NKG team has a cumulative experience of more than 50 Years in Regulatory affairs. Over years, our experts have been providing exhaustive regulatory services for registration, manufacturing and marketing permissions of drug products in India.
A new drug means;
A new drug which is a modified or sustained release form of a drug or Novel Drug Delivery System (NDDS) 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 shall continue to be a new drug forever. However, new drugs covered other than above categories shall be considered as a new drug for a period of 4 years of their approval by the CLA.
An “investigational new drug (IND)” means a new chemical or biological entity or substance that has not been approved for marketing as a drug in any country.
A subsequent new drug means 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. A subsequent new drug also includes a new drug already approved in the country
An “orphan drug” means a drug intended to treat a condition which affects not more than 5 lakh persons in India.
In India, import, manufacturing, sale, and distribution of drugs are regulated under the Drugs and Cosmetics Act 1940 and Rules 1945. At present, bulk drugs (active pharmaceutical ingredients) and finished formulations are regulated under the said Act. Any substance falling within the definition of a drug (Section 3b of the Act) is required to be registered before import into the country. Not only drugs themselves, but the actual manufacturing site manufacturing the drug product also needs to be registered for import.
The application for registration certificate and import license can be made as per the requirements of Rule 24(A) & 24 of Drugs & Cosmetics Rules 1945 to the Licensing Authority under the Act, i.e., to the Drugs Controller General (I) at CDSCO, FDA Bhawan, Kotla Road, Near Bal Bhawan, New Delhi, by the local authorized agent of the foreign manufacturer having either a manufacturing or sale license or by the foreign manufacturers having a wholesale license in the country through the online portal of CDSCO, i.e., “SUGAM.”.
The import of drugs into India is regulated under Chapter III of the Drugs & Cosmetics Act 1940 and Part IV of the Drugs & Cosmetics Rules 1945.
Effective March 19, 2019, the Ministry of Health and Family Welfare (MoHFW) has published the New Drugs and Clinical Trials Rules, 2019. These new rules will apply to all new drugs, investigational new drugs for human use, clinical trials, bioequivalence studies, bioavailability studies, and the Ethics Committee.
The rules will apply to all new drugs, investigational new drugs for human use, clinical trial, bioequivalence study, bioavailability study and Ethics Committee. The new rules will supersede Part XA and Schedule Y of Drugs and Cosmetics Rules, with immediate effect.
If there is any inconsistency between these rules and any other rule made under the Drugs & Cosmetics Act, the provisions of these rules shall prevail over such other rules. Actions taken according to the existing rules [Drugs & Cosmetics Rules, 1945] shall continue to be in effect and valid. This means existing licenses, orders, directions will continue to remain valid.
Regulations for Import and registration of Drugs will remain the same as per earlier Registrations.
Download GSR 227(E)Clear regulatory strategy and understanding of the regulatory framework of Drugs as per Drugs & Cosmetics Act 1940 is very important for successful approvals from the Licensing Authority. NKG experts work closely with Importers & Manufacturers in preparing and filing activities of regulatory dossiers. Needless to say, Our team has been an asset to our clients.
