Lok Sabha Question No. 1427 (UNSTARRED), answered on 2020-02-11
Subject: Raw Materials for Antibiotics
Ministry: CHEMICALS AND FERTILIZERS
Asked by: D. M. Kathir Anand, Prathap Simha

## GOVERNMENT OF INDIA MINISTRY OF CHEMICALS AND FERTILIZERS DEPARTMENT OF PHARMACEUTICALS

LOK SABHA UNSTARRED QUESTION No. 1456

TO BE ANSWERED ON THE 11 th  February, 2020

## Central Drugs Standard Control Organisation

## 1456.  SHRI KIRTI VARDHAN SINGH:

## SHRI MANOJ KOTAK:

Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:

- (a)  whether  the  Government  is  aware  of  the  fact  that  the  Central  Drugs  Standard Control  Organisation  (CDSCO)  has  flagged  37  batches  of  medicines  including crucial ones for failing quality test in the month of November, 2019;
- (b) if so, the details of the medicines and their manufacturers;
- (c) the action taken by the said authority so far;
- (d) whether public sector enterprises manufacturing medicines are also among the defaulters and if so, the details thereof;
- (e) the steps likely to be taken by the Government to prevent such incidents in future so as to maintain the quality of the medicines; and
- (f)  the  action  taken  by  the  Government  on  fake/  imitation  of  a  genuine  medicine during the last five years?

## ANSWER

## MINISTER IN THE MINISTRY OF CHEMICALS & FERTILIZERS (SHRI D. V. SADANANDA GOWDA)

- (a),(b),(c)&(d) : Yes sir, details of drugs declared as spurious/substandard/adulterated/misbranded by Central Drug Testing Laboratories are  regularly  uploaded  on  CDSCO  website  (www.cdsco.nic.in)  under  the  heading 'Alert'.  Details  of  such  cases  of  Not  of  Standard  Quality  for  month  of  November, 2019 is enclosed as Annexure-A .

Licence  for  manufacturing,  sale  &  distribution  of  drugs  are  granted  by  the  State Licensing Authorities appointed by respective State Governments. State Governments are empowered to take action on violations of any of the provisions of Drugs & Cosmetics Act, 1940 and Rules made thereunder.  All above cases have been  forwarded  to  the  State  Drugs  Controllers  of  the  concerned  State  where  the drug was manufactured for taking necessary action.

- (e) & (f): Government have taken various regulatory measures to ensure the quality of medicines in the country.

Details are as under;

1. The Drugs and Cosmetics Act, 1940 was amended under Drugs & Cosmetics (Amendment) Act 2008 to provide stringent penalties for manufacture of spurious and  adulterated  drugs.  Certain  offences  have  also  been  made  cognizable  and non-bailable.

Guidelines  for  taking  action  on  samples  of  drugs  declared  spurious  or  not  of standard quality in the light of enhanced penalties under the Drugs & Cosmetics (Amendment) Act, 2008 were forwarded to the State Drugs Controllers for uniform implementation.

The  States  /  UTs  were  requested  to  set  up  special  Courts  for  trial  of  offences under the Drugs and Cosmetics Act for speedy disposal. So far, 33 States have already set up designated special Courts for trial of cases related to spurious and sub-standard drugs.

The number of sanctioned posts in Central Drugs Standard Control Organization (CDSCO) has been increased from 111 (in April, 2008) to 511 (in June, 2019).

The testing capacities of Central Drugs Testing Laboratories under CDSCO are being constantly strengthened to expedite testing of drug samples in the country.

On 3.4.2017, in order to ensure efficacy of drugs, the Drugs and Cosmetics Rules, 1945  have  been  amended  providing  that  applicant  shall  submit  the  result  of bioequivalence study along with the application for grant of manufacturing license of oral dosage form of drugs falling under the Category II and Category IV of the Biopharmaceutical Classification System.

On 27.10.2017, the Drugs and Cosmetics Rules, 1945 have been amended vide Gazette notification no. G.S.R. 1337 (E) making it mandatory that before the grant of  manufacturing  license,  the  manufacturing  establishment  is  to  be  inspected jointly by the Drugs Inspectors of Central Government and State Government.

The  licensed  manufacturing  premises  shall  be  inspected  jointly  by  the  Drugs Inspectors of Central Government and State Government to verify the compliance with the conditions of license and the provisions of the Drugs & Cosmetics Act and Rules  for  not  less  than  once  in  three  years  or  as  needed  as  per  risk  based approach.

