Date : 16.3.2007

National Pharmaceutical Pricing Authority

Guideline No. 3 / 2007 

Revised Guidelines for monitoring of prices of Non Scheduled formulations

In pursuance of Resolution No. 33/7/97-PI.I, dated 29.8.1997 issued as per the provisions of the Drugs (Prices Control) Order, 1995 read with Essential Commodities Act, 1955, National Pharmaceutical Pricing Authority (NPPA) has decided to revise the guidelines for monitoring of prices of non-scheduled formulations as follows :-

1. The monitoring of prices of non-scheduled formulations will continue to be on the basis of regular data from ORG IMS.
2. Companies will be short listed where there is an increase in prices of a non-scheduled formulation by more than 10% during a period of 12 months and the annual turnover of the formulation pack exceeds Rs.1 crore.  Further, the share of the formulator in that segment of the formulation is required to be at least 20% of the market or the medicine is one of the first 3 top medicines of that group.
3. The manufacturer will be asked to furnish reasons for such prices increases or to bring down the prices voluntarily and to thereafter maintain the price levels.
4. NPPA will initiate action against those who do not comply with the internal guidelines or directions of NPPA for monitoring of prices of non-scheduled formulations and will be liable for action under para 10(b) of DPCO, 1995. 

                                                                                                                 (L. M. KAUSHAL)

                                                                                                                    Director (M&E)

No.20(109)/2006-Div.III/NPPA