Last Updated on November 7, 2022 by The Health Master
New Delhi: The government is in the final stages of the process of mandating pharmaceutical companies print bar codes on the packages of 300 drug formulations so that information such as the manufacturing license and batch number can be accessed upon scanning.
300 drug formulations
The decision has been taken in order to curb the sale of spurious medicines. Furthermore, this will also help in checking the authenticity of the drug.
The amendments to the Drugs and Cosmetic Rules, 1945, once approved, will come into force from May next year.
A sizable number of drugs mentioned in the list are mostly bought over the counter, exposing people to the possibility of consuming counterfeit medicines.
This amendment aims to prevent the supply of fake medicines and ensure improvements in public healthcare.
“A bar code or QR code will authenticate whether a particular drug is original or not,” the official added.
The Union health ministry issued a draft gazette notification regarding the same in June, seeking comments and feedback from the public.
Based on the comments and further deliberations, the ministry is in the process of finalizing it.
Manufacturers of 300 drug formulation products, as specified in Schedule H2 of Rule 96 of the Drugs and Cosmetics Act, will be required to print or affix a bar code or quick response code on its primary packaging or secondary packaging label that stores data or information legible with a software application to facilitate authentication.
The stored data or information shall include particulars such as the unique product identification code, the proper and generic name of the drug, the brand name, the name, and address of the manufacturer, the batch number, the date of manufacturing, and the expiration and manufacturing license number.
In the first phase, 300 drugs from top pharma brands having around 35 percent of the total market share will be brought under this ambit, and by December next year, all drugs may be covered.
The drugs include:
- Allegra,
- Amlokind,
- Azithral,
- Betadine,
- Calpol,
- Ceftum,
- Combiflam,
- Dolo,
- Dulcoflex,
- Ecosprin,
- Gelusil,
- Jalra,
- Lantus,
- Manforce,
- Meftal Spaz,
- Shelcal,
- Human Mixtard,
- Pan 40,
- Otrivin,
- Pantocid,
- Rantac,
- Stamlo,
- T-bact ointment,
- Unwanted kits
- Volini spray.
In a meeting held in November 2021, the Drugs Technical Advisory Board (DTAB) recommended the introduction of bar codes or QR codes in the top 300 brands of drug formulations.
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