Preamble - DRUGS AND COSMETICS (FIFTH AMENDMENT) RULES, 2018
DRUGS AND COSMETICS (FIFTH AMENDMENT) RULES, 2018
PREAMBLE
Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945, was published, as required under sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare), number G.S.R. 1369(E), dated the 3rd November, 2017, for inviting objections and suggestions from persons likely to be affected thereby before the expiry of a period of thirty days from the date on which the copies of the Official Gazette containing the said notification were made available to the public;
And whereas copies of the said Official Gazette were made available to the public on the 3rd November, 2017;
And whereas, objections and suggestions received from the public on the said rules have been considered by the Central Government;
Now, therefore, in exercise of the powers conferred by section 12 and section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs and Cosmetics Rules, 1945, namely:-
Rule 1 - RULE 1
(1) These rules may be called the Drugs and Cosmetics (Fifth Amendment) Rules, 2018.
(2) They shall come into force on the 1st day of November, 2018.
Rule 2 - RULE 2
In the Drugs and Cosmetics Rules, 1945 (hereinafter to be referred as the said rules), in rule 96, in sub-rule (1), in clause (xi),-
(a) for the portion beginning with the words "In addition to the" and ending with the words "in the above list:", the following shall be substituted, namely:-
"In addition to the other particulars which are required to be printed or written under these rules, the label of inner most container of the following categories of drugs and every other covering in which the container is packed shall bear a caution or warning, as applicable, depending on whether the drug is covered under Schedule G or Schedule H or Schedule H1 or Schedule X, as specified in rule 97, in legible black coloured font size in a completely red rectangular box without disturbing other conditions printed on the label under these rules, namely:-
Narcotic analgesics, hypnotics, sedatives, tranquillisers, corticosteroids, hormones, hypoglycemic, antimicrobials, antiepileptics, antidepressants, anticoagulants, anti-cancer drugs and all other drugs falling under Schedules G, H, H1 and Schedule X whether covered or not in the above list:
Provided that if any of the drug referred above category is not covered under any of the Schedule, namely, Schedule G, Schedule H, Schedule H1 and Schedule X, the label of inner most container of drugs and every other covering in which the container is packed shall bear caution or warning, as the case may be, applicable for that drugs covered under Schedule H as specified in rule 97.";
(b) In the Proviso, for the words "Provided that", the words "Provided further that" shall be substituted.
(i) for clauses (a) to (e), the following clauses shall be substituted, namely:-
"(a) if it contains a drug substance specified in Schedule G, be labeled with following words in legible black coloured font size in completely red rectangular box:
SCHEDULE G PRESCRIPTION DRUG - CAUTION
It is dangerous to take this preparation except under medical supervision.
(b) if it contains a drug substance specified in Schedule H, be labeled with symbol Rx and conspicuously displayed on the left top corner of the label and shall also be labeled with the following words in legible black coloured font size in completely red rectangular box:
SCHEDULE H PRESCRIPTION DRUG - CAUTION
Not to be sold by retail without the prescription of a Registered Medical Practitioner.
(c) if it contains a drug substance specified in Schedule H and comes within the purview of the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985) be labeled with symbol NRx, which shall be in red and conspicuously displayed on the left top corner of the label and shall also be labeled with the following words in legible black coloured font size in completely red rectangular box:
SCHEDULE H PRESCRIPTION DRUG - WARNING
To be sold by retail on the prescription of a Registered Medical Practitioner only.
(d) if it contains a drug substance specified in Schedule X, be labeled with symbol XRx, which shall be in red and conspicuously displayed on the left top corner of the label and shall also be labeled with the following words in legible black coloured font size in completely red rectangular box:
SCHEDULE X PRESCRIPTION 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, be labeled with symbol Rx, which shall be in red and conspicuously displayed on the left top corner of the label and shall also be labeled with the following words in legible black coloured font size in completely red rectangular box:
SCHEDULE H1 PRESCRIPTION DRUG - CAUTION
- It is dangerous to take this preparation except in accordance with the medical advice.
- Not to be sold by retail without the prescription of a Registered Medical Practitioner.
(f) if it contains a drug substance specified in Schedule H1 and comes within the purview the label and shall also be labeled with the following words in legible black coloured font size in completely red rectangular box:
SCHEDULE H1 PRESCRIPTION DRUG - CAUTION
- It is dangerous to take this preparation except in accordance with the medical advice.
- Not to be sold by retail without the prescription of a Registered Medical Practitioner.
Rule 4 - RULE 4
In the said rules, in Schedule H, in the Note appended thereto, after paragraph 3, the following paragraph shall be inserted, namely:-
"4. The salts, esters, derivatives and preparations containing steroids for topical or external use shall also be covered under this Schedule.".
Rule 5 - RULE 5
In the said rules, in Schedule K, against serial number 27, for the entries under the column "Class of Drugs", the following shall be substituted, namely:-
"Oral Rehydration Salts (Manufactured as per the following formula):-Composition of the formulation in terms of the amount in g, to be dissolved in sufficient water to produce 1000 ml.
