Lok Sabha Question No. 1098 (UNSTARRED), answered on 2023-12-08
Subject: Ayurvedic Pharmaceutical Manufacturers
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: T.R.V.S. Ramesh, M.K. Vishnu Prasad

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO. 1098 TO BE ANSWERED ON 08 th  DECEMBER, 2023

'Ayurvedic Pharmaceutical Manufacturers'

## 1098. SHRI T.R.V.S. RAMESH: DR. VISHNU PRASAD M.K.:

- Will the Minister of AYUSH be pleased to state: (a) whether the Government proposes to provide financial/technical assistance to any Ayurvedic pharmaceutical factories/manufacturers; (b) if so, the details thereof and if not, the reasons therefor; (c) whether the Government has taken/proposed to take any steps to encourage the entrepreneurs to establish such factories and if so, the details thereof; (d) the details of the guidelines in place to ensure the quality of Ayurvedic medicines; (e) whether the Government has identified any incidence of adulteration for profit; (f) if so, the details thereof along with the action taken/proposed to be taken by the Government against the people involved in such illicit activities; (g)  whether  there  is  any  mechanism  for  certification  of  Ayurvedic  medicines  to  ensure  their
- quality of manufacturing; and
- (h) if so, the details thereof and if not, the reasons therefor?

## ANSWER THE MINISTER OF AYUSH (SHRI SARBANANDA SONOWAL)

(a) to (c) Yes Sir. In the year 2021, Ministry of Ayush has implemented Central Sector Scheme AYUSH  Oushadhi  Gunvatta  Evam  Uttpadan  Samvardhan  Yojana  (AOGUSY).  The  total financial  allocation  to  this  scheme  is  Rs.  122.00  crores  for  five  years.  The  components  of AOGUSY scheme are as follows -

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.

Under  'Strengthening and up-gradation of  Ayush  Pharmacies  and Drug  Testing Laboratories to achieve higher standards' component of AOGUSY scheme, year-wise details of Grant in aid released to Ayush Pharmacies are as follows -

| Year                     | S.no.                    | Name of the Pharmacy                                                            | Amount released          |
|--------------------------|--------------------------|---------------------------------------------------------------------------------|--------------------------|
| 2022- 23                 | 1.                       | Inducare Pharma Pvt.Ltd., Pune                                                  | Rs.3,00,00,000 /-        |
| 2022- 23                 | 2.                       | Ayurchem Products, Maharashtra                                                  | Rs.2,69,00,000/-         |
| 2022- 23                 | 3.                       | Phytovedic India Pvt. Ltd., Maharashtra                                         | Rs.2,14,61,000/-         |
| 2022- 23                 | 4.                       | Visesh Ayurved Pvt. Ltd Pharmacy, Kerala.                                       | Rs.1,91,56,000/-         |
| 2022- 23                 | 5.                       | Amar Pharmaceuticals and labs (India) Pvt. Ltd., U.P                            | Rs.1,43,43,000 /-        |
| 2022- 23                 | 6.                       | Shree Baidyanath Ayurved Bhawan, Pvt. Ltd, Madhya Pradesh                       | Rs.2,08,92,000/-         |
| 2022- 23                 | 7.                       | Kollam District Ayurveda Oushada Nirmana Vyavasaya Co Operative Society, Kerela | Rs.64,29,000/-           |
| 2023- 24                 | 1.                       | Shree Baidyanath Ayurved Bhawan, Pvt. Ltd, Madhya Pradesh                       | Rs.91,08,000/-           |
| Total Rs. 14,82,89,000/- | Total Rs. 14,82,89,000/- | Total Rs. 14,82,89,000/-                                                        | Total Rs. 14,82,89,000/- |

Detailed guidelines of AOGUSY scheme are available at https://ayush.gov.in/images/Schemes/aoushdhi.pdf .

Further, the Central Sector Scheme of Ayush for Promotion of International Co-operation in  AYUSH  (IC  Scheme)  has  provision  to provide financial assistance to Ayush  drug manufacturers, entrepreneurs, Ayush institutions and Hospitals etc. for international propagation of Ayush by participating in international exhibitions, trade fairs, road shows etc. The financial assistance is limited up to maximum of 75% of the expenditure limited to maximum of Rs. 03.00 lakh (whichever is less) per industry/ institution, for Asian and African Countries; and up to Rs. 05.00 lakh per industry or 75% of the total expenditure, whichever is less, for Countries of North and South America, Europe and Australia and per industry/ institution. Applications/ proposals having prior approval of the Ministry of Ayush are considered for reimbursement on submission of expenditure details with proof of participation within 2 month of completion of the event.

To  encourage  AYUSH  Industry/Manufacturer  to  get  market  authorization  for  their product(s) for exports, the facility of reimbursement of expenditure is also extended, under the said IC scheme, for Preparation of product dossier (Excluding office expenses and administrative cost);  Fee  paid  to  the  concerned  regulatory  agency  for  registration/  market  authorization  of Ayush product as Medicine in the foreign country  etc. Reimbursement is  limited to  a  sum  of Rs.50 Lakhs or 75% of the actual total amount incurred on market authorization for one or more products; whichever is less.

