NPPA issues draft Internal Guidelines for dealing with cases of price revision under Para 19 of DPCO, 2013 Ramesh Shankar, Mumbai Monday, August 25, 2014,

The National Pharmaceutical Pricing Authority (NPPA) has issued draft Internal Guidelines for dealing with cases of price revision under Para 19 of DPCO, 2013. As per the draft guidelines, the price revision under para 19 shall be initiated only if the weighted average price of any API used in scheduled formulations based on the immediate last six months purchases goes up by more than 25 per cent as compared to previous six months.  The concerned company/companies having market share more than 50 per cent may submit relevant purchase data to NPPA duly supported with evidences for revision of ceiling price, clearly demonstrating the impact of increase in price of API on the ceiling prices of the scheduled formulation with specified dosage and strength. The NPPA shall examine the request/submission of the company and suitable recommendations will be given for price revision based on the formula,  Increase in CP=(R2-R1)xDCxCF where R1 will be weighted average price of API based on six month purchases made prior to last six months; R2 will be the weighted average price of API based on purchases made during last six months; DC will be per unit drug content as per label and the CF will be conversion factor for API, if any. The NPPA will give suitable recommendations for price revision provided that increase in CP should not be more than twice of the increase worked out for annual increase in WPI, as applicable; and where increase in ceiling price works out more than twice of the increase worked out for annual increase in WPI, the increase shall be  examined on case to case basis, as deemed appropriate. According to the draft guidelines, the ceiling price so fixed shall remain valid for a period of one year from the date of notification after which annual price increase not exceeding WPI increase will be permissible as per provision of DPCO, 2013. After revision of ceiling price, the concerned manufacturer, importer or marketer shall submit quarterly return along with documentary evidences in respect of purchases of API.  If the concerned company/companies fails to submit quarterly return or fails to satisfy NPPA for non-submission of quarterly return, NPPA may review the case for withdrawal of notification even within a period of one year, as per the NPPA's new draft guidelines for dealing with cases of price revision under Para 19 of DPCO, 2013. The NPPA has invited comments from the stakeholders and industry associations within a period of three weeks. http://www.pharmabiz.com/NewsDetails.aspx?aid=83718&sid=1