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NPPA warns cos of penal action for failing to register under IPDMS by Dec 15

Ramesh Shankar, Mumbai
Thursday, November 19, 2015, 08:00 Hrs  [IST]

The National Pharmaceutical Pricing Authority (NPPA) has warned the pharma companies of penal action under the provisions of the DPCO, 2013 read with Essential Commodities Act, 1955, for failing to submit requisite and mandatory form under the DPCO 2013, through Integrated Pharmaceutical Database Management System (IPDMS), which was aimed at facilitating on-line submission of mandatory returns/reports under the DPCO, 2013 by manufacturers as defined under 2(1) (n) of the DPCO, 2013.

“It is also hereby stated that failure to submit mandatory data IPDMS or mandatory returns prescribed under the Drugs (Prices Control) Order, 2013 through the IPDMS will attract penal action under the provisions of the DPCO, 2013 read with EC Act 1955. It shall be noted that, NPPA may be constrained to initiate prosecution proceedings under the provisions of the Essential Commodities Act, 1955, against companies which fail to submit requisite and mandatory form under the DPCO 2013; through IPDMS,” the NPPA warned.

The IPDMS when fully operationalised will be a useful tool for collection of data and information and for monitoring and analysis of data for the industry, the consumer and the regulator, and from which data on production, import and pricing of scheduled and non-scheduled formulations can be accessed, analyzed and reports generated.

The pharmaceutical companies are legally bound to report information through IPDMS under the provisions of DPCO, 2013 issued under section 3 of Essential Commodities Act 1955. Non-submission of return/information through IPDMS tantamount to violation of the provisions of DPCO, 2013 read with EC Act, 1955, the NPPA in a notices said.

Earlier on September 18 last year, for online registration under DPCO, 2013, the NPPA had issued a notice, directing all the pharma manufacturing/marketing companies to register themselves online under IPDMS before 31.10.2014. The timeline was extended up to 30.11.2014 and further extended up to 31.12.2014 on the request of the industry.

As the companies refused to register in spite of several extensions, the NPPA issued a final notice on May 1, 2015, directing all the companies to register on IPDMS immediately. The notice for online submission of data in Form II, III & V as prescribed under second schedule of DPCO, 2013 was notified on 04.06.2015.

Meanwhile, the IPDMS was formally launched by the Union minister of chemicals and fertilizers Ananth Kumar on June 25, 2015, and on July 13, 2015, online submission of data was made mandatory in terms of paragraph 9 (2) of the DPCO, 2013.

The software for IPDMS was designed, developed and fine-tuned after detailed and extensive consultation with the industry. However, despite all efforts by the NPPA, many of the companies have neither registered nor filed mandatory forms/returns as per the NPPA orders.

“In view thereof, the companies are hereby given a final opportunity to register themselves in IPDMS and file all the forms as required by the above notice on or before December 15, 2015. The latest Form-V should also be filed by the companies online for all the formulations manufactured/marketed by them, irrespective of whether they have submitted the same in hard copy or not,” the NPPA notice said.


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