NPPA authority rejects Sun Pharmaceuticals application for separate ceiling price for Antibiotic Suspension Dual Chamber Pack with novel technology

New Delhi: Observing that there is no data or evidence in the survey report that shows reduction in reconstitution time and spillage as claimed, the National Pharmaceutical Pricing Authority (NPPA) in its authority meeting has rejected the application presented by the drug major Sun Pharmaceuticals Industries for a separate ceiling price for scheduled formulation of Amoxicillin 200 mg Clavulanic acid 28.5 mg suspension in a Dual Chamber Pack with Novel Technology.

This came after the authorities deliberated on application to fix a separate ceiling price under paragraph 11(3) of DPCO-2013, of a scheduled formulation of Amoxicillin 200 mg + Clavulanic acid 28.5 mg suspension in a dual chamber pack with novel technology, being introduced in India for the first time, at the 256th authority meeting, which is the 124th meeting under the DPCO, 2013, held on June 7, 2024, under the Chairmanship of Shri Kamlesh Kumar Pant, Chairman, NPPA.

Sun Pharmaceuticals Industries has sought additional price for dual chamber pack over and above existing ceiling price.

The Authority noted the application filed by Sun Pharmaceuticals Industries Limited on 29.09.2023 for fixation of separate ceiling price for scheduled formulation of Amoxicillin 200 mg Clavulanic acid 28.5 mg suspension in a Dual Chamber Pack with Novel Technology under para 11(3) of DPCO, 2013.

Para 11(3) of DPCO, 2013, states,

"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."

In connection with the above, it was noted that the current applicable ceiling price of this formulation is Rs 2.02 per ml and that additional price of Rs.0.34 per ml over the ceiling price has been sought by the applicant on account of novel pack, dose accuracy, hygiene, better efficacy, lesser reconstitution time and no spillage while administering the drug.

The Authority noted that the matter was deliberated in 56th, 57th& 59th meeting of the Multidisciplinary Committee (MDC) held on 20.12.2023, 27.02.20248 08.05.2024 respectively. The representatives of the company gave detailed presentation before the MDC in the 57th meeting held on 27.02.2024 and also attended the 59th MDC meeting through video conferencing.

The Authority also noted that the applicant was asked by MDC in the 57th meeting to submit the Published literature / clinical study / evidence that the dual chamber pack helps in reducing the clinical error or improved compliance as claimed by the applicant.

However, the applicant stated that this kind of novel pack is not available anywhere in the world, therefore no published literature on this novel pack is available nationally or internationally and submitted a self-commissioned survey report dated 28.06.2023.

The MDC in the 59th meeting examined the submissions made by the applicant and observed that there is no data / evidence in the survey report that shows reduction in reconstitution time and spillage as claimed and applicant has not provided any evidence/supporting documents towards improved efficacy of the product due to innovative packaging. Accordingly, the MDC recommended rejecting the application.

In line with the above, the Authority deliberated upon the matter in detail and accepted the recommendation of MDC and accordingly rejected the application of company to fix a separate ceiling price for their scheduled formulation of Amoxicillin 200 mg and Clavulanic acid 28.5 mg suspension in a Dual Chamber Pack with novel technology.

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