The Department of Health and Family Welfare issues Draft Amendments to the Drugs and Cosmetics Rules, 1945

The Department of Health and Family Welfare issues Draft Amendments to the Drugs and Cosmetics Rules, 1945

November 17, 2017 Industry Specific 0

The Department of Health and Family Welfare (“Department”), vide notification dated 3rd November 2017, has issued Draft Amendments to the Drugs and Cosmetics Rules, 1945 (“Principal Rules”) thereby proposing to revise the Principal Rules.

The Department has invited objections and suggestions from any person within a period of 30 days from the date on which the copies of the Official Gazette containing the Draft Amendment is made available to the public, addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 414 A, D Wing, Nirman Bhavan, New Delhi – 110011 or e-mailed at drugsdiv-mohfw@nic.in.

Key highlights of the Draft Amendment Rule:

 

Principal Rules Draft Amendments Implications

 

Rule 96, in sub-rule (1), in clause (xi)

 

In addition to the other particulars which are required to be printed or written under these Rules, the label of innermost container of the following categories of drugs and every other covering in which the container is packed shall bear a conspicuous red vertical line on the left side running throughout the body of the label which should not be less than 1mm in width and without disturbing the other conditions printed on the label under these rules, namely: —

 

Narcotic analgestics, hypnotics, sedatives, tranquillisers, corticosteroids, hormones, hypoglycemics, antimicrobials, antiepileptics, antidepressants, anticoagulants, anti-cancer drugs and all other drugs falling under Schedules ‘G’, ‘H’, and ‘X’ whether covered or not in the above list

Rule 96, in sub-rule (1), in clause (xi)

 

“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 caution/ warning in legible black coloured font size in 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:”

 

Under the Draft Amendments

 

  1. the label of the container of the specified drugs is now required to bear caution/ warning in legible black coloured font size in completely red rectangular box without disturbing other conditions printed on the label under these rules instead of red vertical line on the left side running throughout the body of the label which should not be less than 1mm in width

 

2.  Schedule H1 has been added to the list of Schedules which are to be mentioned on the label of the container

Rule 97, in sub-rule (1), clauses (a), (b), (c) and (d)

 

(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 19 [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’.

 

 

Rule 97, in sub-rule (1), (a), (b), (c) and (d)

 

 

(a)  if it contains a drug substance specified in Schedule G, be labelled 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 labelled with symbol Rx and conspicuously displayed on the left top corner of the label and shall also be labelled 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

The representation format of the Cautions/Warnings on the labels of containers containing Schedule G, H and X drugs have been revised.
Rule 97, in sub-rule (1), clauses (e)

 

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

“SCHEDULE H1 DRUG – WARNING. – 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 97, in sub-rule (1), clauses (e)

 

(e)  if it contains a drug substance specified in Schedule H1, be labelled with symbol Rx which shall be in red and conspicuously displayed on the left top corner of the label and shall also be labelled 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 of the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985) be labelled with symbol NRx which shall be in red and conspicuously displayed on the left top corner of the label and shall also be labelled 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

 

 

1.    The representation format of the Cautions/Warnings on the labels of containers containing Schedule H1 drugs have been revised.

 

2.    A new clause (f) is inserted specifying the labelling procedure for medicines containing a drug substance mentioned in Schedule H1.

Schedule H NOTE

 

1.Preparations exempted under proviso to para 2 of … the substance is exempted from the provisions of Rule 122A/122B.”

 

 

Schedule H NOTE

 

1.Preparations exempted under proviso to para 2 of … the substance is exempted from the provisions of Rule 122A/122B.”

4.The salts, esters, derivatives and preparations containing steroids for topical or external use are also covered by this Schedule.

A new note has been inserted in Schedule H which includes salts, esters, derivatives and preparations containing steroids under prescription drugs.
Schedule K

 

27. Oral Rehydration Salts (Manufactured as per the following formula) … when citrate salt is not available

Schedule K

 

27. 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.

• Sodium Chloride – 2.6

• Dextrose (anhydrous) – 13.5

•Dextrose mono-hydrate – 14.85

• Potassium chloride – 1.5

• Sodium Citrate – 2.9.

 

The Composition of the Oral Rehydration Salts under Schedule K has been changed.

Please refer to the hyperlinked source below for the Draft Drugs and Cosmetics (Amendment) Rules, 2017.

Source: Department of Health and Family Welfare

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