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Centre releases 3 drafts seeking changes to D&C Rules on import permission for personal use, labelling provisions

Nandita Vijay, Bengaluru
Wednesday, November 15, 2017, 08:00 Hrs  [IST]

Union government has issued three separate drafts to further amend the Drugs and Cosmetics Rules, 1945. The government expects the pharma industry to send their objections & suggestions, before December 3, 2017.

In the first draft rule vide Notification No. G.S.R.1367 (E), the government is proposing to substitute the existing clause 3 of Form 12B with respect to permission of the import of small quantities of drugs for personal use allowing it till the patient requires the drug as per prescription of RMP instead of present restriction of six months from the date of issue. However it is also proposed that the permit holder should submit the details drugs imported, utilized to the licensing authorities on yearly basis from the date specified.

In the second draft rule, vide Notification No. G.S.R.1368 (E), the government proposes to substitute serial number 34 under Schedule K. by including production of Oxygen 93 percent IP in addition to Oxygen 93 percent USP for exemption of the provision of the Chapter IV of the Act.

In the third draft rule, vide Notification No. G.S.R.1369 (E), it is proposed to substitute the clauses (a), (b), (c), (d) and (e) of sub-rule (1) of rule 97 of D&C Rules, 1945 indicating the manner of labelling of drugs replacing ‘conspicuous red vertical line on the left side running throughout the body of the label’ by ‘incorporating caution / warning in legible black ink colored font in completely red rectangular box’.

Accordingly first substitution of rule 97 (1) (a) is related with the labelling of drugs falling under Schedule G wherein the wordings of caution being retained which have to be in legible black ink coloured font six size in completely red rectangular box.
 
Similarly the second substitution of rule 97 (1) (b) is related with labelling of drugs falling under Schedule H wherein the symbol Rx being retained however the wordings of caution being changed to be in legible black ink, coloured font six size in completely red rectangular box. It will read as ‘Schedule H Prescription Drug – Caution: Not to be sold by retail without the prescription of a Registered Medical Practitioner’.

The third substitution of rule 97 (1) (c) is related to labelling of drugs under Schedule H which is under the purview of the Narcotic Drugs and Psychotropic Substances Act, 1985 wherein the symbol NRx and wordings of warning being retained which have to be in legible black ink, coloured font six size in completely red rectangular box.

The next substitution of rule 97 (1) (d) is related with drug labelling under Schedule X wherein the symbol XRx and wordings of warning being retained which have to be in legible black ink coloured font six size in completely red rectangular box.

The final substitution of rule 97 (1) (e) is on drug labelling under Schedule H1 wherein the symbol Rx and wordings of warning being retained which have to be in legible black ink coloured font six size in completely red rectangular box.

The same draft proposes to substitute the existing composition of Oral Rehydration Salts under Schedule K against serial No. 27 for entries under the column ‘class of drugs’ with new composition of the formulation in terms of the amount in grams consisting of sodium chloride, dextrose (anhydrous) or dextrose mono-hydrate, potassium chloride and sodium citrate to be dissolved in sufficient water to produce 1000ml.

Further the salts, esters, derivatives and preparations containing steroids for topical or external use are also to be covered in this Schedule H as proposed.

 

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