Pharmaceutical Product Registration in India - Overview
Pharmaceutical product registration in India, also known as the drug approval process in India or drug registration in India, is governed by the Central Drugs Standard Control Organization (CDSCO), an Indian Health Authority operating under the Drugs and Cosmetics Act. The CDSCO oversees six (06) zonal offices, four (04) sub-zonal offices, thirteen (13) port offices, and seven (07) laboratories, managing various aspects related to drugs and cosmetics regulation.
The CDSCO's responsibilities encompass Regulatory control over the import of medicines, approval of specific licenses, authorization of new medicines, clinical trials, Subsequent New Drugs (SND), Fixed-Dose Combinations (FDC), and Investigational New Drug (IND). Additionally, the CDSCO exercises authority over the Central License Approving Authority (CLAA), medical device classification, Drugs Consultative Committee (DCC) meetings, and Drugs Technical Advisory Board (DTAB) at the DCGI headquarters.
With a primary objective of ensuring the safety, efficacy, and quality of medicinal products manufactured, imported, and distributed in India, the CDSCO diligently works towards promoting transparency, accountability, and uniformity in its services. By adhering to the guidelines set forth in the Drugs & Cosmetics Act 1940, both central and state regulators collaborate to regulate drugs and cosmetics effectively, thus safeguarding the health of the nation's citizens.
Medicinal Product Classification in India
Medicinal products are classified into four (04) categories.
- Promising New Drugs (ND).
- Subsequent New Drug (SND).
- Fixed-Dose Combinations (FDC).
- Investigational New Drug (IND).
Medicinal Product Registration in India
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/Apply to conduct Phases I, II, & III of the clinical trials.
- Submit the report of the clinical trials to the Agency.
- Submit an application/Apply for market authorization holding.
- Submit an application/Apply to register the manufacturing site.
- Submit an application/Apply to obtain the Import License.
The drug approval process in India involves granting approval after a thorough 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.
Pharmaceutical Product Registration in India - 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.
- Drug Regulatory Affairs in India 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.
