NPPA Sets Retail Price For Sun Pharma’s Gemcitabine Injections

New Delhi: The National Pharmaceutical Pricing Authority (NPPA), acting on the recommendations of its Multidisciplinary Committee of Experts (MDC), has fixed the retail prices of Gemcitabine Hydrochloride IP eq. to Gemcitabine 10 mg plus Sodium Chloride IP 9 mg Injection manufactured by Sun Pharmaceutical Industries and marketed by Sun Pharma Laboratories.

The matter was deliberated during the MDC meeting, which examined retail price fixation of ‘Each ml contains: Gemcitabine Hydrochloride IP eq. to Gemcitabine 10 mg + Sodium Chloride IP 9 mg Injection’ for Sun Pharmaceutical Industries Ltd (Manufacturer) and Sun Pharma Laboratories (Marketer).

The Committee noted that Sun Pharmaceutical Industries Ltd. was granted exemption from the provisions of DPCO, 2013 under Para 32(ii) for the brand “GEMTAZ INFUSMART,” i.e., Gemcitabine ready-to-use infusion bags 10mg/ml (1200mg/120ml, 1400mg/140ml, 1600mg/160ml) vide S.O. 4064(E) dated 08th November, 2019 for a period of five years from the date of the commencement of its commercial production in the country, i.e., December 2020.

It was also noted that data on the formulation of Gemcitabine ready-to-use infusion bags 10 mg/ml is available with respect to the applicant company only.

It was also noted that ‘Gemcitabine Powder for Injection 1000mg’ is a scheduled formulation and the Ceiling Price applicable six months prior to the date of application, i.e., April 2025, is Rs.5689.88 per vial (SO. 1489(E) dated 27.03.2025).

The Committee deliberated on the matter and recommended the retail price as below:

Note-1:

(i) The retail price of Gemcitabine Hydrochloride Injection 1200 mg/120 mL (i.e. 10 mg/ml) solution based on formula recommended in the Pronab Sen Committee report is as below:

Derived retail price as per recommendation of Pronab Sen Committee:

P(s) = P*[1+a.{(s-s*)/s*}]

Where P(s) = Price ceiling of the strength s

P*= Price ceiling for reference strength s*

s = strength in terms of API content

s*=reference strength

A= 0.8 for tablet / capsule and 0.7 for injectables.

=5689.88 [1+0.7{(1200-1000)/1000}]

=Rs. 6486.46 per Pack (excluding GST)

The retail price of Gemcitabine Hydrochloride Injection 1200 mg/120 mL (i.e. 10 mg/ml) is Rs. 6486.46 per Pack (excluding GST)

Note-2:

The retail price of Gemcitabine Hydrochloride Injection 1400 mg/140 mL (i.e. 10 mg/ml) solution based on formula recommended in the Pronab Sen Committee report is as below:

Derived retail price as per recommendation of Pronab Sen Committee:

P(s) = P*[1+a.{(s-s*)/s*}]

Where P(s) = Price ceiling of the strength s

P*= Price ceiling for reference strength s*

s = strength in terms of API content

s*=reference strength

A= 0.8 for tablet / capsule and 0.7 for injectables.

=5689.88 [1+0.7{(1400-1000)/1000}]

=Rs. 7283.05 per Pack (excluding GST)

The retail price of Gemcitabine Hydrochloride Injection 1400 mg/140 mL (i.e. 10 mg/ml) is Rs. 7283.05 per Pack (excluding GST)

Note-3:

The retail price of Gemcitabine Hydrochloride Injection 1600 mg/160 mL (i.e. 10 mg/ml) solution based on formula recommended in the Pronab Sen Committee report is as below:

Derived retail price as per recommendation of Pronab Sen Committee:

P(s) = P*[1+a.{(s-s*)/s*}]

Where P(s) = Price ceiling of the strength s

P*= Price ceiling for reference strength s*

s = strength in terms of API content

s*=reference strength

A= 0.8 for tablet / capsule and 0.7 for injectables.

=5689.88 [1+0.7{(1600-1000)/1000}]

=Rs. 8079.63 per Pack (excluding GST)

The retail price of Gemcitabine Hydrochloride Injection 1600 mg/160 mL (i.e. 10 mg/ml) is Rs. 8079.63 per Pack (excluding GST).