National drug price regulator the National Pharmaceutical Pricing Authority (NPPA) has issued Guideline and Standard Operating Procedure for disposal of such review cases.
With regard to the compliance of government revision orders with respect to notified ceilings prices of scheduled formulations or retail prices of new medicines, it was found that cases were disproportionately delayed due to non-submission Of the documents required by the pharmaceutical companies that launched these petitions. The NPPA notifies the prices of essential medicines after downloading the "Draft Interim Worksheet" on its website to give companies the opportunity to make representations, if any. Such representations are taken into account by NPPA before notifying the final ceiling prices. Most of the review orders issued by the DoP relate to "re-examination of documents submitted by companies," NPPA said in its new order.
In accordance with the new guidelines, once the revision order has been adopted by the DoP, it will be for the petitioning company (s) in the case to revise to submit all the necessary documents to the Within 15 days of the date of the review order. If documents are not submitted by the petitioner (s), the Prize Division must submit the file to the Secretary / Member Member for the orders. No letter will be issued by NPPA in this regard.
The companies claiming that PTR or any market data taken in NPPA's calculations is incorrect, shall submit these documents in support of their contention--copy of the invoice of the relevant month (August 2015 in case of scheduled formulations listed in NLEM, 2015) duly certified by the competent authority of the company with name, designation, seal, signature, mobile no. and other details; the original sample of the drug clearly showing Batch no., MRP, Mfd. date and other details; and if the sample is very costly, the certified copy of the drug should be submitted and the sample may be presented for inspection to Advisor, NPPA/Director (Pricing) any time during office hours. Concerned officers will endorse the inspection summary on the Xerox copy of the sample and the same will be returned to the company's representative.
If the review petitioner has referred the PTRs or other information relating to some products of the other company(ies), the onus of submitting all the required documents along with samples as per para (2) lies with the review petitioner(s). This information, too, needs to be submitted within 15 days from the date of the review order.
On receipt of the documents from the companies, the NPPA office will seek the comments of Pharmatrac within maximum of five working days and Pharmatrac will be under obligation to submit its comments within 72 hours of receipt of e-mail query from NPPA.
Once the exercise as per paras 2-4 is completed, the Pricing Division must examine the file and put up for orders of the competent authority within five working days and the matter shall be listed as agenda for the subsequent Authority meeting for formal approval/decision. If the matter is of routine nature, NPPA will notify the revised prices with the approval of the Chairman and take post facto approval of the Authority.
Once Authority has approved the revised prices in compliance of the review order, NPPA office shall issue the revised notifications within three working days from the date of such approval by the Authority, the NPPA order said.
