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Are Medicines Made in India Safe?

The responsibility of drug approval and regulation in India lies with the Central Drugs Standards Control Organization (CDSCO), which operates under the Indian Ministry of Health and Family Welfare. CDSCO is akin to the U.S. FDA and is responsible for granting approval for new drugs in the Indian market, conducting post-market surveillance, and taking enforcement actions to safeguard the Indian drug supply.
Pharmacies in India are regulated by the Drugs Control Administration, which operates through State Drug Control Offices, also known as Food and Drug Administration offices. These offices are tasked with inspecting and licensing pharmacies and enforcing the Pharmacy Act of 1940, which mandates stringent safety standards for pharmacies.
Indian pharmacies are subject to similar regulations as those in the United States, such as the requirement of having a licensed pharmacist present during operational hours and safe storage of drugs, particularly those with specific requirements, such as insulin, and controlled substances. However, the enforcement standards in India are generally lower than in high-income countries like the U.S. PharmacyChecker ensures that its accredited pharmacies meet safe standards of mail-order pharmacy practice by routinely inspecting them.
India has a vast and sophisticated pharmaceutical industry and is responsible for manufacturing a significant proportion of the world's pharmaceutical active ingredients and finished products, which are exported to countries such as the U.S. and the EU for final drug product manufacturing or sale in local pharmacies. India is the world's largest exporter of generic drugs.
Many drugs in India are produced in FDA-inspected or approved facilities. In fact, the U.S. FDA inspects more drug manufacturing plants in India than any other country outside of the United States. Nonetheless, review and reports greatly minimize the risk of Indian pharmacies listed from selling counterfeit or substandard drugs.