No Special Price for Novel Pack: NPPA Panel Turns Down Sun Pharma's Amoxicillin-Clavulanic Formulation
Sun Pharma
New Delhi: In a regulatory pushback against what it deemed an ineligible pricing request, the Multi-Disciplinary Committee (MDC) of the National Pharmaceutical Pricing Authority (NPPA) has rejected Sun Pharmaceuticals Industries Limited's application seeking a separate ceiling price under Paragraph 11(3) of the Drugs (Prices Control) Order, 2013 (DPCO, 2013) for its novel dual chamber pack of Amoxicillin 200 mg + Clavulanic acid 28.5 mg Suspension.
Sun Pharma had initially applied on 29.09.2023, seeking an additional price over the existing ceiling rate for the formulation, which is a scheduled drug, citing that the dual-chamber packaging was a “cutting edge novel device developed through incremental innovation to benefit patients.”
The matter had previously been deliberated multiple times—in the 56th, 57th, and 59th MDC meetings—wherein the committee found no grounds to approve a separate ceiling price and recommended rejection. The NPPA formally accepted this view in its 124th meeting held on 07.06.2024.
Despite this, Sun Pharma pursued the matter further by submitting a representation to the Department of Pharmaceuticals (DoP) on 20.11.2024, which was forwarded to NPPA for reconsideration. The application resurfaced in the 65th MDC meeting on 23.01.2025, where the company clarified that “Para 11(3) insists for ‘Therapeutic Rationale’ and not ‘therapeutic advantage’”, challenging the earlier interpretation used to reject the plea.
Sun Pharma further argued that its dual-chamber pack represents “a significant advancement over existing market options, offering an innovative delivery mechanism, ease of use, suitability for pediatric patients, helping in reducing reconstitution error or improving compliance, with 'unique packaging' ensuring 'dosage compliance' as stipulated in Para 11(3) of DPCO, 2013.”
The MDC considered these submissions and directed the company to submit supporting documentation and present the case in the next meeting. Sun Pharma complied via a detailed response dated 17.02.2025, followed by a presentation at the 66th MDC meeting held on 03.03.2025.
However, after hearing the company’s arguments, the Committee once again referred to the scope of Para 11(3), stating, “Para 11(3) may be invoked in case of injections or inhalation or any other medicine for which dosage form or strength or both are not specified in the Schedule-I.”
It then made its final determination, “The applied formulation is an oral suspension and the dosage & strength of the same is mentioned in the Schedule-I. Therefore, the current application does not fall in the purview of Para 11(3). Hence, the committee recommended to reject the application.”
The provision of the Para 11(3) of the DPCO, 2013 read as below:
(3) Notwithstanding anything contained in sub-paragraph (1) and (2), in the case of injections or inhalation or any other medicine for which dosage form or strength or both are not specified in the Schedule-I of the Drugs (Prices Control) Order, 2013, the Government may fix and notify separate ceiling price or retail price for such formulations with specified 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, conforming to Indian Pharmacopeia or other standards as specified in the Drugs and Cosmetics Act, 1940 (23 of 1940) and the rules made thereunder for the same formulation.
