DRUG REGISTRATION SERVICES
Services for New Drug Approval (NDA)
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.
Under the notified rules, “New drug” means,―
- A drug, including active pharmaceutical ingredient or phytopharmaceutical drug, which has not been used in the country to any significant extent, except in accordance with the provisions of the Act and the rules made thereunder, as per conditions specified in the labeling thereof and has not been approved as safe and efficacious by the Central Licencing Authority with respect to its claims; or
- A drug approved by the Central Licencing Authority for certain claims and proposed to be marketed with modified or new claims including indication, route of administration, dosage and dosage form; or
- A fixed dose combination of two or more drugs, approved separately for certain claims and proposed to be combined for the first time in a fixed ratio, or where the ratio of ingredients in an approved combination is proposed to be changed with certain claims including indication, route of administration, dosage and dosage form; or
- A modified or sustained release form of a drug or novel drug delivery system of any drug approved by the Central Licencing Authority; or
- A vaccine, recombinant Deoxyribonucleic Acid (r-DNA) derived product, living modified organism, monoclonal antibody, stem cell derived product, gene therapeutic product or xenografts, intended to be used as drug.
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.
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RULE 122A |
Application for permission to import new drug |
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RULE 122B |
Application for approval to manufacture new drug |
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RULE 122 D |
Permission to import or manufacture fixed dose combination |
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RULE 122DA |
Application for permission to conduct clinical trials for New Drug/Investigational New Drug. |
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RULE 122 DD |
Registration of Ethics Committee |
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RULE 122 DAC |
Permission to conduct clinical trial |
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Rule 122 E |
Definition of New Drugs |
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SCHEDULE Y |
Requirements and Guidelines for Permission to Import/and Or Manufacture of New Drugs For Sale or to Undertake Clinical Trials |
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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 |
Import of New Drugs in India
Overview of Application Forms,Licenses & Applicable Fees in case of an Imported new drugs as well as new drug manufactured in India are clearly prescribed in theNew Drugs and Clinical trial Rules 2019.
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APPLICATION FORM |
APPROVAL FORM |
DESCRIPTION |
GOVERNMENT FEE |
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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/- |
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CT-18 (APPLICATION FOR GRANT OF PERMISSION TO IMPORT NEW DRUG FOR SALE OR FOR DISTRIBUTION) |
CT 19 (PERMISSION TO IMPORT NEW ACTIVE PHARMACEUTICAL INGREDIENT FOR SALE OR FOR DISTRIBUTION) |
Any person who intends to import new drug in the form of active pharmaceutical ingredient or pharmaceutical formulation, as the case may be, for sale or for distribution in India, shall make an application to obtain a permission from the Central Licencing Authority in Form CT-18 along with a fee as specified in the Sixth Schedule. |
INR 5,00,000/- |
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CT-18 (APPLICATION FOR GRANT OF PERMISSION TO IMPORT NEW DRUG FOR SALE OR FOR DISTRIBUTION) |
CT 20 (PERMISSION TO IMPORT PHARMACEUTICAL FORMULATIONS OF NEW DRUG FOR SALE OR FOR DISTRIBUTION) |
After Scrutiny of documents, CDSCO Shall grant the permission to import new drug, in the form of active pharmaceutical ingredient for sale or for distribution in Form CT-19 or pharmaceutical formulation for sale or for distribution in Form CT-20, as the case may be, within a period of ninety working days from the date of receipt of its application in Form CT-18 |
INR 5,00,000/- |
Manufacture of New Drugs in India
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APPLICATION FORM |
APPROVAL FORM |
DESCRIPTION |
GOVERNMENT FEE |
|
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/- |
|
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CT-21 APPLICATION FOR GRANT OF PERMISSION TO MANUFACTURE NEW DRUG FORMULATION FOR SALE OR FOR DISTRIBUTION) |
CT-22 PERMISSION TO MANUFACTURE NEW ACTIVE PHARMACEUTICAL INGREDIENT FOR SALE OR FOR DISTRIBUTION) |
A person who intends to manufacture new drug in the form of active pharmaceutical ingredient or pharmaceutical formulation, as the case may be, for sale or distribution, shall make an application for grant of permission to the Central Licencing Authority in Form CT-21 along with a fee as specified in the Sixth Schedule |
Rs-5,00,000/- |
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CT-21 APPLICATION FOR GRANT OF PERMISSION TO MANUFACTURE NEW DRUG FORMULATION FOR SALE OR FOR DISTRIBUTION) |
CT-23 (PERMISSION TO MANUFACTURE PHARMACEUTICAL FORMULATION OF NEW DRUG FOR SALE OR FOR DISTRIBUTION) |
After Scrutiny of documents, CDSCO Shall grant permission to manufacture new drug, in the form of active pharmaceutical ingredient for sale or for distribution in Form CT-22 or pharmaceutical formulation for sale or for distribution in Form CT-23, as the case may be, within a period of ninety working days from the date of receipt of its application in Form CT-21 |
Rs-5,00,000/- |
Phyto-pharmaceutical drugs
A person intends to market phyto-pharmaceutical drugs shall make an application in CT-18 to the Central Licencing Authority along with data specified in Table 4 of the Second Schedule and it shall be accompanied with a fee as specified in the Sixth Schedule.
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.
