Phytopharmaceuticals are basically plant-based drugs, but they are developed in a more scientific way than the usual herbal products we see in the market. Instead of using the whole plant or a simple extract, these medicines are processed, purified, and tested properly with defined bioactive or phytochemical compounds.
Phytopharmaceuticals sit between traditional knowledge and modern drug development—but the regulatory pathway is under the CDSCO framework. Anyone planning to develop or receive approval for these products in India needs to understand this distinction clearly.
What Are Phytopharmaceuticals?
A phytopharmaceutical is still plant-based. It’s just not the usual herbal-type product. It’s not just about taking a plant extract and using it directly—the useful part is identified and kept consistent across batches. That’s why they’re treated differently from regular herbal products and seen as closer to drug-type products.
According to the New Drugs and Clinical Trial Rules, 2019, the definition of phytopharmaceuticals involves a drug of a purified and standardised fraction. It is assessed qualitatively and quantitatively with a defined minimum of four bioactive or phytochemical compounds. These compounds come from an extract of a medicinal plant or its part. It is intended for internal or external use in humans or animals for the diagnosis, treatment, mitigation, or prevention of disease or disorder. Parenteral administration is excluded from the definition.
Regulatory Agency For Phytopharmaceuticals In India
Phytopharmaceutical drugs are administered by the Central Drugs Standard Control Organisation (CDSCO). The New Drugs Division of CDSCO takes care of new drug approval and clinical-trial-related regulatory functions. The NDCT Rules specifically provide a phytopharmaceutical pathway and prescribe the data to be submitted for an application to conduct a clinical trial or to import or manufacture a phytopharmaceutical drug in India.
Depending on the proposed activity, the application must be made in the applicable CT form under the NDCT Rules, together with the data specified in Table 4 of the Second Schedule and the applicable fee under the Sixth Schedule.
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Phytopharmaceutical Regulations in India
The regulatory requirements for phytopharmaceutical drugs extend well beyond demonstrating that a product is derived from a medicinal plant. Table 4 of the Second Schedule to the NDCT Rules, 2019, specifies the information and data to be submitted for a phytopharmaceutical drug.
The dossier includes information relating to the following:
- Botanical identity and plant authentication
- Plant morphology, anatomy, habitat and geographic distribution
- Whether the plant is cultivated or collected from the wild
- Collection season and source of the plant material
- Quality specifications for the starting plant material
- Foreign matter, ash values, pesticide residues, heavy metals and microbial load
- Chromatographic fingerprinting and phytochemical reference markers
- Assay of bioactive or phytochemical compounds
- Extraction, fractionation and purification processes
- Solvents used and solvent-residue controls
- Characterisation of the final purified fraction
- Bioactive constituents of the purified fraction
- Excipients, diluents, stabilisers or preservatives, where applicable
- Formulation composition and dosage-form information
- Manufacturing process and in-process quality controls
- Packaging materials and final packs
- Stability data
- Safety and pharmacological information
- Human-study and clinical-trial information, where applicable
- Regulatory status in other countries
- Packaging of the purified and characterised final product, storage conditions and labelling
- Information from traditional/ethnomedicine sources, including relevant safety information such as contraindications, side effects and adverse reactions, where applicable
- Physicochemical characteristics, extractive values and finished-product quality specifications
- Package insert/patient information sheet
- Draft label and carton text
- Post-marketing surveillance information
The applicant should show control over the identity, quality, consistency, manufacturing process, safety, and proposed use of the phytopharmaceutical drug.
Phytopharmaceuticals Approval Process In India
There is no single generic “registration” step for a phytopharmaceutical drug. There’s a simplified step-wise procedure you can check below:
Step 1: Deciding the Product Category
Establish whether the proposed product meets the legal definition of a phytopharmaceutical drug. Also, see if it falls within the applicable new-drug framework. Not every plant-derived or herbal product is a phytopharmaceutical drug. Ayurvedic, Siddha, and Unani medicines follow their respective regulatory framework when they meet the applicable requirements.
Step 2: Preparing the Data and Dossier
The dossier should address the requirements that are given in Table 4 of the Second Schedule. This includes botanical authentication, source material controls, quality specifications, extraction and purification, characterisation of the purified fraction, formulation, manufacturing, stability, safety and pharmacological information, human-study data and proposed marketing information.
