Lok Sabha Question No. 3247 (UNSTARRED), answered on 2022-08-05
Subject: Pharmacopoeia Commission for Indian Medicine
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Raja Amareshwara Naik, Sukanta Majumdar, Bhola Singh, Rajveer (Raju Bhaiya) Singh, Vinod Kumar Sonkar, Sangeeta Kumari Singh Deo

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO. 3247 TO BE ANSWERED ON 05 TH  AUGUST, 2022

## 'PHARMACOPOEIA COMMISSION FOR INDIAN MEDICINE'

## 3247. SHRI RAJA AMARESHWARA NAIK:

DR. SUKANTA MAJUMDAR:

SHRI BHOLA SINGH:

SHRI RANVEER SINGH (RAJU BHAIYA):

SHRI VINOD KUMAR SONKAR:

SHRIMATI SANGEETA KUMARI SINGH DEO:

Will the Minister of AYUSH be pleased to state:

- a) Whether  the  Government  has  established  Pharmacopoeia  Commission  for  Indian  Medicine and  Homoeopathy  to  publish  and  revise  Pharmacopoeia  standards  which  are  basic  need  to ensure quality, safety and efficacy of Ayush medicines in the country, if so, the progress made thereon so far;
- b) the Number of monographs of single drugs and compound formulations published during the last five years, year-wise;
- c) the Number of Ayurvedic companies functional and established across the country during the last five years; year-wise and state wise;
- d) Whether there is any mechanism to control and monitor the quality of Ayurvedic medicines and formulations in the country, if so, the details thereof;
- e) Whether  several  complaints  have  been  received  regarding  production/sale  of  sub-standard Ayurvedic medicines/formulations in the country, if so, the action taken thereon; and
- f) The  proposed  corrective  steps  to  be  implemented  for  the  betterment  of  the  Ayurvedic medicine industry?

## ANSWER THE MINISTER OF AYUSH

## (SHRI SARBANANDA SONOWAL)

(a): Yes,  Sir.      The  Government  of  India  has  established  Pharmacopoeia  Commission  for Indian Medicine & Homoeopathy (PCIM&H), as a subordinate office under Ministry of Ayush by merging Pharmacopoeia Commission of Indian Medicine & Homoeopathy (PCIM&H) and the  two  central  laboratories  namely  Pharmacopoeia  Laboratory  for  Indian  Medicine  (PLIM), Ghaziabad  and  Homoeopathic  Pharmacopoeia  Laboratory  (HPL)  vide  gazette  dated  6th  July, 2020).

The Commission is engaged in development of Pharmacopoial Standards for Ayurvedic, Unani, Siddha & Homoeopathic drugs.  Further, PCIM&H is also acting as Central Drug Testing cum Appellate Laboratory for Indian systems of Medicine & Homoeopathy.

After re-establishment, a total of 1483 samples of ASU&H drugs have been tested during 6 th July,  2020  to  till  date  and  03  Pharmacopoeial  monographs  along  with    their  formulary specifications  for  AYUSH  Kwath  related  formulation  has  been  published.    Apart  from Pharmacopoeial  Monographs,  National  Formulary  for  Unani  Medicines,  Part-IV  (2 nd Edition) comprising formulary specifications of 166 formulations have also be published.

(b): 50 monographs of single drugs of Ayurveda along with 51 monographs of formulation of Ayurvedic  drugs,  1  monograph  of  formulation  of  Siddha  drug  and  101  monographs  of formulation of Unani drugs have been published during the last five years .  The details may be seen at Annexure-I.

However, since inception of PLIM & HPL (now PCIM&H w.e.f. 6 th July 2020), a total number of 2199 quality standards on raw materials (Single Drugs of plant/animal/mineral/metal/ Chemical  origin)  used  in  ASU&H  systems  of  medicines  have  been    published  in  various Pharmacopoeias  and  also  405  quality  standards  of  ASU  formulations  also  been  published  in respective pharmacopoeias.

(c): The  number  of  Ayurvedic  companies  functional  and  established  across  the  country during the last five years, year-wise and State wise may be seen at Annxure-II.

(d):  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, 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.

