Lok Sabha Question No. 971 (UNSTARRED), answered on 2023-12-08
Subject: Quality of Medicinal Products
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Ramesh Chander Kaushik, Sunil Kumar Pintu, Navneet Ravi Rana, Rama Devi

†

## GOVERNMENTOFINDIA MINISTRYOF HEALTH AND FAMILY WELFARE DEPARTMENTOFHEALTH AND FAMILY WELFARE

## LOK SABHA UNSTARRED QUESTION NO. † 971 TO BE ANSWERED ON 08 TH DECEMBER, 2023

## QUALITY OFMEDICINALPRODUCTS

971: SHRI RAMESH CHANDER KAUSHIK:

SHRI SUNIL KUMAR PINTU:

SHRIMATI NAVNEET RAVI RANA:

SHRIMATI RAMADEVI:

Will the Minister of HEALTHANDFAMILYWELFARE be pleased to state:

- (a) the details regarding the registered cases of spurious medicinal products along with the number of cases where punishment has been given State/UT-wise;
- (b) whether the Government has taken/proposes to take steps to strengthen the basic infrastructure in Maharashtra under Pradhan Mantri Swasthya Suraksha Yojana (PMSSY) and if so, the details thereof;
- (c) whether the Government has taken steps to maintain the quality standard of the medicinal products since 2019, if so, the details thereof; and
- (d) the expenditure incurred on the scheme during the last three years and the current year, State/UTs/district-wise?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (DR. BHARATI PRAVIN PAWAR)

- (a): Isolated complaints regarding spurious drugs are received. As and when such complaints are received, based on merit, the matter is taken up by CDSCO in coordination with State/UT ' s Drugs Controller for action as per the provisions of the Drugs & Cosmetics Act, 1940 and Rules 1945.

As per information received from State/UT ' s Drugs Controllers, number of drug samples tested, number of drug samples reported spurious/adulterated, sub-standard drugs and action taken against the offenders during each of the last three years (from 2020-2023) is enclosed as Annexure-I.

(b): Pradhan Mantri Swasthya Suraksha Yojana (PMSSY) aims at correcting regional imbalances in the availability of affordable tertiary healthcare services and to augment facilities for quality medical education in the country. The Scheme has two components, namely, (i) Setting up of All India Institute of Medical Sciences (AIIMS); and (ii) Upgradation of existing Government Medical Colleges/Institutions (GMCIs). The setting up of AIIMS contains Medical College, Nursing College, Hospital, Trauma Centre, Emergency, Blood Bank, ICU, Diagnostic & Pathology, Research etc. Up-gradation of GMCIs under PMSSY broadly involves construction of Super Specialty Block (SSB) and/or Trauma Care Centre / or other facilities and/or procurement of medical equipment. In Maharashtra, one AIIMS at Nagpur has been established and 6 projects have been taken up for the up-gradation of GMCI under PMSSY. The details of these projects are as under:

| S. No.   | Name of GMCs                                             | Phase   | Approved outlay (Rs. In Cr)   | Approved outlay (Rs. In Cr)   | Approved outlay (Rs. In Cr)   | Central fund (Rs.                 | Status    |
|----------|----------------------------------------------------------|---------|-------------------------------|-------------------------------|-------------------------------|-----------------------------------|-----------|
|          |                                                          |         | Central Share                 | State/ Institute Share        | Total                         | released Cr)                      |           |
| 1        | Grant Medical College &Sir JJ Group of Hospitals, Mumbai | I       | 100.00                        | 20.00                         | 120.00                        | 93.87                             | Completed |
| 2        | Government Medical College, Nagpur                       | II      | 125.00                        | 25.00                         | 150.00                        | 120.25                            | Completed |
| 3        | Govt. Medical College, Aurangabad                        | III     | 120                           | 30                            | 150                           | 102.93                            | Completed |
| 4        | Govt. Medical College, Latur                             | III     | 120                           | 30                            | 150                           | 101.15                            | Completed |
| 5        | Govt. Medical College, Akola                             | III     | 120                           | 30                            | 150                           | 98.01                             | Completed |
| 6        | Shri Vasantrao Naik Govt. Medical College, Yavatmal      | III     | 120                           | 30                            | 150                           | 103.09                            | Completed |
| 7        | AIIMS, Nagpur                                            |         |                               |                               |                               | 1235.04 (Fund release as on date) | Completed |

(c): CDSCO and Ministry of Health and Family Welfare have taken various regulatory measures to ensure the quality of medicines in the country. Details of such measures taken since 2019 are as under.

