Page 153 - CW E-Magazine (14-5-2024)

Pharmaceuticals

CHANGE IN RULES
State licensors’ power to issue NOC for drug exports

revoked

The Union Government has with- banned/new drugs for export pur-
drawn powers delegated to the state pose,” the order stated. For handling
licensing authorities to issue no objection the change, Mr. Ranga Chandrashekhar
certifi cates (NOCs) for manufacture of Rao, Joint Drugs Controller, will be
unapproved, banned or new drugs for the nodal and designated point person
export purposes, amid heightened global at CDSCO.
scrutiny of Indian made drugs.
In 2018, the CDSCO had waived
The sole licensing authority from zonal offi ce,” the notice said. The regu- the provision of procuring NOCs by
now on will be the Central Drugs Stan- lator asked the drug controllers of the pharmaceutical companies for export-
dard Control Organisation (CDSCO), states and Union Territories to hand ing drugs, medical devices and cos-
India’s apex drug regulatory body. In over all NOCs issued from August 2, metics across ports in the country for
an order issued by Drug Controller 2018, to May 14, 2024, to the respec- ensuring ease of doing business. Before
General India, Dr. Rajeev Raghuvanshi, tive zonal offi ces of the CDSCO. 2018, licensed manufacturers of drugs
on 30 April, the CDSCO has asked the and medical devices could export them
industry to submit fresh applications “All manufacturers may be only to the US, Canada, Japan, Australia
for NOCs only from 15 May onwards. informed that they are required to and the European Union. The change
obtain NOC from respective zonal was then introduced saying that the
“Power delegated to state/UT offi ces of CDSCO through online NOC for licensed manufacturers will
licensing authority stands withdrawn mode (SUGAM) w.e.f 15 May before be waived if “shipping bills” submitted
w.e.f. May 15, 2024 and such NOCs issuing manufacturing license from by the manufacturer include a copy of
shall be granted by head of CDSCO SLA for manufacture of unapproved/ its “valid licence”.

Granules India receives USFDA approval for colchicine

capsules

Granules India has received an (63 Final approvals and one tentative colchicine capsules is approximately
approval from the US Food & Drug approvals). $55-mn in February 2024, according to
Administration (USFDA) for its abbre- industry estimates, the company said
viated new drug application (ANDA) The current annual US market for in a release.
filed by Granules Pharmaceuticals Inc.
(GPI), a wholly owned foreign sub- Dr. Reddy’s launches doxycycline
sidiary of the company for colchicine
capsules. capsules in US

The approved product is bioequiva- Dr. Reddy’s Laboratories has “This formulation of doxycycline
lent and therapeutically equivalent to announced the launch of doxycycline has not been evaluated in the treatment
the reference listed drug (RLD), Miti- capsules 40-mg, in the US market. or prevention of infections. Do not use
gare capsules of Hikma International The drug is a therapeutic generic doxycycline capsules for treating bac-
Pharmaceuticals LLC. Colchicine cap- equivalent of Oracea (doxycycline, terial infections, providing antibacterial
sules are indicated for prophylaxis of USP) capsules (40-mg), approved by prophylaxis, or reducing the numbers or
gout fl ares in adults. With this, Hydera- the US Food and Drug Administra- eliminating microorganisms associated
bad-based Granules now has a total of tion (USFDA), the company said in a with any bacterial disease,” the fi rm
64 ANDA approvals from the USFDA statement. further stated.

Chemical Weekly May 14, 2024 153

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