{"entity":{"id":"drap","kind":"institution","name":"Drug Regulatory Authority of Pakistan (DRAP)","aka":["DRAP","Drug Regulatory Authority of Pakistan"],"tldr":"Pakistan's medicines regulator. Its Registration Board licenses medicines, relying on decisions by twenty-one named foreign regulators, and it fixes the maximum retail prices of essential medicines.","summary":"DRAP was established under the Drug Regulatory Authority of Pakistan Act, 2012. Medicines are registered by its Registration Board under the Drugs (Licensing, Registering and Advertising) Rules, 1976. Its guideline on good reliance practice (QMSC/GL/RM/005, second edition, effective 4 January 2023) states that finished products approved by its reference regulatory authorities are considered safe, effective and of quality when considered for registration, and lists twenty-one: the FDA, Health Canada, the TGA, PMDA, the MHRA, the EMA, the WHO and fourteen European national agencies. Rule 30(10) of the 1976 rules accepts clinical information approved in the USA, EU countries, Canada, Japan or Australia unless the Board modifies it, and DRAP has an agreement with the WHO on collaborative registration of prequalified products. Unregistered medicines can be imported under a no-objection certificate.\n\nPrices are set under the Drug Pricing Policy, 2018. As amended to 30 September 2024, the policy applies only to medicines on the National Essential Medicines List, whose maximum retail prices are fixed; other medicines are exempt from price fixing. Within the policy, a new originator brand is priced at the average of its price in India and Bangladesh, or failing that a basket of Indonesia, the Philippines, Lebanon, Sri Lanka and Malaysia; in hardship cases imported anti-cancer medicines carry a 40% trade mark-up against 45% for other imports. The map position is the city centre.","asOf":"2026-11-04","links":[{"label":"DRAP: Reliance Mechanism in Regulatory Processes, 2nd edition (PDF)","url":"https://www.dra.gov.pk/wp-content/uploads/2023/01/2nd-edition-Relaince-Mechansim-in-Regulatory-Processess.pdf"},{"label":"DRAP: Drug Pricing Policy, 2018, as amended to 30 September 2024 (PDF)","url":"https://www.dra.gov.pk/wp-content/uploads/2025/04/Drug-Pricing-Policy-2018.pdf"},{"label":"DRAP: public price search","url":"https://e.dra.gov.pk/public/price"},{"label":"Elahi and Siddiqui, import of unregistered anticancer drugs, JPMA 2021","url":"https://doi.org/10.47391/jpma.3458"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["nih-pakistan"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"city":"Islamabad","country":"PK","lat":33.6844,"lng":73.0479,"institutionType":"government","website":"https://www.dra.gov.pk/","programs":["Registration Board (Drugs Licensing, Registering and Advertising Rules, 1976)","Reliance on reference regulatory authorities","Drug Pricing Policy, 2018","No-objection certificates for import of unregistered medicines","Pharmacovigilance Rules, 2022"]},"route":"/institutions/drap/","neighbours":{"institution":[{"id":"nih-pakistan","kind":"institution","name":"National Institutes of Health, Islamabad","route":"/institutions/nih-pakistan/"}]}}