Lok Sabha Question No. 4810 (UNSTARRED), answered on 2018-03-23
Subject: Quality of Medicines
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: TAMRADHWAJ SAHU, K. C. VENUGOPAL

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

## LOK  SABHA UNSTARRED  QUESTION NO. 4810 TO BE ANSWERED ON 23 RD MARCH, 2018

## QUALITY OF MEDICINES

## 4810. SHRI TAMRADHWAJ SAHU: SHRI K.C. VENUGOPAL:

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

- (a)  the  details  of  the  activities  being  carried  out  by  the  Government  for  promoti development of Ayurveda, Yoga, Na thuropathy, Unani, Siddha and Homoeopathy systems of medicines in the country;
- (b) the details of the funds earmarked and allocated for the said purpose during each of three years and the current year, State/UT - wise;
- (c) whether the Government proposes to set up a Central Drug Controller's Office for AYUSH to strengthen regulatory measures to ensure safety and quality of AYUSH medicines and if so details thereof;
- (d) whether 36 samples out of 330 samples which were tested during the last three years have been failed and if so, the details thereof and the action taken by the Government agai defaulter companies; and
- (e) the other measures being taken by the Government for safety, quality and standardisa AYUSH medicines in the country?

## ANSWER

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

- (a) : To promote and develop AYUSH systems of medicines in the country, the activitie undertaken by the Government are detailed as under:

t

- (i )  Implementation of  National AYUSH Mission (NAM)  which envisages better access to AYUSH services, strengthening of AYUSH educational institutions, facilitate enforcement of quality control of Ayurveda, Siddha and Unani & Homoeopathy (ASU &H) drugs  an d  sustainable  availability  of  ASU  &  H  raw - materials  by  promotion  of  medicinal plants cultivation in the States/UTs;
- (ii)  Promotion  of  quality  standards  of  ASU&H  drugs  to  promote  safe  use  of  AYUSH medicines;
- (iii)  Organization  of  Arogya  fairs  /  melas,  confe rence,  exhibitions,  seminars,  workshops, symposium and  also publicity through  electronic multimedia, print media campaigning awareness amongst the citizens all over the country;
- (iv) Providing of financial assistance to the various research organizatio ns for conducting the research in AYUSH system of Medicine;
- (v) Celebration of each stream of AYUSH on a specified date, viz. Ayurveda day,  Yoga Unani day, Siddha day and Homoeopathy day;
- (vi) Establishment of National level Institutes under dif ferent systems of AYUSH in different parts of the country.
- (b) : The funds allocated for the different activities for promotion and development of AY system are done through both Central Sector and Central sponsored schemes. The total allo toMinistry of AYUSH for the purpose during last three years are detailed as under:

|          |          |          | (Rs. In Crore)                  |
|----------|----------|----------|---------------------------------|
| 2014- 15 | 2015- 16 | 2016- 17 | 2017- 18 (only revenue/ capital |
| 691      | 1125     | 1307.86  | 1557.80                         |

Further, the details of the fund allocated to different States under the Centrally Scheme of National AYUSH Mission are at Annexure - I .

- (c) : Yes, the Government has set up a Central Drug Controller's Office for AYUSH under Central  Drugs  Stan dard  Control  Organization  (CDSCO)  to  strengthen  regulatory  measures  to ensure safety and quality of AYUSH medicines. Ministry of Finance has approved the propo for creation of posts of two posts of Deputy Drugs Controllers, three posts of Assistan s Controllers and seven posts of Inspectors.

Ministry of Health & Family Welfare has approved the proposal for creation of vertical st of AYUSH in CDSCO. Accordingly, CDSCO has issued an order dated 05.02.2018 for creating AYUSH vertical in CDSCO w ith 12 posts operationalized by giving additional charge to t existing Officers of this Ministry. Recruitment Rules for these posts have been drafted.

- (d) : The details of test report and action taken by the State Government against defaulter companies during the last three years are enclosed at Annexure - II.
- (e) : The Government have taken measures for safety, quality and standardisation of AYUS medicines in the country as detailed below: -
- (i)  Pharmacopoeia  Commission  for  Indian  Medicine and  Homoeopathy  (PCIM&  H)  and Pharmacopoeia Committees have been set up to develop and revise the quality standa and the Standard Operating Procedures for the manufacturing of medicines.

