Your Guide to India
Here below we help you dive deep into the regulatory requirements of India and answer some of the basic questions.
Still confused with the complete process? - Genedrift assists you with all regulatory requirements as mentioned.
Guide to Drugs
The registration - from start to end !
The registration process is carried out with the department within the Ministry of Health - Central Drugs Standard Control Organisation (CDSCO), also usually referred to as Central Licensing Authority. The first requirement is to submit a full and complete dossier including translations along with relevant payment of fees.
A Local Applicant - responsible for the application is mandatory and required to have a valid Drug / Wholesale License (or a license to trade in Drugs).
The review happens through different wings each issuing their own queries and objections - including analysis of the Drug.
Upon successful review, the registration is announced and released along with the copy of the Registration Certificate.
It is important to note, that in case of imported products - the registration certificate is not a license to import. An Import License is required for the purpose of import.
The complete process for a New Drug, could take between 8 to 24 months depending on the type of application
Site Audits are not mandatory, but may be triggered in case serious defaults are observed in the application.
The CDSCO follows a regional checklist, created on basis of CTD.
The CDSCO follows a different checklist for a different type of application - whether a New Drug with all New Ingredients or a New Drug with a Pre-Approval in another country !!
Need our assistance ! We, at Genedrift can handle this for you.
There have been recent change in rules impacting New Drugs, Subsequent New Drug, Clinical Trial and various other applications and procedures. We take you through the complete regulation, highlighting the differences and making it easier for you to understand.
Guide to Medical Devices
The process for Medical Devices is different from Drugs and is taken care off by different departments within the CDSCO. The document requirement is comparatively less and the time too. The CDSCO issues a registration certificates for Medical Devices, with a perpetual validity but a requirement to pay a retention fees on the expiry of the period as mentioned on the registration certificate.
The classification of Medical Devices is done from A to D, as per the classification set out by the CDSCO and in absence of an available classification - a specific request for classification is to be made.
A predicate device is essential in order to avoid a clinical trial for the application.
Site Audits are not mandatory but may be conducted depending on the application.
Guide to Cosmetics
How can Genedrift help?
We file as your applicants
The law mandates that the filing has to be done through a local applicant. Although you remain the true applicant, we file and hold registrations on your behalf.
You registrations remain in safe hands, while you have commercial agreements with anyone.
Timely Updates
Applications are accepted online, in addition to the mandatory offline submission. During the review process, multiple authorities are involved within and outside of CDSCO for review and analysis.
Each stage we ensure rigorous follow up and provide updates within 48 hours of receipt.
Safety of your Data
We ensure your Dossier is used only for CDSCO related activities. Complying with GDPR, we ensure that your data safe & secure. Our Data Centers comply with a minimum of ISO 27001, SOC 1 TYPE II, SOC 2 TYPE II
Pathway
Being locally present, we ensure that each and every application we handle for you is routed correctly through the right workflows at CDSCO ensuring least time in obtaining your certificates.
Are you a consultant yourself? Looking to use our services for your clients ?
We can get this done !!