been earmarked for infrastructure and equipment, Rs.19 lakh for manpower, Rs.24 lakh for training, Rs.12 lakh for data collection and sampling and Rs.5 lakh as contingency fund.
NPPA had discussed and proposed the plan with the state drug regulators to set up a dedicated administrative cell within its office way back in 2015. 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.
Drug pricing regulator NPPA has earlier this year identified 634 cases where non-compliance of notified ceiling prices is suspected. Of the 1389 cases, NPPA has realized around Rs.385 crore, according to data on its website for cases spanning between August 1997 and February 2016.
NPPA after analysis of market data and associated reports of December 2016 submitted by AIOCD-AWACS, has identified 634 cases where non-compliance of notified ceiling price is suspected.
As stipulated under DPCO -2013, NPPA fixes ceiling price of essential medicines of Schedule I. In respect of medicines not under price control, manufacturers are allowed to increase the maximum retail price by 10 per cent annually.
The calculation for essential drugs is based on the simple average of all medicines in a particular therapeutic segment with sales of more than 1 per cent.
The government had notified the DPCO 2013, which covers 680 formulations, with effect from May 15, 2014, replacing the 1995 order that regulated prices of only 74 bulk drugs.