Lok Sabha Question No. 1891 (UNSTARRED), answered on 2019-11-29
Subject: Drug Testing Laboratories in AYUSH
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Shrirang Appa Barne, Vinayak Bhaurao Raut, DNV Senthilkumar. S., Hemant Patil, Ratansinh Magansinh Rathod

## GOVERNMENT OF INDIA MINISTRY OF AYURVEDA, YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY (AYUSH)

## LOK  SABHA UNSTARRED  QUESTION NO. 1891 TO BE ANSWERED ON 29 TH NOVEMBER, 2019

## DRUG TESTING LABORAT ORIES IN AYUSH

## 1891. SHRI SHRIRANG APPA BARNE:

SHRI VINAYAK RAUT:

DR. DNV SENTHILKUMAR S.:

SHRI HEMANT SRIRAM PATIL:

SHRI RATANSINH MAGANSINH RATHOD:

Will  the  Minister of AYURVEDA,  YOGA  AND  NATUROPATHY,  UNANI, SIDDHA AND HOMOEOPATHY (AYUSH) be pleased to state:

- (a)  whether inadequate  number  of  drug  testing  laboratories  for  AYUSH  is  one  of  the  majo reasons for circulation of spurious AYUSH drugs in the country;
- (b) the number of drug testing laboratories for AYUSH functioning and proposed to be opene the country, State / UT- wise;
- (c) the quantum of funds allocated for this purpose during the last three years and th year;
- (d) the mechanism in place to review the functioning of drug testing laboratories for AYUS
- (e)  whether  the  Government  proposes  to  launc h  a  campaign  to  create  awareness  and  ensure public participation against spurious drugs, if so, the details thereof; and
- (f) the steps taken/being taken by the Government to revamp the drug testing laborator AYUSH in the country?

## ANSWER

## THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYURVEDA, YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY (SHRI SHRIPAD YESSO NAIK)

- (a) &(b):   The government has supported 27 State Drug Testing Laboratories have be supported under the Quality Control Scheme of Ayurveda, Siddha, Unani & Homoeopathy drugs under National AYUSH Mission. 58 private Drug Testing Laboratories have also bee approved under the Drugs and Cosmetics Rules 1945 for the testing of ASU&H drugs in th Country.  In  addition  there  are  two  central  Drug  Testing  Laboratories  i.e.  Pharmacop Laboratory for Indian Medicines (PLIM) & Homeopathic Pharmacopoeia Laboratory (HP L), Ghaziabad  which  is  appellate  laboratory  under  the  Drugs  and  Cosmetics  Rules  194

Provisions  for  regulation  and  quality  control  of  Ayurvedic  and  Unani  medicines  be manufactured for sale in the country are prescribed in the Drugs & Cosmetics Act, 19 40 & Rules 1945.  These provisions are enforced by the Licensing Authorities & Drug Cont Officers  appointed  by  the  State  Governments.    As  the  s purious  Ayurvedic  and  Unani medicines are defined in Section 33 -I of the Drugs & Cosmetics Act, 1940 along wit h the penalty  provisions,  accordingly  the  defaulters  can  be  punished  with  monitory  fine imprisonment for a term up to three years as determined by the court.

( c) & ( d) : Under  the  National  AYUSH  Mission  the  funds  allocated  for  quality  control Scheme ofASU&H drugs during last 03 years and the current year is enclosed at Annexure. Government has constituted Central monitoring Team to review the physical and financial progress and functionality of State Drug Testing Laboratories and pharmacies of ASU d in time to time.

