Central Drugs Standard Control Organization
Central Drugs Standard Control Organization (CDSCO)
The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory authority for pharmaceuticals and medical devices. It operates under the Ministry of Health and Family Welfare and is headed by the Drugs Controller General of India (DCGI). CDSCO is the primary body responsible for ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices marketed in India.
Test Batch Manufacturing Licensing
At RGInsight , we provide end-to-end regulatory assistance for obtaining approvals to manufacture test batches under Indian regulatory frameworks. Our expert guidance ensures your process is compliant, streamlined, and expedited, enabling faster progression through R&D, validation, and clinical trial stages.
Form CT-10
Application for grant of permission to manufacture new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study or for examination, test and analysis
This permission is not for commercial sale, but strictly for R&D and regulatory submissions
Form CT-11
Form CT-12
License Assistance for Test Batches:
We assist in securing manufacturing licenses for test batches in accordance with the Drugs & Cosmetics Act and Rules, ensuring full regulatory compliance for R&D, validation, and clinical trial purposes.
Form 29 Application Support:
We manage the complete preparation and submission of Form 29, required for manufacturing test batches used in research and development or regulatory studies.
Product-Specific Regulatory Consulting:
We offer tailored regulatory strategies based on your product category and development objectives.
Our Services
Form CT-14
Permission to manufacture new drug or investigational new drug for clinical trial, bioavailability or bioequivalence study or for examination, test and analysis.
Application for grant of permission to manufactur formulation of unapproved Active pharmaceutical ingredient for test or analysis or clinical trial or Bioavailability or bioequivalence study.
Permission to manufacture formulation of unapproved active pharmaceutical ingredient for test or analysis or clinical trial or bioavailability or bioequivalence study
Permission of Manufacturing & Marketing of New Drugs
We specialize in securing regulatory approvals for the manufacturing and marketing of new drugs in compliance with the New Drugs and Clinical Trials Rules 2019, following the Form CT-21 submission pathway. With extensive experience in preparing and submitting dossiers, we offer comprehensive regulatory services including End-to-End Submission Support & Regulatory Gap Analysis/ Compliance Documentation tailored to meet evolving industry and authority expectations.
New Drug Application (NDA)
We support the submission of investigational and therapeutic products classified as new drugs under Indian regulations. Our service includes the preparation of applications supported by robust preclinical and clinical data, in line with current regulatory requirements.
Subsequent New Drug (SND) Application
We facilitate SND applications for:
Additional dosage forms
New strengths
New indications or routes of administration for already approved new drugs
Fixed-Dose Combination (FDC) Approvals
We offer full regulatory support for FDC applications, including:
Combinations of two or more active pharmaceutical ingredients (APIs) in a single dosage form
Dossiers backed by clinical data or published scientific literature, as required by authorities.
Our regulatory team ensures full alignment with the stringent standards set by the Kokate Committee for Fixed Dose Combinations (FDCs) and leverages the fast-track approval process for OTC products.
Our Services
Import and Export Licensing
Navigating India's complex regulatory environment requires precision, expertise, and up-to-date knowledge of evolving compliance protocols. Our specialized services cover both import licensing for clinical trials and export compliance through BE No Objection Certificates (NOC), supporting pharmaceutical companies in product development, regulatory submissions, and international market access.
Form CT-17
We assist pharmaceutical companies in obtaining BE NOC for export purposes, ensuring compliance with both local Indian regulations and international market requirements. Whether you're exporting generics to regulated markets or emerging economies, we provide seamless regulatory support.
BE NOC
We provide end-to-end support for securing the Form CT-17 Import Licence required for importing new or investigational drugs for clinical trials, bioavailability/bioequivalence (BA/BE) studies, or for analysis as per the New Drugs and Clinical Trials Rules, 2019.
Our Services
Our regulatory affairs team is experienced in navigating the CT-NOC application. The CT-NOC ensures that clinical trials in India are conducted ethically, scientifically, and in compliance with regulatory standards. It reflects CDSCO’s no-objection stance toward the initiation of a clinical trial after thorough evaluation.
CT NOC
Post-Registration Approvals and Compliances
At RGInsight , we go beyond product approval to ensure long-term regulatory compliance and uninterrupted market presence.
We offer end-to-end support for post-registration activities, including:
Timely submission of variations (labeling, CMC, safety) in line with CDSCO and global requirements
Lifecycle management – site changes, shelf-life extensions, packaging updates
Pharmacovigilance compliance – ongoing safety reporting and risk management
Regulatory notifications and communication with authorities
Central Drugs Standard Control Organization
To ensure pharmaceutical manufacturing sites are fully compliant with the revised Schedule M requirements notified by CDSCO in 2023, aligning more closely with WHO-GMP and international best practices, RGInsight Can Support You With:
Gap Assessment & Roadmap Design
QMS & Documentation Upgrades
Training & Mock Audits
Regulatory Inspection Readiness
Manufacturer Type Compliance Deadline
Large Manufacturers By June 2025
MSME Manufacturers By December 2025
Deadlines for Compliance
