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Madras High Court

Tristar Formulations Private Limited vs Union Of India on 28 October, 2025

Author: M.Dhandapani

Bench: M.Dhandapani

                                                                                                W.P.No.27518 of 2013

                                   IN THE HIGH COURT OF JUDICATURE AT MADRAS

                                                    DATED : 28.10.2025

                                                                CORAM

                                    THE HONOURABLE MR.JUSTICE M.DHANDAPANI

                                                 W.P.No.27518 of 2013
                                                          And
                                        M.P.No.1 of 2013 and W.M.P.Nos.43562,
                                                43569 & 43572 of 2025

                     Tristar Formulations Private Limited
                     Plot No.A, 116, 27th Cross,
                     PIPDIC Industrial Estate,
                     Mettupalayam,
                     Pondicherry 605 009.                                                  ... Petitioner

                                                                    Vs.

                     1.Union of India
                       Rep. by its Secretary
                       Ministry of Chemicals and Fertilizers
                       New Delhi.

                     2.National Pharmaceutical Pricing Authority, through its
                       Director/ Member Secretary having its address at
                       5th / 3rd Floor, YMCA Cultural Building,
                       1, Jaisingh Road,
                       New Delhi 110 001.                            ... Respondents


                     Prayer:

                                  Petition filed under Article 226 of the Constitution of India to

                     issue a Writ of Certiorarified Mandamus calling for the records in Order

                     No.31015/18/2011-PI.I dated 17th July, 2013 of the first respondent

                     confirming the Order F.No.21(1093) 2008/DIV.IV/NPPA dated 12th

                     1/7




https://www.mhc.tn.gov.in/judis                  ( Uploaded on: 30/10/2025 01:18:28 pm )
                                                                                           W.P.No.27518 of 2013




                     May 2008 of the second respondent and quash the same and

                     consequentially forbear the respondents by themselves, their servants

                     and agents, officers and subordinates from enforcing the Notification

                     [S.O. 440 (E)] dated 23rd March 2007 against the petitioner's

                     formulation viz. Ecosprin AV 75 by claiming alleged overcharged

                     amount or taking any action pursuant to and consequentially directing

                     the second respondent to refund to the petitioner a Rs.1,25,00,000/-

                     (Rupees One Crore Twenty Five Lakhs Only) deposited by the

                     petitioner by D.D.No.592952117 dt.28.04.2009 under cover of letter

                     dated 28.04.2009 with the second respondent with bank interest,

                     award costs.



                                       For Petitioner        : Mr.P.S.Raman
                                                               Senior Counsel
                                                               for M/s.T.D.Selvan Babu

                                       For Respondents : Mr.Rajesh Vivekanandhan
                                                         Dy. ASC


                                                              ORDER

This writ petition has been filed seeking issuance of Writ of Certiorarified Mandamus calling for the records in Order No.31015/18/ 2011-PI.I dated 17th July, 2013 of the first respondent confirming the 2/7 https://www.mhc.tn.gov.in/judis ( Uploaded on: 30/10/2025 01:18:28 pm ) W.P.No.27518 of 2013 Order F.No.21(1093) 2008/DIV.IV/NPPA dated 12th May 2008 of the second respondent and quash the same and consequentially forbear the respondents by themselves, their servants and agents, officers and subordinates from enforcing the Notification [S.O. 440 (E)] dated 23rd March 2007 against the petitioner's formulation viz. Ecosprin AV 75 by claiming alleged overcharged amount or taking any action pursuant to and consequentially directing the second respondent to refund to the petitioner a Rs.1,25,00,000/- (Rupees One Crore Twenty Five Lakhs Only) deposited by the petitioner by D.D.No.592952117 dated 28.04.2009 under cover of letter dated 28.04.2009 with the second respondent with bank interest, award costs.

