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Govt to amend Rule 96 of D&C Rules to make it mandatory to label red vertical line on Schedule H1 drugs
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Ramesh Shankar, Mumbai
May 30 , 2016
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The Union health ministry will soon amend Rule 96 of the Drugs and
Cosmetics Rules (D&C Rules), 1945 for making it mandatory to label
red vertical line on the left side in respect of Schedule H1 drugs
also.At present, a red vertical line is labelled on the left side in
respect of Schedule G, H and X drugs.
The issue of consideration
of the proposal to amend Rule 96 of the Drugs and Cosmetics Rules, 1945
for making it mandatory to label red vertical line on the left side in
respect of Schedule H1 drugs also came up for discussion during the
Drugs Technical Advisory Board (DTAB)'s 71st meeting held on May 13,
2016. DTAB is the highest authority under the Union health ministry on
technical matters.
The Drugs and Cosmetics Rules, 1945 in rule 96
in sub-rule (1), in clause (xi) it is provided that a conspicuous red
vertical line is required to be printed on the left side running through
out of the body of the label for certain categories of drugs including
Schedule G, H and X. The clause in the present state is not applicable
in respect of Schedule H1 drugs which are also required to be labeled
with the red vertical line, the members were informed in the meeting.
It was therefore proposed to amend the phrase 'Schedules G, H and X' in rule 96 as under. "Schedule G, H, H1 and X".
DTAB
after deliberations agreed to the proposed amendment. The members,
however, further desired to know whether any survey has been conducted
to know whether Schedule H1 drugs are properly regulated especially in
respect of antibiotics to know the impact on antibiotics resistance.
In
reply, the DTAB chairman, Dr Jagdish Prasad, director general of health
services (DGHS), suggested that National Centre for Disease Control may
be requested to conduct such survey.
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