(d) As prescribed in Drugs and Cosmetics Act 1940 and Rules made thereunder, enforcement of the  legal  provisions  pertaining  to  Quality  Control  and  issuance  of  drug  license  of  Ayurveda, Siddha,  Unani  and  Homoeopathy  drugs,  is  vested  with  the  State  Drug  Controllers/  State Licensing Authorities appointed by the concerned State/ Union Territory Government.

Pharmacopoeia  Commission  for  Indian  Medicine  and  Homoeopathy  (PCIM&H)  under Ministry of Ayush, lays down the Formulary specifications and Pharmacopoeial Standards for Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) drugs. The quality standards monographs published by PCIM&H are official as per the regulatory provisions of Drugs and Cosmetics Act, 1940 and Rules made thereunder for compliance by the Ayurvedic drug manufacturers.

Rule  160  A  to  J  of  the  Drugs  and  Cosmetics  Rules,  1945  provides  the  regulatory guidelines for approval of Drug Testing Laboratory for carrying out such tests of identity, purity, quality  and  strength  of  Ayurvedic,  Siddha  and  Unani  drugs  as  may  be  required  under  the provisions of these rules, on behalf of licensee for manufacture of Ayurvedic, Siddha and Unani drugs.  As  on  date,  35  State  Drug  Testing  Laboratories  have  been  supported  for  strengthening their infrastructural and functional capacity.  Further, 102 laboratories are approved or licensed under  the  provisions  of  Drugs  and  Cosmetics  Rules,  1945  for  quality  testing  of  Ayurvedic, Siddha and Unani drugs and raw materials.

(e) and (f) As per the information received from various States/UTs governments, the details  of any incidence of adulteration for profit along with the action taken/proposed to be taken by the Government against the people involved in such illicit activities are at Annexure-I .

(g)  and  (h)  As  prescribed  in  Drugs  and  Cosmetics  Act  1940  and  Rules  made  thereunder, enforcement of the legal provisions pertaining to Quality Control and issuance of drug license of Ayurveda, Siddha,  Unani and Homoeopathy 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. 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 of Drugs and Cosmetics Rules, 1945 and quality standards of drugs given in the respective pharmacopoeia.

In October 2009, Quality Control of India (QCI), at the behest of the then Department of AYUSH (Now Ministry of Ayush), launched a Voluntary Certification Scheme for Ayurvedic Products, which provides for testing for contaminants and compliance to standards prescribed in the  regulation  in  order  to  enhance  the  consumer  confidence  and  also  facilitate  exports.  The Scheme has  two  levels  -  Standard  Mark  based  on  the  compliance  to  the  domestic  regulatory requirements  and  the  other  being  AYUSH  Premium  Mark  based  on  the  World  Health Organisation-Good Manufacturing Practices (WHO-GMP) requirements and product requirements to certify against overseas regulations.

Central Drugs Standard Control Organization (CDSCO)  issues the Certificate of Pharmaceutical  Product  (COPP)  of  Ayurvedic  products  for  export  purpose  based  on  joint inspection by representatives from CDSCO, Ministry of Ayush and respective State Licensing Authority. Details are available at https://cdsco.gov.in/opencms/opencms/en/Aayush/ .

*******

State/  UT-wise  details  of  incidence  of  adulteration  for  profit  along  with  the  action taken/proposed to be taken by the Government against the people involved in such illicit activities are as follows -

