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The Union health ministry has issued labelling norms for Schedule H, H1 and X drugs. The new labelling rules under the Drugs and Cosmetics (Fifth Amendment) Rules, 2018 will be enforced from November 1, 2018.
For norms, under rule 96, in sub-rule (1), of clause (xi), the label of the inner most container will bear a caution or warning. The drugs covered under Schedule G or Schedule H or Schedule H1 or Schedule X, specified in rule 97 will be in legible black coloured font size in a completely red rectangular box. These drugs will be narcotic analgesics, hypnotics, sedatives, tranquillisers, corticosteroids, hormones, hypoglycemic, antimicrobials, antiepileptics, antidepressants, anticoagulants, anti-cancer.
If the packaging contains a drug substance specified in Schedule H, Schedule H1, Schedule G or Schedule X it will be labelled with symbol Rx and conspicuously displayed on the left top corner. The warning will also mandates taking the drug only under medical supervision and not to be sold by retail without a doctor’s prescription.
The drug substance specified in Schedule H1 that 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.
In the Drugs & Cosmetic Rules, under Schedule H, appended after paragraph 3, will have an inclusion that salts, esters, derivatives and steroids preparations for topical or external will also be covered under it.
In Schedule K, against serial number 27, for the entries under the column ‘Class of Drugs’ will be substituted with “Oral Re hydration Salts manufactured. The composition of the formulation in terms of the amount in grams to be dissolved in sufficient water to produce 1000 ml. like for instance Sodium Chloride: 2.6 grams, Dextrose (anhydrous): 13.5 grams, Dextrose mono-hydrate: 14.85 grams, Potassium chloride: 1.5 grams and Sodium Citrate: 2.9 grams.
According to Kaushik Desai, pharma consultant, considering the inventory that goes into the label change, six months seems to be adequate. Yet the industry could ask for more time particularly for slow moving and imported drugs where inventory of primary packing materials like aluminium foils is quite high considering its minimum order quantities.
The government objective is noble in bringing more clarity. However this year, there is already a label change for bigger font size of generic names from September this year and the industry has already initiated work. Now this new norm for Schedule H, H1, G and X drugs results in multiplication of work and expenses. It will impact overall revenues as many of these medicines are under the Drug Price Control Order, he added.
Designing labels is a challenge too. In a limited space inclusion of bar codes and the elaborate text creates readability issues. India is one of the few countries having so many labelling regulations compared to its global counterparts. The frequent changes are bound to affect sales would result in temporary shortage of drugs which will affect the patients. Therefore, it would be pertinent for the government to take cognizance of such expenses and issue a single directive for any label changes all at one go. It avoids re-doing the task with both time and money spends, stated Desai.
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