On 10.04.2018, the Drugs and Cosmetics Rules, 1945 have been amended vide Gazette notification no. G.S.R. 360 (E), making it mandatory for all drugs, that the applicants shall submit evidence of stability, safety of excipients etc. to the State Licensing Authority before grant of product manufacturing license by the Authority.

Draft Rules have been published vide GSR 999 (E), dated 5th 10.2018 to amend the  Schedule  M  of  the  Drugs  and  Cosmetics  Rules,  1945  to  make    it  more comprehensive at par with the WHO-GMP guidelines.

The Government has approved a proposal for strengthening the drug regulatory system in the country, both at the level of Central and the State Governments at a total expenditure of Rs.1750 crores.  Out of this, Rs. 900 crore is for strengthening the  central  drug  regulatory  structures  and  Rs.850  crore  is  for  strengthening  the drug regulatory system in the States. During the years 2016-17 and 17-18, Rs. 128.39 crore was released under the Central component whereas Rs. 87.90 crore was  allocated  during  2018-19  under  this  component.  Rs.  82.90  crore  was allocated during the year 2019-20. Under the State component, Rs. 81.36 crore was  released  during  2016-17  and  17-18  whereas  Rs.  206  crore  was  allocated during 2018-19 under this component.

Further, as per the information received from various  State/U.T. Drugs Controllers the  No.  of  drugs  samples  tested,  No.  of  drugs  samples  declared  sub-standard quality,  spurious/  adulterated  drugs,  its  percentage  and  action  taken  during  last five years is enclosed as Annexure B.

Such  information  received  from  various  Zonal/Sub-zonal  offices  of  CDSCO  is enclosed as Annexure C .

## List of Drugs declared as Not of Standard, for the Month of November, 2019

|   S. No. | Name of Drugs/medical device/cosmetics           | Batch No./Date of Manufacture/Date of Expiry/Manufactured By                                                                                                           |
|----------|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|        1 | Pantoprazole Gastro Resistant Tablets I.P.       | B. No.: T-7172 Mfg dt: 10/2018 Exp dt: 09/2020 Mfd by: M/s Kwality Pharmaceuticals Ltd. Nag Kalan, Majitha Road, Amritsar.                                             |
|        2 | Ibuprofen Tablets I.P. 400 mg.                   | B. No.: 01019-BJA36 Mfg dt: 01/2019 Exp dt: 12/2020 Mfd by: M/s Biogenetic Drugs Pvt. Ltd. Vill-Jharmajri, Baddi, Dist-Solan H.P-174103                                |
|        3 | Pantoprazole Enteric Coated Tablets 40 mg.       | B. No.: T-7224 Mfg dt: 11/2018 Exp dt: 10/2020 Mfd by: M/s Kwality Pharmaceuticals Ltd. Nag Kalan, Majitha Road, Amritsar                                              |
|        4 | Telmisartan Tablets I.P. 40mg. (Telziver-40)     | B. No.: LVT-28800 Mfg dt: 04/2018 Exp dt: 03/2020 Mfd by: M/s Life Vision Healthcare, Plot No. 140-141, E.P.I.P, Phase-I, Jharmajri, Baddi, Dist- Solan, H.P.- 174103  |
|        5 | Levocetirizine Dihydrochloride Tablets I.P. 5mg. | B. No.: LC18004 Mfg dt: 04/2018 Exp dt: 03/2020 Mfd by: M/s Life Max Cancer Laboratories, Plot No. 106 & 106A, Sector-6A, I.I.E., SIDCUL, Haridwar, Uttarakhand-249403 |
|        6 | Albendazole Tablets I.P. (C-Bend)                | B. No.: G002/2561 Mfg dt: 04/2019 Exp dt: 03/2021 Mfd by: M/s Elfin Drugs Pvt. Ltd. Vill-Berson, Nalagarh (H.P)-174101                                                 |
|        7 | Albendazole Tablets I.P. 400 mg.                 | B. No.: 8605318, Mfg dt: 10/2018 Exp dt: 09/2021 Mfd by: M/s Karnataka Antibiotics & Pharmaceuticals Ltd., Plot No. 14, II Phase, Peenya, Bangalore-560058             |
|        8 | Pantoprazole Tablets I.P. (PAD-40)               | B. No.: T03PA11-18 Mfg dt: 11/2018 Exp dt: 10/2020 Mfd by: M/s Adsila Organics Pvt. Ltd. Liwaspur Road, Vill-Bahalgarh-131021, Haryana                                 |
|        9 | Cedoxil 500mg Tablets                            | B. No.: T-16549 Mfg dt: 03/2018 Exp dt: 02/2020 Mfd by: M/s Jackson Laboratories Pvt. Ltd., Bye Pass, Majitha Road, Amritsar-143004                                    |

