Drug manufacturers have hailed the Drugs (Eighth Amendment) Rules, 2022 mandating barcode or quick response (QR) code on the label of top 300 brands of formulations from August 1, 2023, saying that QR codes will help identify misbranded or counterfeit medicines as well as recall the products if its quality gets compromised during manufacturing.
Welcoming the implementation of barcode on the pack of top 300 brands, Raheel Shah, Director at BDR Pharma Pvt Ltd said “QR codes not only help to identify misbranded or counterfeit pharmaceutical products but also to recall products if there is a quality issue in it during manufacturing. And we think it is an encouraging step by the government which will result in strengthening the regulatory systems to monitor quality.”
“On the other hand, this would be an additional cost for manufacturers to change the packaging and implement this, especially for mid-size manufacturers as it can be a teething challenge. However, we welcomed the move as this is a good step in that direction to avoid fake drugs getting into circulation," Shah added.
“This is a welcome move from the government. This will help prevent the sales of spurious drugs which is definitely in the interest of the consumer and also, it will help the manufacturer to trace and track their products. Information stored in a QR code is a lot more extensive and detailed as compared to the info printed on the packaging. ICPA has been implementing bar code on all its products for many years now and we feel it is a decision in the right direction,” says Dr Rajeev Chitguppi, head of research & innovations, ICPA Health Products Ltd.
Amit Chawla, director McW Healthcare said “Implementation of a unique QR code for drugs sold in the domestic market will curtail the menace of spurious and substandard drugs in the country. The QR code will help track and trace medication during the entire supply chain and ensure its authenticity.
According to a notification issued by the ministry on November 17, 2022, the Drugs (Eighth Amendment) Rules, 2022 introduced a new Schedule H2 with a list of 300 top brands, and inserted Sub-Rule (6) and (7) after The Sub-Rule (5) in the Rule 96, of the Drugs and Cosmetics Rules, 1945. This made it mandatory for drug makers to affix QR code on the pack of top 300 formulations from August 1, next year to ensure their authenticity and traceability.
The Sub-Rule (6) says, “The manufacturers of drug formulation products as specified in Schedule H2 shall print or affix bar code or quick response code on its primary packaging label or, in case of inadequate space in primary package label, on the secondary package label that store data or information legible with software application to facilitate authentication.”
According to Sub-Rule (7), “The stored data or information referred to in Sub-Rule (6) shall include unique product identification code; proper and generic name of the drug; brand name; name and address of the manufacturer; batch number; date of manufacturing; date of expiry; and manufacturing licence number.”
In the newly inserted rules, after Schedule H1, the Schedule H2 was inserted containing a list of top 300 brands which will have QR code on the pack.
The list includes various dosages of Aciloc, Actemra, Actrapid (human insulin), Aerocort, Ajaduo, Allegra, Ambisome, Amicin, Amlokind, Ascoril, Asthakind, Asthalin, Augmentin, Avomine, Axcer, Azee, Azithral, Becosules, Betadine, Betnesol, Betnovate, Bett, Bevon, Bio D3 Max, Brilinta, Bro Zedex, Budecort, Calcirol, Caldikind, Calpol, Candiforce, CCM, Cefakind, Ceftum, Cepodem, Chymoral Forte, Cidmus, Cilacar, Cipremi, Claribid, Clavam, Clexane, Cobadex, Codistar, Combiflam, Concor, Corex, Cremaffin, Cypon, Cyra D, Dalacin C, Deca Durabolin, Defcort, Deriphyllin, Derobin, Dexona, Dexorange, Dolo, Dolonex, Doxinate, DOXT, Doxy 1 Forte, Dulcoflex, Duolin, Duphaston, Dydroboon, Dynapar, Easy Six, Ecosprin, Elaxim, Electral sachet, Eliquis, Eltroxin, Enterogermina, EXHEP, Fabiflu, Faronem, Foracort, Forxiga, Gabapin NT, Galvus, Geftinat, Gelusil MPS, Gemcal.
The list also includes various strength of Gemer, Gibtulio, Gluconorm, Glycomet, Glynase, Glyxambi, Grilinctus, Gudcef, HCQS, Hexaxim, Hucog HP, Huminsulin, Infanrix Hexa, Istamet, Ivabrad, Ivermectol, Jalra M, Janumet, Januvia, Jardiance, Kabimol, Karvol Plus, Kenacort, Ketorol, Ketosteril, Lantus, Lantus Solostar, Levera, Levipil, Librax, Limcee Chew, Lipaglyn, LMWX, Lobate GM Neo, Lonopin, Losar, Macbery XT, Magnex Forte, Manforce, Maxtra, Meftal Spas, Megalis, Meganeuron OD Plus, Menactra, Mero, Meromac, Meronem, Meroza, Mifegest, Mikacin, Minipress, Mixtard, Monocef, Montair, Montaz, Montek, Monticope, MOX, Moxclav, Moxikind CV,Mucaine Mint, Mucinac SF, Nebicard, Nefrosave, Neurobion Forte, Nexpro, Nikoran, NISE, Nitrocontin, Novomix, Novorapid, Nurokind, O2, Omez, Omnikacin, Ondero, Orofer, Otrivin, Ovral, Oxra.
The list further contains various strength of Pan 40, Pan D, Panderm, Pantop, Pantin, Pantocid, Pantodac, Phensedyl, Pipzo, Practin, Prega News, Prevenar 13, R.B Tone, Rablet-D, Rantac, Razo, Refresh Tears, Rejunex-CD3, Remdac, Rosuvas, Ryzodeg, Saridon, Seroflo, Shelcal, Silodal, Sinarest, Skinlite, Sompraz D, Spasmo Proxyvon Plus, Spegra, Stamlo, Stemetil, Sucrafil, Sumo, Supradyn, Synflorix, T BACT, Targocid, Taxim O, Tazomac, Telekast-L, Telma, Telmikind, Thrombophob, Thyronorm, Tossex, Trajenta, Tresiba Flextouch, TUSQ DX, Udiliv, Ultracet, Unienzyme, Unwanted 72, Urimax, Uprise D3, Ursocol, Varilrix, Veloz D, Velpanat, Vertin, Volini, Vorier, Voveran, Vymada, Wysolone, Xone, Zavicefta, Zedex, Zerodol, ZIFI, Zoryl-M, Zostum.
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