(ii) Quality standards of 847 Ayurvedic drugs and 448 Unani drugs have been developed and  published  in  the  respective  pharmacopoeias.  Permissible  limits  of  heavy  met pesticide residue, aflatoxins and microbial load in the medicines are also prescribed.

(iii) Rule 158 - B in the Drugs and Cosmetics Rules, 1945 provides the regul atory guidelines for issue of license to manufacture Ayurvedic and Unani medicines in accordance with proof of safety and effectiveness.

(iv)  Two  Central  Laboratories - Pharmacopoeial  Laboratory  of  Indian  Medicine  and  the Homoeopathic Pharmacopoeial Laboratory have been established and notified as appellate laboratories under the provisions of the Drugs and Cosmetics Rules, 1945.

(v) Guidelines of Good Manufacturing Practices (GMP) for Ayurvedic, Siddha, Unani an Homoeopathic medicines have been inc orporated in the Drugs & Cosmetics Rules, 1945.

(vi)  System  of  WHO - GMP  Certification  and  quality  certification  of  ASU  medicines  by Quality Council of India on voluntary basis is in place for the industrial units w interested to export these medici nes.

(vii) Grants - in - aid is provided to the States and UTs under  National  AYUSH  Mission  (NAM)  for  augmenting  quality  control  activities  for ASU&  H  drugs,  including  strengthening  of  Pharmacies,  Drug  Testing  Laboratories, enforcement framework and testing o f drugs.

(viii) Powers are vested with the Central Government under Section 33P of the Drugs & Cosmetics Act, 1940 to give directions to the State Governments as and when required f enforcement of the legal provisions related to Ayurvedic, Siddha and Una ni drugs.

## Annexure-I

## Details of funds earmarked/allocated to States/UTs during the years 2014-15, 2015-16, 2016-17 & 2017-18 under Centrally Sponsored Scheme of National AYUSH Mission (NAM)

(Rs. In Lakh)

| S.No .   | Name of States/UTs   |   2014-15 |   2015-16 |   2016-17 |   2017-18 |   Grand Total |
|----------|----------------------|-----------|-----------|-----------|-----------|---------------|
| 1        | Andaman & Nicobar    |      0    |    151.77 |    394.82 |    302.33 |        848.92 |
| 2        | Andhra Pradesh       |    309.92 |   1400.38 |   1125.53 |   1176.01 |       4011.85 |
| 3        | Arunachal Pradesh    |    101.13 |    527.55 |    465.45 |    545.7  |       1639.84 |
| 4        | Assam                |    668.97 |   1410.5  |   1631.64 |   2390.69 |       6101.82 |
| 5        | Bihar                |      0    |    313.97 |   1752.91 |      0    |       2066.88 |
| 6        | Chandigarh           |      0    |      0    |    509.32 |    490.52 |        999.84 |
| 7        | Chhattisgarh         |    281.41 |    858.25 |   1624.73 |   1226.75 |       3991.16 |
| 8        | Dadra & Nagar Haveli |      0    |      0    |     91.79 |    143.4  |        235.2  |
| 9        | Daman & Diu          |      0    |      0    |    113.18 |      0    |        113.18 |
| 10       | Delhi                |    132.7  |    593.59 |      0    |      0    |        726.3  |
| 11       | Goa                  |      0    |    118.72 |    622.59 |    262.46 |       1003.79 |
| 12       | Gujarat              |    332.39 |    792.69 |   1533.04 |   1274.39 |       3932.52 |
| 13       | Haryana              |    213.58 |    579.79 |   1034.39 |    848.44 |       2676.21 |
| 14       | Himachal Pradesh     |      0    |    421.48 |    614.21 |    718.92 |       1754.61 |
| 15       | Jammu & Kashmir      |    226.26 |    792.15 |    769.2  |    992.58 |       2780.21 |
| 16       | Jharkhand            |      0    |    624.72 |     48.01 |      0    |        672.73 |
| 17       | Karnataka            |    359.11 |   1560.25 |   1241.45 |   2059.86 |       5220.69 |
| 18       | Kerala               |    254.66 |   1273.77 |    891.2  |   2096.23 |       4515.88 |
| 19       | Lakshadweep          |      0    |    189.22 |    509.72 |     63.74 |        762.69 |
| 20       | Madhya Pradesh       |    644.94 |   3253.34 |   2645.33 |   3059.68 |       9603.29 |
| 21       | Maharashtra          |    534.67 |   1282.73 |    529.18 |   1784.28 |       4130.87 |
| 22       | Manipur              |    226.81 |    828.8  |   1229.98 |   1339.32 |       3624.92 |
| 23       | Mizoram              |    134.64 |    405.69 |    603.75 |    693.47 |       1837.57 |
| 24       | Meghalaya            |    116.27 |    375.11 |    802.74 |    738.25 |       2032.38 |
| 25       | Nagaland             |    115.61 |    873.09 |    521.28 |   1516.91 |       3026.9  |
| 26       | Odisha               |    471.72 |   1865.28 |   1221.3  |   1561.02 |       5119.32 |
| 27       | Puducherry           |     60    |    144.17 |    170    |    200    |        574.17 |
| 28       | Punjab               |    316    |    299.5  |   1317.81 |   1348.66 |       3281.98 |
| 29       | Rajasthan            |    638.06 |   2819.6  |   2225.2  |   6893.25 |      12576.1  |
| 30       | Sikkim               |     66.42 |    608.15 |    874.07 |    180.08 |       1728.73 |
| 31       | Tamilnadu            |      0    |     87.7  |   1980.54 |   2789.07 |       4857.31 |
| 32       | Telangana            |    330    |   1091.46 |   1330.69 |   1055.11 |       3807.27 |
| 33       | Tripura              |    238.11 |    472.35 |    334.06 |   1195.54 |       2240.07 |
| 34       | Uttar Pradesh        |      0    |   4539.27 |   8466.62 |   6280.23 |      19286.1  |
| 35       | Uttarakhand          |    284    |    621.23 |   1187.92 |   1986.09 |       4079.26 |
| 36       | West Bengal          |    471.23 |   1924.85 |   1298.05 |   1654.64 |       5348.78 |
|          | TOTAL                |   7528.7  |  33101.2  |  41711.8  |  48867.7  |     131210    |

