CDSCO Authorized Agent Support
DRUG
Understanding all the clinical regulations and complying with the standards to import drugs can be daunting. Experts at CliniExperts are here to help you at every stage of importing drugs, from undertaking to distributors (Form 9) to obtaining an import license (Form 10). We offer services to fill all required forms, complete documentation for an import license, pharmacovigilance, re-registration and post-registration regulatory support, all under one roof in a cost-effective manner.
Authorized Agent For
DRUG – Overview
A foreign company who doesn’t have its establishment in India, wants to enter India market, then they can appoint an authorized agent to register and market their products in India.
An “Authorized Agent” means a person or entity in India authorized by the foreign company. The authorized agent will be responsible for the import and business activities of the foreign company in India including compliance to the provisions of the Drugs and Cosmetics Acts in all respects.
Authorized Agent must possess a valid wholesale license meant for the sale and distribution of products or services in India and should be able to file an application to Central Licensing Authority for Drug registration in India.
Who Would Need
An Authorized Agent Service?
Any foreign company who want to capture the Indian market but does not have its business operations or partner in India.
Services CliniExperts Provides As An Authorized Agent
India's pharmaceutical market is expanding at a breakneck pace, and several new regulations and amendments have been issued in the past few years. The importers of drugs need to register themselves in the country and fulfil stringent quality control requirements with meticulous documentation. The documentation of regulatory procedures is time-consuming and requires an expert's eye.
CliniExperts holds a valid Drug Wholesale License in Form 20B and 21B and can act as your authorized representative in India. We, at CliniExperts, provide you with all the necessary assistance throughout the process of import to launch your product in time.
Owing to years of regulatory experience, CliniExperts authorized agents help clients with the following services:
Registration and Re-registration
License renewal
PSUR
ADR reporting
Pharmacovigilance
Distributor identification
Regulatory compliance of labels as per new guidelines
Complaint handling
Query responses
Product recall support
Procure import license (Form 10)
Notarization of documents from different Embassies in India.
Our expert and skillful team with immense experience in regulatory writing supports clients in regulatory processes to launch products hassle-free.
Responsibilities of
Authorized Agent
The authorized agent must have a wholesale license to sell and distribute pharmaceutical drugs in India. In addition, they are responsible for the manufacturer's business activities in India, including compliance with the Drugs & Cosmetic Act, 1940 & Drugs and Cosmetics Rules, 1945.
The authorized agent is also responsible for testing a sponsor drug at the central government laboratory.
It is the responsibility of authorized agent to submit a Form-40 application to the Central Licensing Authority (CLA) using an identified online portal of the Ministry of Health and Family Welfare in the Central Government by paying the required registration fees. This form grants a registration certificate (RC)in Form 41 for drug.
The holder of a registration certificate is then responsible for issuing Form-9 to importers in order for the drug to be imported on the certificate.
The authorized Agent should also assist with adverse event reporting and product recalls when necessary.
The authorized Agent should also assist with adverse event reporting and product recalls when necessary.
Essential Tips
Two main requisites while preparing for the process of license application are:
Possession of wholesale license for sale and distribution of drugs in India
Appointment as an authorized agent
Expert Advise
With respect to import of drugs, the foreign manufacture has to submit
Free Sale Certificate of their finished product in the GHTF countries
Power of attorney, allowing authorized agent to market their products in India on their behalf
The documentary evidence need to be submitted to the central licensing authority at the time of grant of license and subsequently as and when needed.
Primary Service
CliniExperts offer strategic planning services during product registration in addition to finding distributors and acting as an authorized agent in India. Our hand in glove approach ensures that at no point you find yourself battling with any process by yourself.
Who Can Apply
The applicant who wishes to store, distribute and sale the drugs in wholesale cn apply for wholesale License. The person should be a Registered pharmacist (RP) who have a degree or diploma in pharmacy from a recognized university or competent person (CP). Further, arrange one person with same competency for it.
Frequently Asked Questions
What additional services you are offering along with these services?
CliniExperts helps clients by providing assistance and expert help in the following other services:
- Assistance in drug import and customs clearance
- Issuance of Form-9 to the importers to import the drug based on the RC
- Warehouse and CFA support to distribute your products
- Distributor's identification to map potential distributors for your products in India
- Post-market surveillance and Pre- certification support
What is the purpose of these services?
Any foreign institution must register its product under a legal name in India before being introduced in India. An overseas company that does not have an office or a business partner in India and intends to trade its products in the Indian market, must designate an Indian agent who is a legal entity in India
What are the benefits to hire CliniExperts in place of my own distributor in India?
CliniExperts is India's premier regulatory and business consulting firm and significantly benefits foreign companies when registering. Also, you need only one Indian Authorized Representative to conduct business across all states in India, and CliniExperts can act as a neutral party for your company operations in India. Suppose you have your own distributor, but in the future don't get any business or are seeking another distributor, then you need to go through the registration process again to appoint another distributor. With CliniExperts, the registration process will be a one-time activity as it doesn't impact the business on changing the Indian distributor. You can appoint and replace multiple distributors with CliniExperts if they are not fulfilling business requirements. In addition, trying to setup your own office can be very expensive. Setting up, maintaining it and if it doesn’t succeed, then shutting it down – all these are time consuming and expensive affairs. With CliniExperts these all get eliminated. CliniExperts becomes the authorized agent and distributor for your IVDs and you can focus on sales instead of bureaucracy.
What kind of sales model do you have?
We function as a one-stop neutral party, taking care of registration, import, and round-the-clock logistics support, allowing you to focus on your business and expand your reach in the Indian market.
What are the legal requirements for using these services?
The appointed Authorized Agent is legally responsible for pre-certification and post-market surveillance inquiries. If any Adverse Events Reporting are reported in the future, product recall requests are made, or compensation is required, actual manufacturers will handle all legal compliances to CliniExperts. [N1]Kindly replace ADRs with Adverse Events Reporting