- i. On 17-11-2022, the Drugs Rules, 1945 were amended vide G.S.R. 823(E) which has come into force from 1st of August, 2023 providing that the manufacturers of top 300 brands of drug formulation products, as specified in Schedule H2, shall print or affix Bar Code or Quick Response Code on its primary packaging label or, in case of inadequate space in primary package label, on the secondary package label that store data or information legible with software application to facilitate authentication.
- ii. On 18.01.2022, the Drugs Rules, 1945 were amended vide G.S.R. 20 (E) providing that every Active Pharmaceutical Ingredient (bulk drug) manufactured or imported in India shall bear Quick Response Code on its label at each level of packaging that store data or information readable with software application to facilitate tracking and

tracing. The stored data or information shall include the minimum particulars including unique product identification code, Batch Number, Manufacturing date, Expiry Date etc.

- iii. On 06.11.2019, the Drugs and Cosmetics Rules, 1945 were amended vide G.S.R 828 (E) making it mandatory that, in case the applicant intends to market the drug under a brand name or trade name the applicant shall furnish an undertaking in Form 51 to the licensing authority that such or similar brand name or trade name is not already in existence with respect to any drug in the country and the proposed brand name or trade name shall not lead to any confusion or deception in the market.
- iv. On 11.02.2020, the Drugs Rules, 1945 were amended vide G.S.R. 101 (E), providing that with effect from 01.03.2021 any marketer who sells or distributes any drug shall be responsible for quality of that drug as well as other regulatory compliances along with the manufacturer under these Rules.
- v. The number of sanctioned posts in Central Drugs Standard Control Organization (CDSCO) has been increased from 111 in 2008 to 492 till January 2022. Further, 220 posts have been created on 16-06-2022 and 219 posts have been created on dated 13.07.2022.
- vi. Central regulator coordinates activities of State Drug Control Organisations and provides expert advice through the Drugs Consultative Committee (DCC) meetings held with State Drugs Controllers for uniformity in administration of the Drugs and Cosmetics Act.

(d): Details of funds released under Pradhan Mantri Swasthya Suraksha Yojana (PMSSY) for All India Institute of Medical Sciences (AIIMS); and Government Medical Colleges/Institutions (GMCIs) during the last three years and current year is annexed at Annexure- II.

******

## Annexure-I

As per information received from various States/U.Ts Drugs Controllers, Number of drug samples tested and enforcement action taken, number of drug samples reported Not of Standard Quality/spurious/adulterated and enforcement action taken by the States/UTs Drugs Controller during last three years is as below:

| Year (1 st April of preceding year to 31 st March of following year)   | No. of drugs samples tested   |   No. of drugs samples declared not of standard quality |   No. of drugs samples declared spurious/adulterate d |   No. of prosecution launched for manufacturing, sale and distribution of spurious/adulterate d drugs |   No. of persons arrested |
|------------------------------------------------------------------------|-------------------------------|---------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------|
| 2020-21                                                                | 84,874                        |                                                    2652 |                                                   263 |                                                                                                   236 |                       164 |
| 2021-22                                                                | 88,844                        |                                                    2545 |                                                   379 |                                                                                                   592 |                       450 |
| 2022-23                                                                | *89729                        |                                                    2921 |                                                   422 |                                                                                                   642 |                       262 |