# |
Form Applied form |
Approval Recieved form |
Fees |
CDSCO |
SLA |
|---|---|---|---|---|---|
| 1 | Form 8 Application For Licence To Import Drugs (Excluding Those Specified In Schedule X) To The Drugs And Cosmetics Rules, 1945 |
Form 10 Licence To Import Drugs (Excluding Those Specified In Schedule X) To The Drugs And Cosmetic Rules, 1945 |
Rs.10000/- For One Product Rs.1000/- For Additional Product |
 |
|
| 2 | Form 8A Application For Licence To Import Drugs Specified In Schedule X To The Drugs And Cosmetics Rules, 1945 |
Form 10A Licence To Import Drugs Specified In Schedule X To The Drugs And Cosmetics Rules, 1945 |
Rs.10000/- For One Product Rs.1000/- For Additional Product |
|
|
| 3 | Form 40 Application To Import Drugs |
Form 41 License To Import Drugs |
USD 10000 For Plant |
|
|
| 4 | Form CT-01 Application For Registration/Renewal Of Ethics Committee Relating To Clinical Trial Or Bioavailability And Bioequivalence Study Or Biomedical Health Research |
Form CT-03 Grant Of Registration Of Ethics Committee Relating To Biomedical Health Research Form CT-02 Grant Of Registration Of Ethics Committee Relating To Clinical Trial Or Bioavailability And Bioequivalence Study |
Will Confirm You Soon Not Found In Rule | |
|
| 5 | 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 |
Phase I-Rs.3,00,000/- Phase II,III & IV- Rs. 2,00,000/- |
|
|
| 6 | Form CT-05 Application For Grant Of Permission To Conduct Bioavailability Or Bioequivalence Study |
Form CT-07 Permission To Conduct Bioavailability Or Bioequivalence Study Of New Drug Or Investigational New Drug |
Rs.2,00,000/- | |
|
| 7 | Form CT-08 Application For Registration/Renewal Of Bioavailability Or Bioequivalence Study Centre |
Form CT-09 Grant Of Registration Of Bioavailability Or Bioequivalence Study Centre |
Rs.5,00,000/- | |
|
| 8 | 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 | |
|
| 9 | 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 | |
|
| 10 | 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 | |
|
| 11 | Form CT-14 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 | |
|
| 12 | 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 | |
|
| 13 | Form Ct-18 Application For Grant Of Permission To Import New Drug For Sale Or For Distribution |
Form CT-20 Permission To Import Pharmaceutical Formulations Of New Drug For Sale Or For Distribution Form CT-19 Permission To Import New Active Pharmaceutical Ingredient For Sale Or For Distribution |
Rs.5,00,000/-
Rs.5,00,000/- |
|
|
| 14 | 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/- |
|
|
| 15 | Form CT-24 Application For Licence To Import Of Unapproved New Drug For Treatment Of Patients Of Life Threatening Disease In A Government Hospital Or Government Medical Institution |
Form CT-25 Licence To Import Unapproved New Drug For Treatment Of Patients Of Life Threatening Disease In A Government Hospital Or Medical Institution |
Rs.10,000/- | |
|
| 16 | Form CT-26 Application For Grant Of Permission To Manufacture Unapproved New Drug But Under Clinical Trial For Treatment Of Patients Of Life Threatening Disease In A Government Hospital Or Medical Institution |
Form CT-27 Permission To Manufacture Unapproved New Drug But Under Clinical Trial For Treatment Of Patients Of Life Threatening Disease In A Government Hospital Or Medical Institution |
Rs.5000/- | |
|
| 17 | Renewal or Re-Registration Form 40-Application for Import of Drugs |
Form 41 License To Import Drugs |
USD 10000 For Plant USD 5000 For Product (Per Product) |
|
|
| 18 | Shelf Life Extension/Reduction | Amendment of Certificate | USD 1800 | |
|
| 19 | Personal Use Form 12A Application for the issue of a permit to import small quantities of drugs for personal use |
Form 12 B Permit for the import of small quantities of drugs for personal use |
Zero | |
|
| 20 | CT-28 Application for import of unapproved new drug for Compassionate use for treatment of patients by hospitals or and medical institution |
CT-29 Grant of licence for import of new drug for compassionate use |
N.A | |
|
| 21 | CT-30 Application for the permission to manufacture new drug for Compassionate use |
CT-31 Grant of the permission to manufacture new drug for Compassionate use |
N.A | |
IMPORTER
“Registration Certificate” means a certificate issued under Rule 27A by the licensing authority in Form 41 for registration of the premises and the drugs intended to be imported in India. CDSCO Registers Both the Product as well as the Manufacturing site from where the product has to be imported to ensure Quality of the Product.
NKG experts are well versed with dossiers for registration in Form 41 and make the process of filing and approval efficient and predictable.
Import ,Manufacturing & Distribution of Drugs is regulated under Drugs and Cosmetics Act 1940.
In case, an applicant intends to Import Drugs, an application seeking permission from CDSCO has to be Applied in Form 8 or Form 8A for approval in Form 10 and Form 10A respectively.
NKG team works efficiently to ensure timely communication of documents and submission so that clients can obtain permissions smoothly.
know more about this serviceIMPORTER MANUFACTURER
A new drug means a drug, including API , FDC or phytopharmaceutical drug, which has not been approved by DCG(I) with respect to its claims; or dosage, new claims, route of administration, modified or sustained release of a drug or novel drug delivery system, veterinary products and for vaccines, recombinant Deoxyribonucleic Acid (r-DNA) derived products, living modified organisms, monoclonal antibodies, stem cells, gene therapeutic products and xenografts which are intended to be used as drugs.
