Page 49 - Traditional Medicine Systems of BIMSTEC Member States – 2023 Report

Control Authorities. Drug Controller cum Licensing Authorities are available

in the States. Drugs Technical Advisory Board is established to advise the
Government on all aspects related to Quality Control and standardisation

of Ayurveda, Siddha and Unani drugs. Independent Drugs Consultative
Committees comprising State Drugs Licensing Authorities are set up to secure

uniformity in the administration of Act. The Drugs & Magic Remedies Act,
1954 prohibits advertisements of certain drugs & magic remedies. Emerging

global developments in the area of drug regulatory compliance are incorporated
for ASU&H medicines in accordance with the national health circumstances

and regulatory needs of standardisation & quality control, research &
development of ASU&H drugs.

b) Provisions relating to Ayurveda, Siddha and Unani Drugs are contained
in section 3a, section 3h (i), section 33B to 33 O of Chapter IVA, First

Schedule of the Drugs and Cosmetics Act, 1940. Further in Drugs and
Cosmetics Rules, 1945, Rules 151 to 170, Schedules E(I), T & TA pertain

to Ayurveda, Siddha and Unani drugs.
c) Ayurveda, Siddha, Unani Drugs Technical Advisory Board (ASUDTAB)

and Ayurveda, Siddha, Unani Drugs Consultative Committee (ASUDCC)
are statutory bodies under the Drugs and Cosmetics Act to advise the Central

and State Governments on technical matters and for securing uniformity
throughout the country in the administration of the Act

d) Provision for Licensing of Traditional Medicine Products: Rules 151
T raditional Medicine Systems of BIMSTEC Member States – 2023 Report
to 159 of the Drugs and Cosmetics Rules, 1945 provide the regulatory

provisions for grant of licenses to manufacture Ayurveda, Siddha and Unani
drugs and promote their safety and quality. Licensing Authorities are appointed

by the State Governments to oversee the enforcement of legal provisions for
the manufacture and sale of ASU drugs. Good Manufacturing Practices and

adherence to standards of drugs as prescribed in the pharmacopoeia are
mandatory for the manufacturing of licensed products to ensure quality, safety

and efficacy of ASU medicines. The commercial production of ASU&H drugs
without license is not permitted. Compliance to Good Manufacturing Practices

(GMP) is mandatory for obtaining manufacturing license. Requirement of
In-house testing laboratories is prescribed under Drugs and Cosmetics Rules,

1945, Schedule T for the GMP of ASU Manufacturing units and Schedule
M1 for Homoeopathy drugs manufacturing units. The units which don’t have

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