Page 54 - Traditional Medicine Systems of BIMSTEC Member States – 2023 Report

8.9 Regulatory Laws and other measures taken to ensure the availability

of standardised and safe Traditional Medicines include:
• Food Safety and Standards Act administered by the Food Safety and Standards

Authority of India

• Drugs & Magic Remedies (Objectionable Advertisements) Act,1954
• Biological-diversity Act, 2002
• Wildlife Protection Act, 1972

• Indian Forests Act, 1927

• Narcotics Drugs and Psychotropic Substances Act, 1985
• The Medicinal and Toilet Preparation (Excise Duties) Act, 1955
• The standards of Weights and Measures Act, 1956

• Licensing of Traditional Drug Manufacturing Units is Mandatory

• Central Government is empowered to prohibit manufacture and sale of certain
Traditional drugs in public interest
• Government Drug Analysts and Drug Inspectors have been notified and their

Qualifications and Duties prescribed

• Publication of Pharmacopoeial standards of A.S.U. drugs
• Enforcement of GMP as Schedule ‘T’ of the drugs and Cosmetics Act, 1940
and Rules therein

• Notification of Schedule “E (1)” of the Drugs and Cosmetics Act which provides

list of poisonous and potentially poisonous materials used in Ayurveda
(21 drugs), Siddha (17 drugs) and Unani (19 drugs)
• Publication of Ayurvedic Formulary of drugs

• Publication of National Essential Drugs Lists of ASU systems

• Provision of Punitive action in the Act for dealing in misbranded, adulterated
and spurious drugs of ASU systems
• Provision of Mandatory Testing of Heavy metals of ASU medicines for export

• Launch and implementation of Schemes to provide financial assistance for

strengthening of infrastructure, functional capacity of Pharmacies & Drug
Testing Laboratories
• Specifications have been outlined for Labelling/ Packing provisions for Export/

Domestic use of Traditional drugs

• Recognition of private and public drug testing laboratories for sample
analysis
India

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