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.
NKG experts assist clients with successful approval of their New Drug applications.
know more about this serviceIMPORTER MANUFACTURER
A subsequent new drug means 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. A subsequent new drug also includes a new drug already approved in the country.
NKG experts are well versed with SND dossiers and make the process of filing and approval efficient and predictable.
know more about this serviceIMPORTER MANUFACTURER
Conducting Clinical trials in India require mandatory approvals from the Central Licensing authority i.e. CDSCO.
At NKG, we understand the procedure for the same and work closely with our clients to obtain various permissions for conducting clinical trials such as Phase I, II & III permissions.
know more about this serviceIn case, someone is in need of importing small quantities of Drugs for personal use, an application in form 12A needs to be submitted to CDSCO through the online SUGAM portal.
Trust NKG experts to handle such a situation swiftly and efficiently.
know more about this serviceThe licensing authority has clearly laid out the regulatory requirements for BA/BE in public domain. Information and details with respect to type of Drug, type of disease and corresponding study are required to be submitted to the regulator with an applicant for Export/Import of BA/BE studies.
NKG experts assist clients with successful approval of such permissions.
know more about this serviceIMPORTER MANUFACTURER
In case an importer or manufacturer intends having a valid wholesale license in form 20 B & 21 C, intends to import drugs for the purpose of examination, test or analysis in small quantities which is otherwise prohibited under Section 10 of the D & C Rules, 1945. an application seeking permission to import for Test License.
NKG experts have competent understanding of how to obtain Test License.
know more about this serviceIMPORTER
Under the Drugs & Cosmetics Act 1940 & Rules 1945, the permissions issued to applicants for registration certificates and import licenses are valid for a particular and defined time period. Such registration certificates and import licenses are expected to be renewed within the stipulated time by submitting prescribed documents and fee before expiration if the applicant intends to continue such permissions issued in its favor.
NKG team understands that ensuring timely submission of dossiers for renewal or re-registration are critically important to ensure that there is neither any regulatory gap nor there is any disruption in supply chain of its clients.
know more about this serviceThere can be Changes in Shelf life of a product once an approval is received by an applicant. Shelf life of products can either be extended or reduced.
In both cases, an application for seeking permission to change Shelf Life of a product post approval has to be submitted to the Import & Registration Division of CDSCO.
Only when the approval is granted, can an applicant claim the new shelf life on the product label.
NKG experts assist clients in filing and approval of applications for Shelf Life Extension to ensure that there is neither any regulatory gap nor there is any disruption in supply chain of its clients.
know more about this serviceDual use means drugs which can be used in both pharmaceutical as well as other industries.
In cases of imports of such drugs, an application for NOC i.e. No Objection Services need to be procured from the Zonal Office of CDSCO.
NKG experts have competent understanding of how to obtain Dual NOC from Zonal offices.
know more about this serviceMany a times, in cases of export of pharmaceutical products , special codes are required on the product label due to external regulatory requirements. In such cases, NKG experts assist our clients in obtaining NOC for special codes on label for products such as finished formulations, Bulk drug, Narcotic drug, Psychotropic substances, etc.
know more about this serviceFor Manufacturing of Pharmaceutical products falling under the purview of Drugs & Cosmetics Act 1940, obtaining a manufacturing permission is mandatory from State Licensing Authority (SLA). The requisite documents and presibried government fee need to be deposited to the SLA for processing and grant of manufacturing permission.
License in Form 20 B & 21 B for wholesale and stocking is mandatory for sale or distribution of drug products under the purview of Drugs & Cosmetics Act 1945.
The requisite documents and presibried government fee need to be deposited to the State Licensing Authority i.e. SLA for processing and grant of license in Form 20 B & 21 B.
The license can be renewed in Form 21 C.
Free Sale certificate is a document issued by a regulatory authority of an overseas country to an overseas brand holder/manufacturer giving evidence that products manufactured by such a manufacturer are legally sold or distributed freely without restriction, and approved by the regulatory authority of the country of origin
NKG Has assisted More than 2000 Brands and Registered more than Half a Million Skus and NKG Experts has a Clear Overview of the Claims accepted by the Department.
NKG keeps in Close communications with various Trade Commissions, Business Chambers, embassies of many countries on various existing & new Rules & Regulations of government of India
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.