2.The learned Senior Counsel appearing for the petitioner submitted that the petitioner is a small scale industrial unit registered with State Directorate of Industries manufactured and marketed pharmaceutical products that included a formulation called 'Ecosprin AV 75', a hard gelatin capsule having a combination of Atorvastatin Calcium 10 mg in powder form and Aspirin IP 75 mg in enteric coated tablet form having colour sunset yellow. The petitioner was one of the major manufacturer and or in any event the market leader in the country of the said formulation in such form. 3/7 https://www.mhc.tn.gov.in/judis ( Uploaded on: 30/10/2025 01:18:28 pm ) W.P.No.27518 of 2013

3.The learned Senior Counsel appearing for the petitioner further submitted that the second respondent did not initiate any specific enquiry concerning cost and efficacy or petitioner as contemplated under paragraph 9(1) of the DPCO 1995, before fixing a ceiling price of the formulation under Notification [S.O.440(E)] dated 23.03.2007, fixing a ceiling price at Rs.17.42 per strip. Aggrieved by the same, the petitioner preferred review before the first respondent and the said review petition was rejected.

4.The learned Senior Counsel appearing for the petitioner further submitted that this Court, without going into the merits of the case, may grant liberty to the petitioner to approach the National Pharmaceutical Pricing Authority [hereinafter referred to as 'NPPA'] and permit the petitioner to canvass all the points including price fixation between two components, petitioner's cost of manufacturing before NPPA and issue direction to NPPA to decide the issue without being influenced by any of the observations made in this order or in the impugned order. The learned Senior Counsel further submitted that the petitioner has already deposited 1/3 of the amount before the second respondent and hence this Court may direct the respondents to 4/7 https://www.mhc.tn.gov.in/judis ( Uploaded on: 30/10/2025 01:18:28 pm ) W.P.No.27518 of 2013 not to take any coercive action against the petitioner till the completion of proceedings before NPPA and further submitted that the period during which this writ petition was pending before this Court may be excluded for the purpose of limitation.

5.This Court is not an expert to decide the price fixation done by the Authority under the Drugs (Price Control) Order, 1995. Considering the limited request now made by the learned Senior Counsel appearing for the petitioner, this Court, without expressing any opinion on the merits of the case, grants liberty to the petitioner to approach the National Pharmaceutical Pricing Authority [NPPA], within a period of two weeks from the date of receipt of a copy of this order. Further liberty is granted to the petitioner to canvass all the points including price fixation between two components, petitioner's cost of manufacturing before NPPA. On such approach by the petitioner, NPPA is directed to decide the issue without being influenced by any of the observations made in this order or in Order No.31015/18/2011-PI.I dated 17th July, 2013 of the first respondent confirming the Order F.No.21(1093) 2008/DIV.IV/NPPA dated 12th May 2008 of the second respondent, as expeditiously as possible. 5/7 https://www.mhc.tn.gov.in/judis ( Uploaded on: 30/10/2025 01:18:28 pm ) W.P.No.27518 of 2013 Since the petitioner has already deposited 1/3 of the amount before the second respondent, the respondents are directed to not to take any coercive action against the petitioner till the completion of proceedings before NPPA. The period during which the writ petition was pending before this Court is excluded for the purpose of limitation.

6.The writ petition is disposed of with the above observations and directions. No costs. Consequently, connected miscellaneous petitions are closed.

28.10.2025 pri Index: Yes/ No Speaking Order: Yes/ No NCC: Yes/ No To

1.Union of India Rep. by its Secretary Ministry of Chemicals and Fertilizers New Delhi.

2.National Pharmaceutical Pricing Authority, through its Director/ Member Secretary having its address at 5th / 3rd Floor, YMCA Cultural Building, 1, Jaisingh Road, New Delhi 110 001.

6/7 https://www.mhc.tn.gov.in/judis ( Uploaded on: 30/10/2025 01:18:28 pm ) W.P.No.27518 of 2013 M.DHANDAPANI,J.

pri W.P.No.27518 of 2013 And M.P.No.1 of 2013 and W.M.P.Nos.

43562, 43569 & 43572 of 2025 28.10.2025 7/7 https://www.mhc.tn.gov.in/judis ( Uploaded on: 30/10/2025 01:18:28 pm )