MOHFW notifies Drugs and Cosmetics (Amendment) Rules, 2019; effective 10th January, 2019

MOHFW notifies Drugs and Cosmetics (Amendment) Rules, 2019; effective 10th January, 2019

This is a quick update to let you know that the Ministry of Health and Family Welfare has, by a Notification dated 10th January, 2019, notified the Drugs and Cosmetics (Amendment) Rules, 2019.

Going forward, Licensees will have to upload information pertaining to the licenses granted for manufacture for sale or distribution of drugs as per the format provided in the SUGAM portal.

BACKGROUND

The Principal Rules provided an option for the licensees to obtain registration certificate, license to import etc.  through the SUGAM portal.

In light of the above facility, the Amendment Rules mandate licensees licensed under the Part VII of the Principal Rules to upload information pertaining to the licences granted for manufacture for sale or distribution of drugs as per the format provided in the SUGAM portal. The licensees should also update this information from time to time. The information uploaded by the licensee with SUGAM portal will also be verified by the concerned Licensing Authorities.

Source: Ministry of Health and Family Welfare

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