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    Relief to Foreign Drugmakers: No price cap on innovative drugs for first five years

    Farhat NasimWritten by Farhat Nasim Published On 2019-01-05T10:44:25+05:30  |  Updated On 16 Aug 2021 5:31 PM IST

    New Delhi: Through a recent Gazette notice the Central Government has made amendments to the Drugs Prices Control Orders (DPCO),2013 which aim to exempt novel/innovative drugs developed and manufactured overseas from price control. The exemption of these drugs would commence from the date of its commercial marketing by the manufacturer in the country and would continue for a period of first 5 years. Besides innovative drugs, DPCO has also exempted orphan drugs.


    The amendments come in the form of addition and substitutions to the Paragraph 32 of the said order that talks about non application of DPCO in certain cases


    sub-paragraph(i) of the said said section focuses on the non-application of the provision to "a manufacturer producing a new drug patented under the Indian Patent Act, 1970 (39 of 1970) (product patent) and not produced elsewhere, if developed through indigenous Research and Development, for a period of five years from the date of commencement of its commercial production in the country."


    In Drugs Price Control Amendment Order,2019 effective from 03 January 2019 paragraph 32, sub-paragraph(i) has been substituted namely,




    "a manufacturer producing a new drug patented under the Indian Patent Act, 1970 (39 of 1970), for a period of five years from the date of commencement of its commercial marketing by the manufacturer in the country."



    With this latest amendment, drugs manufactured and marketed abroad will also be exempted from price control for five years. The exemption of innovative drugs would commence from the date of its commercial marketing by the producer in the country. Earlier as per DPCO 2013, drugs produced within the country was exempted from price control for five years.


    In addition to this, the amendment has also inserted in the following sub-paragraph after sub-paragraph (iii), 32, DPCO 2013, in the list of non applications of DPCO namely,




    " Drugs for treating orphan diseases as decided by the Ministry of Health and Family Welfare, Government of India."



    Orphan drugs are highly expensive drugs produced to treat rare diseases.


    Also Read: Government forms panel to make drugs more affordable

    Advanced Medical Technology AssociationamtaCoronary StentsDPCOdrugsdrugs price control ordersEssential Commodities Actessential commodities act 1955foreign drug companiesgovt of indiaindian govtindian patent actindian patent act 1970innovative drugsknee replacement implantsmedicinesMinistry of Chemicals and Fertilizersorphan drugspharmapharmaceuticalprice capPrice Controlschedule 1scheduled drugus tradeUSTR
    Source : With input

    Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

    Farhat Nasim
    Farhat Nasim

      Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here

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