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The Drugs and Cosmetics Act, 1940 is an act of the Parliament of India which regulates the import, manufacture and distribution of drugs in India. [1] The primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards. [2]
South Africa (1971), India (1984), United Nations (1971–1988) Withdrawn because of risk of addiction and overdose [33] [34] Metipranolol: 1990 UK, others Uveitis. [3] Metofoline: 1965 US Unspecific experimental toxicity. [3] Mibefradil: 1998 European Union, Malaysia, US, others Fatal arrhythmia, drug interactions. [2] [3] Minaprine: 1996 ...
The Drugs and Cosmetics Rules, 1945 are the rules which the government of India established for the implementation of the Drugs and Cosmetics Act, 1940. These rules classify drugs under given schedules and present guidelines for the storage, sale, display and prescription of each schedule. [1] [2]
The Act is designed to fulfill India's treaty obligations under the Single Convention on Narcotic Drugs, Convention on Psychotropic Substances, and United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances. The Act has been amended three times - in 1988, 2001, and most recently in 2014.
The Truth Pill: The Myth of Drug Regulation in India is a 2022 book by whistleblower Dinesh Thakur and lawyer Prashant Reddy. The book highlights the problems in India's drug regulatory framework, and the government oversight relating to poor manufacturing practices and clinical trials of drugs by Indian pharmaceutical companies.
The Union Health Ministry of India has come out with draft rules on sale of drugs by online / e-pharmacies with an aim to regulate online sale of medicines across India and provide patients access to genuine drugs from authentic online portals. The draft rules on "sale of drugs by e-pharmacy" states the following points [15] a.
Many Indian families live below the poverty line due to healthcare expenses. From 1972 to 2005, due to a lack of patent laws for drugs in India, Indian drug companies were able to use alternative, legal processes to manufacture generic versions of drugs. These generic drug companies were able to produce low-priced drugs that were considered ...
India exports generic drugs to the United States and the European Union. [23] also the according to market research community the Global Generic Drugs Market was evaluated US$465.96 million in 2021 and is expected to rise with a CAGR of 5.5% from 2022- 2028 during the forecast period. [24]