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Drugs
and Cosmetics (3rd Amendment) Rules, 2002
IDMA
Note:
The
amendment suggests that where application under Rule 69(5) or other
Rules Specified in Notification (as prescribed under this rule),
is for manufacture of drug/ formulation falling under the purview
of a ‘‘New Drug’’ as defined under Rule 122
(E), such application shall also be accompanied with the approval
in writing in favour of the applicant from the Licensing Authority,
as defined under Rule 21. This means that the approval will have
to be obtained from the Drug Controller General (India), who is
the Licensing Authority under Rule 21 of the Drugs and Cosmetics
Rules.
Rule
122 (E) referred to in this amendment specifies the definition of
‘New Drug’. Rule 122 (E) specifies ‘‘New Drug
Formulation,’’ which may be referred to.
In
short, the State Licensing authority in future will have no authority
to grant licence for any formulation which is considered as a new
drug under Rule 122 (E) (c), and explanation, approval of which
is exclusively within the purview of the DCG (I), who is the Licensing
Authority under Rule 21 of the Drugs and Cosmetics Rules and application
for new drug formulation to State Licensing Authority will be accompanied
with approval letter from Drugs Controller General (India).
Ministry
of Health and Family Welfare (Department of Health)
New
Delhi, 1 May, 2002
GSR
311 (E) - Whereas a draft of certain rules further to amend the
Drugs and Cosmetic Rules, 1945 was published as required by Sections
12 and 33 of the Drugs and Cosmetic Act. 1940 (23 of 1940), at paper
3 and 4 in part II section 3, sub-section (i), of the Gazette of
India, Extraordinary, dated 19 October, 2001, under the notification
of the government of India in the Ministry of Health and Family
Welfare (Department of Health), number GSR 785 (E), dated 19 October,
2001 inviting objections and suggestions from all persons likely
to be affected thereby before the expiry in a period of forty-five
days from the date on which copies of the official Gazette containing
the said notification were made available to the public;
And
whereas copies of the said Gazette were made available to the public
on 20 October, 2001;
And
whereas objections or suggestions received from the public on the
said draft have been considered by the central government;
Now,
therefore, in exercise of the powers conferred by sections 12 and
33 of the said Act, the central government, after consultation with
the Drugs Technical Advisory Board, hereby makes the following rules
further to amend the Drugs and Cosmetics Rules, 1945, namely:
1
(1) These rules may be called the Drugs and Cosmetics (3rd Amendment)
Rules, 2002
(2)
They shall come into force on the date of their publication in the
Official Gazette.
2
In the Drugs and Cosmetics Rules, 1945 (hereinafter referred to
as the said rules), in rule 69 after sub-rule (5), the following
sub rule shall be inserted, namely.
(6)
where an application under this rule is for the manufacture of drug
formulations falling under the purview of new drug as defined in
rule 122-E, such application shall also be accompanied with approval
in writing in favour of the applicant from the licensing authority
as defined in clause (b) of rule 21.
In
rule 71 of the said rules, in-rule (6), after clause (iv), the following
clause shall be inserted, namely
(v)
have the approval, in writing, in favour of the applicant to manufacture
drug formulations falling under the purview of new drugs as defined
in rule 122-E, from the licensing authority as defined in clause
(b) of rule 21.
4
In rule 75 of the said rules, in sub-rule (5) following sub-rule
shall be inserted, namely.
(6)
where an application under this rule is for the manufacture of drug
formulations falling under the purview of new drug as defined in
rule 122-F, such application shall also be accompanied with approval
in writing in favour of the applicant from the licensing authority
as defined in clause (b) of rule 21.
In
rule 76 of the said rules, in sub-rule (6) after clause (iv), the
following clause shall be inserted, namely:
(v)
have the approval, in writing, in favour of the applicant to manufacture
drug formulations falling under the purview of new drug as defined
in rule 122-E, from the licensing authority as defined in clause
(b) of rule 21.
(No
X-11014/4/2000-DMS and PFA)
Deepak
Gupta, Jt Secy
Foot
note: The Drugs and Cosmetics Rules, 1945, as amended upto 1/5/1979
are contained in the publication of the Ministry of Health and Family
Welfare (Department of Health) containing the Drugs and Cosmetics
Act 1940 and the Rules (PDGHS-61) and last amended vide GSR 250
(E), dated 4/4/2002.
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