Drugs registered on SUGAM portal to be exempted from obtaining licence for purpose of examination, test, analysis

The exemption from obtaining a licence for Form 29 is subject to the condition that the information about the manufacturing of approved drugs for examination, test or analysis shall be uploaded on the SUGAM Portal.

New Delhi: In a major relief to drug manufacturers, the Government will soon amend the Drugs and Cosmetics Rule to exempt drug manufacturers from obtaining a licence in Form 29 for the manufacture of approved drugs who are already holding a licence in Form 25/Form 28 to manufacture any drug in the same dosage form.

The matter was deliberated in the 82nd meeting of Drugs Technical Advisory Board (DTAB) wherein the board was apprised that, licence to manufacture drugs for the purposes of examination, test or analysis is granted in Form 29 under Rule 89 of the Drugs and Cosmetics Rules, 1945 and licence to manufacture of drugs for sale or for distribution is granted in Form 25 or Form 28 under the said rules.

Rule 89 of the Drugs and Cosmetics Rules, 1945 is reproduced below:-

"89. Licence.–If the person proposing to manufacture a drug for the purpose of examination, test or analysis does not hold a licence in Form 25 or Form 28 in respect of such drugs he shall, before commencing such manufacture, obtain a licence in Form 29."

Also Read: Information about licenses to be uploaded on online portal SUGAM: Health Ministry Gazette

It was proposed to exempt for obtaining a licence in Form 29 for the manufacture of approved drugs for the purposes of examination, test or analysis by the manufactures who are already holding valid product permission for manufacturing of same dosage form of any drug in Form 25 or Form 28.

DTAB examined the proposal in detail and agreed to exempt for obtaining licence in Form 29 for manufacture of approved drugs by the manufacturers who are already holding licence in Form 25/Form 28 to manufacture any drug in same dosage form subject to the condition that the information about the manufacturing of such drugs for examination, test or analysis shall be uploaded on the SUGAM Portal.

Accordingly, the Drugs and Cosmetics Rules shall be amended.

Medical Dialogues had earlier reported that through Gazette notification, the Ministry of Health and Family Welfare had amended the Drugs and Cosmetics Rules, 1945. The Gazette dated 11th July 2018 talked about the amendment of the Drugs and Cosmetics Rules, 1945, in order to insert Information to be uploaded by the licensee on online portal SUGAM

Also Read: Upload application in SUGAM as per new Rules: CDSCO issues notice