(e)  :  As  prescribed  in  Drugs  and  Cosmetics  Act  1940  and  Rules  1945  made  there  under, enforcement of the legal provisions pertaining to Quality Control and issuance of drug license of Ayurveda, Siddha, Unani, is vested with the State drug Controllers/ State Licensing Authorities appointed by the concerned State/ Union Territory Government. As per the information received from States/ UTs, action taken by  State drug Controllers/ State Licensing Authorities regarding production/sale of sub-standard Ayurvedic medicines/formulations  is as follows -

|   S. no. | Name of the State/UTs   | Action taken                                                                                   |
|----------|-------------------------|------------------------------------------------------------------------------------------------|
|        1 | Tamil Nadu              | 92 license suspended/ cancelled since 2017 to 2021                                             |
|        2 | Odisha                  | 13 license of cancelled since 2017-18 to 2022-23                                               |
|        3 | Maharashtra             | Since 2016-17 to 2022, 84 prosecution orders issued, 38 prosecutions filed and 46 are pending. |

(f): 1. This Ministry has issued Gazette notification no. G.S.R 716 E for Amendment in the Drugs Rules,  1945  related  to  licensing  process  of  ASU  drugs  on  01.10.2021.  The  amendments  have been done with a view to reduce the compliance burden and facilitate ease of doing business. The process to grant license to manufacture Ayurveda, Siddha and Unani (ASU) drugs has been made swift, paperless and more  transparent the license application system through online eaushadhi.gov.in  portal.  The  license  of  the  ASU  drugs  have  been  made  perpetual  i.e.  with  one time registration fee the license of the product will be valid lifetime with no further retention or renewal fees thereafter. The maximum time in granting the license to manufacture ASU drugs has been reduced from three months to two months.

(2.)  In  addition  to  the  above,  for  facilitating  exports,  Ministry  of  Ayush  encourages  following certifications of AYUSH products as per details below:-

- Certification  of  Pharmaceutical  Products  (CoPP)  as  per  WHO  Guidelines  for  herbal products.
- Quality  Certifications  Scheme  implemented  by  the  Quality  Council  of  India  (QCI)  for grant of AYUSH Premium mark to Ayurvedic, Siddha and Unani products on the basis of third party evaluation of quality in accordance with the status of compliance to international standards.
- (3.)  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. Pharmaco vigilance 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.

******

## The number of monographs of single drugs and compound formulations published during the last five years, year-wise (2017 to 2022)

|   Sl.No. | System of Medicine   | Single drugs and compound formulations published                                                  | Year of Publication   | Number of Monographs   |
|----------|----------------------|---------------------------------------------------------------------------------------------------|-----------------------|------------------------|
|        1 | Ayurveda             | Ayurveda                                                                                          | Ayurveda              | Ayurveda               |
|        1 | Single Drugs         | Ayurvedic Pharmacopoeia of India Part I (Single Drugs), Vol. IX (Hydro-alcoholic &Water extracts) | 2017                  | 50                     |
|        1 | Formulation          | Ayurvedic Pharmacopoeia of India, Part II (Formulations), Vol. IV                                 | 2017                  | 50                     |
|        1 | Formulation          | Pharmacopoeial Monograph of AyushKvātha Cūrṇa(Stand- alone)                                       | 2021                  | 01                     |
|        2 | Siddha               | Siddha                                                                                            | Siddha                | Siddha                 |
|        2 | Single Drugs         |                                                                                                   | Nil                   |                        |
|        2 | Formulation          | Pharmacopoeial Monograph of AyushKuṭinīrCūraṇam (Stand-alone)                                     | 2021                  | 01                     |
|        3 | Unani*               | Unani*                                                                                            | Unani*                | Unani*                 |
|        3 | Single Drugs         | Nil                                                                                               |                       |                        |
|        3 | Formulation          | Unani Pharmacopoeia of India, Part II (Formulations), Vol. III,                                   | 2017                  | 50                     |
|        3 | Formulation          | Unani Pharmacopoeia of India, Part II (Formulations), Vol. IV                                     | 2019                  | 50                     |
|        3 | Formulation          | Pharmacopoeial Monograph of AyushSafūf-i-Joshānda (Stand-alone)                                   | 2021                  | 01                     |
|        4 | Homoeopathy          | Homoeopathy                                                                                       | Homoeopathy           | Homoeopathy            |
|        4 | Single Drugs         | Nil                                                                                               | Nil                   | Nil                    |
|        4 | Formulation          |                                                                                                   |                       |                        |

