- Home
- >
- All Countries
- >
- India
Lifesciences Compliance Services In India
Seamless Seamless regulatory services by our quality-assured experienced team from product registration to market access with no recalls.
Artixio serves as a leading partner working in more than 120 countries helping regulatory compliance of life science products. We at Artixio work as the backbone you need to support your product regulatory approval. We have expertise in leveraging regulatory services and compliance solutions, meeting your expectations to comply with CDSCO and achieve a successful product.
Expertise In Managing Regulatory Authorities:
Artixio can leverage the regulatory authorities with a local team member with 300+ regulatory and market access experience to achieve a successful product of pharmaceuticals, medical devices, animal care, veterinary products, beauty, and wellness products. We provide customized regulatory strategies to achieve product approval and expedite market access with no recalls.
In India, drug approval is regulated by CDSCO, Legal Metrology, WPC, FSSAI, CBN, and BIS. These regulatory authorities are responsible for confirming the safety and efficacy of the drug product and making it eligible for market access. These authorities work under the government to regulate products such as pharmaceuticals, medical devices, wellness and beauty products, animal care products etc.
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.
Our Services
Regulatory Affairs
Product Registration
Market Access
IND (Investigational New Drug)
NDA (New Drug Application)
Regulatory Operations
Technical Writing
Regulatory Strategy
Market Access
Why Trust Artixio with
Your Regulatory Journey?
Specialized staff working in 120+ countries.
Experienced regional professionals with 15 to 35 years of experience with adequate knowledge.
A quality assured team which is ISO 9001:2015 certified to help you build a quality product.
End-to-end support in product development, its approval, and post-approval aspects.
Specialization in Indian regulatory compliance and market access.
Seamless regulatory services from product registration to market access with no recalls.
Industries We Serve in the India
Pharmaceuticals
MedTech
Cosmetics
Nutrition
Biologics
Veterinary
FAQs
Which regulatory authorities are responsible for pharmaceuticals, medical devices, animal care, veterinary products, beauty and wellness products?
In India Central Drug Standards and Control Organization (CDSCO) is responsible for the regulation of pharmaceuticals, medical devices, and veterinary products, and wellness and beauty products are regulated by the Ministry of Health and Family Welfare and Bureau of Indian Standards (BIS).
How to approach the regulatory bodies in India?
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
Which is the reference drug regulatory agencies in India?
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.
How do the regulatory authorities charge in India?
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.
How can a foreign manufacturer register in India?
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
India
Singapore
Mexico
Brazil
Vietnam
Malaysia
Argentina
Colombia
Taiwan
China
European
Thailand
Indonesia
Philippines
USA
Japan
Qatar
