NPPA Relief: Sun Pharma anti-cancer drug Gemcitabine gets price control exemption

New Delhi: Through a recent order, the apex drug price regulator, National Pharmaceutical Pricing Authority (NPPA) has exempted drugmaker, Sun Pharmaceuticals Ltd.'s (Sun Pharma) oncology drug Gemcitabine Hydrochloride Injection from price control citing that the drug fulfils the criterion of a new drug under Para 32 of the Drug Price Control Order.

Under paragraph 32 of the Drug (Price Control) Order, 2013, the NPPA can exempt drugs from price control which are either new or have a new delivery system that is developed through indigenous research.

The decision to exempt Sun Pharma's anti-cancer drug came during the 70th NPPA meeting held in October 2019, following a plea submitted by the firm. The firm sought exemption for its ready to use infusion bags Gemcitabine Hydrochloride Injection 10mg/ml (Ready to use infusion bags 1200mg/120ml, 1400mg/140ml & 1600mg/160ml) which was duly approved by the office of Central Drugs Standard Control Organisation (CDSCO) as ‘new drug’ under Rule 122(E) of the Drugs and Cosmetics Act and Rules thereunder, and patented by The Patent Office, India under the Patents Act, 1970 (Patent No. 296771 and Date of Grant: 14.05.2018).

This came after the authority deliberated upon the matter in detail and noted that the application has been received under para 32 (ii) of DPCO 2013. The imperatives of para 32(ii) of DPCO 2013 are:

• The drug should be a new drug as per the definition provided in rule 122E of the Drugs and Cosmetic Rules, 1945


• The drug is produced by a new process


• Developed through indigenous Research and Development, and


• patented under the Indian Patent Act, 1970 (process patent)

The matter was referred to the Multidisciplinary Committee of Experts that stated that the submission of the documents by the firm meets the requirements of para 32 (ii) of DPCO, 2013.

Thereafter, it was noted that the NPPA had referred the applications to Standing National Committee on Medicines for revision of NLEM (SNCM) with a request to examine the products from the perspective of any significant therapeutic advantage and increased efficacy that may merit exemption under para 32 of DPCO 2013.

Earlier NPPA had refused to give it relief in terms of price cap exemption for its anti-cancer gemcitabine hydrochloride injection from price caps set by the government. However, it had decided to refer to its application to ‘Standing National Committee on Medicines for revision of NLEM’ with a request to examine the products from the perspective of any significant therapeutic advantage and increased efficacy that may merit an exemption under para 32 of DPCO, 2013.

Also Read: Setback to Sun Pharma: NPPA refuses to give relief of price cap exemption for Gemcitabine

SNCM stated that there is no clinical study to suggest that Gemcitabine hydrochloride injection 10mg/ml (ready to use infusion bags 1200mg/120ml, 1400mg140ml and 1600mg/160 ml) offers significant therapeutic advantage and increases efficacy. The availability of gemcitabine in infusion bags is only helpful in the practical sense of administration to patients.

Recently NPPA discussed and noted that establishing significant therapeutic advantage and increased efficacy is not a requirement or pre-condition for obtaining an exemption under para 32(ii) of DPCO, 2013 and further as the company fulfils the conditions as per para 32(ii) of DPCO2013.

Subsequently, NPPA decided that exemption may be granted to Sun Pharma under para 32(ii) of DPCO, 2013 for their product Ready to use infusion bags Gemcitabine hydrochloride injection 10mg/ml (Ready to use infusion bags 1200mg/120ml, 1400mg/140ml and 1600mg/160ml).