The Policy Guidelines for Fixed Dose Combinations in India was released by the Ministry of Health and Family Welfare in 2013. The policy defines co-packaged products as “a product consisting of two/more separate pharmaceutical products or items in their final dosage form that are packaged together for distribution to patients in the co-packaging”. The United States Food and Drug Administration defines co-packaged combination products under U.S FDA 21 CFR 3.2 (e)(2) as “two/more independent items packaged together in a single container/as a unit & constituted of drug & device products, device and biological products, or biological or drug products”.
As defined above, co-packaged combination products are made up of a group of products that either contain two or more different pharmaceutical products, like a medicine and a medical device or medicine and a biological product/a biological product and a medical device. Generally, both products are supplied and packaged together for a particular medical purpose. These involve separate products grouped together based on the intended medical use and packaged together so that the end user can use both products in combination, which is required to tackle the medical issue. A product that contains only separate medical devices or separate medicine shall not qualify as a co-packaged combination product. Some examples of co-packaged combination products are, inter alia, bandages, delivery devices, inhalers along with a cartridge filled with the drug, antibacterial swabs, surgery kits, automated injectors, and powder inhalers.
According to the United States Food & Drug Administration, in a combination product, the separate drug or medical device parts will still retain their regulatory status as a drug or device or even after they are combined and co-packaged as a combination product. Co-packaged combination products must undergo various tests to check the compatibility, functionality and human factor associated with the product. When co-packaged combination products are tested, they should be assessed and scrutinized as one single unit and not as individual components. It is imperative that the machine and device work together as a unit to bring out positive results.
Types of Co-Packaged Combination Products
There are largely nine various combinations of co-packaged combination products. They are listed down below:
- Drug Delivery System, which is prefilled– In these products, the medicine already comes filled into the device or is combined with the device for the purpose of delivering the medicine from the device. Some examples of such products are nasal sprays, powder inhalers, and drug syringes which are prefilled.
- Co-package or convenience kits– In this product, the medical device and the medicine are provided as separate parts inside the same packaging. Some examples of such products are surgical kits or first aid kits.
- Biologic Delivery System, which is prefilled- In these products, the biological product already comes filled into the device or is combined with the device for the purpose of delivering the biological product from the device. Some examples of such products are vaccines, nasal sprays, and automated injectors.
- A device which is combined with or coated with the medicine– In these products, the device carries out other functions along with delivering the medicine. Some examples of such products are contact lenses coated with medicine or dental floss, which contains fluoride or medicine pills which are placed with sensors.
- A device which is combined with or coated with a biologic- In these products, the device carries out other functions along with delivering the medicine. An example of such a products is a device where live cells are placed inside the scaffolding of a medical device.
- Biological product and Medicine Combination – These products have a combination of a separate biological product and medicine aimed for a medical purpose. An example of such products is medicine- antibody product.
- Different Products which Require Cross-Labelling- This product requires other separate products which require cross-labelling. An example of such products is medicines which are light activated which are not co-packaged but are to be used with a particular light device.
- Combinations Based on Cross-Labelling of Separate Products- An example of such products is where the medicine or biological product which is being developed makes use of a device, but there is no such clarity on whether the final product requires to be cross-labelled.
- Other Combinations are not falling under the above categories- Any other combination of products not falling in any of the above categories. An example of such a product is a product where all three articles, medicine and biologic and device, are combined together, like a syringe which is prefilled with a medicine and antibody mixture.
Co-packaged combination products contain different components and generally either contain two or more different pharmaceutical products like a medical device and a medicine or a biological product and a medicine or a biological product and a medical device. Generally, both products are supplied and packaged together for a particular medical purpose. Even though when the products are combined to form one unit or system, the medical device or the medicine shall still be governed using the existing regulatory framework for such medicines and medical devices.