NPPA issues guidelines for timely disposal of review cases

Drug price regulator NPPA today came out with fresh guidelines and procedures for timely disposal of review cases filed by pharmaceutical companies with regard to price fixation of medicines.
The move assumes significance as non-submission of necessary documents by drug makers during the review cases have led to inordinate delays in implementation of drug price revision by the NPPA.
Compliance of review orders of the government with regard to notified ceiling prices of scheduled drugs or retail prices of new drugs get inordinately delayed because of non submission of necessary documents by the pharma companies which initiate such review petitions," the NPPA said in a notification.

"It is found that for several months companies do not submit the required documents despite several reminders to this effect. This situation is unwarranted," NPPA Chairman Bhupendra Singh said in the notification.
Therefore, in suppression of all earlier notices in this regard, standard procedure shall be adopted by the NPPA for examination of review cases, the notification said.
As part of the new guidelines, the National Pharmaceutical Pricing Authority (NPPA) said, once the review order is passed by the department it will be the responsibility of the petitioner in case to submit all necessary documents in support of their contention within 15 days from the date of the review order.

If the documents are not submitted by the petitioner, pricing division shall submit the file to member secretary /chairman for orders, it added.

"No letter shall be issued by the NPPA in this regard," the notification said.
Further, the company's claiming that any data taken in NPPA's calculations for price revision is incorrect, they shall submit copy of the invoice of the relevant month duly stamped by the competent authority of the company.
Once the authority has approved the revised prices in compliance of the review order, the NPPA shall issue the revised notifications within three working days from the date of such approval, it said.

All efforts shall be made by the NPPA's pricing division to dispose of review cases within the stipulated time in the review order as far as possible, it added.
As a standard procedure, the NPPA notifies prices of essential medicines after uploading draft provisional price working sheet on its website to provide an opportunity to companies to make representations if any.
Such representations are taken into consideration by the NPPA before notifying the final ceiling prices. Most of review orders issued by the Department of Pharma are related to reconsideration of documents submitted by the companies.
The authority fixes the prices of essential drugs based on the simple average of all medicines in a particular therapeutic segment, having sales of more than 1 per cent.

Companies are allowed to hike prices of such drugs by up to 10 per cent in a year.
The government had notified DPCO, 2013, which covers 680 formulations, with effect from May 15, 2014, replacing the 1995 order that regulated prices of only 74 bulk drugs.