Lok Sabha Question No. 2104 (UNSTARRED), answered on 2021-12-10
Subject: Safety and Quality of AYUSH Medicines
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Naranbhai Bhikhabhai Kachhadiya, Parbatbhai Savabhai Patel

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO-2104 TO BE ANSWERED ON 10 TH  DECEMBER, 2021

## SAFETY AND QUALITY OF AYUSH MEDICINES

## 2104.  SHRI NARANBHAI KACHHADIYA: SHRI PARBATBHAI SAVABHAI PATEL:

Will the Minister of AYUSH be pleased to state:

- (a) the efforts being made by the Ministry to win the trust of the global community about the safety and quality of Ayurveda, Unani and Homeopathy medicines;
- (b)  the  roadmap  prepared/being  prepared  by  the  Ministry  to  increase  the  productivity  of Ayurveda and other Indian medicine products and herbs in every State in the country;
- (c) the details of the productivity of the said medicines, State-wise including Gujarat; and
- (d) the name of States which have high productivity of the said medicines and the States which have low productivity?

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

(a)  to  (d)  As  per  the  provisions  of  Drugs  and  Cosmetics  Rules,  1945,  the  manufacture  of Ayurvedic (Including  Siddha)  or  Unanidrugs  are  to  be  carried  out  in  such  premises  and  such hygienic  conditions  as  are  specified  in  Schedule-T  (Good  Manufacturing  Practices)  and homoeopathy manufacturers are required to comply with the provisions of Schedule M1(Good Manufacturing Practices). It is mandatory for the manufacturers to comply with this for obtaining license of Ayurveda, Siddha andUnani (ASU) and Homoeopathy drug manufacturing.

For Standardization of Indian medicines and Homoeopathy in the country, the Government has established  Pharmacopoeia  Commission  for  Indian  Medicine  and  Homoeopathy  (PCIM&H) under the Ministry of AYUSH.The prime mandate of the Commission is to publish and revise Ayurvedic  Pharmacopoeia  of  India  (API),  Siddha  Pharmacopoeia  of  India  (SPI),  Unani Pharmacopoeia of India (UPI) and Homoeopathic  Pharmacopoeia of India (HPI). The Pharmacopoeial  standards  are  basic  need  to  ensure  quality,  safety  and  efficacy  of  Ayurvedic, Siddha, Unani and Homoeopathic medicines.

Ministry  of  AYUSH  is  implementing  a  Central  Sector  Scheme  of  Pharmacovigilance  of Ayurveda,  Siddha  Unani&  Homeopathy  Drugs  since  June  2018  for  inculcating  the  culture  of Adverse Drug Events (ADE) reporting, documentation and analysis for further regulatory action. The Scheme has an established three tier network. All India Institute of Ayurveda (AIIA), New Delhi has been designated as the National Pharmacovigilance Coordination Centre (NPvCC), 5 Intermediary  PharmacovigilanceCentres  (IPvC's)  and  74  Peripheral  PharmacovigilanceCentres (PPvC's).

In  addition  to  the  above,  for  facilitating  export,  Ministry  of  AYUSH  encourages  following certifications of AYUSH products as per details below:-

(i)  Certification  of  Pharmaceutical Products (CoPP) as per WHO Guidelines for herbal products.

(ii) 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.

The  licence  of  Ayush  products  are  granted  by  the  concerned  State  Licensing  Authorities  in accordance with the provisions of Drugs and Cosmetics Act, 1940 and Rules made thereunder. There  are  about    7345  (Ayurveda),  151  (Siddha),  566  (Unani)  and  345  (Homoeopathy) manufacturers producing Ayush products ( State-wise list is at Annexure ).

## Annexure

## State-wise/System-wise number of Licensed Pharmacies under AYUSH as on 01-04-2019

| S.No.   | State / UT        | Ayurveda   | Unani   | Siddha   | Homoeopathy   | Total   |
|---------|-------------------|------------|---------|----------|---------------|---------|
| (1)     | (2)               | (3)        | (4)     | (5)      | (6)           | (7)     |
| 1       | Andhra Pradesh    | 288        | 9       | 0        | 7             | 304     |
| 2       | Arunachal Pradesh | 1          | 0       | 0        | 0             | 1       |
| 3       | Assam             | 40         | 0       | 0        | 0             | 40      |
| 4       | Bihar             | 191        | 23      | 0        | 38            | 252     |
| 5       | Chhattisgarh      | 32         | 0       | 0        | 0             | 32      |
| 6       | Delhi             | 83         | 20      | 0        | 0             | 103     |
| 7       | Goa               | 6          | 0       | 0        | 0             | 6       |
| 8       | Gujarat           | 578        | 0       | 0        | 9             | 587     |
| 9       | Haryana           | 514        | 4       | 0        | 0             | 518     |
| 10      | Himachal Pradesh  | 132        | 0       | 0        | 6             | 138     |
| 11      | Jammu &Kashmir    | 8          | 5       | 0        | 2             | 15      |
| 12      | Jharkhand         | 19         | 0       | 0        | 8             | 27      |
| 13      | Karnataka         | 210        | 0       | 0        | 12            | 222     |
| 14      | Kerala            | 897        | 4       | 4        | 0             | 905     |
| 15      | Madhya Pradesh    | 555        | 8       | 0        | 21            | 584     |
| 16      | Maharashtra       | 725        | 0       | 0        | 0             | 725     |
| 17      | Manipur           | 0          | 0       | 0        | 0             | 0       |
| 18      | Meghalaya         | 0          | 0       | 0        | 0             | 0       |
| 19      | Mizoram           | 0          | 0       | 0        | 0             | 0       |
| 20      | Nagaland          | 0          | 0       | 0        | 0             | 0       |
| 21      | Odisha            | 85         | 0       | 0        | 5             | 90      |
| 22      | Punjab            | 232        | 0       | 0        | 0             | 232     |
| 23      | Rajasthan         | 349        | 1       | 0        | 0             | 350     |
| 24      | Sikkim            | 2          | 0       | 0        | 1             | 3       |
| 25      | Tamil Nadu        | 152        | 5       | 139      | 9             | 305     |
| 26      | Telangana         | 429        | 173     | 0        | 32            | 634     |
| 27      | Tripura           | 0          | 0       | 0        | 0             | 0       |
| 28      | Uttar Pradesh     | 1416       | 309     | 0        | 30            | 1755    |
| 29      | Uttarakhand       | 196        | 0       | 0        | 0             | 196     |
| 30      | WestBengal        | 160        | 5       | 0        | 160           | 325     |
| 31      | A&NIsland         | 0          | 0       | 0        | 0             | 0       |
| 32      | Chandigarh        | 1          | 0       | 0        | 0             | 1       |
| 33      | D&NHaveli         | 7          | 0       | 0        | 0             | 7       |
| 34      | Daman&Diu         | 10         | 0       | 0        | 0             | 10      |
| 35      | Lakshadweep       | 0          | 0       | 0        | 0             | 0       |
| 36      | Puducherry        | 27         | 0       | 8        | 5             | 40      |
|         | TOTAL             | 7345       | 566     | 151      | 345           | 8407    |