DRUG REGISTRATION SERVICES
Subsequent New Drug
Effective 19 March 2019 New Drugs are regulated under New Drugs and Clinical trial Rules 2019 which ultimately fall under the ambit of Drugs & Cosmetics Act 1940 & RUles 1945.
Subsequent new drug division deals with applications for approval of an already approved new drug (within 4 years) and A drug already approved by the Licensing Authority mentioned in Rule 21 for certain claims, which is now proposed to be marketed with modified or new claims, namely,
- indications, or
- dosage, or
- dosage form (including sustained release dosage form) or
- route of administration
IMPORTANT RULES GOVERNING NEW DRUGS
Under New Drugs and Clinical Trial Rules 2019 , various sub rules have been notified which lay out a regulatory framework for enforcing regulations on New Drugs.
|
RULE 122A |
Application for permission to import new drug |
|
RULE 122B |
Application for approval to manufacture new drug |
|
RULE 122 D |
Permission to import or manufacture fixed dose combination |
|
RULE 122DA |
Application for permission to conduct clinical trials for New Drug/Investigational New Drug. |
|
RULE 122 DD |
Registration of Ethics Committee |
|
RULE 122 DAC |
Permission to conduct clinical trial |
|
Rule 122 E |
Definition of New Drugs |
|
SCHEDULE Y |
Requirements and Guidelines for Permission to Import/and Or Manufacture of New Drugs For Sale or to Undertake Clinical Trials |
|
GSR No. 227 (E) Dated 19th March 2019 |
Registration of new drugs, investigational new drugs for human use, clinical trial, bioequivalence study, bioavailability study and Ethics Committee |
Subsequent new drug application can be made for the following cases:
- Bulk Drug already approved in the country (approved within 4 years).
- New drug (Formulation) already approved in the country (approved within 4 years).
- A drug already approved and proposed to be marketed with new indication.
- A drug already approved and proposed to be marketed as a ‘New Dosage Form/ New Route of Administration’.
- A drug already approved and proposed to be marketed as a ‘Modified release dosage form’.
- A drug already approved and proposed to be marketed with additional strength
Application Form :
Subsequent New Drug for Import
|
Form Applied |
Approval Received |
Government Fees |
|
Form CT-04 Application For Grant Of Permission To Conduct Clinical Trial Of New Drug Or Investigational New Drug |
Form CT-06 Permission To Conduct Clinical Trial Of New Drug Or Investigational New Drug |
Rs-50,000/- |
|
Form CT-16 Application For Grant Of Licence To Import New Drug Or Investigational New Drug For Clinical Trial Or Bioavailability Or Bioequivalence Study Or For Examination, Test And Analysis |
Form CT-17 Licence To Import New Drug Or Investigational New Drug For The Purpose Of Clinical Trial Or Bioavailability Or Bioequivalence Study Or For Examination, Test And Analysis |
Rs-5000/- Per Product |
|
Form CT-18 Application For Grant Of Permission To Import New Drug For Sale Or For Distribution |
Form CT-20 Form CT-19 |
Rs-5,00,000/- Rs-5,00,000/- |
Subsequent New Drug for Manufacturer
|
Form Applied |
Approval Received |
Government Fees |
|
Form CT-04 Application For Grant Of Permission To Conduct Clinical Trial Of New Drug Or Investigational New Drug |
Form CT-06 Permission To Conduct Clinical Trial Of New Drug Or Investigational New Drug |
Rs-50,000/- |
|
Form CT-10 Application For Grant Of Permission To Manufacture New Drug Or Investigational New Drug For Clinical Trial Or Bioavailability Or Bioequivalence Study Or For Examination, Test And Analysis |
Form CT-11 Permission To Manufacture New Drug Or Investigational New Drug For Clinical Trial, Bioavailability Or Bioequivalence Study Or For Examination, Test And Analysis |
Rs-5000/- Per Product |
|
Form CT-12 Application For Grant Of Permission To Manufacture Formulation Of Unapproved Active Pharmaceutical Ingredient For Test Or Analysis Or Clinical Trial Or Bioavailability Or Bioequivalence Study |
Form CT-15 Permission To Manufacture Unapproved Active Pharmaceutical Ingredient For The Development Of Formulation For Test Or Analysis Or Clinical Trial Or Bioavailability Or Bioequivalence Study |
Rs-5000/- Per Product |
|
Form CT-13 Application For Grant Of Permission To Manufacture Unapproved Active Pharmaceutical Ingredient For Development Of Formulation For Test Or Analysis Or Clinical Trial Or Bioavailability Or Bioequivalence Study |
Form CT-15 Permission To Manufacture Unapproved Active Pharmaceutical Ingredient For The Development Of Formulation For Test Or Analysis Or Clinical Trial Or Bioavailability Or Bioequivalence Study |
Rs-5000/- Per Product |
|
Form CT-21 Application For Grant Of Permission To Manufacture New Drug Formulation For Sale Or For Distribution |
Form CT-22 Permission To Manufacture New Active Pharmaceutical Ingredient For Sale Or For Distribution Form CT-23 Permission To Manufacture Pharmaceutical Formulation Of New Drug For Sale Or For Distribution |
Rs-5,00,000/- Rs-5,00,000/- |
Why NKG for Drug Regulatory Services
Our team works efficiently to ensure timely communication of documents and submission so that clients can obtain permissions smoothly.
NKG experts are well versed with dossiers for registration under the New Drugs & Clinical Trial Rules 2019 . Our team makes the process of filing and approval under these rules efficient and predictable.
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NKG has a Dedicated and Efficient team of experienced regulatory professionals who have Registered more than 2000 brands until now who can help you Plan your regulatory needs and smoothen the process for Regulatory approvals. Strategically located in New Delhi, the “regulatory “ capital of India, NKG makes a head start by following its unique time tested “Step-by- Step “ process that puts a lot of method in between the madness.
