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NPPA fixes retail price of Sun Pharma Baclofen Oral Solution


NPPA fixes retail price of Sun Pharma Baclofen Oral Solution

New Delhi: Through a recent notification, the drug price regulator, the National Pharmaceutical Pricing Authority (NPPA) has fixed the retail price of Baclofen Oral Solution manufactured by Sun Pharmaceuticals.

Baclofen is used to treat muscle spasms caused by certain conditions (such as multiple sclerosis, spinal cord injury/disease). It works by helping to relax the muscles. Baclofen Oral Solution is also indicated in adults and children for the relief of spasticity of voluntary muscle arising from e.g. cerebrovascular accidents, cerebral palsy, meningitis, traumatic head injury.

The so fixed retail price is exclusive of goods and services tax, the manufacturer may add goods and services tax(GST) only if they have paid actually or it is payable to the Government on the retail price as mentioned. The below-mentioned table summarises the detail as;

Sl.

No.

Name of the Formulation Dosage form & Strength Unit Retail Price

(Rs.)

Review Order number and

date

Existing SO number &

date

Manufacturer & Marketing

Company

(1) (2) (3) (4) (5) (6) (7) (8)
1. Baclofen      Oral Solution Each 5 ml contains: Baclofen IP 5 mg 1 ML 1.44 31015/45/2018-

Pricing dated 10.01.2019

5638(E)

dated 02.11.2018

(at Sl. No. 18)

M/s Sun Pharmaceuticals Industries Limited M/s Sun Pharma Laboratories

Ltd

The Notice further adds,

  • The manufacturer of above-mentioned formulations i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (5) of the table hereinabove.
  • The manufacturer may add goods and services tax only if they have paid actually or it is payable to the Government on the retail price mentioned in column (5) of the abovesaid table.
  • The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (5) of the above table as per provisions contained in paragraph 11 of the DPCO, 2013. The manufacturer shall issue a price list in Form–V from 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.
  • As per para 24(4) of DPCO 2013, every retailer and dealer shall display 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.
  • The above mentioned retail prices are applicable only to the manufacturer / marketer as mentioned above for generic / any brand of the same composition / strength of the subject formulations, subject to fulfilment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies.
  • In case the retail price of any of the aforesaid formulations is not complied with, as per instant price notification and notes specified hereinabove, then the concerned manufacturer/marketing company shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955.

Also Read: NPPA caps trade margins to 30per cent for 42 cancer drugs



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