## Annexure II

Statement refer to in reply to Part (d) of Lok Sabha Unstarred Question no. † 971 dated 08.12.2023

| S. No.   | Government Medical College/Institutions                        | Funds released during last 3 years (Amount in Rs.)   | Funds released during last 3 years (Amount in Rs.)   | Funds released during last 3 years (Amount in Rs.)   |
|----------|----------------------------------------------------------------|------------------------------------------------------|------------------------------------------------------|------------------------------------------------------|
| S. No.   | Government Medical College/Institutions                        | (2020-21)                                            | (2021-22)                                            | (2022-23)                                            |
| 1        | Government Medical College, Anantapur                          | 0.00                                                 | 8030028.74                                           | 3000552.98                                           |
| 2        | Siddhartha Medical College, Vijaywada                          | 281565.50                                            | 2548906.19                                           | 1140719.73                                           |
| 3        | Kakatiya Medical College, Warangal, Telangana                  | 30069099.00                                          | 998209.39                                            | 16036240.73                                          |
| 4        | Rajiv Gandhi Institute of Medical Science, Adilabad, Telangana | 31658675.00                                          | 3628769.65                                           | 1907787.62                                           |
| 5        | Gauhati Medical College, Guwahati, Assam                       | 3427418.39                                           | 3593059.05                                           | 1295033.38                                           |
| 6        | Assam Medical College, Dibrugarh                               | 4197169.22                                           | 1637042.22                                           | 1651381.07                                           |
| 7        | Sri Krishna Medical College, Muzaffarpur, Bihar                | 199828769.60                                         | 26339.71                                             | 0.00                                                 |
| 8        | Govt. Medical College, Darbhanga, Bihar                        | 27515076.64                                          | 162618845.41                                         | 82492392.67                                          |
| 9        | Goa Medical College, Goa                                       | 12800000.00                                          | 0.00                                                 | 0.00                                                 |
| 10       | P.D.U Government Medical College, Rajkot, Gujarat              | 167013868.00                                         | 2003804.85                                           | 24459517.47                                          |
| 11       | Indira Gandhi Medical College, Shimla, H.P                     | 879100.00                                            | 0.00                                                 | 106116390.92                                         |
| 12       | Patliputra Medical College, Dhanbad                            | 80080154.00                                          | 170734.07                                            | 19563.79                                             |
| 13       | Vijaynagar Institute of Medical Science, Bellary, Karnataka    | 45914425.00                                          | 1909701.62                                           | 1286425.11                                           |
| 14       | Karnataka Institute of Medical Science, Hubli, Karnataka       | 29386668.00                                          | 1845549.31                                           | 64431888.07                                          |
| 15       | Kozhikode Medical College, Kozhikode, Kerala                   | 146675984.78                                         | 576670.09                                            | 2223421.27                                           |
| 16       | T.D Medical College, Alappuzha, Kerala                         | 140240277.00                                         | 36163.49                                             | 1055809.62                                           |
| 17       | Netaji Subhash Chandra Bose Medical College, Jabalpur          | 1535526.09                                           | 2898925.35                                           | 563277.84                                            |
| 18       | Shyam Shah Medical College, Rewa                               | 520113.24                                            | 4018697.29                                           | 1097659.88                                           |

