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CHAPTER IV
ADVERTISING OF DRUGS, Etc.
31. Conditions for Advertising:
(1) The Federal Government may, after
seeking advice of the Committee on Advertising, allow the advertisement of a drug, or any
substance or a remedy as specified in Schedule D-1 or a treatment or offer of a treatment
for any disease. approve the contents of such advertisement and specify conditions subject
to which such advertisement shall be made:
Provided that the Federal Government may, if in its opinion the public interest so
required, withdraw the approval granted to any advertisement or modify or alter any
condition subject to which the advertisement was approved.
(1-A) An application for advertisement of
any drug, substance, remdy, treatment or offer of treatment for any disease shall be made
it Form-8, addressed to the Secretary of the Commissioner on Advertising and there shal be
made a separate application for each advertisement.
(l-B) An application under sub-rule (l-A)
shall be accompanied by the proper fee specified in Schedule F : and
(1-C) The approval of the advertisement,
granted under sub-rule (1), shall be valid for a period of two years only.
(2) A drug or any substance referred to in clause (ii) of Sec. 24 may be advertised to the
medical, pharmaceutical and allied professions, without referring to the Federal
Government, through medical representatives or through professional journals and
publication which are meant for circulation exclusively amongst the members of the
medical, pharmaceutical and allied professions ·
Provided that:
(i)one copy of each issue of such journal or publication is sent to the Drug
Administration of the Health Division; and
(ii) the Federal Government may, after giving an opportunity of being heard, prohibit the
publication of any advertisement in any such journal as it is found to violate any of the
conditions specified under sub-rule (1).
(3) Advertisements under sub-rule (2) shall be subjected to the following conditions,
namely :--
(i)All claims shall be made in accordance with these approved for registration of that
drug.
(ii) Where the usual information on indications and dosage is provided, that advertisement
material shall contain information on contra-indications, side effects and other necessary
precautions as may be applicable.
(4) A drug or any substance referred to
in clause (ii) of Section 24, may be advertised through Press without reference to the
Federal Government if it is merely intended to inform the public of the availability or
the price of such drug or any substance referred to in clause
(ii) of Section 24 subject to the condition that the Federal Government may prohibit
such advertisement if, in its opinion, the public interest so requires.
(5) A drug or any substance referred to
in clause (ii) of Section 24, may be advertised to the medical, pharmaceutical and allied
professions through a documentary film.
(6) No advertisement under this rule shall contain any direct or indirect comparison in
any way with any other drug or substance or remedy for any disease for the purpose of
attracting customers or with a view to discredit other such product.
(7) Advertisement material shall be presented with courtesy and good taste and words and
phrases implying urgency, uniqueness or such expressions which are absolute in character,
such as "the most potent", "the most rapid", "the most
efficacious", or which make exaggerated claims or to general claims, such as
"effective in all cases" or "effective against all complaints" or
superlatives shall be avoided.
(8) Advertisement of a drug or any
substance referred to in clause (ii) of Section 24 shall include such information or any
risks and other precautions as may be necessary for the protection of public health, and
in the case of drug also its maximum retail price fixed under Section 12.
(9) No drug or any other substance shall be advertised in a manner which encourages
self-medication or use to the extent that it endangers health.
(10) No drug or any remedy, treatment or after treatment of any disease specified in
Schedule 'E' shall be advertised except
as provided in sub-rule (2).
(11) Reminder publications for the medical, pharmaceutical and allied professions shall
include the name of the drug and its exact composition, the price, the name and address of
the manufacturer and a statement to the effect that "Full information is available on
request".
32. Sampling of drugs: Samples of drugs may be provided to the physicians or
dentists or Pharmacists or Veterinarians or a medical institution in a reasonable quantity
and in reduced packings marked with the words "Physicians Sample Not for Sale".
33. Expenditure on advertisement: No person shall spend more than five per cent of
his turnover on advertisement, sampling and other promotional activities in respect of
drugs,
Explanation: The expenditure on
pay and allowances of the field force connected with the promotional activities shall not
be included in expenditure for the purpose of this rule.
34. Substances required to be prescribed under Section 24: Any substance or a
mixture of substances offered for sale which is injurious, or likely to become hazardous,
to the health of a person shall be deemed to be a substance for the purpose of Section 24
of the Ordinance.
35. Retailer's discount: The
retailers discount shall be 15% of the maximum retail price.
