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DoP asks NPPA to form Committee of Experts to examine Betacap 40mg capsules TR 10 is incremental formulation with specific therapeutic rationale

Ramesh Shankar, Mumbai
Tuesday, September 12, 2017, 08:00 Hrs  [IST]

The Department of Pharmaceuticals (DoP) has directed the National Pharmaceutical Pricing Authority (NPPA) to constitute a Committee of Experts as per Para 11(2&3) of DPCO to recommend whether the formulation Betacap 40mg capsules TR 10 is to be treated as an incremental formulation with specific therapeutic rationale.

 Delivering its decision on a review application filed by Sun Pharma Laboratories Ltd. against price fixation of “Propranolol 40mg capsules” vide NPPA order No. S.O. 3180(E), dated 07.10.2016 issued under DPCO 2013, the DoP stated that there is a provision in DPCO as per Para 11(2&3) that a Committee of Expert may recommend fixing of separate ceiling price of scheduled formulations or retail price for such formulations with specific therapeutic rationale, considering the type of packaging or pack size, or dosage compliance or content in the pack namely liquid, gaseous or any other form, in the unit dosage as the case may be.

In view of this, NPPA may be directed to get the claim of petitioner examined by the Committee of Experts and recommend whether the formulation Betacap 40MG capsules TR 10 is to be treated as an incremental formulation with specific therapeutic rationale. NPPA may thereafter take a decision about inclusion or exclusion of subject formulation of the petitioner company from the ceiling price fixation of propranolol capsule, on merit basis on the recommendation of the Expert Committee.

Earlier in its review petition, the petitioner contended that it had asked the NPPA to exclude their product Betacap 40MG capsules TR 10 and other incremental formulation from the ceiling price calculation as per Explanation Note (2) of Department of Pharmaceuticals’ S.O. 701(E) dated 10.03.2016. NPPA has notified the ceiling price of the captioned formulation via S.O. No. 3180(E) dated 07.10.2016 without giving due consideration to their representation. This has led to the ceiling price which is not as per the provision of DPCO 2013. Considering such scenario, it seems that overall purpose of bringing transparency in ceiling price calculation/fixation is being defeated.

In reply, the NPPA stated that the representation submitted by the company had no merit. Therefore, the company’s representation was not considered by NPPA. NPPA has considered the PTR & MAT value of Betacap 40mg capsule TR 10 for working out the ceiling price of this formulation, which is in conformity with the provisions of explanation to note (1) of DPCO S.O. 701(E) dated 10.3.2016 and as per 37th Authority meeting decision held on 06.10.2016.

During examination, the reviewing authority DoP noted that the petitioner company in its review application submitted that their product Betacap 40mg capsules TR 10 is a prolonged release formulation and not an immediate release formulation in propranolol 40 mg capsule category. Hence, this product pack along with some other prolonged release formulations should not have been included in the ceiling price calculation of propranolol 40mg capsule as per explanation note (2) of DoP’s notification SO 701(E), dated 10.3.2016.

It further noted that Schedule-I of DPCO, 2013 does not specifically notify the prolonged release drug, hence, NPPA has included the subject formulation of the petitioner company along with other conventional tablets and fixed the ceiling price. As per company’s submission that their product Betacap 40mg capsules TR 10 is a prolonged release formulation and not an immediate release formulation and should not be included in the ceiling price calculation of propranolol 40mg capsules.     

“NPPA is directed to get the claim of the petitioner examined by the Committee of Experts and their recommendation, on whether the formulation Betacap 40MG capsules TR 10 can be treated as an incremental formulation with specific therapeutic rationale, be obtained. NPPA may thereafter take a decision about inclusion or exclusion of subject formulation of the petitioner company from the ceiling price fixation of propranolol capsule, on merit, based on the recommendation of the Expert Committee,” the DoP ordered after examination of the matter.

 

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