Understanding Key Drug Terminology in India
A clear understanding of drug-related definitions is fundamental for manufacturers, importers, and regulatory professionals operating within India’s pharmaceutical and healthcare sector. The definitions outlined below are governed by the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, and serve as the foundation for all regulatory decisions related to drug approval, import, manufacture, and distribution in India.
Introduction to Drug Definitions
Under Indian law, the term “drug” carries a broad and comprehensive meaning. It encompasses all medicines intended for internal or external use in human beings or animals, as well as any substance used in the diagnosis, treatment, mitigation, or prevention of any disease or disorder. This definition also includes preparations applied externally on the human body for the purpose of repelling insects such as mosquitoes.
The definition further covers substances (other than food) that are intended to influence the structure or any function of the human body, or those used for the elimination of vermin or insects responsible for causing disease in human beings or animals, as notified by the Central Government through the Official Gazette from time to time. All substances intended to serve as components in drug manufacture — including empty gelatin capsules — also fall within this definition.
Who Does This Apply To?
These definitions are applicable to:
- Domestic drug manufacturers producing pharmaceutical products within India
- Foreign manufacturers seeking to import and market drug products in India
- Importers and authorized agents representing overseas pharmaceutical companies
- Research institutions and organizations conducting clinical trials or studies involving new drugs
- Regulatory professionals and consultants involved in drug registration and compliance
Key Drug Definitions and Their Meanings
What is a “New Drug”?
A new drug refers to any drug, including an active pharmaceutical ingredient (API) or phytopharmaceutical drug, that meets one or more of the following criteria:
- Has not been used to any significant extent in India and has not received approval from the Central Licencing Authority (CLA), i.e., DCG(I), with respect to its stated claims
- Has received prior CLA approval for specific claims but is now proposed to be marketed with modified or new claims, including changes to indication, route of administration, dosage, or dosage form
- Is a fixed dose combination (FDC) of two or more individually approved drugs being combined for the first time in a fixed ratio — or an already approved combination in which the ratio of ingredients is proposed to be changed
- Is a modified or sustained release form of a drug or a Novel Drug Delivery System (NDDS) of any drug approved by the Central Licencing Authority
- Is a vaccine, r-DNA derived product, living modified organism, monoclonal antibody, stem cell derived product, gene therapeutic product, or xenograft intended for use as a drug
What is an “Investigational New Drug (IND)”?
An Investigational New Drug (IND) refers to a new chemical or biological entity or substance that has not yet received marketing approval as a drug in any country anywhere in the world.
What is a “Subsequent New Drug”?
A subsequent new drug refers to a drug that has already received approval from the Central Licencing Authority for specific claims and is now proposed to be marketed with modified or new claims, including changes related to indication, route of administration, dosage, or dosage form. This category also includes new drugs that have already been approved within India.
What is an “Orphan Drug”?
An orphan drug is a drug specifically developed and intended to treat a medical condition that affects no more than 5 lakh (500,000) persons in India.
Duration of “New Drug” Status
| Drug Category | Duration of New Drug Status |
| Modified or sustained release form / NDDS | Permanently classified as a new drug |
| Vaccine / r-DNA derived product / monoclonal antibody | Permanently classified as a new drug |
| Stem cell derived product / gene therapeutic product / xenograft | Permanently classified as a new drug |
| All other new drug categories | 4 years from the date of CLA approval |
Step-by-Step Registration Procedure for New Drugs
Step 1: Determine Drug Classification
Before initiating the registration process, the applicant must:
- Confirm whether the product qualifies as a new drug, investigational new drug, subsequent new drug, or orphan drug
- Identify the applicable regulatory pathway under the New Drugs and Clinical Trials Rules, 2019
- Consult with the Central Licencing Authority (CLA) if classification is unclear
Step 2: Prepare Required Documents
Typical documents required for new drug registration include:
- Completed application form in the prescribed format
- Detailed product composition and formulation data
- Pre-clinical and clinical study data establishing safety and efficacy
- Certificate of Analysis (CoA) from a government-approved laboratory
- GMP certificate of the manufacturing facility
- Valid manufacturing license or import license copy
- Product labels and packaging artwork
- Power of Attorney (for importers or authorized agents)
- Fee payment receipt
Step 3: Submit Application to CDSCO
- All applications must be submitted to the Drugs Controller General of India (DCGI) at CDSCO, FDA Bhawan, Kotla Road, Near Bal Bhawan, New Delhi
- Applications must be filed through the CDSCO online portal — SUGAM
- Foreign manufacturers must apply through their locally appointed authorized agent holding a valid manufacturing or sale license in India
Step 4: Regulatory Review and Evaluation
- CDSCO conducts a thorough scientific and technical review of all submitted data
- The authority may convene an expert committee to evaluate the safety and efficacy data
- Additional clarification, supplementary data, or product samples may be requested during this stage
Step 5: Clinical Trial Approval (if applicable)
- For investigational new drugs, the applicant must obtain prior approval to conduct clinical trials in India
- Clinical trials must be conducted in accordance with the New Drugs and Clinical Trials Rules, 2019
- Results of all clinical trials must be submitted to CDSCO before final marketing approval is granted
Step 6: Issuance of Registration Certificate and Import License
If all regulatory requirements are satisfactorily met:
- A Registration Certificate is issued in the prescribed form
- An Import License is granted as applicable
- The certificate includes product details, license number, validity period, and manufacturing site information
- Processing time generally varies depending on the drug category and complexity of the application
Important Points
- Any substance falling within the definition of a drug under Section 3(b) of the Act must be registered before it can be imported into India
- Not only the drug itself, but also the actual manufacturing site must be registered for import purposes
- The New Drugs and Clinical Trials Rules, 2019 supersede Part XA and Schedule Y of the Drugs and Cosmetics Rules, 1945
- All existing licenses, orders, and directions issued under earlier rules continue to remain valid
- In the event of any inconsistency between the New Drugs and Clinical Trials Rules, 2019 and any other rule under the Act, the 2019 Rules shall prevail
- Regulations governing the import and registration of drugs remain unchanged and continue to be applied as per the earlier registration framework
Understanding the precise definitions of drugs under Indian law is the first and most critical step for any manufacturer, importer, or regulatory professional seeking to operate within India’s pharmaceutical sector. All products falling within the statutory definition of a drug must be duly registered with CDSCO before they can be legally manufactured, imported, or marketed in India. Ensuring compliance with the Drugs and Cosmetics Act, 1940 and the New Drugs and Clinical Trials Rules, 2019 is essential for uninterrupted regulatory approval and market access.