|   10 | Amlodipine Tablets IP 5mg                                           | B. No.: CHT-9124 Mfg dt: 03/2019 Exp dt: 02/2021 Mfd by: M/s. Bengal Chemicals & Pharmaceuticals Ltd., NH-No.74 Roorkee-Dehradun Highway, Kisanpur, Roorkee-247667, Uttarakhand.           |
|------|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|   11 | Carbamazepine Extended Release Tablets IP (ACETOL CR-200 TABLETS)   | B. No.: AAB8B007 Mfg dt: 03/2018 Exp dt: 02/2020 Mfd by: Psychotropics India Limited, Plot No.- 46 & 49, Sector-6A, IIE, SIDCUL, Industrial Area, Ranipur, Haridwar-249 403 (Uttarakhand ) |
|   12 | Albendazole Vet. Oral Suspension (FLUKGON )                         | B. No.: 205 Mfg dt: 11/2018 Exp dt: 10/2020 Mfd by: Albro Pharmaceuticals Pvt. Ltd. GMP Certified Company Muktsar 152026, Punjab.                                                          |
|   13 | Prebiotic and Probitic Capsules (REPURE CAPSULES)                   | B. No.: HC-1805016 Mfg dt: 05/2018 Exp dt: 04/2020 Mfd by: Helax Health Care Private Limited, Khasra No. 410, Village- Karondi, Roorkee- 247667, District- Haridwar                        |
|   14 | Suspension of Calcium, Vitamin B12 and Vitamin D3 ( CALCI-D )       | B. No.: SL-398 Mfg dt: 05/2019 Exp dt: 04/2021 Mfd by: Sridhara Life sciences Pvt. Ltd. Khasra No. 285,290, Village- Sisona, Bhagwanpur, Roorkee, Haridwar (Uttrakhand )-247661            |
|   15 | Ferrous Ascorbate, Folic, Zinc and Cynocobalamin Syrup (FEROFOL-BZ) | B. No.: MSL-091 Mfg dt: 03/2019 Exp dt: 02/2021 Mfd by: Maskon Life Sciences Pvt. Ltd. Kh. No. 69& 70 Khatakheri, Bhagwanpur, Roorkee (U.K.) INDIA                                         |
|   16 | MDZIME - DT (Cetrizine Dihydrochloride Tablets)                     | B. No.: ZT-8313 Mfg dt: 01/2019 Exp dt: 12/2021 Mfd by: M/s. Zenith Healthcare Ltd., 388/34, Chandogar Ind. Estate, Sarkhej Bavla Highway, Changodar -382210                               |
|   17 | Ramizim - 2.5 (Ramipril Tablets I.P. 2.5 mg)                        | B. No.: EH97M801 Mfg dt: 12/2018 Exp dt: 11/2020, Mfd by: M/s. ZIM Laboratories Limited (Unit-II), A-8/14, MIDC, Area, Kalmeshwar 441501, Dist Nagpur, Maharashtra                         |
|   18 | Trypsin Chymotrypsin Tablets                                        | B. No.: T 53903 Mfg dt: 05/2018 Exp dt: 04/2021 Mfd by: M/s. Vardhman Exports, A-188, T. T.C., MIDC, Khairne, Navi Mumbai - 400 710.                                                       |
|   19 | Ramipril Tablets I.P. 2.5 mg                                        | B. No.: RAPT18004 Mfg dt: 12/2018 Exp dt: 11/2020 Mfd by: M/s. Ravian Life Sciences Pvt. Ltd., Plot No. 34,                                                                                |

