Lok Sabha Question No. 4250 (UNSTARRED), answered on 2019-12-13
Subject: Patent Rights of AYUSH Products
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Sisir Kumar Adhikari

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

LOK  SABHA UNSTARRED  QUESTION NO. 4250 TO BE ANSWERED ON 13 TH DECEMBER, 2019

## PATENT RIGHTS OF AYU SH PRODUCTS

## 4250. SHRI SISIR KUMAR ADHIKARI:

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

- (a) whether the Government has any mechanism in place for regular monitoring on safety, rights and well being of the products of AYUSH;
- (b)if so, the details thereof and whether the international standards and the patent for maintained by the domestic units; and
- (c) the details of products with patent rights and the manufacturing units, State/ UT - wise?

## ANSWER

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

(a)to (c):   Ayurvedic, Siddha and Unani (ASU) drugs are regulated under the provision Drugs & Cosmetics Act, 1940 and Rules, 1945. License for manufacturing for sale of these d is  granted  and  renewed  by  the  respective  Licensing  Authorities  appointed  by  the Governments. State Licensing Authorities oversee the enforcement of the legal prov isions for ASU drugs and are empowered to take action in case of any violation or contravention o provisions  for  licensed  manufacturing  and  quality  of  drugs.  Rule  158 -B  of  the  Drugs  and Cosmetics Rules, 1945 provides the requirement of proof of safety and effectiveness including data of clinical studies for grant of license for manufacturing of various types of ASU Voluntary certification scheme in accordance with international standards for ASU produ administered by Drugs Controller Ge neral on the basis of WHO - GMP Guidelines and to grant AYUSH  Premium  mark  by  Quality  Council  of  India.    Drugs  &  Cosmetics  Act,  1940  has provisions for Patent or Proprietary ASU medicines and the licenses for such products hav granted  to  the  drug  manuf acturers  in  the  country.    However,  Ayurvedic  medicines  and  other traditional medicines are not patentable in accordance with the provisions of Section 3 ( Indian Patents Act, which provides that, an invention, which in effect is based on tr al knowledge or which is an aggregation or duplication of known properties of traditionally component  or  components,  is  not  an  invention  for  the  purpose  of  the  Patents  Act.  Howe patents can be granted for an invention relating to new formulations based on herbal and plant -related products or processes, which fulfill the criteria of patentability under the PatentsAct.

Department  for  Promotion  of  Industry  and  Internal  Trade  under  Ministry  of  Commerce  an Industry  has  informed  that  201  patents  have  been  granted  by  Controller  General  of  Pa Designs  &  Trade  (CGPDTM),  Govt.  of  India  for  inventions  related  to  herbal  medi cinal products/processes/formulations  during  the  period  from  01.01.2005  to  31.01.2019. Central Council for Research in Ayurvedic Sciences (CCRAS) has obtained patents on 17 Ayurvedi drugs and filed patent applications for 19 new Ayurvedic drugs. Similarl y, Central Council for Research in Unani Medicine (CCRUM) has obtained patents for 17 Unani drugs and Central Council  for  Research  in  Siddha  (CCRS)  has  filled  patent  applications  for  05  Siddha  d State/UT wise number of licensed AYUSH drug manufacturin g n ts is given in the annexure.

Annexure State wise number of Licensed Pharmacies under AYUSH as on 1-4-2018

| S.No.   | State / UT        |   Ayurveda |   Unani |   Siddha |   Homoeopathy |   Total |
|---------|-------------------|------------|---------|----------|---------------|---------|
| 1       | 2                 |          3 |       4 |        5 |             6 |       7 |
| 1       | Andhra Pradesh    |        298 |      16 |        0 |            12 |     326 |
| 2       | Arunachal Pradesh |          1 |       0 |        0 |             0 |       1 |
| 3       | Assam             |         43 |       0 |        0 |             0 |      43 |
| 4       | Bihar             |        216 |      22 |        0 |            48 |     286 |
| 5       | Chhattisgarh      |         31 |       0 |        0 |             0 |      31 |
| 6       | Delhi             |         83 |      25 |        0 |             0 |     108 |
| 7       | Goa               |          6 |       0 |        0 |             0 |       6 |
| 8       | Gujarat           |        563 |       0 |        0 |             8 |     571 |
| 9       | Haryana           |        458 |       0 |        0 |             0 |     458 |
| 10      | Himachal Pradesh  |        159 |       0 |        0 |             8 |     167 |
| 11      | Jammu &Kashmir    |         20 |       3 |        0 |             3 |      26 |
| 12      | Jharkhand         |         30 |       0 |        0 |             7 |      37 |
| 13      | Karnataka         |        248 |       0 |        0 |            11 |     259 |
| 14      | Kerala            |        766 |       4 |        3 |             0 |     773 |
| 15      | Madhya Pradesh    |        684 |       5 |        0 |            18 |     707 |
| 16      | Maharashtra       |        782 |      13 |        0 |            39 |     834 |
| 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            |         84 |       0 |        0 |             5 |      89 |
| 22      | Punjab            |        277 |       0 |        0 |             0 |     277 |
| 23      | Rajasthan         |        337 |       0 |        0 |             0 |     377 |
| 24      | Sikkim            |          2 |       0 |        0 |             0 |       2 |
| 25      | Tamil Nadu        |        152 |      60 |      205 |             9 |     426 |
| 26      | Telangana         |        425 |     178 |        0 |            34 |     637 |
| 27      | Tripura           |          0 |       0 |        0 |             0 |       0 |
| 28      | Uttar Pradesh     |       1576 |     292 |        0 |            30 |    1898 |
| 29      | Uttarakhand       |        281 |       2 |        0 |             0 |     283 |
| 30      | West Bengal       |        151 |       5 |        0 |           160 |     316 |
| 31      | A&N Island        |          0 |       0 |        0 |             0 |       0 |
| 32      | Chandigarh        |          1 |       0 |        0 |             0 |       1 |
| 33      | D&N Haveli        |          7 |       0 |        0 |             0 |       7 |
| 34      | Daman&Diu         |          9 |       0 |        0 |             0 |       9 |
| 35      | Lakshdweep        |          0 |       0 |        0 |             0 |       0 |
| 36      | Puduchery         |         28 |       0 |        6 |             5 |      39 |
|         | Total             |       7718 |     625 |      214 |           397 |    8954 |