Chemists seek clarification on substitution of branded medicines with generics

While pharmacists understand that doctors prescribe branded medicines, the BDCDA seeks clarification on the permissibility of substituting one brand for another

The Health Master

July 2, 2024

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Last Updated on October 17, 2024 by The Health Master

Medicines

The Bangalore District Chemists & Druggists Association (BDCDA) has reached out to the Drugs Controller General of India (DCGI) and the Karnataka drugs control department seeking clarification on several aspects of pharmacy regulations, particularly regarding generic substitution and medicines packaging.

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Generic Substitution and Patient Care

Brand vs. Brand Substitution:

While pharmacists understand that doctors prescribe branded medicines, the BDCDA seeks clarification on the permissibility of substituting one brand for another.

This can impact both patient cost and access to specific formulations.

Brand vs. Generic Substitution:

The Association also seeks clarity on substituting prescribed brands with generic equivalents.

This can be a cost-saving option for patients, but ensuring quality and bioequivalence is crucial.

Generic Substitution by Pharmacists:

The BDCDA further inquires whether pharmacists are authorized to suggest generic alternatives to patients, considering both cost and potential therapeutic benefits.

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Challenges with Medicine Packaging

Unit Pack Strips and Leftover Medication:

Many medications come in pre-packaged strips containing varying numbers of tablets or capsules (3, 5, 7, 10, 14, 15, 20, 30).

For example, a doctor might prescribe six or seven Azithromycin tablets, but the medication only comes in packs of five.

Cutting the strip leaves leftover medication unsellable.

The BDCDA seeks clarification from the Drugs and Cosmetics Act on the legality of selling cut strips.

Other Areas of Inquiry

Automatic Drug License Renewal:

The Association seeks to understand if successful payment of the retention fee automatically renews a drug license, or if licensees need to collect a physical intimation letter from the Assistant Drugs Controller’s office.

Discount Banners and Regulations:

Following a Maharashtra directive prohibiting pharmacies from displaying discount banners, the BDCDA seeks clarity on whether registered pharmacists or drug licensees can advertise discounts on medicines at their stores under the Pharmacy Practice Regulations (PPR) 2015.

Barcode Stickers on Medication:

The Association inquires about the permissibility of registered pharmacists or drug licensees placing barcode stickers on medicine strips for inventory management purposes, considering potential tampering concerns.

By seeking clarification on these issues, the BDCDA aims to ensure its members operate within legal guidelines while also promoting patient safety and access to affordable medications.

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