|    |                                                         | Sec. 8A, IIE, SIDCUL, Haridwar -249 403, UK.                                                                                                                                                     |
|----|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 20 | Cadpril 5 (Ramipril Tablets I.P)                        | B. No.: ZPR0037 Mfg dt: 08/2018 Exp dt: 07/2020 Mfd by: M/s. Preet Remedies Ltd., 183-186, HPSIDC, Industrial Area, Baddi, Distt. Solan - (H.P.) - 173205                                        |
| 21 | Vitamin B-Complex Tablets NFI                           | B. No.: KA19001 Mfg dt: 01/2019 Exp dt: 06/2020 Mfd by: M/s. Ortin Laboratories Ltd., 275 & 278 (Part) I.D.A. Pashamylaram -502307, Medak, AP.                                                   |
| 22 | Medtoin (Phenytoin Sodium Tablets I.P.)                 | B. No.: SPT190048A, Mfg dt: 01/2019 Exp dt: 12/2020 Mfd by: M/s. Salus Pharmaceuticals, 480/211, Harraipur, P.O. Gurumajra, Teh. Baddi, Distt. Solan, (H.P.) - 173 205                           |
| 23 | DOXYGUARD (Doxycycline & Lactic Acid Bacillus Capsules) | B. No.: SOC-615F Mfg dt: 01/2018 Exp dt: 12/2019 Mfd by: M/s. Symbiosis Pharmaceuticals Pvt. Ltd., (Unit- III), Trilokpur Road, Kala Amb-173030 (H.P)                                            |
| 24 | OMEP (Omeprazole Capsule I.P. 20mg)                     | B. No.: UOME 1803 Mfg dt: 02/2018 Exp dt: 01/2020 Mfd by: M/s. Bal Pharma Limited, Plot No. 1, 2, 3 & 69, Sector 4 IIE, SIDCUL, Pantnagar, Rudrapur Distt- Udham Singh Nagar, Uttarakhand, India |
| 25 | CREPE BANDAGE (10 CMS X 4 MTRS)                         | B. No.: 37 Mfg dt: 10/2017 Exp dt: 3 Yrs from Mfg. Date Mfd by: M/s. Hindustan Surgical Appliances, 29, Huzuri Mull Lane, Kolkata - 700 014.                                                     |
| 26 | Metronidazole Tablets I.P. 400 mg                       | B. No.: 7596027 Mfg dt: 08/2017 Exp dt: 07/2020 Mfd by: M/s. Bengal Chemical & Pharmaceuticals Ltd., 164, Maniktala Main, Road, Kolkata - 700054                                                 |
| 27 | Ramizim 5 (Ramipril Tablets I.P. 5 mg)                  | B. No.: EO82M801 Mfg dt: 12/2018 Exp dt: 11/2020 Mfd by: M/s. Zim Laboratories Limited (Unit-II), A-8/14, MIDC Area, Kalmeshwar 441501, Dist Nagpur, Maharashtra                                 |
| 28 | Zinc Sulphate Tablets IP 20 mg                          | B. No.: 05069 Mfg dt: 06/2019 Exp dt: 05/2021 Mfd by: M/s. Healthy Life Pharma Pvt. Ltd., N-31/1, M.I.D.C., Tarapur, Dist. Palghar, Boisar-401506, Maharashtra                                   |
| 29 | Bacitracin Zinc                                         | B. No.: B190304 Mfg dt: 03/2019 Exp dt: 03/2023 Mfd by: M/s. Yancheng Youhua Pharmaceutical &                                                                                                    |

|    |                                                                                                                                                                 | Chemical Technology, Co. Ltd., China                                                                                                                                                |
|----|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 30 | Ciprofloxacin Tablets IP 250 mg                                                                                                                                 | B. No.: (10)CITW-31 Mfg dt: 04/2019 Exp dt: 03/2021 Mfd by: M/s. Nestor Pharmaceuticals Limited, 11, Western Extension Area, Faridabad-121001                                       |
| 31 | Cycloserine Capsules USP 250 mg                                                                                                                                 | B. No.: ECB5836A Mfg dt: 07/2018 Exp dt: 06/2021 Mfd by: M/s. Macleods Pharmaceuticals Ltd., Plot No. 25-27, Survey No.366, Premier Industrial Estate, Kachigam, Daman 396210 (U.T) |
| 32 | Rabiun-DSR (Enteric coated Rabeprazole Sodium and Domperidon SR Capsules)                                                                                       | B. No.: NY1180 Mfg dt: 05/2019 Exp dt: 04/2021 Mfd by: M/s. Intas Pharmaceuticals Limited, Samardung Road, Kabrey Block, Namthang Elaka, South Sikkim- 737 132                      |
| 33 | Eptoin 300 ER (Phenytoin Sodium Extended Release Tablets 300 mg)                                                                                                | B. No.: SDE0020 Mfg dt: 03/2019 Exp dt: 02/2021 Mfd by: M/s. Sidmak Laboratories (India) Pvt. Ltd., Plot No.20, Pharma City, Selaqui Industrial Area, Dehradun- 248197, Uttarakhand |
| 34 | Cefpirome Injection (Azzicef),                                                                                                                                  | B. No.: GS1547G, Mfg. dt: 08/2018, Exp. dt: 07/2020, Mfd by: Not mentioned                                                                                                          |
| 35 | 'Purport to contain Amoxycillin & Potassium Clavulanate equivalent to Amoxycillin 500 mg, Potassium Clavulanate Diluted IP equivalent to Clavulanic Acid 125 mg | B. No.: Not Specified, Mfg. dt: Not Specified, Exp. dt: Not Specified, Mfd by: Not Specified                                                                                        |

