The Drugs Controller General (India) has issued a notification regarding the extension of the validity of Free Sale Certificates (FSC) for notified medical devices.
The notification instructs State Licensing Authorities (SLAs) to issue FSCs with a validity period matching the expiry date of the manufacturing license held by the manufacturer, for export purposes.
This decision aims to promote the export of notified medical devices from the country.
Key Changes
The validity of the Free Sale Certificate (FSC) for notified medical devices is extended from the current two years to the expiry date of the manufacturing license.
This change applies to the 15 medical devices currently notified and regulated as 'Drugs' under Section 3(b)(iv) of the Drugs & Cosmetics Act.
State Licensing Authorities (SLAs) are authorized to charge a fee of Rs. 5000 per application for issuing the extended validity FSC.
The decision was made following concerns raised by Medical Devices Associations and a meeting held in the Ministry of Health & Family Welfare.
Impact Analysis
Manufacturers of Notified Medical Devices
Action Item: Manufacturers should be prepared to pay a fee of Rs. 5000 per application.
State Licensing Authorities (SLAs)
Action Item: SLAs should ensure a streamlined process for manufacturers to apply and obtain the extended validity FSCs.
Medical Device Associations (CII, FICCI, AIMED, ADMI, IDMA, ASSOCHAM)
Action Item: Associations can assist their members in navigating the application process for obtaining the extended validity FSCs.
Government (Ministry of Health & Family Welfare, CDSCO)
Action Item: The Ministry of Health & Family Welfare should monitor the impact of the extended FSC validity on medical device exports.
Key Entities Referenced
Drugs & Cosmetics Act: The primary legislation in India regulating the import, manufacture, distribution, and sale of drugs and cosmetics. Notified medical devices are regulated as 'Drugs' under section 3(b)(iv) of this act.
Drugs Controller General (India) - DCG(I): Head of the Central Drugs Standard Control Organization (CDSCO), responsible for regulating pharmaceuticals and medical devices in India.
State Licensing Authority (SLA): The state-level authority responsible for granting manufacturing licenses and Free Sale Certificates for medical devices within their jurisdiction.
Free Sale Certificate (FSC): A certificate issued by the State Licensing Authority to a manufacturer, certifying that the medical device is freely sold in the country and meets the required quality standards. This certificate is required for exporting medical devices.
CDSCO: Central Drugs Standard Control Organisation. India's national regulatory body for pharmaceuticals and medical devices.
CII, FICCI, AIMED, ADMI, IDMA, ASSOCHAM: Industry Associations representing medical device manufacturers in India.
No.29JMISCJ3J2015-DC(290)
Dte. General of Health services
Office of Drugs Controller General (India)
FDA Bhawan, Kotla Road, New Delhi-110002
To,
All state JUT Drugs controllers,
Subject: Extending the validity of Free Sale Certificate for notified medical devices
till the expiry of manufacturing licence for export purpose- Reg.
Sir,
Under the provrsions of Drugs & Cosmetics Act, notified medical devices are
regulated as "Drugs" under section 3(b)(iv). At present, only 15 medical devices are
notified and regulated for its import, manufacture and market in the country under the
said Act & Rules. A Free Sale Certificate (FSC) with the validity of two years is issued to
the manufacturer by the concerned State Licensing Authority (SLA) for export purpose.
A concern was raised by Medical Devices Associations at various forums from
time to time to extend the validity of FSC for such notified medical devices till the expiry
of the manufacturing license granted to the manufacturer. In order to address the
concern, it was decided in the meeting held in Ministry of Health & family W.elfare, New
Delhi that in order to promote the export from the country, the State Licensing Authority
may issue Free Sale Certificate to the manufacturer with the validity of their
manufacturing license. .
In view of the above, in order to bring uniformity in its implementation, you are
requested to grant FSC to the manufacturer located under your jurisdiction with the
validity of their manufacturing license to promote export from the' country.' .
You may also charge a fee of Rs. 5000/- per application from the manufacturer for
issuing of such certificate.
(Dr. G. N. Singh)
Drugs Controller G neral (I)
Copy to:
1. PPS to JS (R), Ministry of Health & Family Welfare, Nirman Bhawan, New Delhi
2. All DOC (I) of Zonal offices of CDSCO
3. Industry Associations-CII, FICCI, AIMED, ADMI, IDMA, ASSOCHAM
4. CDSCO Website