Regulation
Two organizations regulate drugs and pharmacies in Bangladesh.
The Directorate General of Drug Administration (DGDA) is the national drug regulatory authority which is under the Ministry of Health and Family Welfare. DGDA regulates all activities related to import and export of raw materials, packaging materials, production, sale, pricing, licensing, registration of all kinds of medicine including those of Ayurvedic, Unani, herbal and homeopathic systems. [2]
The Pharmacy Council of Bangladesh(PCB) was established under the Pharmacy Ordinance Act in 1976. [3] to control the pharmacy practice in Bangladesh. The Bangladesh Pharmaceutical Society is affiliated with the International Pharmaceutical Federation and Commonwealth Pharmaceutical Association. The National Drug Policy (2005) states that the World Health Organization’s current Good Manufacturing Practices (GMP) should be strictly followed and that manufacturing units will be regularly inspected by the DDA. Other key regulation features are restrictions on imported drugs (where these are produced by four or more local firms), a ban on local production of around 1,700 drugs that are considered non-essential or harmful and strict price controls on some 117 principal medicines. [4]
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.
A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active chemical substance is the same, the medical profile of generics is equivalent in performance compared to their performance at the time when they were patented drugs. A generic drug has the same active pharmaceutical ingredient (API) as the original, but it may differ in some characteristics such as the manufacturing process, formulation, excipients, color, taste, and packaging.
A prescription drug is a pharmaceutical drug that is permitted to be dispensed only to those with a medical prescription. In contrast, over-the-counter drugs can be obtained without a prescription. The reason for this difference in substance control is the potential scope of misuse, from drug abuse to practicing medicine without a license and without sufficient education. Different jurisdictions have different definitions of what constitutes a prescription drug.
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS).
The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia.
Dr. Reddy's Laboratories is an Indian multinational pharmaceutical company based in Hyderabad. The company was founded by Kallam Anji Reddy, who previously worked in the mentor institute Indian Drugs and Pharmaceuticals Limited. Dr. Reddy manufactures and markets a wide range of pharmaceuticals in India and overseas. The company produces over 190 medications, 60 active pharmaceutical ingredients (APIs) for drug manufacture, diagnostic kits, critical care, and biotechnology.
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 pharmaceutical industry in India was valued at an estimated US$42 billion in 2021 and is estimated to reach $130 billion by 2030. India is the world's largest provider of generic medicines by volume, with a 20% share of total global pharmaceutical exports. It is also the largest vaccine supplier in the world by volume, accounting for more than 60% of all vaccines manufactured in the world. Indian pharmaceutical products are exported to various regulated markets including the US, UK, European Union and Canada.
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.
Beximco Pharmaceuticals Ltd, also known as Beximco Pharma is a Bangladeshi multinational pharmaceutical company. It is a part of Bangladesh Export Import Company Limited (BEXIMCO).
Pharmacy in China involves the activities engaged in the preparation, standardization and dispensing of drugs, and its scope includes the cultivation of plants that are used as drugs, the synthesis of chemical compounds of medicinal value, and the analysis of medicinal agents. Pharmacists in China are responsible for the preparation of the dosage forms of drugs, such as tablets, capsules, and sterile solutions for injection. They compound physicians', dentists', and veterinarians' prescriptions for drugs. Pharmacological activities are also closely related to pharmacy in China.
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.
Drug packaging is process of packing pharmaceutical preparations for distribution, and the physical packaging in which they are stored. It involves all of the operations from production through drug distribution channels to the end consumer.
The Pharmacy and Poisons Board is the Drug Regulatory Authority established under the Pharmacy and Poisons Act, Chapter 244 of the Laws of Kenya.
The pharmaceutical industry in Pakistan is strictly regulated by the Drug Regulatory Authority of Pakistan, which oversees drug approvals and pricing.
The distribution of medications has special drug safety and security considerations. Some drugs require cold chain management in their distribution.
The pharmaceutical industry in Russia had a turnover of $16.5 billion in 2016, which was equal to 1.3 % of GDP and 19.9% of health spending.
Square Group is a Bangladeshi diversified multinantional conglomerate based in Dhaka. Samuel S Chowdhury is the chairman and Tapan Chowdhury is managing director of Square Group. Square Group has 60 thousand employees.
