NPPA issues notices to drug cos over violations of DPCO 2013

Taking a serious view of
non-compliance of DPCO, 2013, the National Pharmaceutical
Pricing Authority (NPPA) has issued notices to major drug
firms for failing to register products on online database
IPDMS and not filing mandatory returns through it.
The authority also plans to issue notices to other firms
as well that have not furnished information so far.
"We have issued notices to top 10 firms that have not
registered their products under IPDMS and will be also be
issuing notices to others," NPPA Chairman Bhupendra Singh told
PTI.
NPPA had asked all pharma firms to register themselves
with the Integrated Pharmaceutical Database Management System
(IPDMS) in September 2014 and had extended the last date to
submit the requisite information repeatedly.
The authority has issued many price notifications,
especially during March-June 2016, but many pharma companies
have not submitted the forms as required under DPCO, 2013, in
IPDMS, NPPA said in a notice on its website.
NPPA has taken a serious view about the willful violation
of the Drug Prices Control Order (DPCO), 2013, by some of the
companies, it added.
"In this regard, NPPA is now constrained to issue
show-cause notices to individual companies for not having
their pharmaceutical products under IPDMS and not having filed
mandatory returns in form II, III and V through IPDMS," it
added.
Toughening the stance, it added that "NPPA shall also be
constrained to take necessary legal action against the
companies including exercises of its powers under para 29,
para 30 of DPCO 2013, including prosecution under the EC Act
under unavoidable circumstances".
Form II is submitted for revised prices for scheduled
formulations while Form V is to be filed for all formulations
under IPDMS after registration.
The pricing regulator has also asked industry
associations to sensitise their members on this compliance
urgently.
NPPA had asked all pharmaceutical firms to register
themselves under IPDMS for online filing of returns for
monitoring, fixing and revision of drug prices.