|   S.no. | Name of the State/ UT   | Details of productivity of Ayurveda products                                                                                                                                                                                                                                                                                                                    | Details of productivity of Ayurveda products                                                                                                                                                                                                                                                                                                                    | Details of productivity of Ayurveda products                                                                                                                                                                                                                                                                                                                    | Details of productivity of Ayurveda products                                                                                                                                                                                                                                                                                                                    | Details of productivity of Ayurveda products                                                                                                                                                                                                                                                                                                                    |
|---------|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|       1 | Assam                   | 17 numbers of Ayurvedic medicines found to be of not of standard quality and Drug Inspector has initiated legal action against the manufacture.                                                                                                                                                                                                                 | 17 numbers of Ayurvedic medicines found to be of not of standard quality and Drug Inspector has initiated legal action against the manufacture.                                                                                                                                                                                                                 | 17 numbers of Ayurvedic medicines found to be of not of standard quality and Drug Inspector has initiated legal action against the manufacture.                                                                                                                                                                                                                 | 17 numbers of Ayurvedic medicines found to be of not of standard quality and Drug Inspector has initiated legal action against the manufacture.                                                                                                                                                                                                                 | 17 numbers of Ayurvedic medicines found to be of not of standard quality and Drug Inspector has initiated legal action against the manufacture.                                                                                                                                                                                                                 |
|       2 | Maharashtra             | Routine inspections are done and samples are drawn for testing. If it is found to be Not of Standard quality due to various reasons. The action is taken as per provisions of Drugs & Cosmetics Act, 1940 and Rules thereunder. Details of Ayurvedic Samples drawn from Maharashtra state (information taken from fdamfg.maharashtra.in) -                      | Routine inspections are done and samples are drawn for testing. If it is found to be Not of Standard quality due to various reasons. The action is taken as per provisions of Drugs & Cosmetics Act, 1940 and Rules thereunder. Details of Ayurvedic Samples drawn from Maharashtra state (information taken from fdamfg.maharashtra.in) -                      | Routine inspections are done and samples are drawn for testing. If it is found to be Not of Standard quality due to various reasons. The action is taken as per provisions of Drugs & Cosmetics Act, 1940 and Rules thereunder. Details of Ayurvedic Samples drawn from Maharashtra state (information taken from fdamfg.maharashtra.in) -                      | Routine inspections are done and samples are drawn for testing. If it is found to be Not of Standard quality due to various reasons. The action is taken as per provisions of Drugs & Cosmetics Act, 1940 and Rules thereunder. Details of Ayurvedic Samples drawn from Maharashtra state (information taken from fdamfg.maharashtra.in) -                      | Routine inspections are done and samples are drawn for testing. If it is found to be Not of Standard quality due to various reasons. The action is taken as per provisions of Drugs & Cosmetics Act, 1940 and Rules thereunder. Details of Ayurvedic Samples drawn from Maharashtra state (information taken from fdamfg.maharashtra.in) -                      |
|       2 | Maharashtra             | Time period                                                                                                                                                                                                                                                                                                                                                     | Ayurvedic Samples collected                                                                                                                                                                                                                                                                                                                                     | Ayurvedic samples tested                                                                                                                                                                                                                                                                                                                                        | No. of samples declared NSQ                                                                                                                                                                                                                                                                                                                                     | No. of consent for prosecution issued                                                                                                                                                                                                                                                                                                                           |
|       2 | Maharashtra             | 01.04.2022 to 31.03.2023                                                                                                                                                                                                                                                                                                                                        | 833                                                                                                                                                                                                                                                                                                                                                             | 526                                                                                                                                                                                                                                                                                                                                                             | 17                                                                                                                                                                                                                                                                                                                                                              | 12                                                                                                                                                                                                                                                                                                                                                              |
|       2 | Maharashtra             | 01.04.2023 to 31.10.2023                                                                                                                                                                                                                                                                                                                                        | 360                                                                                                                                                                                                                                                                                                                                                             | 282                                                                                                                                                                                                                                                                                                                                                             | 01                                                                                                                                                                                                                                                                                                                                                              | NIL                                                                                                                                                                                                                                                                                                                                                             |
|       3 | Gujarat                 | In 2019, the court of law had given punishment till rising of the court and fine of Rs. 20,000/- for an Ayurveda product manufactured without license. In 2020, product permission of 02 Ayurveda products has been cancelled. In 2022, 02 Ayurveda products are under investigation and court case C.C. no. 2054/22 for 01 Ayurveda product has been launched. | In 2019, the court of law had given punishment till rising of the court and fine of Rs. 20,000/- for an Ayurveda product manufactured without license. In 2020, product permission of 02 Ayurveda products has been cancelled. In 2022, 02 Ayurveda products are under investigation and court case C.C. no. 2054/22 for 01 Ayurveda product has been launched. | In 2019, the court of law had given punishment till rising of the court and fine of Rs. 20,000/- for an Ayurveda product manufactured without license. In 2020, product permission of 02 Ayurveda products has been cancelled. In 2022, 02 Ayurveda products are under investigation and court case C.C. no. 2054/22 for 01 Ayurveda product has been launched. | In 2019, the court of law had given punishment till rising of the court and fine of Rs. 20,000/- for an Ayurveda product manufactured without license. In 2020, product permission of 02 Ayurveda products has been cancelled. In 2022, 02 Ayurveda products are under investigation and court case C.C. no. 2054/22 for 01 Ayurveda product has been launched. | In 2019, the court of law had given punishment till rising of the court and fine of Rs. 20,000/- for an Ayurveda product manufactured without license. In 2020, product permission of 02 Ayurveda products has been cancelled. In 2022, 02 Ayurveda products are under investigation and court case C.C. no. 2054/22 for 01 Ayurveda product has been launched. |
|       4 | Arunachal               | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             |
|       5 | Goa                     | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             |
|       6 | Odisha                  | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             |
|       7 | West Bengal             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             |
|       8 | Puducherry              | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             |
|       9 | Kerala                  | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             |
|      10 | Karnataka               | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             |
|      11 | Haryana                 | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             |
|      12 | Uttarakhand             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             |
|      13 | Andaman & Nicobar       | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             |
|      14 | Andhra Pradesh          | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             |
|      15 | Delhi                   | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             | NIL                                                                                                                                                                                                                                                                                                                                                             |