Page 50 - Traditional Medicine Systems of BIMSTEC Member States – 2023 Report

such facilities are allowed to get their drugs tested from approved laboratories

for the purpose. Also, as per rule 161B of Drugs and Cosmetics Rules, 1945,
stability study data has been made as mandatory requirement for license

since 2019. Quality standards of identity, purity and strength of drugs and
compliance for permissible limits of heavy metals, pesticide residue,

and microbial load as prescribed in the respective Pharmacopoeias of
ASU&H system are mandatory to follow. Drug inspectors, Technical

Committees and Drug Testing Laboratories are provided for the Licensing
Authorities to take considered and objective decisions in licensing and quality

control matters.
e) Second Schedule (4A) of the Drugs and Cosmetics Act, 1940 provides

standards for Homoeopathic drugs and further Rules 2dd, 30AA, 67,
85 (A to I), 106-A, Schedule K, Schedule M-I pertain to Homoeopathic

drugs.

8.2 Drug Policy Section (DPS):

Ministry of Ayush has a Drug Policy Section (DPS) to administer regulatory and
quality control provisions for ASU&H drugs under the ambit of Drugs and Cosmetics

Act, 1940 and Rules thereunder. In this regard, the Section coordinates with the state
licensing authorities and drug controllers to achieve uniform administration of the Act

and for providing regulatory guidance and clarifications. Section is the secretariat for
two statutory bodies- Ayurvedic, Siddha and Unani Drugs Technical Advisory Board

(ASUDTAB) and Ayurvedic, Siddha and Unani Drugs Consultative Committee (ASUDCC)
and also manages the implementation of the Quality Control of ASU&H drugs related

part of the National AYUSH Mission (NAM) through which grant-in-aid is provided for
improving infrastructural and functional capacity building of Drug Testing Laboratories

and Pharmacies and enforcement framework of ASU&H drugs. At the central level, the
DPS interacts with Central Drug Standard Control Organisation (CDSCO), Directorate

General Foreign Trade (DGFT), Ministry of Environment, Forests and Climate Change
(MoEF&CC), National Medicinal Plants Board and other government agencies for WHO-

GMP/CoPP certification scheme, export/import and clinical trials related matters,
availability issues of raw materials and quality certification in respect of ASU&H Drugs,

and industry related issues.

India

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