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.
Cold medicines are a group of medications taken individually or in combination as a treatment for the symptoms of the common cold and similar conditions of the upper respiratory tract. The term encompasses a broad array of drugs, including analgesics, antihistamines and decongestants, among many others. It also includes drugs which are marketed as cough suppressants or antitussives, but their effectiveness in reducing cough symptoms is unclear or minimal.
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.
Ranbaxy Laboratories Limited was an Indian multinational pharmaceutical company that was incorporated in India in 1961 and remained an entity until 2014. The company went public in 1973. Ownership of Ranbaxy changed twice over the course of its history.
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.
Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same.
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.
Diethylene glycol (DEG) is an organic compound with the formula (HOCH2CH2)2O. It is a colorless, practically odorless, and hygroscopic liquid with a sweetish taste. It is a four carbon dimer of ethylene glycol. It is miscible in water, alcohol, ether, acetone, and ethylene glycol. DEG is a widely used solvent. It can be a normal ingredient in various consumer products, and it can be a contaminant. DEG has also been misused to sweeten wine and beer, and to viscosify oral and topical pharmaceutical products. Its use has resulted in many epidemics of poisoning since the early 20th century.
Secobarbital is a short-acting barbiturate derivative drug that was patented in 1934 in the United States. It possesses anaesthetic, anticonvulsant, anxiolytic, sedative, and hypnotic properties. In the United Kingdom, it was known as quinalbarbitone. It is the most frequently used drug in physician-assisted suicide within the United States. Secobarbital is considered to be an obsolete sedative-hypnotic, and as a result, it has largely been replaced by the benzodiazepine family. Seconal was widely abused, known on the street as "red devils" or "reds". Among the barbiturates, secobarbital carries a particularly high risk of abuse and addiction, largely responsible for its falling out of use.
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.
Malvinder Mohan Singh is a businessman who is now under arrest for criminal breach of trust. He, along with his brother Shivinder Mohan Singh, has many cases of fraud registered against him.
Since the 1990s, several mass poisonings from toxic cough syrup have occurred in developing countries. In these cases, an ingredient in cough syrup, glycerine (glycerol), was replaced with diethylene glycol, a cheaper alternative to glycerine for industrial applications. Diethylene glycol is nephrotoxic and can result in multiple organ dysfunction syndrome (MODS), especially in children.
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.
Drugs Controller General of India (DCGI) is the head of department of the Central Drugs Standard Control Organization of the Government of India responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines, and sera in India. Drugs Controller General of India, comes under the Ministry of Health & Family Welfare. DCGI also sets standards for manufacturing, sales, import, and distribution of drugs in India.
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 Food and Drug Administration (FDA) of the United States or the European Medicines Agency of the European Union. 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).
Alembic Pharmaceuticals Ltd. is an Indian multinational pharmaceutical company headquartered in Vadodara. It is involved in the manufacture of pharmaceutical products, pharmaceutical substances and intermediates. It is also termed to be a market leader in macrolides segment of anti-infective drugs in India.
BGR-34 is an Ayurvedic-derived product that is sold in India as an over-the-counter pill for the management of type 2 diabetes. It was developed in 2015 by two government-owned laboratories and launched commercially in 2016. It has been tested in only one, modest-sized, human trial. The drug has been heavily criticized, and without more clinical trials, its efficacy remains unproven. The manufacturers have refused to acknowledge the claims of inefficacy and other concerns.
Molnupiravir, sold under the brand name Lagevrio, is an antiviral medication that inhibits the replication of certain RNA viruses. It is used to treat COVID‑19 in those infected by SARS-CoV-2. It is taken by mouth.
The Ministry of Food and Drug Administration is a ministry of the Government of Maharashtra. The ministry is responsible for consumer protection and regulating food and drug related issues in Maharashtra
The Uzbekistan cough syrup scandal was a series of poisonings that resulted in the deaths of 18 children in Samarkand and two more children elsewhere in Uzbekistan in December 2022 and January 2023. It was caused by the toxic levels of diethylene glycol and ethylene glycol in cold medicines produced by the Indian company Marion Biotech, such as the Dok-1 Max brand. Subsequently, the Indian government investigated Marion Biotech's manufacturing processes, while Uzbek authorities opened a criminal case against members of the health system that had contributed to the children's deaths, such as regulatory officials and pharmacy administrators.
