Phytopharmaceutical Regulations & CDSCO Registration Process In India

India has introduced a progressive regulatory pathway for phytopharmaceutical drugs, bridging traditional plant-based knowledge with modern pharmaceutical science. Unlike conventional herbal or Ayurvedic products, phytopharmaceuticals are scientifically standardized, clinically evaluated, and regulated as new drugs under India’s pharmaceutical framework.

This detailed guide by Maven Regulatory Solutions explains the phytopharmaceutical registration process in India, CDSCO regulatory requirements, clinical trial expectations, GMP standards, fees, timelines, and post-marketing obligations structured to deliver maximum SEO visibility and regulatory clarity.

What Are Phytopharmaceuticals? (Regulatory Definition)

As per the Drugs and Cosmetics Rules (8th Amendment), 2015, a phytopharmaceutical drug is defined as:

A purified and standardized fraction of a plant or its part or extract, containing defined active phytochemicals, intended for therapeutic use and supported by scientific evidence.

Key Characteristics of Phytopharmaceuticals

• Derived from plant sources, but not crude extracts
• Purified, standardized, and reproducible
• Defined active phytochemical markers
• Supported by preclinical and clinical data
• Regulated as new drugs, not AYUSH products

This clear distinction places phytopharmaceuticals under the Central Drugs Standard Control Organization (CDSCO) rather than the Ministry of AYUSH.

Regulatory Authority for Phytopharmaceuticals in India

All phytopharmaceutical approvals in India are governed by:

Central Drugs Standard Control Organization (CDSCO)

Under the leadership of the Drugs Controller General of India (DCGI)

CDSCO evaluates phytopharmaceuticals using a framework similar to new chemical entities (NCEs), requiring comprehensive data on:

• Plant source and authentication
• Extraction and purification processes
• Standardization parameters
• Safety and toxicology
• Human clinical evidence

Phytopharmaceuticals vs Herbal & Ayurvedic Products

Phytopharmaceutical Registration Approval in India

Phytopharmaceuticals are treated as new drugs under Rule 122E of the Drugs and Cosmetics Rules and require DCGI approval before manufacture or import.

Approval Pathway

1. Dossier submission to CDSCO
2. Technical evaluation by expert committees
3. Clinical trial authorization (if applicable)
4. Final approval issued by DCGI

Phytopharmaceutical Registration Guidelines – India

1. Dossier Requirements (CTD-Based)

A. Source & Identification of Plant Material

• Botanical name (Genus, species, author)
• Plant part used
• Geographical origin and cultivation details
• Voucher specimen and authentication records

B. Extraction & Standardization

• Detailed extraction and purification methodology
• Solvents, processing steps, and controls
• Batch-to-batch consistency data

2. Characterization of Active Phytochemicals

• Identification of active markers
• Quantification using validated analytical methods
• Chromatographic and spectroscopic profiles

3. Quality Control & Stability Data

4. Non-Clinical & Pharmacological Data

• Acute, sub-acute, and chronic toxicity studies
• Genotoxicity and reproductive toxicity (if applicable)
• Pharmacodynamic and pharmacokinetic data

5. Clinical Trial Requirements

Phytopharmaceuticals generally require Phase I–III clinical trials, unless CDSCO grants partial waivers based on prior evidence.

Mandatory Steps:

• Ethics Committee approval
• Registration with Clinical Trials Registry – India (CTRI)
• Compliance with ICH-GCP guidelines

Manufacturing & GMP Requirements (Schedule M)

Facility & Design Controls

• Segregated areas for raw material handling, extraction, purification, and packing
• Environmental controls for humidity, temperature, and dust

Equipment Standards

• Non-reactive materials (e.g., SS 316)
• Validated cleaning and maintenance procedures

Raw Material Management

• Approved suppliers
• Botanical identity verification
• Controlled storage conditions

Standardization & Finished Product Testing

Labeling Requirements for Phytopharmaceuticals

Labels must clearly display:

• Product name & botanical source
• Standardized active phytochemical content
• Dosage, indication, and route of administration
• Contraindications, warnings, and storage conditions

Regulatory Fees (Indicative)

Post-Marketing Surveillance (PMS)

After approval, companies must:

• Conduct Phase IV studies
• Submit Periodic Safety Update Reports (PSURs)
• Report adverse events to CDSCO
• Maintain pharmacovigilance systems

Why Phytopharmaceutical Regulations Matter in India

India’s phytopharmaceutical framework encourages:

• Scientific validation of plant-based medicines
• Global acceptability of Indian Phyto drugs
• Innovation beyond traditional formulations
• Integration of evidence-based natural therapeutics

Why Maven Regulatory Solutions?

Maven Regulatory Solutions offers end-to-end support for:

• Phytopharmaceutical regulatory strategy
• CDSCO dossier preparation & submission
• Clinical trial approvals & management
• GMP compliance & inspections
• Lifecycle management & post-approval support

Frequently Asked Questions (FAQs)

Q1. Who approves phytopharmaceuticals in India?
CDSCO under the DCGI approves phytopharmaceutical drugs.

Q2. Are phytopharmaceuticals the same as herbal medicines?
No. They require standardized actives and clinical evidence.

Q3. Are clinical trials mandatory?
Yes, in most cases, unless scientifically justified exemptions are granted.

Q4. Which GMP standard applies?
Schedule M GMP under Drugs & Cosmetics Rules.

Q5. Can phytopharmaceuticals be exported?
Yes, once approved, they are globally acceptable due to scientific validation.