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DoP rejects Inventia Healthcare's review application on metformin HCl, gliclazide and pioglitazone tablets
Ramesh Shankar, Mumbai | Tuesday, March 17, 2015, 08:00 Hrs  [IST]

The Department of Pharmaceuticals (DoP) has rejected the review application filed by Inventia Healthcare against the fixation/revision of retail prices of metformin HCl, gliclazide and pioglitazone tablets.

Earlier, the National Pharmaceutical Pricing Authority (NPPA)  vide price fixation Order S.O. No. 2101(E) dated 20/8/2014 had fixed/revised retail price of metformin HCl, gliclazide and pioglitazone tablets under DPCO, 2013. The said formulation is a non-scheduled formulation.

Aggrieved by the NPPA notification, Inventia Healthcare submitted review application dated 12.9.2014 with the reviewing authority, DoP, under para.31 of DPCO, 2013 for the review of NPPA Price fixation Order S.O.No. 2101(E) dated 20/8/2014 fixing retail price of metformin HCl, gliclazide and pioglitazone.

In the review application, the petitioner mentioned that the monopoly condition applied by NPPA does not prevail as formulation is being manufactured by Inventia Healthcare for more than one marketers i.e. Ipca Lab and Panacea Biotech since 2011 i.e. prior to DPCO 2013.

In reply, the NPPA mentioned that Micro Lab applied for price fixation in Form I for the said formulation. As NPPA received information from Panacea Biotech only and informed that Inventia Healthcare is the manufacturing company. Therefore they applied monopoly condition and fixed the price under para 6 of DPCO 2013.

The petitioner further mentioned that their name should not have been appeared in the price notification as they did not apply in Form I.

The NPPA then commented that as per information received by them in Form I from Micro Lab, Inventia is the manufacturer of the said formulation. Therefore the words manufactured and marketed by Inventia Healthcare and Micro Labs respectively as the manufacturer mentioned in the notification and not the marketer.

After hearing both the parties, the reviewing authority DoP observed that an ideal marketing competition does not exist in this case. Sole manufacturer is selling the same formulation to two marketers and both are selling at different prices which is unethical. Ideally there should be no reduction in prices and the conditions of monopoly under para 6(1) of DPCO 2013 are satisfied.

DoP further observed that the contention of the company does not appear to be justified. Since they have been mentioned as only manufacturer of the said formulation and Micro Labs Ltd has been mentioned as the marketing company. Deletion of their name as the manufacturing company will not be justified since the price fixation has been done for the formulation manufactured by the petitioner and marketed by Micro Labs Limited.

“The review application of the petitioner is rejected,” the DoP ordered.

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