approval from the
licensing authority i.e., Central Drugs Standard Control Organization
(CDSCO). To bolster this submission, copies of two such permits granted by
CDSCO ... OSITAB
shall be made to India except under the permission granted by CDSCO
4
CS(COMM) 248/2022, order dated 11th July, 2022.
5
Under
Subject Expert Committee (SEC) (Oncology) of
the Central Drugs Standard Control Organization (CDSCO). These
recommendations disclose that the Defendant has applied for grant of
permission ... 2024 at 23:04:00
Biotechnology (Ministry of Science and Technology) and CDSCO (Ministry
of Health and Family Welfare), Government of India ["Guidelines
purposes, to the Subject Expert Committee (Oncology), Central Drugs
Standard Control Organisation (CDSCO). Plaintiffs have conducted
CS(COMM) 496/2024 Page 6 of 11
This
Abemaciclib (50mg, 100mg, 150mg, 200mg) by
the Central Drug Standard Control Organization (CDSCO).
14.5. Abemaciclib is the active pharmaceutical ingredient (API) in the
commercial product ... compound Abemaciclib, which has received regulatory approvals in various
countries, including from CDSCO in India. There has been no pre-grant or
post-grant opposition
Elder Project Limited.
In a letter written to the chief of CDSCO, the Drug Controller General of
India (DCGI) in December, Elder's managing
versus
UNION OF INDIA THROUGH DRUSGS INSPECTOR CENTRAL
DRUGS STANDARD CONTROL ORGANISATION (CDSCO)
NORTH ZONE .....Respondent
Through: Mr. Nishant Gautam CGSC along
with Mr. Dinesh
Court's
notice, Mr. Vaidyanathan clarifies that the approval from CDSCO was only
a conditional approval. The permission to market the drug in question ... Court's decisions and the Plaintiff's
responses.
1
"CDSCO."
CS(COMM) 159/2024 Page 4 of 6
This
versus
UNION OF INDIA THROUGH DRUSGS INSPECTOR CENTRAL
DRUGS STANDARD CONTROL ORGANISATION (CDSCO)
NORTH ZONE .....Respondent
Through: Mr Nishant Gautam, CGSC with Mr.
Prithviraj