## Number of Ayurvedic companies functional and established across the country during the last five years; state wise

| S.no.   | Name of the   | State/UT                                                                                                                      | Year wise (for last five years)                                                                                               | Year wise (for last five years)                                                                                               | Year wise (for last five years)                                                                                               | Year wise (for last five years)                                                                                               | Year wise (for last five years)                                                                                               | Year wise (for last five years)                                                                                               |
|---------|---------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
|         |               |                                                                                                                               | 2017                                                                                                                          | 2018                                                                                                                          | 2019                                                                                                                          | 2020                                                                                                                          | 2021                                                                                                                          | 2022                                                                                                                          |
| 1.      | Karnataka     | Karnataka                                                                                                                     | -                                                                                                                             | 16                                                                                                                            | 15                                                                                                                            | 23                                                                                                                            | 13                                                                                                                            | 11                                                                                                                            |
| 2.      | Punjab        | Punjab                                                                                                                        | -                                                                                                                             | 20                                                                                                                            | 18                                                                                                                            | 26                                                                                                                            | 34                                                                                                                            | 48                                                                                                                            |
| 3.      | Manipur       | Manipur                                                                                                                       | -                                                                                                                             | -                                                                                                                             | -                                                                                                                             | -                                                                                                                             | -                                                                                                                             | -                                                                                                                             |
| 4.      | Tripura       | Tripura                                                                                                                       | -                                                                                                                             | -                                                                                                                             | -                                                                                                                             | -                                                                                                                             | -                                                                                                                             | -                                                                                                                             |
| 5.      | Mizoram       | Mizoram                                                                                                                       | -                                                                                                                             | -                                                                                                                             | -                                                                                                                             | -                                                                                                                             | -                                                                                                                             | -                                                                                                                             |
| 6.      | Lakshadweep   | Lakshadweep                                                                                                                   | -                                                                                                                             | -                                                                                                                             | -                                                                                                                             | -                                                                                                                             | -                                                                                                                             | -                                                                                                                             |
| 7.      | Tamil Nadu    | Tamil Nadu                                                                                                                    | 07                                                                                                                            | 11                                                                                                                            | 07                                                                                                                            | 08                                                                                                                            | 14                                                                                                                            | -                                                                                                                             |
| 8.      | Delhi         | Delhi                                                                                                                         | 83                                                                                                                            | 82                                                                                                                            | 90                                                                                                                            | 85                                                                                                                            | 83                                                                                                                            | -                                                                                                                             |
| 9.      | Odisha        | No. of existing units as on 01 st April of the year                                                                           | 79                                                                                                                            | 84                                                                                                                            | 85                                                                                                                            | 87                                                                                                                            | 90                                                                                                                            | 96                                                                                                                            |
| 9.      | Odisha        | No. of new added                                                                                                              | 06                                                                                                                            | 05                                                                                                                            | 06                                                                                                                            | 04                                                                                                                            | 07                                                                                                                            | 05                                                                                                                            |
| 9.      | Odisha        | No. of unit license cancelled                                                                                                 | 01                                                                                                                            | 04                                                                                                                            | 04                                                                                                                            | 01                                                                                                                            | 01                                                                                                                            | 02                                                                                                                            |
| 10.     | Goa           | No. of own Ayurvedic companies established                                                                                    | NIL                                                                                                                           | 01                                                                                                                            | 02                                                                                                                            | NIL                                                                                                                           | NIL                                                                                                                           | NIL                                                                                                                           |
