Pharmaceutical Product Registration Process in India - Overview
Pharmaceutical product registration in India, also known as the drug approval process in India or the pharmaceutical product registration process 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 and registration of drugs in India, 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.
To ensure the safety, efficacy, and quality of medicinal products manufactured, imported, and distributed in India, the CDSCO diligently follows the CDSCO guidelines for product registration, aiming to promote transparency, accountability, and uniformity in its services. By adhering to the pharmaceutical regulations in India (outlined 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 as per CDSCO registration process:
- 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, following the drug registration guidelines in India. The in-country representative will be responsible for ensuring the authenticity of documents, correctness of the information, and periodical follow-ups with the Health Authorities (HA) regarding the registration dossier, as outlined in the guidelines for Pharmaceutical Regulatory Affairs in India by CDSCO. The MAH should have the credentials for the online SUGAM portal.
Key steps in the CDSCO approval process for 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 involves a thorough review of these specific forms by the respective divisions, as part of the CDSCO Approval Process before granting final approval. Any changes (major/minor) in the registered medicine should be filed and submitted to the CDSCO with relevant documents.
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). |
Pharmaceutical Product Registration Process 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.
Freyr’s expertise in Pharmaceutical Regulatory Affairs in India provides clients with a comprehensive approach to efficiently navigate the drug registration process in India. To accelerate your market access, consult our experts today.
