In order to promote the export of pharmaceutical products from the country, the Drug Controller General of India (DCGI) has extended the validity of Free Sale Certificate for notified medical devices till the expiry of manufacturing licence. The DCGI has issued a directive to all the state drug controllers in this regard.
Under the provisions of Drugs & Cosmetics Act (D&C 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 marketing in the country under the D&C Act & Rules. A Free Sale Certificate with the validity of two years is issued to the manufacturers by the concerned State Licensing Authority (SLA) for export purpose.
However, medical devices industry associations in the country have been raising concern for quite some time to extend the validity of Free Sale Certificate 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 Welfare, New Delhi that 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,” the DCGI in his directive to the SLAs said.
“In view of the above, in order to bring uniformity in its implementation, you are requested to grant Free Sale Certificate 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,” the DCGI further said.