Navigate India’s pharmaceutical regulatory framework
The Central Drugs Standard Control Organisation (CDSCO) is India’s central regulatory authority for matters including new drug approvals, clinical trials and the regulation of specified categories of drugs.
Regulatory support for companies entering or operating in India
Pharmaceutical companies entering the Indian market must understand the applicable requirements under the Drugs and Cosmetics Act, 1940, the Drugs Rules, 1945, and the New Drugs and Clinical Trials Rules, 2019, as applicable.
RIAR Consulting assists domestic and international pharmaceutical companies in understanding Indian regulatory requirements and preparing documentation for applicable approval, import, manufacturing and lifecycle activities.
For medical devices, we handle product classification, documentation, application submission and regulatory follow-ups for CDSCO registration.
Our CDSCO regulatory services
Support across approval, clinical trial, import, manufacturing and lifecycle activities.
- 01
Regulatory strategy and product assessment
- Assessment of Indian regulatory requirements
- Product classification and pathway evaluation
- Applicable approval and licensing requirements
- Regulatory gap assessment and submission planning
- 02
New drug and marketing authorisation support
- Documentation support for new drug applications
- Technical dossier preparation and review
- Applicable import and manufacturing permission applications
- Review of drug substance and drug product documentation
- 03
Clinical trial regulatory support
- Documentation for applicable clinical trial applications
- Relevant application forms and technical documents
- Requirements under the New Drugs and Clinical Trials Rules, 2019
- Submission-readiness review
- 04
Import and registration support
- Applicable import registration requirements
- Product and manufacturing site documentation
- Technical and administrative document review
- Documentation for applicable import permissions and licences
- 05
CMC and quality documentation
- Pharmaceutical development and manufacturing documentation
- Quality and analytical documentation
- Stability data review
- GMP-related documentation support
- 06
Post-approval and lifecycle support
- Applicable post-approval changes
- Regulatory impact assessment
- Renewal and amendment documentation, where applicable
- Responses to regulatory queries
- 07
Medical devices
- Product classification
- Documentation and application submission
- Regulatory follow-ups for CDSCO registration
A structured approach to the Indian market
Each engagement follows the same structured sequence, adapted to the product and the applicable Indian pathway:
- Understanding the product, its development or marketing status and your regulatory objectives
- Assessing the applicable regulatory pathway, authority and documentation expectations
- Identifying gaps in technical, quality and administrative documentation
- Preparing, reviewing and compiling documentation to the market’s requirements
- Supporting submission readiness, authority correspondence and query management
- Lifecycle support for variations, renewals, regulatory changes and documentation maintenance
RIAR aims to simplify the regulatory process for companies entering or operating in India through structured documentation support and an understanding of the Indian regulatory framework.
How VERA 2.0 supports this sector
Indian manufacturers must meet the revised Schedule M good manufacturing practice requirements. VERA 2.0 was developed with Indian pharmaceutical plants in mind, including sterile manufacturing.
- VERA 2.0
Schedule M manufacturing visibility
Continuous visibility into the facility, environmental and equipment conditions that Schedule M good manufacturing practice depends on, where supported by connected systems.
- VERA 2.0
Sterile and cleanroom monitoring
Airflow, differential pressure, temperature, humidity and particulate conditions across classified areas, presented in one connected view.
- VERA 2.0
Deviation investigation support
Anomaly identification and contextual advisories help authorised personnel investigate abnormal conditions before they affect a batch.
- VERA 2.0
Inspection-readiness records
Structured records of events, observations and advisories support internal reviews ahead of regulatory inspections.
VERA 2.0 is an advisory decision-support system. It does not write to or control plant systems, and it does not replace the site’s quality management system, validated records or regulatory determinations. Capabilities depend on the systems connected at each site.
Planning to register or manufacture in India?
Whether you are preparing a new drug application, an import or manufacturing permission, or preparing your plant for Schedule M expectations, RIAR Consulting can support your objectives.