NPPA Fixes Ceiling Price of Latanoprost drop

The ceiling price for Latanoprost Drops 0.005% has been set at Rs.232.57 per ml. This came in line with the decision of the 113th Authority meeting on 26th May 2023.

Latanoprost is in a class of medications called prostaglandin analogs. Latanoprost ophthalmic is used to treat glaucoma, a condition in which increased pressure in the eye can lead to gradual loss of vision, and ocular hypertension, a condition that causes increased pressure in the eye.

The notice stated, "The National Pharmaceutical Pricing Authority (NPPA) was established vide Resolution No. 33/7/97-PI.I dated 29th August 1997 of the Government of India in the Ministry of Chemicals and Fertilizers to fix/revise, monitor prices of drugs/formulations and oversee the implementation of the Drugs (Prices Control) Order (hereinafter referred as DPCO); and the Government of India by S.O. 1349(E) dated 30th May 2013 in the exercise of the powers conferred by Section 3 and 5 of the Essential Commodities Act, 1955 (10 of 1955) has delegated the powers in respect of paragraphs 4,5,6,7,8,9,10,11,12,13,14,15,16,18,19, 20,21,23,24,25,26,27,28,29,30 and 32 of the DPCO, 2013 to the NPPA to exercise the functions of the Central Government."

Furthermore, the notification added, "The Department of Pharmaceuticals (hereinafter referred to as DOP) has amended Schedule I of the DPCO 2013 vide S.O. 5249(E) dated 11.11.2022 based on National List of Essential Medicine (hereinafter referred to as NLEM 2022)."

"Under the revised Schedule I, certain new formulations have been added. In respect of some of these formulations, high Inter brand variation within the same company has been observed. The matter was deliberated in the 111th Authority meeting and based on reasons detailed in S. O. 1579(E) dated 31.03.2023, the ceiling prices of such formulations have been fixed under Para 19 of DPCO 2013 and notified vide the said notification. Similar inter-brand price variation has been observed in the case of the scheduled formulation “Latanoprost Drops 0.005%”. The matter has been deliberated in the 113th Authority meeting and based on reasons as detailed in S.O. 1579(E) dated 31.03.2023, the Authority has approved the ceiling price of the said formulation under Para 19 of DPCO 2013", the notification further added." the notice further stated.

Additionally, the notice stated that in the exercise of the powers conferred by paragraphs 19 of the DPCO, 2013, read with S.O. 1394(E) dated the 30th May 2013 issued by the Government of India in the Ministry of Chemicals and Fertilizers, the NPPA hereby fixes the ceiling prices exclusive of goods and services tax applicable, if any, as specified in column (5)of the table in respect of the Scheduled formulations specified in the corresponding entry in column (2) of the said Table with the dosage form &strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof:

The notification further added,

(a) All manufacturers of Latanoprost Drops 0.005%, selling the branded or generic or both versions of Latanoprost Drops 0.005%, at a price higher than the ceiling price (plus Goods and Services Tax as applicable) so fixed and notified by the Government, shall revise the prices of the said scheduled formulation downward not exceeding the ceiling price specified in column (5) in the above table plus goods and services tax as applicable, if any.

(b) All the existing manufacturers of the above-mentioned scheduled formulation having MRP lower than the ceiling price specified in column (5) in the above table plus GST as applicable, if any, shall continue to maintain the existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013.

(c) The manufacturers may add goods and services tax only if they have paid actually or if it is payable to the Government on the ceiling price mentioned in column (5) of the above-said table.

(d) Information about the revision, if carried out, shall be forwarded to the Government in either electronic or physical form in Form-II within a period of fifteen days of such revision and non-submission of information under this subparagraph shall be construed as non-revision of maximum retail price (MRP) and the concerned manufacturer shall be liable to deposit the amount charged over and above the pre- revised maximum retail price (MRP), alongwith interest thereon from the date of overcharging.

(e) The ceiling price for a pack of the scheduled formulation shall be arrived at by the concerned manufacturer in accordance with the ceiling price specified in column (5) of the above table as per provisions contained in paragraph 11 of the Drugs (Prices Control) Order, 2013. The manufacturer shall issue a price list in Form–V from the date of Notification as per paragraph 24 of the DPCO, 2013 to NPPA through IPDMS and submit a copy to State Drug Controller and dealers.

(f) As per para 24(4) of DPCO 2013, every retailer and dealer shall display the price list and the supplementary price list, if any, as furnished by the manufacturer, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same.

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