Rejecting a review application filed by Reckitt Benckiser (India) Ltd. against fixation of ceiling prices of “Acetyl salicylic acid tablet 100 mg (ASA tablets)”, the Department of Pharmaceuticals (DoP) has ordered that ASA 100 mg tablet is a scheduled drug of NLEM 2011 and included at Section 12.1.1 of Schedule I of DPCO 2013. There is no provision in DPCO 2013 to consider ASA tablet (effervescent) separately for price fixation.
Earlier, the national drug price regulator National Pharmaceutical Pricing Authority (NPPA), vide price fixation Order S.O. No. 1204(E) dt. 6.5.2015 had fixed ceiling price of “Acetyl salicylic acid tablet 100 mg (ASA tablets)” under DPCO, 2013. Aggrieved by this notification, Reckitt Benckiser (India) Ltd submitted a review application dated 22.5.2015 under para 31 of DPCO, 2013 for the review of NPPA price fixation order.
During examination, the reviewing authority DoP noted that the acetyl salicylic acid (ASA) 100 mg tablet is included in NLEM 2011 and under Section 12.1.1 of Schedule I of the DPCO, 2013. Vide SO dated 24.3.2008 (p.36/c), NPPA has fixed retail prices of FDC, i.e. acetyl salicylic acid with calcium carbonate and anhydrous citric acid. However, while fixing the ceiling price of acetyl salicylic acid 100 mg tablet vide notification dated 6.5.2015, NPPA has not taken into account the PTR of the aforesaid FDC treating the same as different from ASA tablets.
It further noted that the company has represented that their product Colspirin Effervescent tablet contain acetyl salicylic acid + calcium carbonate as active pharmaceutical ingredients (APIs) and Anhydrous Citric Acid as excipient. Petitioner company has, therefore, requested that price fixation dated 24.3.2008 should have been taken into consideration by NPPA for fixing the ceiling price of their product Colspirin vide NPPA Notification dated 06.05.2015.
The DoP noted that the NPPA has mentioned that the Calcium Carbonate and Citric Acid are not only used as excipients but they are also used as active ingredients e.g. Citric Acid is used as active ingredient in ORS. NPPA has further mentioned that their Order dated 24.3.2008 with regard to ASA+calcium carbonate+anhydrous citric acid are different than acetyl salicylic acid mentioned in Section 12.1.1 of DPCO, 2013. As such, they have not considered the PTR of the above FDC while fixing the ceiling price of ASA 100 mg tablets vide their SO No.1204(E) dated 06.05.2015. Acetyl salicylic acid is a scheduled drug mentioned under Section 12.1.1 of DPCO, 2013. NPPA Order dated 24.3.2008 is with regard to an FDC i.e. ASA+calcium carbonate+anhydrous citric acid.
In view of this, if the product of the petitioner company is FDC, as above, the petitioner company should have applied in Form I to NPPA to consider their product as a new drug and for fixation of the price of the same under Para 2(u) of DPCO, 2013. Acetyl salicylic acid (ASA) 100 mg tablet (ASA tablet) is a scheduled drug of NLEM 2011 and included at Section 12.1.1 of Schedule I of DPCO 2013. There is no provision in DPCO 2013 to consider ASA tablet (effervescent) separately. Further, NPPA has mentioned that acetyl salicylic acid tablet 100 mg effervescent tablet has been included in NLEM 2015 of DPCO, 2013 and hence included in revised Schedule-I of DPCO 2013.
After examination, the DoP ordered, “There is no provision in DPCO 2013 to consider ASA tablet (effervescent) separately. Therefore, the request of the petitioner company is rejected”.