- ( e) &( f) : In order to create awareness and ensure public participation against spur ious drugs the government has conducted 07 training programmes for strengthening of all States/UT State regulatory staff ASU drug manufacturing units Drug Testing Laboratories of AYUS drugs. Following other steps have also been taken: -
1. Pharmacopoeial  Laboratory  for  Indian  Medicines  &  Homoeopathic  Pharmacopoeia Laboratory, Ghaziabad are conducting training programs of the State Regulators, In -charges of Drug Testing Laboratories, Pharmacies in every year.
2. States/UTs  have  been  directed  to  constitu te  an  expert  committee  for  examination  of Licenseapplications vide order dated 12.02.2019 and to appoint controlling Authoritie the State Licensing Authority & Inspectors.
3. e- aushadi  portal  has  been  developed  for  online  submission  and  disposing  of license applications and certificates of the ASU&H Drug manufacturers.
4. Ministry of AYUSH notified creation of 09 regulatory posts on 24 - 07- 2019 including the posts  of  Deputy  Drugs  Controllers  (01),  Assistant  Drugs  Controllers  (04)  (one  each Ayurveda, Homoeopathy, Unani and Siddha drugs) and Drug Inspectors (04) (one each fo Ayurveda,  Homoeopathy,  Unani  and  Siddha  drugs)  as  approved  by  the  Department  of Expenditure vide ID No. 1141843/E.Coord.I/2019 dated 12.07.2019. Recruitment Rules fo these  posts are  being  finalized  in  consultation  with  Department  of  Personnel  &  Traini (DoPT),  Union  Public  Service  Commission  (UPSC)  and  Law  Ministry  to  initiate  the recruitment of regular incumbents. Meanwhile, the posts have been operationalized by g additio nal charge to the existing Technical Officers of the Ministry of AYUSH.

………………

Annexure

Grants relased to State Drug Testing Laboratories during last 03 years and current year In Lakhs

| S.No   | Name of the state /UT   | 2016- 17   | 2017- 18   | 2018- 19   | 2019- 20   | Total   |
|--------|-------------------------|------------|------------|------------|------------|---------|
| 1.     | Andaman & Nicobar       | -          | -          | -          | -          | -       |
| 2.     | Andhra Pradesh          | 210.00     | -          | -          | 25.95      | 235.95  |
| 3.     | Arunachal Pradesh       | 41.86      | 36.96      | 19.60      | -          | 98.42   |
| 4.     | Assam                   | 20.60      | 51.00      | -          | -          | 71.60   |
| 5.     | Chandigarh              | -          | -          | -          | -          | -       |
| 6.     | Chhattisgarh            | -          | -          | -          | -          | -       |
| 7.     | Goa                     | -          | 6.10       | -          | -          | 6.10    |
| 8.     | Gujarat                 | -          | -          | -          | -          | -       |
| 9.     | Haryana                 | -          | -          | 16.00      | 18.00      | 34.00   |
| 10.    | Himachal Pradesh        | 20.72      | -          | 55.16      | 20.00      | 95.88   |
| 11.    | Jammu and Kashmir       | -          | -          | 12.00      | -          | 12.00   |
| 12.    | Jharkhand               | -          | -          | -          | -          | -       |
| 13.    | Karnataka               | -          | 35.42      | 65.00      | -          | 100.42  |
| 14.    | Kerala                  | 45.00      | 89.84      | -          | -          | 134.84  |
| 15.    | Lakshwadeep             | -          | -          | -          | -          | -       |
| 16.    | Madhya Pradesh          | -          | -          | -          | -          | -       |
| 17.    | Maharashtra             | -          | 80.00      | -          | -          | 80.00   |
| 18.    | Manipur                 | -          | -          | 97.01      | 15.00      | 112.01  |
| 19.    | Meghalaya               | 19.06      | -          | -          | 10.00      | 19.06   |
| 20.    | Mizoram                 | -          | 25.00      | 25.00      | -          | 50.00   |
| 21.    | Odisha                  | 9.92       | 73.61      | 10.00      | 76.62      | 170.15  |
| 22.    | Puducherry              | 8.00       | -          | -          | -          | 8.00    |
| 23.    | Punjab                  | 52.00      | -          | -          | -          | 52.00   |
| 24.    | Rajasthan               | -          | 39.10      | 14.87      | -          | 53.97   |
| 25.    | Sikkim                  | -          | -          | -          | -          | -       |
| 26.    | Tamil Nadu              | 15.50      | -          | 7.20       | -          | 22.70   |
| 27.    | Telangana               | -          | 25.00      | -          | -          | 25.00   |
| 28.    | Tripura                 | 16.40      | 19.34      | -          | -          | 35.74   |
| 29.    | Uttar Pradesh           | 200.00     | -          | 50.00      | -          | 250.00  |
| 30.    | Uttarakhand             | 23.00      | 10.75      | 51.40      | -          | 85.15   |
| 31.    | West Bengal             | -          | 20.00      | 20.00      | 10.00      | 50.00   |
|        | Total                   | 682.06     | 512.124    | 443.24     | 175.57     | 1802.99 |