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Ramesh Shankar, Mumbai May 30 , 2016
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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