AYUSH
azadi ka amrit mahotsav g20-india-2023

Quality Control of Ayush Drugs

Posted On: 02 AUG 2022 5:07PM 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/UT

Year-wise no. of samples  of ASU&H tested by PCIM&H

2017-2018

2018-19

2019-20

2020-21

2021-22

April 2022 to 13.07.2022

  1.  

Bihar

03

-

01

03

-

-

  1.  

Delhi

211

466

252

51

319

08

  1.  

Gujarat

02

 

-

-

-

-

  1.  

Karnataka

46

09

20

-

-

-

  1.  

Maharashtra

66

26

04

10

03

20

  1.  

Odisha

58

69

43

09

220

12

  1.  

Punjab (Chandigarh)

04

-

79

-

-

62

  1.  

Rajasthan

88

-

 

-

-

76

  1.  

Uttar Pradesh

05

05

02

-

01

-

  1.  

Uttrakhand

03

08

37

08

132

06

  1.  

West Bengal

39

 

02

01

18

05

  1.  

Arunachal Pradesh

-

04

-

03

-

-

  1.  

Goa

-

02

06

-

-

-

  1.  

Jharkhand

-

36

22

58

14

02

  1.  

Rajasthan

-

71

132

143

287

-

  1.  

Tripura

-

45

-

-

02

-

  1.  

Kerala

-

-

03

-

-

01

  1.  

Madhya Pradesh

-

-

01

-

-

-

  1.  

Manipur

-

-

39

39

-

-

  1.  

Andaman & Nicobar

-

-

-

-

05

-

Total

525

741

643

324

1008

192

 

    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

2017-18

2018-19

2019-20

2020-21

2021-22

2022-till date

  1.  

Manipur

NIL

NIL

38

16

33

-

  1.  

Chhattisgarh

333

693

511

376

566

-

  1.  

Goa

10

01

07

29

75

54

  1.  

Odisha

967

 

451

 

2506

 

1969

 

2672

 

-

  1.  

Himachal Pradesh

590

 

38    

462

 

404

 

443

 

-

  1.  

Arunachal Pradesh

155

145

161

172

96

-

  1.  

Tamil Nadu

1754

1104

3448

1725

1746

-

  1.  

Kerala

483

938

719

308

244

-

  1.  

Andhra Pradesh

101

07

16

164

25

-

  1.  

Karnataka

1014

882

1706

1259

416

-

  1.  

Andaman & Nicobar

NIL

NIL

NIL

NIL

10

 

  1.  

Gujarat

302

304

97

408

71

-

  1.  

Maharashtra

259

443

406

167

458

115

(from 01.04.2022 to 30.06.2022)

  1.  

Madhya Pradesh

290

265

05

521

353

482

  1.  

Uttar Pradesh

0

09

37

54

89

-

  1.  

Puducherry

NIL

 

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.

***

SK



(Release ID: 1847448) Visitor Counter : 1600


Read this release in: Urdu , Manipuri