- Introduction: A brief description of the drug and the therapeutic class to which it belongs.
- Chemical and pharmaceutical information
- Information on active ingredients—Drug information (Generic Name, Chemical Name or International Non-proprietary Names (INN))
- Physicochemical data—
(a) Chemical name and Structure Empirical formula Molecular weight
(b) Physical properties Description Solubility Rotation Partition coefficient, Dissociation constant. - Analytical data
- Elemental analysis
- Mass spectrum
- NMR spectra
- IR spectra
- UV spectra
- Polymorphic identification
- Complete monograph specification including Identification
- Identity or quantification of impurities
- Enantiomeric purity
- Assay.
- Validations
- Assay method
- Impurity estimation method
- Residual solvent/other volatile impurities (OVI) estimation method.
- Stability studies (for details refer clause 5 of this Schedule)
- Final release specification
- Reference standard characterization
- Material safety data sheet.
- Data on formulation
- Dosage form
- Composition
- Master manufacturing formula
- Details of the formulation (including inactive ingredients)
- In process quality control check
- Finished product specification
- Excipient compatibility study
- Validation of the analytical method
- Comparative evaluation with international brand or approved Indian brands, if applicable.
- Pack presentation
- Dissolution assay
- Impurities
- Content uniformity pH
- Force degradation study
- Stability evaluation in market intended pack at proposed storage conditions
- Packing specifications
- Process validation
- Animal pharmacology (for details refer clause 3 of this Schedule)
- Summary
- Specific pharmacological actions
- General pharmacological actions
- Follow-up and supplemental safety pharmacology studies
- Pharmacokinetics: absorption, distribution; metabolism; excretion
- Animal toxicology (for details refer clause 2 of this Schedule)
- General aspects
- Systemic toxicity studies
- Male fertility study
- Female reproduction and developmental toxicity studies
- Local toxicity
- Allergenicity or Hypersensitivity
- Genotoxicity
- Carcinogenicity
- Human or Clinical pharmacology (Phase I)
- Summary
- Specific Pharmacological effects
- General Pharmacological effects
- Pharmacokinetics, absorption, distribution, metabolism, excretion
- Pharmacodynamics / early measurement of drug activity
- Therapeutic exploratory trials (Phase II)
- Summary
- Study report as given in Table 6 of Third Schedule
- Therapeutic confirmatory trials (Phase III)
- Summary
- Individual study reports with listing of sites and investigators.
- Special studies
- Summary
- Bio-availability or Bio-equivalence.
- Other studies e.g. geriatrics, paediatrics, pregnant or nursing women
- Regulatory status in other countries
- Countries where the drug is
- Marketed
- Approved
- Approved as Investigational New Drug (IND)
- Withdrawn, if any, with reasons
- Restrictions on use, if any, in countries where marketed / approved
- Free sale certificate or certificate of analysis, as appropriate.
- Prescribing information
- Proposed full prescribing information
- Drafts of labels and cartons
- Samples and Testing protocol/s
- Samples of pure drug substance and finished product (an equivalent of 50 clinical doses, or more number of clinical doses if prescribed by the Central Licencing Authority), with testing protocols, full impurity profile and release specifications.
- New chemical entity and Global clinical trial:
- Assessment of risk versus benefit to the patients
- Innovation vis-a-vis existing therapeutic option
- Unmet medical need in the country.
- Copy of license to manufacture any drug for sale granted by State Licencing Authority (in case the application is for manufacture for sale of new drug)
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