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Labelling of medicines (Drugs and Cosmetics Act ,1940 and Rules, 1945)

Labelling of medicines (Drugs and Cosmetics Act ,1940 and Rules, 1945)

(1) The container of a medicine for internal use shall—

(a) if it contains a substance specified in Schedule G, be labelled with the words ―Caution: it is dangerous to take this preparation except under medical supervision‖ – conspicuously printed and surrounded by a line within which there shall be no other words.

(b) if it contains a substance specified in Schedule H, be labelled with the symbol Rx and conspicuously displayed on the left top corner of the label and be also labelled with the following words:

Schedule H drug- Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only‘,

(c) if it contains a substance specified in Schedule H, and comes within the purview of the 2[Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985)] be labelled with the symbol NRx which shall be in red and conspicuously displayed on the left top corner of the label, and be also labelled with the following words:

Schedule H drug -Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only‘.

(d) If it contains a substance specified in Schedule X, be labelled with the symbol XRx which shall be in red conspicuously displayed on the left top corner of the label and be also labelled with the following words : –

Schedule X drug -Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only‘.

(e) if it contains a drug substance specified in Schedule H1, the drug formulation shall be labeled with the symbol Rx which shall be in red conspicuously displsyed on the left top corner of the label, and shall also be labelled with the following words in a box with a red border:

(2) The container of an embrocation, liniment, lotion, ointment, antiseptic cream,] liquid antiseptic or other liquid medicine for external application shall be labelled with the words:

―FOR EXTERNAL USE ONLY‖.

3) The container of a medicine made up ready only for treatment of an animal shall be labelled conspicuously with the words  Not for human use; for animal treatment only‘ and shall bear a symbol depicting the head of a domestic animal.]

The container of a medicine for treatment of food producing animals shall be labeled with the withdrawal period of the drug for the species on which it is intended to be used:

Provided that if the specific withdrawal period has not been validated, the withdrawal period shall not be less than seven days for eggs or milk, twenty eight days for meat from poultry and mammals including fat and offal, five hundred degree days for fish meat.

Explanation:- For the purpose of this Rule, the withdrawal period is the period of interval between the last administration of a veterinary medicine to animals under the normal conditions of use and the production of food stuff from such animals to ensure that food stuffs do not contain residues in quantities in excess of the maximum residue limits laid down.

The container of a medicine prepared for treatment of human ailments shall if the medicine contains industrial methylated spirit, indicate this fact on the label and be labelled with the words :

For External Use only

Substances specified in Schedule X in bulk form shall bear a label wherein the symbol as specified in sub-Rule (1) shall be given conspicuously in red letters.

Non-Sterile Surgical Ligature and Suture.- Every container of, and wrapper enclosing surgical ligature or suture other than a ligature or suture offered or intended to be offered for sale as sterile, shall bear a label on which are printed or written in a conspicuous manner in indelible red ink the words

―Non-sterile surgical ligature (suture) – not to be used for operations upon the human body unless efficiently sterilized.

(2) The name and address of the manufacturer shall be printed on the label of the container of a patent or proprietary medicine.

The true formula or list of the ingredients shall be printed or written in indelible ink on the outer label of every package containing patent or proprietary medicine.

Use of letter I.P. etc.–The letters I.P‘. and recognized abbreviations of pharmacopoeias and official compendia of drug standards prescribed under these Rules shall be entered on the label of the drug only for the purpose of indicating that the drug is in accordance with standards set out in the Indian Pharmacopoeia or in any such pharmacopoeia or official compendium of drug standards recognized under the Rules.

Prohibition against altering inscriptions on containers, labels or wrappers of drug. –No person shall alter, obliterate or deface any inscription or mark made or recorded by the manufacturer on the container, label or wrapper of any drug:
Provided that nothing in this rule shall apply to any alteration, any inscription or mark made on the container, label or wrapper of any drug at the instance or direction or with the permission of the Licensing Authority.

 

 

 

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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