Drug
Regulatory
Services

Definition of
DRUG

• 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.

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INTRODUCTION TO
DRUGS

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.

Notification of New Drugs and Clinical trial Rules 2019

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.

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OVERVIEW of VARIOUS
FORMS & FEES

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. Norega 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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drugs regulatory services
Authorized Agent Services

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.

Norega 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.

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

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drugs regulatory services
REGISTRATION CERTIFICATE and IMPORT LICENSE

“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.

Norega 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.

Norega 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.

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drugs regulatory services
New Drugs Approval

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.

NKNoregaG experts assist clients with successful approval of their New Drug applications.

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drugs regulatory services
Subsequent New Drugs

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.

Norega experts are well versed with SND dossiers and make the process of filing and approval efficient and predictable.

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drugs regulatory services
Clinical Trials

Conducting Clinical trials in India require mandatory approvals from the Central Licensing authority i.e. CDSCO.

At Norega, 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.

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drugs regulatory services
NOC For Personal Use

In 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 Norega experts to handle such a situation swiftly and efficiently.

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drugs regulatory services
BA/BE

The 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.

Norega experts assist clients with successful approval of such permissions.

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drugs regulatory services
Test License

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.

Norega experts have competent understanding of how to obtain Test License.

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drugs regulatory services
Renewal/Re-registration of Drugs in Form 40

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.

Norega 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.

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drugs regulatory services
Shelf Life Extension/Reduction

here 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.

Only when the approval is granted, can an applicant claim the new shelf life on the product label.

Norega 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.

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