Annexure-II Action Taken by the States/UTs during last three years against defaulters companies

|   S No. | Name of the State/UTs   |   No of tested conducted during the last three years and current year | Declared spurious/sub - standard/ adulterated drugs   | Cases booked against the sale and distribution of Spurious AYUSH medicines   | Action Taken                                                                                                                            |
|---------|-------------------------|-----------------------------------------------------------------------|-------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
|       1 | Chhattisgarh            |                                                                   309 | 19                                                    | Nil                                                                          | Action was taken against failed sample per recommendation of Screening Committee formed as per Govt. India                              |
|       2 | Gujarat                 |                                                                   913 | 9                                                     | 10                                                                           |                                                                                                                                         |
|       3 | Karnataka               |                                                                  3433 | 76                                                    | -                                                                            | 1. Failed batch of medicine are withdrawn from the Market. 2. Sale of failed medicine was banned Karnataka.                             |
|       4 | Chandigarh              |                                                                  2128 | 218                                                   | -                                                                            | 1. Licenses of 10 pharmacies were cancelled. Show cause notices were issued 20 pharmacies. 2. Licenses of 08 pharmacies were suspended. |
|       5 | Tamil Nadu              |                                                                  5574 | 171                                                   | -                                                                            |                                                                                                                                         |
|       6 | Odisha                  |                                                                   224 |                                                       | -                                                                            |                                                                                                                                         |
|       7 | Delhi                   |                                                                 13573 | 83                                                    | -                                                                            |                                                                                                                                         |
|       8 | Tripura                 |                                                                   307 |                                                       | -                                                                            |                                                                                                                                         |
|       9 | Uttarakhand             |                                                                   513 | 46                                                    | -                                                                            |                                                                                                                                         |
|      10 | West Bengal             |                                                                    31 | 10                                                    | 4                                                                            | Action has been taken against the firm as parameter.                                                                                    |
|      11 | Himachal Pradesh        |                                                                  2696 | 144                                                   | -                                                                            |                                                                                                                                         |
|      12 | Kerala                  |                                                                  1749 | 23                                                    | 7                                                                            | 06 such products were cancelled.                                                                                                        |

Note: -Remaining states have reported Nil information.