Drugmakers get NPPA notice for violating pricing control order

Concerned over 'wilful violation' of its drug pricing control rules, the National Pharmaceutical Pricing Authority (NPPA) has slapped show-cause notices on ten top drugmakers for failing to register their products on its online database and submit the mandatory disclosures.
The Authority, which plans to issue notices to more firms that have not furnished the information so far, warned that it would have to launch prosecution, among other legal actions, under the Essential Commodities Act.
The NPPA is authorised to cap the drug prices to ensure that the companies do not overcharge for essential medicines while the companies are also required to make certain disclosures and list their products on the Authority's online database to ensure compliance and transparency.

"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.
He, however, did not disclose the names of the companies.
NPPA had asked all pharma firms to register themselves on the Integrated Pharmaceutical Database Management System (IPDMS), an online database, in September 2014, while the last date was extended several times to ensure the requisite information was submitted.

In a notice published on its website, the NPPA said it has issued many price notifications, especially during March-June 2016, but many pharma companies have not submitted the forms as required under the Drug Prices Control Order (DPCO), 2013.

NPPA has taken a serious view about the wilful violation of the DPCO 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 its stand, 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 Essential Commodities 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.