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DoP asks NPPA to examine review applications filed by various pharma cos against NPPA's price fixation

Ramesh Shankar, Mumbai
Tuesday, May 10, 2016, 08:00 Hrs  [IST]

The Department of Pharmaceuticals (DoP) has directed the national drug price regulator National Pharmaceutical Pricing Authority (NPPA) to examine the review applications filed by various pharma companies against the ceiling prices fixed by the NPPA vide their notifications S.O. No. 2863 (E) dated 20,09.2013, S.O. No. 3127 (E) dated 10.12.2014 and S.O. No.3131(E) dated 10th December, 2014.

The affected drugs included the scheduled medicines Glucose (Dextrose) injection (5%w/v), Glucose (Dextrose) (5% w/v) + Normal Saline (Sodium Chloride) (0.9% w/v) Injection and Normal Saline (Sodium Chloride) injection (0.9%).

Earlier several companies had filed several review applications against the NPPA under Para 31 of DPCO, 2013. Fresenius Kabi India filed the review petition dated 7.1.2015 against notification No. S.O. 3127(E) dated 10.12.2014 fixing ceiling price of scheduled medicine "Glucose (Dextrose) injection (5%w/v), Glucose (Dextrose) (5% w/v) + Normal Saline (Sodium Chloride) (0.9% w/v) Injection and Normal Saline (Sodium Chloride) injection (0.9%).

Amanta Healthcare filed the petition dated 29.12.2014 against notification No. S.O. 3127(E) dated 10.12.2014 fixing ceiling price of scheduled medicine "Dextrose injection (5%w/v), Sodium Chloride Injection (0.9%) and Sodium Chloride (0.9% w/v) and Dextrose (5% w/v) Injection.

B.Braun Medical (India) filed the petition dated 18.10.2013 against notification No. S.O. 2863(E) dated 20.9.2013 fixing ceiling price of scheduled medicine 'Ringer Lactate Injection'. It also filed a petition dated 7.1.2015 against notification No. S.O. 3127(E) dated 10.12.2014 fixing ceiling price of scheduled medicine Glucose (Dextrose) injection (5%w/v), Glucose (Dextrose) (5% w/v) + Normal Saline (Sodium Chloride) (0.9% w/v) Injection and Normal Saline (Sodium Chloride) injection (0.9%).

Claris Otsuka filed the petition dated 8.1.2015 against notification No. S.O. 3127(E) dated 10.12.2014 fixing ceiling price of scheduled medicine Glucose (Dextrose) injection (5%ow/v), Glucose (Dextrose) (5% w/v) + Normal Saline (Sodium Chloride) (0.9% w/v) Injection and Normal Saline (Sodium Chloride) injection (0.9%).

Shree KrishnaKeshav Laboratories had also filed a petition dated 29.12.2014 against notification No. S.O. 3127(E) dated 10.12.2014 fixing ceiling price of scheduled medicine Glucose (Dextrose) injection (5%w/v), Glucose (Dextrose) (5% w/v) + Normal Saline (Sodium Chloride) (0.9% w/v) Injection and Normal Saline (Sodium Chloride) injection (0.9%).

Likewise, Nirma Limited (Healthcare Division) filed a Review petition dated 5.1.201 against notification No. S.O. 3127(E) dated 10.12.2014 fixing ceiling price of scheduled medicine o' Glucose (Dextrose) injection (5%ow/v), Glucose (Dextrose) (5% w/v) + Normal Saline (Sodium Chloride) (0.9% w/v) Injection and Normal Saline (Sodium Chloride) injection (0.9%).

Ahlcon Parenterals filed a petition dated 7.1.2015 against notification No. S.O. 3127(E) dated 10.12.2014 fixing ceiling price of scheduled medicine "Glucose (Dextrose) injection (5%w/v), Glucose (Dextrose) (5% w/v) + Normal Saline (Sodium Chloride) (0.9%o w/v) Injection and Normal Saline (Sodium Chloride) injection (0.9%). AXA Parenterals filed a petition dated 7.1 .2015 against notification No. s.o. 3127(E) and 3131 (E) dated 10.12.2014 and fixing ceiling price of scheduled medicine Glucose (Dextrose) injection (5%ow/v), Glucose Injection (10%), Glucose (Dextrose) (5%w/v) + Normal Saline (Sodium Chloride) (0.9%w/v) Injection and Normal Saline (Sodium Chloride) injection (0.9%).

These companies had sought the attention of the DoP to its Order No. S.O. 1192 (E) dated 22.03.2016 published in the Gazette of India Extraordinary, which inter alia provides as under: In the Drugs (Prices Control) Order, 20l3 in Paragraph-11, after sub-paragraph (2), the following sub-paragraphs shall be inserted, namely :- "(3) Notwithstanding anything contained in sub-paragraphs (l) and (2), in the case of injections or inhalation or any other rnedicine 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 specific 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 Pharmacopoeia or other standards as specified in the Drugs and Cosmetics Act, 1940 (23 of 1940) and the rules made thereunder for the same formulation. (4) The government shall form a Committee of Experts as it may deem fit, within a period of fifteen days from the date of issue of this order, to recommend fixing of separate ceiling price of scheduled formulations or retail price of a new drug as per the above parameters".

“Based on the above and other documents on record, the government has decided as under: Since the contents and issues are similar in all the above review petitions, these review petitions are disposed off with the instructions to NPPA to examine these cases in the light of this Department's Order No. S.O. 1192 (E) dated 22.03.2016”, the DoP in its order said.

 

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