The Department of Pharmaceuticals (DoP) has rejected Abbott India's review petition against price fixation of “Carbimazole 10 mg tablet” by the National Pharmaceutical Pricing Authority (NPPA).

Earlier, the NPPA had issued a notification S.O. No.1816(E) [Corrected SO No.1819(E)] dated 18.05.2016 fixing the ceiling price of Carbimazole 10 mg tablet. Aggrieved by the notification, the Abbott India filed a review petition with the reviewing authority DoP under paragraph 31 of the Drugs (Prices Control) Order, 2013 (DPCO, 2013).

To examine the matter, the DoP held personal hearing on 23.8.2016, and during the hearing, the petitioner stated that the intent of para 18(i) was to ensure stable environment and prices for the scheduled drugs listed in NLEM 2011 for a period of five years. It was also stated that para 18(i) should only be applicable to the medicines which have been included for the first time in NLEM 2015. While fixing the ceiling prices in 2013 for the first time, NPPA considered PTR basis MAT September, 2012 and issued ceiling price notification without adding WPI as applicable as on 1st April, 2013 whereas while fixing the ceiling price in 2016, NPPA has issued notification basis PTR August, 2015 by deducting negative WPI as applicable as on 1st April, 2016 from the ceiling price.   

It is, therefore, submitted that while WPI was not added in 2013 ceiling price fixation, in the same spirit the negative WPI should not have been deducted while fixing ceiling price in 2016.

In response, the NPPA stated that the ceiling price, for the formulation for which the company submitted this review petition, have been fixed strictly within the provision of para 18(i) of DPCO 2013. DoP has revised the NLEM before the expiry of five years. Para 18(i) states that the refixation of ceiling prices can be made after five years or revision of NLEM whichever is earlier.

While examining the matter,  DoP noted that Para 18(i) of DPCO 2013 clearly states that the revision of ceiling prices on the basis of moving annual turnover value shall be carried out “as and when the National List of Essential Medicines is revised by the ministry of health and family welfare or five years from the date of fixing the ceiling price under this Order whichever is earlier.” In view of this, NPPA has revised the ceiling prices of the formulations strictly as per the provision of DPCO 2013. As regards the other point that negative WPI should not be taken while fixing the ceiling price vide notification dated 2.6.2016, since the drugs are not new drugs in NLEM 2015, the WPI impact has to be taken care of while fixing the ceiling prices. Therefore, the petitioner company has no merit in the petition and may be rejected.

“The issues raised by the petitioner company in the review petition have no merit and hence the review petition is hereby rejected,” the DoP ordered.