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. [4]
The Pharmacy Council of Bangladesh(PCB) was established under the Pharmacy Ordinance Act in 1976. [5] 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. [6]
The economy of Bangladesh is a major developing mixed economy. As the second-largest economy in South Asia, Bangladesh's economy is the 35th largest in the world in nominal terms, and 25th largest by purchasing power parity. Bangladesh is seen by various financial institutions as one of the Next Eleven. It has been transitioning from being a frontier market into an emerging market. Bangladesh is a member of the South Asian Free Trade Area and the World Trade Organization. In fiscal year 2021–2022, Bangladesh registered a GDP growth rate of 7.2% after the global pandemic. Bangladesh is one of the fastest growing economies in the world.
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.
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 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.
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 was estimated to be worth Rs. 748 billion (US$2.6 billion) in 2023, representing about 1% of the country's GDP. The industry is largely import-dependent, with more than 90% of raw material being imported and only 12% of active pharmaceutical ingredients locally produced. Pakistani pharmaceutical companies are engaged in importing raw materials, compounding active pharmaceutical ingredients with excipients, coating of pills, and fill-finish activities. The industry is regulated by the Drug Regulatory Authority of Pakistan, which oversees drug approvals and pricing.
Pharmaceutical fraud is when pharmaceutical companies engage in illegal, fraudulent activities to the detriment of patients and/or insurers. Examples include counterfeit drugs that do not contain the active ingredient, false claims in packaging and marketing, suppression of negative information regarding the efficacy or safety of the drug, and violating pricing regulations.
The distribution of medications has special drug safety and security considerations. Some drugs require cold chain management in their distribution.
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 60,000 employees.
Generic medicine in India refers to pharmaceuticals that are sold under their chemical name rather than a specific brand name. These medications contain the same active ingredients, dosage form, strength, route of administration, quality, and intended use as their brand-name counterparts but are typically sold at significantly lower prices. The Indian generic medicine market has risen to international prominence due to the country's ability to produce affordable, high-quality medications, particularly following the 1970 Patent Act which permitted domestic companies to manufacture drugs using alternative processes. This has enabled India to become one of the world's leading suppliers of generic medicines, currently providing approximately 20% of the global supply and 40% of the generic drugs consumed in the United States.
