DoP orders NPPA to re-evaluate ceiling price of vitamin product Thiamin 100 mg

In its application, Ordain alleged that the NPPA had erred in determining the ceiling price and that the revised price should include a higher price reference (PTR) for Thiamin 100mg Injection 2ml.

The drug maker claimed that it had implemented the WPI base increase in MRP under para 16 of DPCO 2013 in the month of April, 2022. Further, Form-V was submitted on 06.07.2022 as per DPCO, 2013 requirements.

"A delay in the implementation of revised MRP or PTR based on WPI impact should not be construed as non-implementation of WPI based revision and does not limit the implementation of the said WPI revision in case of an increase in the ceiling price of the formulation. Hence, the ceiling price of formulation "Thiamin 100 mg Injection 2 ml" containing "Thiamine 100 mg per ml" at Sr. No. 4 should have included the revised PTR for 'Thiamin 100mg Injection 2ml' at Rs. 46.01 and not Rs. 41.75," the firm argued.

Further, based on the market information, Ordain confirmed that the formulation 'Vitneurin AQ 100mg Injection 2ml' as marketed by Corona Remedies Pvt. Ltd. is not a 'Thiamine 100mgper ml Injection', but an FDC of "Vitamin Bl -100mg, Vitamin B650mg, Vitamin B12-1000mg, D Panthenol 50mg". Therefore, the brand 'Vitneurin AQ 100mg Injection 2ml' should be removed from the calculation.

In response, the NPPA maintained that the company had not fulfilled the requisite formalities of submitting the necessary forms within the prescribed time limit and that the "Vitneurin AQ 100mg Injection 2ml" should be considered for ceiling price calculation.

The Authority argued that as per the provisions of para 16(2) the manufacturers may increase the MRP of scheduled formulations once in a year, in the month of April on the basis of WPI. Further, as per para 16(3), information about the revision, if carried out, shall be forwarded to the Government in Form-Il within a period of 15 days of such revision. This implies that Form-Il for price revision based on WPI may be submitted latest by 15 May.

"Ordain Health Care Global Private Limited has not filed Form-Il for the subject formulation and Form-V too was filed on 06.07.2022 after the prescribed time as per DPCO, 2013. Hence, as per DPCO, 2013, delay in the implementation of WPI beyond April and the non-receipt of information about the revision within 15 days of such revision will be construed as non-revision of MRP," NPPA clarified.

NPPA further said that the draft worksheet based on Pharmatrac database was uploaded on NPPA's website on 28.01.2023 for 10 working days to invite comments, if any. However, no representation was filed by Ordain Health Care Global Private Limited or any other company within the prescribed time of 10 working days.

With respect to the brand "Vitneurin AQ 100mg Injection 2ml" as marketed by Corona Remedies Private Limited, NPPA examined that the brand contains Vitamin Bl IP 100mg + Vitamin B6 IP 50mg + Vitamin B12 IP IOOOmg + D Panthenol IP 50mg + Phenol IP 0.5%.

"The company's contention regarding exclusion of Vitneurin AQ 100mg Injection 2ml from the calculation of PTR is acceptable as the brand does not have composition as mentioned in Schedule. However, the ceiling price was fixed for the drug since no company represented within 10 working days of upload of draft calculation sheet," the Authority clarified.

Deliberating the matter, the Department of Pharmaceuticals noted that Ordain had not fulfilled the requisite formalities of submission of Forms-Il and Form-V within prescribed time limit as per the extant provisions of DPCO 2013. Further, DPCO expressly maintains that non-submission of information under Para 16(3) is construed as non-revision of MRP.

The Department further observed that NPPA has considered the "Vitneurin AQ 100mg Injection 2ml" as marketed by Corona Remedies Private Limited, for calculation of ceiling price based on Pharmatrac database. No company filed representation for exclusion of the same to NPPA within the prescribed period of 10 working days.

However, DoP clearly said that;

"the brand "Vitneurin AQ 100mg Injection 2ml" marketed by M/S Corona Remedies Private Limited is different from the Scheduled formulation. Therefore, price of the same should not be considered for ceiling price calculation of subject formulation. The failure to represent within ten days against the ceiling price fixed by NPPA, may not deprive the Applicant of the legitimate prices of drugs manufactured by them."

Given these findings, the Department of Pharmaceuticals recommended that the NPPA reconsider the issue and revise the ceiling price based on the existing provisions of the DPCO 2013. The Department noted;

"The PTR of Thiamin 100mg Injection 2ml considered by NPPA in fixation of ceiling price of the schedule formulation is as per the provisions of DPCO, 2013 and suffers no infirmity. However, the contention of the Applicant(Ordain) regarding removing brand 'Vitneurin AQ 100mg Injection 2ml' from the calculation of P TR is accepted. Accordingly, the case is referred back to NPPA for re-examination and re-calculation of the prices of the subject formulation as per the extant provisions of DPCO 2013."