Regulatory Affairs Services in India
End-to-end regulatory affairs solutions in India for product approvals across the pharmaceuticals, MedTech, nutrition, cosmetics, biologics, and veterinary industries.
Services We Offer
Register your Product in India’s Regulated Sectors
India’s healthcare industry has evolved into one of the most significant global hubs with government incentives, increasing R&D investments, and increasing demand for affordable therapies. India ranks among the top pharmaceutical and healthcare markets globally, with its domestic pharma sector valued at over $50 billion currently and projected to reach $130 billion by 2030
Although the scale and opportunity is increasing, product registration in India involves a complex regulatory ecosystem coordinated between central and state authorities, governed by multiple legislations, and aligned increasingly with international standards such as ICH, WHO GMP, and ISO.
Regulatory Authorities in India
| Authority | Scope |
|---|---|
| Central Drugs Standard Control Organization (CDSCO) | Central authority for new drug approvals, clinical trials, import licenses, and post-market surveillance. |
| Drug Controller General of India (DCGI) | Heads CDSCO and leads national policy for drugs and medical devices. |
| State Drug Licensing Authorities (SLAs) | Approve manufacturing and sales licenses at state level. |
| FSSAI (Food Safety & Standards Authority of India) | Regulates food supplements and nutraceuticals. |
Regulatory Affairs Process In India
To legally market regulated products in India, companies must follow a structured approval process. While the process varies by product type, it generally involves the following steps:
Step 1 - Product Classification
Classifying a product is necessary to determine the documentation and regulatory approval pathway. Examples include:
- New drug: Not previously approved in India
- Generic drug: Same active ingredient as before
- Biosimilar or Vaccine
- Medical Devices: Class A to D, based on the risk
- Cosmetics/Nutraceuticals
Step 2 - Appointment of Authorized Indian Agent (For Imports)
It is essential to appoint an authorised Indian agent for foreign manufacturers intending to market products in India. The Indian agent acts as a local liaison with regulatory authorities and is responsible for compliance.
Step 3 - Documentation and Dossier Preparation
Proper dossier preparation is important to avoid delays in product approval. Companies must prepare regulatory dossiers, which include:
- Common Technical Document (CTD/eCTD) format for drugs
- Device Master File (DMF) for medical devices
- Product composition and specifications
- Stability and toxicity studies
- Clinical trial data (if applicable)
- Manufacturing site GMP certification
- Product labels and package inserts
- Free Sale Certificate (for imported products)
- Product testing data (for cosmetics or food products)
Step 4 - Clinical Trial Authorisation
For new drugs, vaccines, or innovative biologics, receive the clinical trial approval from CDSCO before marketing. Initial CTA approvals take 45 – 90 days from submission, if complete.
- Submit the approval application via the SUGAM online portal
- Trials must be in compliance with Schedule Y of the Drugs and Cosmetics Rules
- Register the trials in the Clinical Trials Registry India (CTRI)
- Ethics committee clearance and GCP compliance are required
Step 5 - Submission of Application for Product Approval
The application for registration or marketing authorization is submitted to the relevant authority, typically via the SUGAM portal.
Step 6 - Review and Evaluation by Regulatory Authorities
After the submission, the application is reviewed for:
- Technical validity
- Indian pharmacopoeial standards compliant
- Manufacturing facility inspection report
- Clinical trial data or literature evidence
- Labelling and packaging compliance
Step 7 - Product Approval & Post-Market Obligations
Once approved, the company must:
- Submit adverse event and PSUR reports
- Batch testing release and documentation
- Undergo audits, when required
Why Artixio?
dossiers successfully filed with CDSCO
ISO 9001:2015 certified documentation workflows
End to End product lifecycle support and renewals
In-country agent representation across ___ states
Real-time tracking & submission support via eCTD & SUGAM portals
Are you launching your product in India ?
Artixio helps with the end-to-end seamless product registration process.We help with local insight, regulatory accuracy, and full-cycle support and ensure that your products enter the market without delays or compliance risks. Connect with our regulatory affairs consultant in India today for expert guidance and swift market entry.
FAQs
Are CTD/eCTD formats accepted in India?
Yes, CTD is accepted ( not mandatory). eCTD submissions are preferred through the SUGAM online portal.
Is a separate license needed for each state in India?
Manufacturing licenses are granted at the state level. However, import and marketing authorizations are handled centrally by CDSCO.
What is the validity period of product registrations in India?
Registrations (Marketing Authorizations) are typically valid for 5 years, after which a renewal must be filed at least six months before expiration.
Is prior approval in US/EU markets sufficient for Indian registration?
No, while prior approvals from USFDA, EMA, or PMDA can support your application and may help secure a waiver for local clinical trials, you still need to submit a full dossier to CDSCO for independent review under Indian regulations.
Still Have Questions ?
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Specialized Registration Services Across Multiple Industries
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