rear sensing unit 121b housed
within a detachable rear mounting housing 122b. According to
various embodiments, the front sensing unit 121a comprises
various road image
Drugs Rules with effect from
21st September, 1988 by introducing Rules 122A, 122B, 122D &
122E and Schedule Y which required that the manufacturers ... response to a query informs that such permission
was sought under Rule 122B of the Drugs and Cosmetics Rules,
1945, as for a new drug
which is defined under Rule 122E is under Rule 122. Rule
122B provides that no new drug shall be manufactured without
approval of Licensing Authority ... defined under Rule 21(b). Sub-rule
(2) of Rule 122B provides that manufacturer of a new drug shall
submit data as given in Appendix
biosimilar to the drug of the plaintiffs
under Rule 122B of the Drugs Rules;
(ii) that a biosimilar drug is a „new drug‟ within ... same;
(iv) that Cadila, for the subject drug has approval under
Rule 122B(1)(a) of the Drugs Rules;
(v) that Rule 122DC provides
Cosmetics
Rules, in particular the provisions of Rules Rule-122 A, 122B & 122D.
In terms thereof, no new drug shall be imported or manufactured ... thereon to
defendant No.2 in exercise of its powers under Rule 122B of the
Drugs Rules. Additionally, the remedy of an appeal
required to seek approval from the
Licensing Authority in terms of Rule 122B of the Rules. Rule 122B of
the Rules is set out below ... 122B. Application for approval to manufacture new
drug :(1) (a) No new drug shall be manufactured for sale
unless it is approved by the Licensing
Bayer Corporation vs Union Of India & Ors. on 22 April, 2019
Equivalent citations: AIRONLINE
DGCI, has to apply under Form 44 to obtain
marketing approval [Rule 122B (1) (b)]. Marketing approval for a drug already approved drug ... required under Appendix IA of Schedule Y. [third proviso
to Rule 122B (1) (b)]. Further data demonstrating the safety and efficacy of the drug
sale or to undertake clinical trials are
specified in Rule 122A, 122B, 122D and Schedule-Y of the Rules.
9.9 Schedule-Y prescribes detailed requirements
also the APIs per se; (i) attention was
invited to Rule 122B(1)(a) and to Rule 122B(2) and to Schedule Y Appendix