Step 3: Generating the Required Safety & Clinical Evidence
The NDCT Rules specifically provide for safety/pharmacological information and human studies. Table 4 includes requirements relating to Phase I data/protocols, dose-finding information and confirmatory clinical studies, as applicable.
The Rules also recognise that the extent of studies may be abbreviated, modified or relaxed in certain circumstances, including where the phytopharmaceutical drug has already been marketed for more than five years or where adequate published evidence of safety is available.
Step 4: Submit the Applicable Application to CDSCO
The application route depends on how the phytopharmaceutical drug will be supplied in India. For a phytopharmaceutical drug intended to be imported for sale or distribution, the applicable new-drug permission is sought through Form CT-18, supported by the required Table 4 data and prescribed fee. For a phytopharmaceutical drug intended to be manufactured in India for sale or distribution, the applicable application is made through Form CT-21, together with the required information and fee.
Step 5: Regulatory Review and Queries
CDSCO reviews the submitted information. They may raise queries or require additional information, clarification, or data before making a regulatory decision.
Step 6: Get the Applicable Permission/Licence
The applicable regulatory permission and subsequent manufacturing/import licensing requirements must be obtained before the product can be marketed in India.
Also Read: CDSCO Pharmaceutical Regulations in India
Import Requirements for Phytopharmaceuticals in India
Importing a phytopharmaceutical drug into India involves more than obtaining new-drug permission. Where a phytopharmaceutical drug is intended to be imported for sale or distribution in India, the applicant must follow the applicable new-drug import and drug-import licensing requirements.
Under the New Drugs and Clinical Trials Rules, 2019, a person intending to market a phytopharmaceutical drug must submit an application in Form CT-18 to the Central Licensing Authority, supported by the data specified in Table 4 of the Second Schedule and the applicable fee under the Sixth Schedule.
For imported products, the regulatory process therefore involves the following key elements:
- New-drug import permission: Form CT-18 is the applicable application for permission to import the phytopharmaceutical drug.
- Phytopharmaceutical dossier: The application must include the information and data specified in Table 4. It should cover botanical identity, source material, quality specifications, extraction and purification, characterisation, formulation, manufacturing, stability, safety, clinical information, and proposed labelling, whatever applies.
- Overseas manufacturing information: Details of the overseas manufacturer and manufacturing site must be provided as required under the applicable import framework.
- Indian applicant/importer requirements: The current CDSCO FAQ states that an applicant seeking permission to import and market a new drug should have a valid wholesale licence for sale and distribution of drugs under the Drugs and Cosmetics Rules, 1945.
- Import licensing/registration: In addition to new-drug permission, the applicable drug import registration and licensing requirements must be fulfilled before commercial importation.
- SUGAM submission: CDSCO processes relevant new-drug applications through its online regulatory submission system, with the applicable application and supporting documents submitted through the prescribed route.
Fees For Phytopharmaceuticals Application
The fee applicable to a phytopharmaceutical application depends on the regulatory activity and the regulatory framework applicable to the application. The New Drugs and Clinical Trials Rules, 2019, under the Sixth Schedule, prescribe a fee of Rs. 2,00,000 for an application for permission to import or manufacture a phytopharmaceutical drug.
The Rules also provide a fee concession for eligible Micro, Small and Medium Enterprises (MSMEs) in specified categories. For eligible MSME applications for clinical trials, new-drug approval, and pre- and post-submission meetings, the applicable fee is 50% of the fee otherwise prescribed.
For a clearer estimate on overall costs and support through the full phytopharmaceutical registration process, you can reach out to our team at info@artixio.com
GMP Requirements for Phytopharmaceuticals in India
Phytopharmaceutical manufacturing is subject to GMP requirements, including the specific requirements for phytopharmaceuticals under Part VI of Schedule M.
The GMP framework recognises that plant-derived starting materials can show natural variability and may present risks relating to contamination, adulteration and consistency. Consequently, manufacturers need appropriate controls over the identity, quality and storage of starting materials and over the extraction, processing and manufacturing stages.
