Health ministry to amend Rule 96 of D&C Rules to streamline labeling requirements of iron tablets and polio drops
The Union
health ministry will soon amend Rule 96 of the Drugs and Cosmetics (D&C)
Rules to streamline labeling requirements of iron tablets and polio drops to
provide requisite information to the consumer.
The proposal to amend Rule 96 of the D&C Rules, 1945 for labeling of iron
tablets and polio drops distributed to the children under government programmes
with name and expiry date in Hindi also was deliberated at the Drug Technical
Advisory Board (DTAB)'s 78th meeting.
In order
to do the same, the ministry had constituted a sub-committee under the
chairmanship of Indian Medical Association (IMA) Secretary General Dr RN Tandon
to examine and give recommendations for streamlining the labeling requirements
of drugs.
The
sub-committee members and co-opted experts, as per the terms of references,
examined the feasibility of printing the name of medicine and expiry date in
Hindi on label of the drug products and submitted the minutes of meetings along
with recommendations.
The
sub-committee in its recommendations concluded that while name of medicines
shall be printed both in English and Hindi for open market, medicines procured
by any Government agency are at liberty to ask for regional language on label
of drug products along with English.
DTAB
deliberated on the recommendation of the sub-committee and suggested that
government procurement agencies take necessary steps in tendering process to
include drug name and expiry date in Hindi or regional language along with
English on the label of iron tablets and polio drops in Government programmes
in addition to the existing conditions of Rule 96 of D&C Rules. It was further
recommended that an advisory may be issued by Government in this regard.
DTAB also
recommended that the sub-committee may co-opt the representatives from
pharmaceutical manufacturing industry and Indian pharmaceutical association for
further deliberations on the overall issues related to labeling requirements of
drugs.
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