Quality Control of Ayush Drugs

Ayurvedic Plants
Ayurvedic Plants
0 0
Azadi Ka Amrit Mahoutsav

InterServer Web Hosting and VPS
Read Time:4 Minute, 20 Second

Quality Control of Ayush Drugs

By PIB Delhi

As prescribed in Drugs and Cosmetics Act 1940 and Rules 1945 made thereunder, enforcement of the legal provisions pertaining to Quality Control and issuance of drug license of Ayurveda, Siddha, Unani and Homoeopathic drugs, is vested with the State drug Controllers/ State Licensing Authorities appointed by the concerned State/ Union Territory Government. Rule 158-B in the Drugs and Cosmetics Rules, 1945 provides the regulatory guidelines for issue of license to manufacture Ayurvedic, Siddha, Unani medicines and Rule 85 (A to I)in the Drugs and Cosmetics Rules, 1945 provides the regulatory guidelines for issue of license to manufacture Homoeopathic medicines. It is mandatory for the manufacturers to adhere to the prescribed requirements for licensing of manufacturing units & medicines including proof of safety & effectiveness, compliance with the Good Manufacturing Practices (GMP) as per Schedule T & Schedule M-Iof Drugs and Cosmetics Rules, 1945 and quality standards of drugs given in the respective pharmacopoeia.

Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H), a subordinate office under Ministry of Ayush lays down Pharmacopocial Standards and Formulary specifications for Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) drugs within the ambit of Drugs & Cosmetics Act, 1940, which serve as official compendia for ascertaining the quality of the drugs included therein.          Further, PCIM&H as an appellate drug testing laboratory receives the samples from Government agencies as per Drugs & Cosmetics Act & Rules there under for ascertaining their quality.           

Details of the number of AYUSH drug and product samples tested by PCIM&H is as follows –

S. No.Name of the State/UTYear-wise no. of samples  of ASU&H tested by PCIM&H
2017-20182018-192019-202020-212021-22April 2022 to 13.07.2022
 Punjab (Chandigarh)047962
 Rajasthan88 76
 Uttar Pradesh05050201
 West Bengal39 02011805
 Arunachal Pradesh0403
 Madhya Pradesh01
 Andaman & Nicobar05

    As per the information received from State/ UT Governments, list of Ayush drug and product samples tested in the last five is as follows –

S.no.Name of the State/UT Information received from State/ UT Governments regarding  Ayush drug samples tested in the last five
2017-182018-192019-202020-212021-222022-till date
 Odisha967 451 2506 1969 2672 
 Himachal Pradesh590 38    462 404 443 
 Arunachal Pradesh15514516117296
 Tamil Nadu17541104344817251746
 Andhra Pradesh101071616425
 Andaman & NicobarNILNILNILNIL10 
 Maharashtra259443406167458115(from 01.04.2022 to 30.06.2022)
 Madhya Pradesh29026505521353482
 Uttar Pradesh009375489

Under Centrally Sponsored Scheme of National Ayush Mission (NAM) as per the proposals received from State/UT Governments through their State Annual Action Plans, an amount of Rs. 10723.14 Lakhs has been approved under the component of quality control of Ayurveda, Siddha, Unani & Homeopathy drugs (ASU&H drugs) for different activities including quality testing of drugs from the year 2014-15 to 2019-20.

Ministry of Ayush has implemented Central Sector Scheme AYUSH Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY). The objectives of the Scheme are as under;

i. To enhance India’s manufacturing capabilities and exports of traditional medicines and health promotion products under the initiative of Atmanirbhar Bharat.

ii. To facilitate adequate infrastructural & technological upgradation and institutional activities in public and private sector for standardization, quality manufacturing and analytical testing of Ayush drugs & materials.

 iii. To strengthen regulatory frameworks at Central and State level for effective quality control, safety monitoring and surveillance of misleading advertisements of Ayush drugs.

iv. To encourage building up synergies, collaborations and convergent approaches for promoting standards and quality of Ayush drugs & materials.

The components of the AYUSH Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY) Scheme are as under;

A. Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards.

B. Pharmacovigilance of ASU&H drugs including surveillance of misleading advertisements.

C. Strengthening of Central and State regulatory frameworks including Technical Human Resource & Capacity Building programs for Ayush drugs.

D. Support for development of standards and accreditation/ certification of Ayush products & materials in collaboration with Bureau of Indian Standards (BIS), Quality Control of India (QCI) and other relevant scientific institutions and industrial R&D centres.   

AYUSH Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY) was approved by Standing Finance Committee (SFC) on 16.03.2021. The total financial allocation to this scheme is Rs 122.00 crores for five years.       

This information was given by Minister of Ayush Shri Sarbananda Sonowal in a written reply in Rajya Sabha today.

About Post Author

Editor Desk

Antara Tripathy M.Sc., B.Ed. by qualification and bring 15 years of media reporting experience.. Coverred many illustarted events like, G20, ICC,MCCI,British High Commission, Bangladesh etc. She took over from the founder Editor of IBG NEWS Suman Munshi (15/Mar/2012- 09/Aug/2018 and October 2020 to 13 June 2023).
0 %
0 %
0 %
0 %
0 %
0 %



Please enter your comment!
Please enter your name here