The National Pharmaceutical Pricing Authority (NPPA) has approved a 15% increase in the ceiling price of Ciprofloxacin Injection 200mg/100ml for M/s Aculife Healthcare Pvt. Ltd., due to the special features of their packaging. This order was issued on June 14, 2024.
Ciprofloxacin Injection 200mg/100ml is a scheduled formulation under Schedule-I of the Drug Price Control Order (DPCO), 2013, with a fixed ceiling price. M/s Aculife Healthcare Pvt. Ltd. applied for a separate ceiling price, citing the unique attributes of their product, which includes Aseptic Blow Fill Seal (ABFS) process, Low Density Polyethylene Plastic, self-sealability, self-collapsibility, and a Precise Pressure Dosing System.
The Multidisciplinary Committee of Experts reviewed this application in its 52nd, 53rd, 55th, 56th, 57th, and 59th meetings, held on various dates between July 2023 and May 2024. The Committee acknowledged the special features of the packaging and recommended a 15% price increase above the existing ceiling price for this specific formulation.
Following the committee’s recommendation, the NPPA, in its 124th Authority meeting on June 7, 2024, accepted the proposed price adjustment.
This decision will set a new ceiling price for Ciprofloxacin Injection 200mg/100ml as manufactured by M/s Aculife Healthcare Pvt. Ltd., detailed in Table ‘A’ of the official notification. The revised ceiling price is exclusive of applicable Goods and Services Tax.
This adjustment aims to recognize the innovative packaging efforts by Aculife Healthcare and ensure the availability of advanced formulations in the market.
NPPA has also announced new ceiling prices for Ciprofloxacin Injection 200mg/100ml, applicable exclusively to the manufacturers listed in Table B of the official notification.
Key Points of the New Pricing Regulation
Manufacturer Compliance: M/s Aculife Healthcare Pvt. Ltd., whether selling branded or generic versions of Ciprofloxacin Injection 200mg/100ml, must not exceed the ceiling price of Rs. 0.23/ ml (plus applicable Goods and Services Tax). Prices for all such formulations must be revised downward if they exceed the set ceiling price plus local taxes.
Goods and Services Tax: Manufacturers may add GST only if it has been paid or is payable to the government based on the ceiling price in Table A.
Price List Issuance: Manufacturers must issue a price list in Form-V in accordance with paragraph 24 of the DPCO, 2013, effective from the date of this notification.
Retailer and Dealer Obligations: Retailers and dealers are required to display the price list and any supplementary price lists provided by manufacturers prominently on their premises, ensuring easy access for customers.
Application for Separate Ceiling Price: Other manufacturers seeking a separate ceiling price for Ciprofloxacin Injection 200mg/100ml with special packaging features must apply to the NPPA for approval.
Specific Price Approval for Special Features: Manufacturers must approach the NPPA for specific price approval for formulations with other special features or different pack sizes.
Approval for New Drugs: Existing manufacturers launching new drugs with the same dosage or strength must apply for prior price approval from the NPPA using Form I, as outlined in Schedule-II of the DPCO, 2013.
Quarterly Reporting: Manufacturers must submit quarterly returns to the NPPA regarding the production, import, and sale of scheduled formulations in Form-III of Schedule-II of the DPCO, 2013. Any intent to discontinue production must be reported six months in advance using Form-IV.
Penalties for Non-Compliance: Manufacturers not adhering to the ceiling prices will be required to deposit the overcharged amount with interest, as per the provisions of the DPCO, 2013 and the Essential Commodities Act, 1955.