| 10.     | Goa           | No. of loan Ayurvedic companies established                                                                                   | NIL                                                                                                                           | 02                                                                                                                            | 01                                                                                                                            | 01                                                                                                                            | NIL                                                                                                                           | NIL                                                                                                                           |
| 10.     | No.           | of own Ayurvedic companies functional in Goa is 09 and loan Ayurvedic companies functional in Goa is 05                       | of own Ayurvedic companies functional in Goa is 09 and loan Ayurvedic companies functional in Goa is 05                       | of own Ayurvedic companies functional in Goa is 09 and loan Ayurvedic companies functional in Goa is 05                       | of own Ayurvedic companies functional in Goa is 09 and loan Ayurvedic companies functional in Goa is 05                       | of own Ayurvedic companies functional in Goa is 09 and loan Ayurvedic companies functional in Goa is 05                       | of own Ayurvedic companies functional in Goa is 09 and loan Ayurvedic companies functional in Goa is 05                       | of own Ayurvedic companies functional in Goa is 09 and loan Ayurvedic companies functional in Goa is 05                       |
| 11.     | West Bengal   | No. of newly established firms                                                                                                | -                                                                                                                             | -                                                                                                                             | 13                                                                                                                            | 18                                                                                                                            | 18                                                                                                                            | 09                                                                                                                            |
| 12.     | Chhattisgarh  | No. of newly established firms                                                                                                | 03                                                                                                                            | 01                                                                                                                            | 03                                                                                                                            | 00                                                                                                                            | 05                                                                                                                            | -                                                                                                                             |
| 13.     | Uttarakhand   | Companies established                                                                                                         | -                                                                                                                             | 07                                                                                                                            | 09                                                                                                                            | 29                                                                                                                            | 12                                                                                                                            | 02                                                                                                                            |
| 13.     | Uttarakhand   | At present total 320 (223 units and 97 lone licensee) companies are registered for manufacturing of Ayurvedic &Unani medicine | At present total 320 (223 units and 97 lone licensee) companies are registered for manufacturing of Ayurvedic &Unani medicine | At present total 320 (223 units and 97 lone licensee) companies are registered for manufacturing of Ayurvedic &Unani medicine | At present total 320 (223 units and 97 lone licensee) companies are registered for manufacturing of Ayurvedic &Unani medicine | At present total 320 (223 units and 97 lone licensee) companies are registered for manufacturing of Ayurvedic &Unani medicine | At present total 320 (223 units and 97 lone licensee) companies are registered for manufacturing of Ayurvedic &Unani medicine | At present total 320 (223 units and 97 lone licensee) companies are registered for manufacturing of Ayurvedic &Unani medicine |
| 14.     | Himachal      | License issued                                                                                                                | 10                                                                                                                            | 12                                                                                                                            | 03                                                                                                                            | 12                                                                                                                            | 11                                                                                                                            | -                                                                                                                             |
| 14.     | Pradesh       | Total number of Ayurvedic companies functional - 159                                                                          | Total number of Ayurvedic companies functional - 159                                                                          | Total number of Ayurvedic companies functional - 159                                                                          | Total number of Ayurvedic companies functional - 159                                                                          | Total number of Ayurvedic companies functional - 159                                                                          | Total number of Ayurvedic companies functional - 159                                                                          | Total number of Ayurvedic companies functional - 159                                                                          |
| 15.     | Kerala        | Functional firm                                                                                                               | 715                                                                                                                           | 718                                                                                                                           | 692                                                                                                                           | 698                                                                                                                           | 641                                                                                                                           | -                                                                                                                             |
| 15.     | Kerala        | Fresh license issued                                                                                                          | 38                                                                                                                            | 48                                                                                                                            | 65                                                                                                                            | 52                                                                                                                            | 54                                                                                                                            | -                                                                                                                             |
| 16.     | Maharashtra   | Functional                                                                                                                    | 440                                                                                                                           | 460                                                                                                                           | 458                                                                                                                           | 477                                                                                                                           | 495                                                                                                                           | 482 (as on 31 st July,20 22)                                                                                                  |
| 16.     | Maharashtra   | New established                                                                                                               | 28                                                                                                                            | 31                                                                                                                            | 14                                                                                                                            | 31                                                                                                                            | 33                                                                                                                            | 13                                                                                                                            |
| 17.     | Puducherry    | Total 42 Ayurvedic companies as of year 2022                                                                                  | Total 42 Ayurvedic companies as of year 2022                                                                                  | Total 42 Ayurvedic companies as of year 2022                                                                                  | Total 42 Ayurvedic companies as of year 2022                                                                                  | Total 42 Ayurvedic companies as of year 2022                                                                                  | Total 42 Ayurvedic companies as of year 2022                                                                                  | Total 42 Ayurvedic companies as of year 2022                                                                                  |
| 18.     | Chandigarh    | One pharmaceutical company Wahe Products was functional last year. Now,                                                       | One pharmaceutical company Wahe Products was functional last year. Now,                                                       | One pharmaceutical company Wahe Products was functional last year. Now,                                                       | One pharmaceutical company Wahe Products was functional last year. Now,                                                       | One pharmaceutical company Wahe Products was functional last year. Now,                                                       | One pharmaceutical company Wahe Products was functional last year. Now,                                                       | One pharmaceutical company Wahe Products was functional last year. Now,                                                       |