Mumbai : The National Pharmaceutical Pricing Authority (NPPA) has directed pharmaceutical companies to provide relevant data based on the updated provisional list of 324 overcharging cases under litigation related to Drug Prices Control Order (DPCO) -1979, 1987, 1995 and 2013 violations.
The concerned companies may provide their feedback within 15 days from the date of publication of this provisional list which is January 11, 2021.
As per the NPPA order issued, the companies have been directed based on the subject cited and to state that National Pharmaceutical Pricing Authority has taken up an exercise to update the database in respect of overcharging cases (OC) under litigation relating to DPCO -1979, 1987, 1995 and 2013. The data available in respect of such OC cases has been updated.
NPPA order further stated, “It has been decided to upload the provisional list of OC cases under litigation on the website of NPPA so that companies involved may see the status of their case and if there is any discrepancy in the provisional list, the concerned companies may provide appropriate information or feedback. Such feedback from the companies would help in timely updation and reconciliation of data.”
Feedback from companies, seeking any modifications in the provisional list, should be appropriately backed by supporting documents. The interest amount in respect of cases included in the provisional list have been updated wherever possible upto November 30, 2020. Any payment/ part -payment made has been adjusted from overcharged amount while updating the interest, due to which in some cases the date of updation on interest may vary.
In case any modification, addition or deletion is required in the provisional list, the concerned company may provide relevant data within15 days on the publication of this list. The data provided by the company shall be examined by NPPA. If found correct, required modifications, additions or deletions shall be done in the provisional list, the NPPA order stated.
The national drug pricing regulator NPPA had earlier last year in February asked for suitable responses from manufacturers on 228 cases of DPCO-2013 violation following show cause notices (SCN).
It was recommended that in cases where companies had not submitted data even after issuance of SCN as required by NPPA guidelines, the SCN may be converted into a demand notice and the company given last opportunity to submit data failing which action will be taken as per the law of the land.
Further, it was also decided to examine the cases and related recommendations and undertake necessary changes in the existing NPPA guidelines. It was also decided that CA audited data may be certified by the statutory auditor of the manufacturer or company and countersigned by the respective company secretary.
As per a notification, NPPA has proposed to set up Price Monitoring and Research Units (PMRUs) in states and Union territories (UTs) across the country to support state drug controllers and itself to check drug price ceiling violations.
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.
The Union Territory of Jammu and Kashmir and states like Maharashtra, Gujarat, Uttar Pradesh (UP) and Rajasthan are some of the latest states where PMRUs have been set up.