Drug Regulatory Law

For the manufacture, import, export, storage, distribution, and sale of therapeutic products in the nation, there are legal requirements outlined in the Drug Regulatory Authority of Pakistan Act, 2012 and the Drugs Act, 1976. The purpose of the DRAP Act 2012 is to improve interprovincial trade and commerce of therapeutic products while also effectively coordinating and enforcing The Drugs Act, 1976. Additional information on the regulatory elements of therapeutic goods, such as their licencing, registration, quality assurance, and other topics addressed by these Acts, is provided by several rules and regulations that are in support of these Acts. Drugs, biological products, medical devices, medicated cosmetics, alternative medicines, and health and OTC products are examples of therapeutic commodities controlled by the Acts. Registration, marketing authorization, vigilance, market surveillance and control, licencing establishments, regulatory inspection, laboratory testing, clinical trials oversight, pharmacovigilance, and lot release of biologicals are all regulatory mechanisms created under the Acts.