DRUG REGULATORY SERVICES

CliniCounsel team has a cumulative experience of more than 10+ 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.

  • All medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on the human body for the purpose of repelling insects like mosquitoes.
  • Such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of [vermin] or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette.
  • All substances intended for use as components of a drug including empty gelatin capsules
WHAT IS A “NEW DRUG”? 

A new drug means;

  • drug, including active pharmaceutical ingredient or phytopharmaceutical drug, which has not been used in the country to any significant extent has not been approved as safe and efficacious by Central Licencing Authority (CLA) i.e. DCG(I) with respect to its claims; or
  • drug approved by the CLA 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 by CLA 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, r-DNA derived product, living modified organism, monoclonal antibody, stem cell derived product, gene therapeutic product or xenografts, intended to be used as a drug.

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.

WHAT IS AN “INVESTIGATIONAL NEW DRUG ( IND)” 

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.

WHAT IS A “SUBSEQUENT NEW DRUG”? 

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

WHAT IS AN “ORPHAN DRUGS”? 

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 is regulated under Drugs and Cosmetics Act 1940 and Rules 1945. At present, bulk drug (Active Pharmaceutical Ingredients) and finished formulations are regulated under the said Act. Any substance falling within the definition of drug (Section 3b of the Act) required to be registered before import into the country. Not only drugs itself,  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 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 Drugs & Cosmetics Act 1940 & Part IV of Drugs & Cosmetics Rules 1945.

NOTIFICATION OF NEW DRUGS AND CLINICAL TRIAL RULES 2019

Effective  19 March 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 trial, bioequivalence study, bioavailability study and 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.

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.

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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
USD 5000 For Product (Per Product)
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
DRUGS REGULATORY SERVICES

AUTHORIZED AGENT SERVICES

IMPORTER

In India, Overseas Brands or Manufacturers of drugs cannot submit an application for registration as applicants. Appointing an Indian Entity as applicant is mandatory in order to submit an application for registration of imported Drugs or Cosmetics. A registration certificate once issued to a brand holder and an Indian Entity can be used by only such companies to import products in India.

We holds a valid stock and sale license (Form 20B and 21B) to assist foreign manufacturers to import their products  in India in less time and without any hassle.

We understands the needs of global brand owners and offers bespoke services to such Brand Owners or manufacturers. We can be nominated by overseas companies to act as its Authorised Agent in India.

DRUGS REGULATORY SERVICES

REGISTRATION CERTIFICATE AND IMPORT LICENSE

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.

Our 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.

Our team works efficiently to ensure timely communication of documents and submission so that clients can obtain permissions smoothly.

Drug Regulatory Services