{"id":51126,"date":"2022-12-05T11:53:55","date_gmt":"2022-12-05T06:23:55","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=51126"},"modified":"2022-12-05T12:30:36","modified_gmt":"2022-12-05T07:00:36","slug":"what-are-co-packaged-combination-products","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/what-are-co-packaged-combination-products\/","title":{"rendered":"What Are Co-Packaged Combination Products?"},"content":{"rendered":"\n

The\nPolicy Guidelines for Fixed Dose Combinations in India was released by the\nMinistry of Health and Family Welfare in 2013. The policy defines co-packaged\nproducts as \u201ca product consisting of two\/more separate pharmaceutical\nproducts or items in their final dosage form that are packaged together for\ndistribution to patients in the co-packaging”<\/em>. The United States Food\nand Drug Administration defines co-packaged combination products under U.S\nFDA 21 CFR 3.2 (e)(2) <\/em>as \u201ctwo\/more independent items packaged together\nin a single container\/as a unit & constituted of drug & device\nproducts, device and biological products, or biological or drug products<\/em>\u201d. <\/p>\n\n\n\n

As\ndefined above, co-packaged combination products are made up of a group of\nproducts that either contain two or more different pharmaceutical products,\nlike a medicine and a medical device<\/a><\/strong> or medicine and a biological\nproduct\/a biological product and a medical device. Generally, both products are\nsupplied and packaged together for a particular medical purpose. These involve\nseparate products grouped together based on the intended medical use and\npackaged together so that the end user can use both products in combination,\nwhich is required to tackle the medical issue. A product that contains only\nseparate medical devices or separate medicine shall not qualify as a\nco-packaged combination product. Some examples of co-packaged combination\nproducts are, inter alia, bandages, delivery devices, inhalers along with a\ncartridge filled with the drug, antibacterial swabs, surgery kits, automated\ninjectors, and powder inhalers.<\/p>\n\n\n\n

According\nto the United\nStates Food & Drug Administration<\/strong>[1]<\/strong><\/a><\/sup>, in a combination product, the\nseparate drug or medical device parts will still retain their regulatory status\nas a drug or device or even after they are combined and co-packaged as a\ncombination product. Co-packaged combination products must undergo various\ntests to check the compatibility, functionality and human factor associated\nwith the product. When co-packaged combination products are tested, they should\nbe assessed and scrutinized as one single unit and not as individual\ncomponents. It is imperative that the machine and device work together as a\nunit to bring out positive results.<\/p>\n\n\n\n

Types of Co-Packaged Combination Products<\/h2>\n\n\n\n

There are largely nine various combinations of\nco-packaged combination products. They are listed down below:<\/p>\n\n\n\n

  1. Drug\nDelivery System, which is prefilled<\/strong>– In these products, the medicine already comes filled\ninto the device or is combined with the device for the purpose of delivering\nthe medicine from the device. Some examples of such products are nasal sprays,\npowder inhalers, and drug syringes which are prefilled.<\/li>
  2. Co-package\nor convenience kits<\/strong>– In\nthis product, the medical device and the medicine are provided as separate\nparts inside the same packaging. Some examples of such products are surgical\nkits or first aid kits.<\/li>
  3. Biologic\nDelivery System, which is prefilled-<\/strong> In these products, the biological product already\ncomes filled into the device or is combined with the device for the purpose of\ndelivering the biological product from the device. Some examples of such\nproducts are vaccines, nasal sprays, and automated injectors.<\/li>
  4. A\ndevice which is combined with or coated with the medicine<\/strong>– In these products, the device carries out\nother functions along with delivering the medicine. Some examples of such\nproducts are contact lenses coated with medicine or dental floss, which\ncontains fluoride or medicine pills which are placed with sensors.<\/li>
  5. A\ndevice which is combined with or coated with a biologic-<\/strong> In these products, the device carries out other\nfunctions along with delivering the medicine. An example of such a products is\na device where live cells are placed inside the scaffolding of a medical\ndevice.<\/li>
  6. Biological\nproduct and Medicine Combination<\/strong> \u2013 These products have a combination of a separate biological product\nand medicine aimed for a medical purpose. An example of such products is\nmedicine- antibody product.<\/li>
  7. Different\nProducts which Require Cross-Labelling- <\/strong>This product requires other separate products which\nrequire cross-labelling. An example of such products is medicines which are\nlight activated which are not co-packaged but are to be used with a particular\nlight device.<\/li>
  8. Combinations\nBased on Cross-Labelling of Separate Products- <\/strong>An example of such products is where the medicine or\nbiological product which is being developed makes use of a device, but there is\nno such clarity on whether the final product requires to be cross-labelled.<\/li>
  9. Other\nCombinations are not falling under the above categories- <\/strong>Any other combination of products not falling in\nany of the above categories. An example of such a product is a product where\nall three articles, medicine and biologic and device, are combined together,\nlike a syringe which is prefilled with a medicine and antibody mixture.<\/li><\/ol>\n\n\n\n

    Conclusion<\/h2>\n\n\n\n

    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.<\/p>\n\n\n\n

    Read Our Article<\/b>: A Step by Step guide for Registration Process for Medical Devices in India<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"

    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 \u201ca 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 […]<\/p>\n","protected":false},"author":47,"featured_media":51137,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[946],"tags":[2928],"acf":{"service_id":"385"},"authorName":"Sherin Jose","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/11\/MicrosoftTeams-image-4-e1668575330329.jpg","authorDescription":"Sherin has degrees in Law and English Literature from the University of Delhi. She is adept at legal research and writing and enjoys discussing and analysing important legal developments. Her primary interests lie in Corporate, FinTech and IPR Law and she is always on the lookout for exploring new developments in the area. She is an avid reader who loves classics and contemporary fiction. She likes to travel, bake and obsess over cat videos in her free time.","postViews":3132,"readingTime":3,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/51126"}],"collection":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/users\/47"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=51126"}],"version-history":[{"count":4,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/51126\/revisions"}],"predecessor-version":[{"id":51131,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/51126\/revisions\/51131"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/51137"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=51126"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=51126"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=51126"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}