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Food Supplement Registration in Pakistan

Regulatory Authority

Drug Regulatory Authority of Pakistan

Regulatory Website

License Validity

5 Years

Complementary medicine ingredients like vitamins, minerals, herbal items, and homoeopathic preparations are included in alternative medicines and health products. They are referred to as alternative medications and health products and are non-prescription goods.

Regulations govern alternative medicine and health items to guarantee citizens receive safe and high-quality products. The DRAP Act of 2012 and its implementing regulations establish the prerequisites for the production or importation of these goods for use in Pakistan.

Alternative medicine refers to pharmaceuticals such as:

  • Native American or Unani medicine
  • Homeopathic medications
  • Plant, animal, or mineral ingredients alone, or in combination, to create herbal preparations, herbal substances, herbal patented medicines, herbal medical products, phy to-medicines, or other similar items that don’t contain chemically defined synthetic ingredients
  • Products covered by enlistment regulations are called “health products,” including infant dietetic diets, nutritional supplements, and other items.

In accordance with the DRAP Act of 2012, the Division of Health & OTC is in charge of carrying out the following duties to oversee regional producers, importers, and their goods (both human and animal).

  • Review and assessment of local importers’ and manufacturers’ applications prior to their enlistment as local importers and manufacturers.
  • Enlisting regional producers and importers.
  • Evaluation of applied products from local importers and producers prior to enlisting.
  • Listing of goods with regional producers and importers.
  • Variations of local producers and importers after enlisting.
  • Post-enlistment modifications of enrolled goods from regional producers and importers
  • Evaluation of applications for local contract manufacturers to perform contract manufacturing
  • Pre-enrollment assessments of goods submitted for contract production
  • Products enlisted for contract manufacture.

Food Supplement Registration in Pakistan

This application process is divided into following three phases which require separate application form and processing fee at each stage:

  • Site verification of the proposed premises.
  • Approval of Layout plan of the proposed site.
  • Final Inspection for verification of manufacturing and testing facilities and grant of provisional enlistment certificate (Form-6).

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