Abbreviation | DRAP |
---|---|
Formation | 2012 |
Type | Autonomous body |
Legal status | Active |
Headquarters | Islamabad, Pakistan |
Region served | Pakistan |
CEO | Asim Rauf |
Parent organization | Ministry of National Health Services, Regulations & Coordination |
Website | www |
The Drug Regulatory Authority of Pakistan (DRAP) is a self-governing entity under the Federal Government of Pakistan. It functions under the administrative supervision of the Ministry of National Health Services, Regulations & Coordination. DRAP was formed in accordance with the DRAP Act 2012 and is tasked with ensuring effective coordination and implementation of The Drugs Act, 1976. [1] [2]
DRAP is committed to ensuring that all drugs, medical devices, [3] cosmetics, alternative medicines, and health products meet a certain standard of quality and are safe and effective for use. [4] It is responsible for making sure that therapeutic goods, which are approved and available in the market, comply with the prescribed standards of quality, safety, and efficacy. The regulatory tasks carried out by DRAP encompass registration and marketing authorization, vigilance, market surveillance and control, licensing establishments, regulatory inspection, laboratory testing, clinical trials oversight, pharmacovigilance, and lot release of biologicals. [5]
In response to the shortage of life-saving medicines across the country, DRAP has taken several initiatives:
DRAP has set the maximum retail prices for 25 life-saving drugs and 25 newly introduced medicines in an effort to make these essential drugs more affordable for the public. [6] [7]
A committee was formed to propose strategies to alleviate the scarcity of life-saving medicines and liaise with pharmaceutical manufacturers and importers. [8]
In an effort to eradicate black market practices and put an end to hoarding, DRAP introduced a mobile application. This app provides real-time and evidence-based information about drug shortages in the market. [5]
There is no restriction on hospitals or individuals on importing vital medicines from India for their own use under the Import Policy Order 2022 after obtaining a No Objection Certificate (NOC) from DRAP. [4]
DRAP decided to launch a crackdown against spurious medicines to eradicate the menace of unregistered, spurious and sub-standard medicine. [9]
Allegations have been made against Asim Rauf the CEO of DRAP for operating a Benami pharmaceutical company, which is perceived as a clear instance of conflict of interest. [10]
The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
A medication is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy (pharmacotherapy) is an important part of the medical field and relies on the science of pharmacology for continual advancement and on pharmacy for appropriate management.
An epinephrine autoinjector is a medical device for injecting a measured dose or doses of epinephrine (adrenaline) by means of autoinjector technology. It is most often used for the treatment of anaphylaxis. The first epinephrine autoinjector was brought to market in 1983.
Pharmacovigilance, also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: pharmakon and vigilare. As such, pharmacovigilance heavily focuses on adverse drug reactions (ADR), which are defined as any response to a drug which is noxious and unintended, including lack of efficacy. Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction.
The National Medical Products Administration is a national bureau responsible for drug supervision under the State Council of China and is managed by the State Administration for Market Regulation.
The pharmaceutical industry is one of the leading industries in the People's Republic of China, covering synthetic chemicals and drugs, prepared Chinese medicines, medical devices, apparatus and instruments, hygiene materials, packing materials, and pharmaceutical machinery. China has the second-largest pharmaceutical market in the world as of 2017 which is worth US$110 billion. China accounts for 20% of the world's population but only a small fraction of the global drug market. China's changing health-care environment is designed to extend basic health insurance to a larger portion of the population and give individuals greater access to products and services. Following the period of change, the pharmaceutical industry is expected to continue its expansion.
An essential medicines policy is one that aims at ensuring that people get good quality drugs at the lowest possible price, and that doctors prescribe the minimum of required drugs in order to treat the patient's illness. The pioneers in this field were Sri Lanka and Chile.
The National Medicinal Drugs Policy is an essential part of Sri Lanka's Health Policy, aimed at the rational use of pharmaceuticals.
An online pharmacy, internet pharmacy, or mail-order pharmacy is a pharmacy that operates over the Internet and sends orders to customers through mail, shipping companies, or online pharmacy web portal.
For health issues in Iran see Health in Iran.
The pharmaceutical industry in Bangladesh is one of the most developed technology sectors within the country. Manufacturers produce insulin, hormones, and cancer drugs. This sector provides 97% of the total medicinal requirement of the local market. The industry also exports medicines to global markets, including Europe. Pharmaceutical companies are expanding their business with the aim to expand the export market.
The National Institutes of Health, Islamabad (NIH), is a Pakistani research institute located in Islamabad, Pakistan.
The Ministry of National Health Services, Regulation and Coordination is a cabinet level ministry of the government of Pakistan with responsibility for national public health.
A counterfeit medication or a counterfeit drug is a medication or pharmaceutical item which is produced and sold with the intent to deceptively represent its origin, authenticity, or effectiveness. A counterfeit drug may contain inappropriate quantities of active ingredients, or none, may be improperly processed within the body, may contain ingredients that are not on the label, or may be supplied with inaccurate or fake packaging and labeling. Counterfeit drugs are related to pharma fraud. Drug manufacturers and distributors are increasingly investing in countermeasures, such as traceability and authentication technologies, to try to minimise the impact of counterfeit drugs. Antibiotics with insufficient quantities of an active ingredient add to the problem of antibiotic resistance.
The Faculty of Pharmaceutical Medicine (FPM) is a faculty of the three Royal Colleges of Physicians of the United Kingdom. It is a UK-based professional membership organisation with 1,600 members; physicians with a professional interest in the speciality of pharmaceutical medicine, the science of discovering, developing and testing new drugs, their regulation, and monitoring them for safety both during development and when they are prescribed. FPM is a registered charity and ultimately exists to bring about an improvement in health in patients and the general population.
The pharmaceutical industry in Pakistan is strictly regulated by the Drug Regulatory Authority of Pakistan, which oversees drug approvals and pricing.
During late January 2012, a fake medicine crisis at the Punjab Institute of Cardiology (PIC) hospital in the Lahore region of Punjab, Pakistan, claimed the lives of over 100 heart patients.
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012. It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics. It also creates the breakthrough therapy designation program and extends the priority review voucher program to make eligible rare pediatric diseases. The measure was passed by 96 senators voting for and one voting against.
The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for cosmetics, pharmaceuticals and medical devices. It serves a similar function to the European Medicines Agency of the European Union, the PMDA of Japan, the Food and Drug Administration (FDA) of the United States, and the Medicines and Healthcare products Regulatory Agency of the United Kingdom, and the State Administration for Market Regulation of China. The Indian government has announced its plan to bring all medical devices, including implants and contraceptives under a review of the Central Drugs and Standard Control Organisation (CDSCO).
Shahzada 'Prince' Jamal Nazir is a Pakistani politician. In 2011, he was appointed by Prime Minister Syed Yousaf Raza Gilani as adviser with the status of Federal Minister of State for the Ministry of National Regulations and Services. In 2013, he served in the interim cabinet as the Federal Minister for four ministries that included Ministry of Religious Affairs, Ministry of National Interfaith Harmony, Ministry of National Health Services Regulations & Coordination, and Ministry of National Heritage & Integration. Currently, he is serving as Member National Commission on Minorites as a former Minister for National Interfaith Harmony.