| S. No.   | Government Medical College/Institutions               | Funds released during last 3 years (Amount in Rs.)   | Funds released during last 3 years (Amount in Rs.)   | Funds released during last 3 years (Amount in Rs.)   |
|----------|-------------------------------------------------------|------------------------------------------------------|------------------------------------------------------|------------------------------------------------------|
| S. No.   | Government Medical College/Institutions               | (2020-21)                                            | (2021-22)                                            | (2022-23)                                            |
| 19       | Gajra Raje Medical College, Gwalior                   | 409598.02                                            | 3179710.65                                           | 801177.04                                            |
| 20       | Government Medical College, Latur                     | 423539.56                                            | 1972790.38                                           | 1035418.20                                           |
| 21       | Govt. Medical College, Akola                          | 60164002.00                                          | 233726.39                                            | 1361304.11                                           |
| 22       | Shri Vasantrao Naik Govt. Medical College, Yavatmal   | 175291.00                                            | 486286.99                                            | 588067.32                                            |
| 23       | Government Medical College, Aurangabad                | 573155.68                                            | 2091900.30                                           | 247976.24                                            |
| 24       | MKCG Medical College, Berhampur                       | 4634991.76                                           | 1825746.28                                           | 2046009.69                                           |
| 25       | VSS Medical College, Burla                            | 30265224.90                                          | 397539.67                                            | 9522948.33                                           |
| 26       | Government Medical College, Patiala                   | 1873519.21                                           | 2155021.99                                           | 52836233.66                                          |
| 27       | Sardar Patel Medical College, Bikaner                 | 726445.08                                            | 1504397.19                                           | 37739260.84                                          |
| 28       | Government Medical College, Kota                      | 309795.22                                            | 2978185.28                                           | 10921288.70                                          |
| 29       | Rabindra Nath Tagore Medical College, Udaipur         | 7950428.77                                           | 2714474.04                                           | 1091000.91                                           |
| 30       | Thanjavur Medical College, Thanjavur (Tamil Nadu)     | 64866652.00                                          | 2554977.63                                           | 300037.55                                            |
| 31       | Tirunelveli Medical College, Tirunelveli (Tamil Nadu) | 44500000.00                                          | 2719299.85                                           | 175147.23                                            |
| 32       | Agartala Government Medical College, Tripura          | 120412988.00                                         | 76200829.35                                          | 975684.53                                            |
| 33       | Maharani Laxmi Bai Medical College, Jhansi            | 1062051.07                                           | 2901082.86                                           | 430413.94                                            |
| 34       | Motilal Nehru Medical College, Allahabad              | 290104.48                                            | 2430526.02                                           | 294633.63                                            |
| 35       | Government Medical College, Gorakhpur                 | 233260.00                                            | 2109776.89                                           | 589802.69                                            |
| 36       | LLRM Medical College, Meerut                          | 416824.00                                            | 1580933.12                                           | 576018.95                                            |
| 37       | North Bengal Medical College, Siliguri, Darjeeling    | 1415776.30                                           | 2161331.89                                           | 121990.82                                            |
| 38       | BS Medical College, Bankura                           | 31344468.00                                          | 484919.84                                            | 1148897.24                                           |
| 39       | Government Medical College, Malda                     | 760851.00                                            | 1581242.36                                           | 877398.20                                            |

| S. No.   | Government Medical College/Institutions                                       | Funds released during last 3 years (Amount in Rs.)   | Funds released during last 3 years (Amount in Rs.)   | Funds released during last 3 years (Amount in Rs.)   |
|----------|-------------------------------------------------------------------------------|------------------------------------------------------|------------------------------------------------------|------------------------------------------------------|
| S. No.   | Government Medical College/Institutions                                       | (2020-21)                                            | (2021-22)                                            | (2022-23)                                            |
| 40       | Government Medical College, Bilaspur                                          | 19852559                                             | 267900000                                            | 0                                                    |
| 41       | Government Medical College, Jagdalpur                                         | 2509048                                              |                                                      | 0                                                    |
| 42       | Government Medical College, Patna                                             | 211119177                                            | 0                                                    | 0                                                    |
| 43       | Government Medical College, Bhagalpur                                         | 306609345                                            | 0                                                    | 0                                                    |
| 44       | Government Medical College, Gaya                                              | 300045848                                            | 0                                                    | 0                                                    |
| 45       | Government Medical College, Agra                                              | 281495964                                            | 2908848                                              | 5482575                                              |
| 46       | Government Medical College, Kanpur                                            | 90071556                                             | 7657487                                              | 10965150                                             |
| 47       | Government Medical College, Indore                                            | 68921000                                             | 809800                                               | 0                                                    |
| 48       | Government Medical College, Bhavnagar                                         | 59156000                                             | 2311821                                              | 0                                                    |
| 49       | Government Medical College, Jaipur                                            | 72952284                                             | 9741907                                              | 22913700                                             |
| 50       | Government Medical College, Cuttack                                           | 2268000                                              | 0                                                    | 0                                                    |
| 51       | Government Medical College, Surat                                             | 0                                                    | 0                                                    | 0                                                    |
| 52       | University College of Medical Sciences - Guru Teg Bahadur Hospital, Delhi     |                                                      |                                                      | 0                                                    |
| 53       | Institute of Medical Sciences, Banaras Hindu University, Varanasi             | 0                                                    |                                                      | 0                                                    |
| 54       | Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum | 0                                                    |                                                      | 0                                                    |
| 55       | RIO IMS BHU Varanasi                                                          | 125454000                                            |                                                      | 0                                                    |
| 56       | Indira Gandhi Institute of Medical Sciences, Patna                            | 0                                                    | 180770000                                            | 0                                                    |

