Page 51 - Traditional Medicine Systems of BIMSTEC Member States – 2023 Report

8.3 Good manufacturing Practices (GMP):

As per provisions under Rule 157 of Drugs & Cosmetics Rules, 1945, the
manufacture of Ayurvedic (including Siddha) or Unani drugs shall be carried out in such

premises and under such hygienic conditions as are specified in Schedule T. For issuing

of the certificate of Good Manufacturing Practices, the Licensing Authority shall verify
the requirements as per schedule T and issue the Good Manufacturing Practices certificate
simultaneously along with grant or renewal of licence. Good Manufacturing Practices

(GMP) for Ayurvedic, Siddha and Unani Medicines are prescribed under Schedule T of

Drugs & Cosmetics Act, 1940 & Rules thereunder. Schedule T comprises of Part I and
Part II. Part I describes Good Manufacturing Practices for factory premises. Part II
prescribes-

a) List of recommended machinery, equipment and minimum manufacturing

premises required for the manufacture of various categories of Ayurvedic,
Siddha and Unani system of medicines.
b) List of equipment recommended for in house quality control section.

c) Supplementary guidelines for manufacturing of rasaushadhies or

rasamarunthukal and kushtajat (herbo-mineral-metallic compounds) of
Ayurveda, Siddha and Unani medicines.

8.4 Central Ayush Drugs Control Framework:

In order to control quality of Ayurveda, Siddha, Unani & Homoeopathy (ASU&H)
Drugs, a new initiative has been undertaken by forming an independent vertical structure
T raditional Medicine Systems of BIMSTEC Member States – 2023 Report
in Central Drugs Standard Control Organisation with creation of 9 regulatory posts.

It will enhance the enforcement mechanism of the provisions of Drugs and Cosmetics
Act 1940 and Rules made there under thus assuring availability of quality drugs to
public.

8.5 Pharmacovigilance of ASU&H Drugs:
The programme is initiated to collect, collate and analyse data to establish

evidence for clinical safety of ASU & H drugs in a scientific manner for documenting

clinical evidence of safety and to undertake surveillance of misleading advertisements of
ASU & H drugs for regulatory actions. A three-tier structure comprising of a National
Pharmacovigilance Co-ordination Centre (NPvCC), Intermediary Pharmacovigilance

Centres (IPvCs) and Peripheral Pharmacovigilance Centres (PPvCs) are established. All

India Institute of Ayurveda (AIIA), New Delhi under Ministry of Ayush is the National

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