NPPA Authority rejects Abbott Healthcare's application for separate retail price for Flagyl Gel with soft tip applicator
New Delhi: Noting the company did not submit any published literature/ clinical study/ evidence in support of the claim, the National Pharmaceutical Pricing Authority (NPPA) has rejected the drug major Abbott Healthcare's application for a special retail price for the product "Flagyl Gel with Soft Tip Applicator" under Paragraph 11(3) of the Drug Price Control Order (DPCO), 2013.
This came after the authorities deliberated on the application received for special retail price for the product "Flagyl Gel with Soft Tip Applicator" under Paragraph 11(3) of the Drug Price Control Order (DPCO), 2013, for incremental innovation, 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.
The Authority noted that retail price for the formulation "Chlorhexidine Gluconate solution IP eq. to Chlorhexidine 1% w/w Metronidazole Benzoate IP eq. to metronidazole 1% w/w + Lignocaine Hydrochloride 2%w/w gel" has already been fixed for M/s Abbott Healthcare Pvt. Ltd. at Rs. 3.75 per gm vide SO No. 2123 (E) dated 04.05.2023.
Abbott Healthcare Pvt. Ltd. has applied for a special price under para 11(3) on account of Incremental Innovation for the same formulation titled "Flagyl Gel with Soft Tip Applicator" under para 11(3) of DPCO, 2013 vide application dated 25.10.2023.
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."
Furthermore, the authority observed that the applicant has claimed special features like hands-free application, targeted application, mitigating cross contamination and spreading of bacteria, non-messy and controlled dispensing and improved compliance as the special features of the product.
The applicant has also mentioned that the design of the Soft Tip Applicator has been registered with the Office of CGPTD. It was noted that the applicant has claimed an additional cost of Rs. 25/- per Soft Tip Applicator + Shoulder Cap.
i. Published literature/clinical study, or evidence that the applicator helps in administering the drug to improve the compliance of patients, compared to the same drug without the applicator.
ii. If the evidence for the benefit of the applicator is only in a subset of patients, the company may provide this detail.
iii. Comments regarding whether the applicator would be classified as a medical device.
iv. The quantum of the residual drug in the applicator.
v. Why this applicator needs to be sold with the drug itself? It is more like additional/optional package item that can be sold separately.
VI. Data with respect to bacterial load on multiple usage duly supported with clinical data
The Authority also mentioned that the Committee examined the submissions made by the applicant vide letter dated 02.04.2024 and it was held that the applicant had submitted a Patent application filed for European and US Patent but did not submit any Published literature/ clinical study/ evidence in support of the claim.
The MDC also did not find the report titled "A Day on the Field with our Sales force (Oro Care)" submitted by the company as satisfactory.
In addition to the above, the authority stated that the applicant has informed MDC that the applicator is designed to create a "drug-device combination".
Accordingly, MDC stated that a 'drug-device combination' is a new drug for which a separate license is required as per NDCT rules 2019. However, the applicant has not submitted the same. Accordingly, the MDC deliberated upon the submissions of the company and rejected the claim.
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