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Artixio

India

CDSCO Authorized Agent & Compliance Support in India

We help global lifesciences brands manage CDSCO compliance, and secure market authorization in India — without delays or recalls.

India Compliance Experts for Life Sciences Companies

Artixio helps lifesciences businesses meet CDSCO compliance needs, gain market authorization, and maintain product quality in India. With in-country consultants and proven experience across 120+ markets, we offer clear, responsive support — from CDSCO submissions to authorized agent representation.

From preparing your dossier to managing submissions, responding to queries, and acting as your CDSCO consultancy services partner, we make Indian market entry faster, predictable, and fully compliant.

Expertise in Meeting Regulatory Requirements by Authorities

We’ve worked with over 300 companies — some just starting out, others expanding into India — helping them get through CDSCO submissions and all the paperwork that comes with it.

Whether it’s a medical device, a new pharma product, or even cosmetics, our in-country consultants guide you through every step. No fluff, no missed timelines — just solid compliance support designed for India’s healthcare system.

From CDSCO submissions to in-country representation, we serve as your trusted compliance consulting company in India — focused on speed, accuracy, and zero-recall approvals.

regulatory bodies for compliance in India

Product approvals in India go through different compliance bodies depending on the type. CDSCO handles pharmaceuticals and medical devices, while FSSAI looks after food and nutrition products. For things like cosmetics, telecom, and animal care, other authorities like BIS, WPC, Legal Metrology, and CBN may step in. 

Regulatory Bodies Involved in Compliance in India

CDSCO:

The Central Drugs Standards Control Organization (CDSCO) is the highest regulatory authority responsible for all drug and drug product-related regulations in India. CDSCO is divided into 6 zonal offices which are regulated by Dy. Drugs Controller of India. CDSCO helps in maintaining transparency between the manufacturer and the consumers, confirming its safety and efficiency.

FSSAI:

The Food Safety and Standards Authority of India (FSSAI) created in 2006 is a branch of the Ministry of Family and Welfare that aims to standardize all food products, nutraceuticals, etc. FSSAI monitors the manufacturing and marketing process of all food-related products.

LEGAL METROLOGY:

Legal Metrology deals with the accuracy of measurements in the production process. It checks for the standardization of measurement equipment used. So, indirectly it deals it aims at the safety and efficacy of the drug.

BIS:

The Bureau of Indian Standards (BIS) works under the Ministry of Consumer Affairs, Food and Distribution in India. It designs a set of regulations that aims to implement certain standards for the products. After the product approval from BIS, it provides certifications such as ISI mark.

State FDA:

The State Food and Drug Administration is responsible for the state-level regulations of life sciences products. It has its branches in every state.

CBN:

The Central Bureau of Narcotics (CBN) governs under the Ministry of Home Affairs. It enforces the Narcotic Drugs and Psychotic Substance (NDPS) Act in India. The CBN provides a license after its approval for the production, cultivation and manufacturing process.

WPC:

The Wireless Planning and Coordination (WPC) sets rules and regulations for equipment such as medical devices that work in wireless mode.

Why Trust Artixio with Your Regulatory Journey?

Compliance consulting services company
Specialized staff working in 120+ countries.
Compliance consulting services company
Experienced regional professionals with 15 to 35 years of experience with adequate knowledge.
Compliance consulting services company
Acting as your authorized agent and compliance representative
Compliance consulting services company
End-to-end support in product development, its approval, and post-approval aspects.
Compliance consulting services company
Specialization in Indian regulatory compliance and market access.
Compliance consulting services company
Regulatory documentation and submission support
Compliance consulting services company
Managing the CDSCO registration process end-to-end
Compliance consulting services company
Providing ongoing compliance support and lifecycle maintenance

Industries We Serve in the India

Regulatory and compliance expert – Artixio

Pharmaceuticals

Medical device regulatory services – Artixio

MedTech

Cosmetics regulatory consulting – Artixio

Cosmetics

Nutrition regulatory consulting – Artixio

Nutrition

Biologics regulatory consulting – Artixio

Biologics

Veterinary regulatory consulting – Artixio

Veterinary

FAQs

Who handles regulatory compliance for product approvals in India?

Regulatory bodies such as CDSCO, FSSAI, BIS, and WPC handle product approvals and compliance based on the type of product.

The regulatory bodies in India can be approached by submitting the online application with the authentic documents on the CDSCO online portal for pharmaceuticals, medical devices, animal care, veterinary products, beauty and wellness products
In India Drug Controller General of India (DCGI) is the reference drug regulatory agency which is looks over the approval applications’s received and performs inspection of the overall process ensuring the safety, efficacy and adverse reactions of the drug product and then confirming the approval request. DCGI works in collaboration of CDSCO. There are various departments of DCGI such as drug imports, drug approval, license granting, medical devices regulations, etc.
The regulatory fee for each product may vary according to the type of product, its risk category, approval process, etc. However, the fee for each product can be checked on the CDSCO official page for the specific product category.
A foreign manufacturer can register in India by collaborating with an Indian local representative commonly known as an Indian Agent (IA), Authorized Agent (AA), etc.

Our Global Reach: Serving Life
Sciences Clients Worldwide

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Insights from Artixio - Tips & Articles

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