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Ref: PXL/H.O./CIR-121/2015-16 Date: 02.02.2016
Hyderabad
Subject: Notification issued by MoH inviting public comments: G.S.R.1011 (E) dated 29.12.2015 of Minister of Health& Family Welfare regarding amendment in Drugs & Cosmetics Act, relating to fee structure
We would like to inform member companies that Ministry of Health and Family Welfare has issued a notification dt:29.Dec.2015 inviting comments from public, indicating increase in the fee structure for new approvals, renewals etc. The notification has given a period of 45 days for public comments from the date of issue i.e 29.Dec.2015 and last date for submission of your comments is 12.Feb.2016.
The government has proposed hike in regulatory fees for testing, manufacturing and selling medicines in the country, a move that is likely to have significant adverse impact both domestic and export sectors.
Some of the significant changes in the fees structure are given below:
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Rule
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Type of Application
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Current Fee
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Proposed Fee
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69.2.2
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Grant/Renewal of Manufacturing License(Form 25/Form 28)
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INR 6000 and inspection fee of INR 1500
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INR 50000 and inspection fee of INR 1500
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24.1
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Application Form for Import License-Form 8
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INR 1000 for single Drug
Additional drug INR 100
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INR 10000 for single drug
Additional drug INR 1000
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24.3
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Duplicate copy of Import License
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INR 250
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INR 1500
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24A.3
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Registration Fee for Premises-Form 40
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USD 1500
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USD 10,000
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24A.3.2
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Drug Registration (Form 40)
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USD 1000 for a single drug
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USD 5000 for a single drug
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24A.3.5
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Inspection of the Manufacturing Premises
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USD 5000
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USD 25000
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24A.3.7
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Duplicate copy of the Registration certificate
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USD 300
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USD 1800
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34.3
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(Form 12)-Application for license for examination ,test or analysis
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INR 100 for 1st drug
INR 50 for additional
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INR 5000 for 1st drug
INR 2000 for additional
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34.A.3
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(Form 12 AA)-Application for license to import small quantities of new drugs
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INR 100 for single drug
INR 50 for additional
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INR 600 for single drug
INR 300 for additional
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122A.1.b
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Grant of permission to import new drug-Form 44
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INR 50,000
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INR 250,000
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122B.1.b
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Grant of permission to manufacture new drug-Form 44
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INR 50,000
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INR 250,000
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122D
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Permission to import or manufacture fixed dose combinations
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INR 15,000
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INR 1,00,000
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122DA.a
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Clinical Trial (Phase 1)
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INR 50,000
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INR 250,000
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122DA.b
& 122DA.c
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Clinical Trial (Phase 2, 3)
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INR 25000
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INR 250,000
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Pharmexcil is proposing to send representation on the subject matter to Ministry of Health & Family Welfare. Members are requested to send their inputs/suggestions to dgdesk@pharmexcil.com for taking up the matter with MoH. It is also advised to send your comments through post to Under Secretary, Ministry of Health and Family Welfare, Government of India, Nirman Bhawan, New Delhi- 110011
A copy of the notification is linkedfor your information.
With regards,
Dr.P.V.Appaji
Director General |