The specific requirements and inspection checklist cover areas such as:
- Control and identification of plant-derived starting materials
- Processing and extraction controls
- Process validation
- Control of extraction time and temperature
- Solvent quality and related controls
- Microbial and contamination controls
- In-process quality control
- Analytical testing and chromatographic fingerprinting
- Stability studies
- Packaging materials
- Labelling and package inserts
- Change control
- Sanitation
- Complaints and adverse-reaction handling
The GMP inspection checklist also examines whether the label/package insert contains adequate information. It looks into whether the quantity of plant material or phytopharmaceutical preparation is appropriately stated in relation to the defined quantity of constituents with known therapeutic activity.
Also Read: SUGAM For Regulatory Submissions
Phytopharmaceuticals Clinical Trials & Post-Approval Requirements
The NDCT Rules require the applicable regulatory permission and Ethics Committee approval before the clinical trial can start. Clinical trials must be conducted according to the applicable regulatory requirements and Good Clinical Practice requirements. Regulatory clinical trials in India are also required to be prospectively registered with the Clinical Trials Registry–India (CTRI) before enrolment of the first participant.
The phytopharmaceutical requirements also provide for post-marketing surveillance. Table 4 specifies the submission of Periodic Safety Update Reports (PSURs) every six months for the first two years following approval and annually for the subsequent two years.
The CDSCO New Drugs Division also monitors the safety of approved medicinal products using information such as PSURs, serious adverse-event reports and complaints.
Phytopharmaceutical Labelling Requirements in India
Labelling is specifically addressed in the phytopharmaceutical requirements under Table 4 of the Second Schedule to the NDCT Rules, 2019.
The requirements begin at the purified-product stage. The dossier must provide details of the packaging of the purified and characterised final product, storage conditions and labelling.
The formulation and manufacturing sections also require information concerning packaging materials, packing steps and the description of the final packs.
Importantly, the marketing-information section of Table 4 specifically requires:
- Package insert or patient information sheet
- Draft text for the label and carton
The proposed labelling should therefore be developed consistently with the approved product information and the technical characteristics of the phytopharmaceutical. The dossier also needs to establish the composition and proportion of the final purified fraction and its defined markers per unit dose.
The GMP inspection requirements provide an additional practical check on phytopharmaceutical labelling and packaging. They include verification that adequate information is provided on the label/package insert and address how the quantity of plant material or phytopharmaceutical preparation is represented in relation to defined quantities of constituents with known therapeutic activity.
Conclusion
Phytopharmaceuticals in India sit somewhere between traditional plant use and modern drug development. The regulations reflect that balance, asking for proper data while still working with plant-based sources.
So, anyone planning to enter this space needs to approach it with that mindset from the beginning.
For support with phytopharmaceutical approvals, CDSCO submissions, import requirements, and regulatory compliance, explore Artixio’s regulatory services in India.
FAQs
1. How are the phytopharmaceuticals different from herbal or Ayurveda products?
Both categories can originate from plants, but their regulatory basis is different.
- Phytopharmaceutical drugs are defined around purified and standardised fractions of medicinal plant extracts containing defined bioactive or phytochemical compounds.
- Ayurvedic, Siddha and Unani medicines, where they meet the applicable statutory definition, are regulated according to the traditional-system framework and the authoritative texts specified under the Drugs and Cosmetics Act and Rules.
Therefore, the fact that a product is plant-derived does not by itself determine whether it is an AYUSH medicine or a phytopharmaceutical drug.
2. Who handles approvals for phytopharmaceuticals?
In India, CDSCO handles phytopharmaceutical approvals. They treat these products like new drugs. The CDSCO New Drugs Division specifically lists phytopharmaceuticals among the applications it processes for new-drug approval.
Under the NDCT Rules, the Central Licensing Authority exercises the relevant regulatory authority
3. Do phytopharmaceuticals require clinical trials like regular drugs?
Clinical evidence is part of the regulatory framework for phytopharmaceutical drugs. However, it would be too broad to say that every product automatically requires an identical clinical-trial programme. The required data depend on the product, its regulatory status and the evidence available.
The NDCT Rules provide specific requirements for phytopharmaceutical drugs and also provide for certain modifications or relaxations in prescribed circumstances. Where a clinical trial is required, it must comply with the applicable regulatory and Ethics Committee requirements.
