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Medicinal Products Regulatory Support in India

Overview

The Central Drugs Standard Control Organization (CDSCO) is an Indian Health Authority prevailing under the Drugs and Cosmetics Act. The CDSCO has six (06) zonal offices, four (04) sub-zonal offices, thirteen (13) port offices, and seven (07) laboratories under its control. The Drugs & Cosmetics Act 1940 has entrusted various responsibilities to the central and state regulators to regulate drugs & cosmetics. Significant functions of the CDSCO are, Regulatory control over the import of medicines, approval of specific licenses, approval of new medicines, clinical trials, Subsequent New Drugs (SND), Fixed-Dose Combinations (FDC), and Investigational New Drug (IND). The Central License Approving Authority (CLAA), medical devices classification, devices meetings of Drugs Consultative Committee (DCC), and Drugs Technical Advisory Board (DTAB) are exercised by the CDSCO, DCGI headquarters. The CDSCO is responsible for the pharmaceutical products’ registration in India. The Agency is constantly thriving to bring transparency, accountability, and uniformity in its services to ensure the safety, efficacy, and quality of the medicinal products manufactured, imported, and distributed in the country.

The CDSCO houses welcoming yet strict Regulatory practices for pharmaceutical product registration in India and thus, an applicant seeking success in India needs to understand the CDSCO registration process and the product registration guidelines for CDSCO.

Medicinal Product Classification

Medicinal products are classified into four (04) categories.

  • New Drugs (ND)
  • Subsequent New Drug (SND)
  • Fixed-Dose Combinations (FDC)
  • Investigational New Drug (IND)

Medicinal Product Registration

For any foreign manufacturer who does not have an office in India, the appointment of an in-country representative as the Marketing Authorization Holder (MAH) is mandatory for the approval of the market authorization application. The in-country representative will be responsible for the authenticity of documents, correctness of the information, and periodical follow-ups with the Health Authorities (HA) for the registration dossier, submitted to the HA. The MAH should have the credentials for the online SUGAM portal.

Steps for obtaining the MAH

  • Submit an application to conduct the Clinical Trials, Phase I, II, & III
  • Submit the report of the clinical trials to the Agency
  • Submit an application for market authorization holding
  • Submit an application to register the manufacturing site
  • Submit an application to obtain the Import License

Approval is given after a critical review of these forms is carried out by the respective divisions.

Product Maintenance & Compliance

Sl. No

Application

Validity

01

Validity for import registration

Three (03) years from the date of registration

02

Renewal of import registration certificate

Nine (09) months before the expiry of the existing certificate

03

Validity for import license

Three (03) years (till the registration certificate is valid)

04

Renewal of import license

Minimum three (03) months before the expiry of the import license (applications for the import license should be submitted along with the application for renewal with the importer).

Any changes (major/minor) in the registered medicine should be filed and submitted to the CDSCO with relevant documents.

Pharma Regulatory services and pharma Regulatory consulting are at the core of Freyr’s competencies. Freyr offers expert strategic solutions and end-to-end services for compliant pharmaceutical product registration in India. For faster pharma market access, consult today.

Freyr Expertise

  • End-to-end Registration Support
  • Authorized Local Agent Support
  • Marketing Authorization Application
  • Manufacturing Site Approval Support
  • Import Registration Support
  • Sample Import License Support
  • Regulatory Affairs Consulting
  • Gap Analysis of the Dossier as per the CDSCO Regulatory Requirements
  • Preparation of Gap Analysis Report and Remediation Plan
  • Pharmaceutical Dossier Preparation and Submission to the CDSCO
  • Query Support Management till Approval
  • Pharmaceutical Artwork Management
  • Pharmaceutical Market Access strategy
  • Artwork Pharma Packaging
  • Pharmaceutical Lifecycle Management Support
  • Ad-hoc Regulatory Consultation

Location

Level 4, Building No. H-08,
Phoenix SEZ, HITEC City 2, Gachibowli,
Hyderabad – 500081

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