CDSCO Application processof India’s Central Drugs Standard Control Organization (CDSCO) has published several notices since mid-March in response to the ongoing pandemic. These address new measures to expedite access to devices intended to prevent or treat COVID-19, to safeguard supply of other critical IVDs, and to reduce the exposure of CDSCO staff to the SARS-CoV-2 virus.
TheCDSCO Application processinvolves the development of the online licensing system for multiple stakeholders like Industry applicants, CDSCO officials from HQ, Zones, Subzones, Port offices, Investigators, medical practitioners.
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The system will provide an online interface for Applicants to submit applications, upload supporting documents, respond to queries from CDSCO officials and track theirCDSCO Application processstatus. It will also enable CDSCO officials to process the applications, generate note sheet, and raise queries and issue approvals / permissions online. The purpose of the document is to specify in detail the Processing of applications of medical devices by the regulatory authority (CDSCO and SFDA).For medical devices registration in India, 21 devices categories have been listed as ‘Notified Medical Devices’ by the CDSCO. However, devices which requireCDSCO Application processextend beyond the listed.
The CDSCO announced that it will prioritize COVID-19 IVD test kits for expedited approval. Manufacturers who already have approval for an IVD in another market are encouraged to contact the Drugs Controller General of India (DCGI) to discuss fast-track approval. Additionally, manufacturers pursuing the development of new IVDs may contact the DCGI directly to solicit guidance on the applicable regulatory pathway.
Priority applications are to be processed within seven days. As part of the expeditedCDSCO Application process、数据需求(例如,临床沟纹e evaluations) may be condensed, deferred, or waived on a case-by-case basis.
CDSCO Application process
- An application shall be made to the Licensing Authority in Form 40, either by the manufacturer himself, having a valid wholesale License, for sale or distribution of drugs or by his authorized agent in India either having a valid License to manufacture for sale of a drug or having a valid wholesale License for sale or distribution of drugs.
- DETAILS TO BE CAPTURED IN FORM 40: The authorized signatory name, designation, department, along with the complete address of the Company.
- i) Authorized Signatory: The person authorized preferably Director approved by the Board of Directors in case of company or by the proprietor in case of proprietorship firm. The application to accompany affidavit in respect of authorized person or the Power of Attorney in the name of the authorized person.
The Form shall detail the Foreign Manufacturer‘s contact person in the manufacturing site complete address, (i.e. address of the manufacturing premises), with corporate office address, along with the Telephone number, Fax number and E-mail address.
- ii) The address of manufacturing premises shall be captured as below: Undertaking on the document contents by the responsible person at the manufacturing site (contact person in the manufacturing site) – In respect of import of more than one drug or class of drugs manufactured by the same manufacturer, provided that drug or the classes of drugs, are manufactured at one factory or more than one factory functioning conjointly as a single manufacturing unit. – In respect of the drugs manufactured in two or more factories situated in different places, for the manufacturing of the same or different drugs the name and address of both the manufacturing site should be included e.g. if the tablets are manufactured at one location and packed at another location, Name and Address of both the locations indicating the activity of each location.
iii) The drug(s) name shall be captured as below: – The brand name shall be captured. – Different pack, pack size and/or different strengths of the same brand shall be captured. Importer‘s undertaking letter declaring for the information specified in Schedule D
- And Schedule D (II), provided by the original manufacturer. The registration Fees amount (Challan number and date) shall be mentioned on Original TR 6 challan having complete name and address of the applicant and details of application to be enclosed.
- iv) Fee structure for Import Registration under Form 40: – Fees and Form(s) and the undertakings as per Schedule D(I) (for registration of the manufacturing premises) and Schedule D(II) (for registration of the drugs): – Applicant shall make a payment of 1500 USD (or its equivalent to Indian Currency), as registration fee for the Manufacturing premises. – Applicant shall make an payment of 1000 USD (or its equivalent to Indian Currency), as registration fee for a single drug and additional fee of 1000 USD for each additional drug in case the manufacturing site remains the same. Fees shall be paid through a Challan
How to apply Cdsco?
To view Submitted Application, click on Menu Form Submission Submitted Applications. If application is approved by CDSCO, then it will be visible under Approved Applications tab. To view Approved Application, click on Menu Form Submission proved Applications.
Cdsco registration process
After submitting the Registration Form, Check Registered email for E-mail Verification. Submit ID proof, Undertaking, Address Proof Document in hard copy to CDSCO office. Registration will be approved by CDSCO only after evaluation of the submitted documents. Check your registered email id for all communications.
Manufacturers of medical devices, cosmetics, IVDs, are attracted to the Indian market due to the reliance of it on the imports. However the challenge is that the regulatory body in India is currently at its infancy and rules may be updated within short periods. The general timeline followed by the CDSCO for the various process of approval, trails, applications, can be found on CDSCO timelines.