## Annexure-B

## Number of samples tested and enforcement actions taken by States/UTs Drugs Controller during last five years

| Year     | No. of drug s samp les teste d   | No. of drugs samples declared not of standard quality   | %No. of drugs sample s declare d not of standar d quality   | No. of drugs sample s declare d spuriou s/ adulter ated   |   % No. of drugs samples declared spurious/ adulterated |   No. of prosecutio n launched for manufactur ing, sale and distributio n of spurious/ adulterated drugs |   No. of cases (as mention ed in the earlier column) decided |   No. of perso ns arrest ed | Approx. value of drug seized (in INR)   | No. of Raid s Cond ucte d   |
|----------|----------------------------------|---------------------------------------------------------|-------------------------------------------------------------|-----------------------------------------------------------|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|-----------------------------|-----------------------------------------|-----------------------------|
| 2014- 15 | 7419 9                           | 3702                                                    | 4.98 83                                                     |                                                           |                                                    0.11 |                                                                                                      152 |                                                           10 |                          85 | 58251111                                | 1404 2                      |
| 2015- 16 | 74,58 6                          | 3703                                                    | 4.96                                                        | 234                                                       |                                                    0.31 |                                                                                                      289 |                                                            2 |                          59 | 55313470.5 + Govt. Supply               | 3648                        |
| 2016- 17 | 76,72 1                          | 2,780                                                   | 3.6                                                         | 123                                                       |                                                    0.16 |                                                                                                      186 |                                                           17 |                         106 | 7,72,68,717.5                           | 10,92 1                     |
| 2017- 18 | 82,59 9                          | 2783                                                    | 3.36                                                        | 236                                                       |                                                    0.28 |                                                                                                      131 |                                                           16 |                         163 | 17,86,08,008                            | 7067                        |
| 2018- 19 | 76,10 1                          | 2,549                                                   | 3.35                                                        | 205                                                       |                                                    0.27 |                                                                                                      484 |                                                           77 |                         153 | 80389057 (Approx.)                      | 33,49 2                     |

## Annexure-C

Number of samples tested and enforcement actions taken by Zonal/Sub-zonal offices of CDSCO during last five years

| Year     | No. of drug s samp les teste d   |   No. of drugs samples declared not of standard quality | %No. of drugs sample s declare d not of standar d quality   | No. of drugs sample s declare d spuriou s/ adulter ated   | % No. of drugs samples declared spurious/ adulterated   | No. of prosecutio n launched for manufactur ing, sale and distributio n of spurious/ adulterated drugs   | No. of cases (as mention ed in the earlier column) decided   | No. of perso ns arrest ed   | Approx. value of drug seized (in INR)   |   No. of Raid s Cond ucte d |
|----------|----------------------------------|---------------------------------------------------------|-------------------------------------------------------------|-----------------------------------------------------------|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|-----------------------------|-----------------------------------------|-----------------------------|
| 2014- 15 | 3605                             |                                                     121 | 3.36 0                                                      | 0                                                         |                                                         | Nil                                                                                                      | Nil                                                          | Nil                         | Nil                                     |                          48 |
| 2015- 16 | 2897                             |                                                     115 | 3.96                                                        | 5                                                         | 0.17                                                    | 38                                                                                                       | Nil                                                          | 4                           | 21052298                                |                          42 |
| 2016- 17 | 5207                             |                                                     146 | 2.80                                                        | Nil                                                       | 0.0                                                     | 21                                                                                                       | 4                                                            | Nil                         | 3911850                                 |                          56 |
| 2017- 18 | 7088                             |                                                     381 | 5.37                                                        | 2                                                         | 0.028                                                   | 17                                                                                                       | 1                                                            | 6                           | 8820385                                 |                           8 |
| 2018- 19 | 1038 2                           |                                                     310 | 2.98                                                        | 5                                                         | 0.048                                                   | 31                                                                                                       | 9                                                            | 4                           | 38218920                                |                          52 |