Medicinal Products Regulatory Support in India

Overview

Central Drugs Standard Control Organization (CDSCO) is an Indian Health Authority prevailing under the Drugs and Cosmetics Act. CDSCO has six (06) zonal offices, four (04) sub-zonal offices, 13 port offices and seven (07) laboratories under its control. The Drugs & Cosmetics Act, 1940, has entrusted various responsibilities to central and state regulators to regulate drugs & cosmetics. Significant functions of 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) & Investigational New Drug (IND). Central License Approving Authority (CLAA), Medica Device Classification, devices meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB) are exercised by the CDSCO, DCGI headquarters. CDSCO is responsible for pharmaceutical product registration in India. The Agency is constantly thriving to bring out transparency, accountability, and uniformity in its services to ensure the safety, efficacy and quality of the medical products manufactured, imported, and distributed in the country.

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

Medicinal Product Classification

Medicinal products are classified into four 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, an appointment of in-country representative to hold the Marketing Authorization Holder (MAH) is mandatory for the approval of market authorization application. The in-country representative will be responsible for the authenticity of documents, correctness of information and periodically follow-up with HA for the registration dossier, submitted to HA. MAH holder should have the credential for online SUGAM portal.

Steps for obtaining the MAH

  • Submit the application to conduct the Clinical Trails, Phase I,II & III
  • Submit the report of the clinical trials to the agency
  • Submit the application for Market Authorization Holding
  • Submit application for registering the manufacturing site
  • Submit the application to obtain the Import License

After a critical review and of these forms by the respective divisions is carried out, the approval is passed.

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 of the expiry of the import license (applications for the import license should be submitted along with the application for renewal with importer).

Any change (major/minor) of registered medicine should be filled and submitted to CDSCO with relevant documents.

Pharma Regulatory services and pharma Regulatory consulting are at the core of Freyr’s competencies.

Freyr Expertise

  • End-to-end Registration Support
  • Authorized Local Agent Support
  • Market 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
  • 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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