Labelling norms for high-risk medicines made Stringent, Check out details

The new rules will be applicable to medicines such as Narcotic analgesics, hypnotics, sedatives, tranquillizers, 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.

New Delhi: Through a gazette notification, Ministry of Health and Family Welfare has stringent the labeling norms for high-risk medicines and made it mandatory for the pharma companies to print warnings prominently on such drug packs, in order to improve the safety of drugs and consumer awareness.

The new rules will be called as the Drugs and Cosmetics (Fifth Amendment) Rules, 2018 and will come into force from November 1, 2018.

The Central Government has made the amendment to the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board.

The notice states that, "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."

The new rules will be applicable to medicines such as Narcotic analgesics, hypnotics, sedatives, tranquillizers, 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.

According to the norms, if the medicine 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."

The new rules also specify that if the medicine contains a drug substance specified in Schedule H, be labeled with symbol Rx and conspicuously displayed on the left top corner of the label 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"

In case of substances specified under Schedule H, which comes within the purview of the Narcotic Drugs and Psychotropic Substances Act, 1985, the packaging will be labelled with symbol NRx, in red colour with caution statement on the left top corner 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"

As per the new labeling norms, if a medicine contains a drug substance specified in Schedule X will be labeled with symbol XRx, in red colour with caution statement on the left top corner of the label 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 new norms also states that if a drug substance specified in Schedule H1 will be labeled with symbol Rx in red color with caution statement on the left top corner of the label 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"

In case of substances specified under Schedule H1 and comes within the purview of the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985) be labeled with symbol NRx in red color with caution statement on the left top corner of the label 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"

According to the new amendment, the salts, esters, derivatives and preparations containing steroids for topical or external use will also be covered under the Schedule H.

The notice further states that 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. • Sodium Chloride 2.6 • Dextrose (anhydrous) or 13.5 • Dextrose mono-hydrate 14.85 • Potassium chloride 1.5 • Sodium Citrate 2.9. ".

The move also follows another significant labeling change which made it mandatory for pharmaceutical companies to print generic names of drugs in a font which is two-font sizes larger than the brand name.

Below is the attachment for the same.