| Sr.No.   | All India Institute of Medical Sciences (AIIMS)   | Fund Released Funds released during last 3 years for new AIIMS (Rs. in Crores)   | Fund Released Funds released during last 3 years for new AIIMS (Rs. in Crores)   | Fund Released Funds released during last 3 years for new AIIMS (Rs. in Crores)   | Fund Released Funds released during last 3 years for new AIIMS (Rs. in Crores)   |
|----------|---------------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Sr.No.   | All India Institute of Medical Sciences (AIIMS)   | (2020-21)                                                                        | (2021-22)                                                                        | (2022-23)                                                                        | (2023-24)                                                                        |
| 1        | AIIMS, Mangalagiri, Andhra Pradesh                | 261.10                                                                           | 258.17                                                                           | 181.95                                                                           | 7.05                                                                             |
| 2        | AIIMS, Nagpur, Maharashtra                        | 231.77                                                                           | 219.11                                                                           | 65.35                                                                            | 0.00                                                                             |
| 3        | AIIMS, Kalyani, West Bengal                       | 274.02                                                                           | 331.73                                                                           | 44.62                                                                            | 8.13                                                                             |
| 4        | AIIMS, Gorakhpur, U.P                             | 127.13                                                                           | 96.36                                                                            | 41.08                                                                            | 8.67                                                                             |
| 5        | AIIMS, Bathinda, Punjab                           | 202.02                                                                           | 47.57                                                                            | 110.46                                                                           | 0.00                                                                             |
| 6        | AIIMS, Guwahati, Assam                            | 166.32                                                                           | 179.94                                                                           | 213.90                                                                           | 77.82                                                                            |
| 7        | AIIMS, Bilaspur, Chhattisgarh                     | 378.78                                                                           | 444.02                                                                           | 121.06                                                                           | 1.06                                                                             |
| 8        | AIIMS, Deoghar, Jharkhand                         | 206.63                                                                           | 350.70                                                                           | 189.88                                                                           | 25.91                                                                            |
| 9        | AIIMS, Jammu                                      | 322.35                                                                           | 305.00                                                                           | 398.45                                                                           | 410.24                                                                           |
| 10       | AIIMS, Kashmir                                    | 211.16                                                                           | 130.00                                                                           | 290.00                                                                           | 250.00                                                                           |
| 11       | AIIMS, Madurai, Tamil Nadu                        | 4.23                                                                             | -                                                                                |                                                                                  | 6.02                                                                             |
| 12       | AIIMS, Rajkot, Gujarat                            | 161.86                                                                           | 128.96                                                                           | 380.52                                                                           | 155.03                                                                           |
| 13       | AIIMS, Bibinagar, Telangana                       | 6.77                                                                             | 5.42                                                                             | 350.63                                                                           | 144.97                                                                           |
| 14       | AIIMS, Manethi, Haryana                           | 0.00                                                                             | 0.00                                                                             | 5.00                                                                             | 6.03                                                                             |
| 15       | AIIMS, Darbhanga, Bihar                           | 0.00                                                                             | 0.00                                                                             | 0.00                                                                             | 0.00                                                                             |