Lok Sabha Question No. 1988 (UNSTARRED), answered on 2024-12-06
Subject: Supply of Medicines to Jan Aushadhi Kendras
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Shri Rajesh Ranjan, Dr. Amar Singh

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

LOK SABHA UNSTARRED QUESTION No. 1988 TO BE ANSWERED ON 6 th  DECEMBER 2024

## Supply of Medicines to Jan Aushadhi Kendras

## 1988.   Shri Rajesh Ranjan:

Dr. Amar Singh:

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

- (a) the details of generic drug manufacturers supplying medicines to Jan Aushadhi Kendras, State-wise;
- (b) the total number of drug inspection officers in the country, State-wise;
- (c)  whether  the  Government  has  taken  note  of  the  apprehensions  raised  that  the  proposed changes by the CDSCO could result in poor-quality drugs being sold in Jan Aushadhi outlets; and
- (d)  if  so,  the  steps  taken/proposed  to  be  taken  by  the  Government  to  ensure  proper quality control?

## ANSWER

## THE MINISTER OF STATE IN THE MINISTRY OF CHEMICALS & FERTILIZERS (SMT. ANUPRIYA PATEL)

- (a): As on date, 206 pharmaceutical manufacturers are associated with Pharmaceuticals & Medical  Devices  Bureau  of  India  (PMBI),  the  implementation  agency  of  Pradhan  Mantri Bhartiya  Janaushadhi  Pariyojana  (PMBJP)  for  supplies  of  medicines,  surgical  devices, nutraceuticals and ayurvedic products. List of these pharmaceutical manufacturers is enclosed as Annexure.
- (b):  The number of sanctioned posts of Drugs Inspector in CDSCO is 504 which include 419 posts  of  Drugs  Inspector  and  85  posts  of  Drugs  Inspector  (Medical  device).  State-wise information of Drug Inspection Officers is not maintained centrally.
- (c): As informed  by Ministry of Health & Family Welfare, there is no such proposal.
- (d):  For ensuring the quality of products, Pharmaceuticals & Medical Devices Bureau of India (PMBI)  procures  medicines  only  from  World  Health  Organization  -  Good  Manufacturing Practices  (WHO-GMP)  certified  suppliers.  Each  batch  of  drug  is  tested  at  laboratories accredited by 'National Accreditation Board for Testing and Calibration Laboratories' (NABL). Only after passing the quality tests, the medicines are dispatched to Jan Aushadhi Kendras (JAKs).

Central Drugs Standard Control Organization (CDSCO) and Ministry of Health and Family Welfare have taken various measures to ensure quality, efficacy and safety of medicines manufactured in the country. The key measures are as stated below;

- i. In  order  to  assess  the  regulatory  compliance of  drug manufacturing premises in the country, the Central Drugs Standard Control Organization (CDSCO) along with State Drugs Controllers  (SDCs) have conducted  risk-based  inspections  of  more  than  400 premises. The firms have been identified based on risk criteria like number of drugs declared as Not of Standard Quality, complaints, criticality of the products etc. Based on findings of inspections, more than 300 actions like issuance of show cause notices, stop production order, suspension, cancellation of licenses /product licenses etc., have been taken by the State Licensing Authorities as per the provisions of the Drugs Rules 1945.
- ii. Central Government has amended the Drugs Rules 1945 vide G.S.R. 922 (E) dated 28.12.2023 to revise the schedule M to the said rules related to Good Manufacturing Practices  and  requirements  of  premises,  plant  and  equipment  for  pharmaceutical products.  As  per  the  amendment,  the  revised  Good  Manufacturing  Practices  and Requirements shall come into force for manufacturers for implementation as under:
- iii. 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.
- iv. 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.
- v. 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.
- vi. 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.
- vii. States/  UTs  have  set  up  special  Courts  for  trial  of  offences  under  the  Drugs  and Cosmetics Act for speedy disposal.
- viii. 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 some drugs.
- ix. The Drugs and Cosmetics Rules, 1945 have been amended 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.
- x. The Drugs and Cosmetics Rules, 1945 have been amended, making it mandatory that the applicants shall submit evidence of stability, safety of excipients etc. to the State Licensing Authority before grant of manufacturing license by the Authority.
- xi. 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.
- xii. Central government is providing regular Residential, regional training and workshops to CDSCO, State Drug Regulatory Authorities on Good Manufacturing Practices. In the training Financial Year 2023-24 CDSCO has trained 22854 persons while in F.Y 2024-25 so far 13007 persons have been trained.
- xiii. Further, for strengthening the drug regulatory system in the country both at the Central and State level, the Government had approved Rs.1750 Crore. Out of this, Rs. 900 Crore was for strengthening the central drug regulatory structures and Rs. 850 Crore is for the Centrally  Sponsored  Scheme  'Strengthening  of  States'  Drug  Regulatory  System (SSDRS) which envisages to strengthen the laboratory infrastructure and up-gradation of existing State Drug Controller offices in States. So far under the SSDRS scheme, 17 New Drug Testing Labs have been constructed and 24 existing labs have been upgraded.

| Category of manufacturers [Based on turnover (INR)]    | Time line for implementation                               |
|--------------------------------------------------------|------------------------------------------------------------|
| Large manufacturers (Turnover > 250 crores)            | Six months from the date of publication of these rules.    |
| Small and Medium manufacturers (Turnover ≤ 250 crores) | Twelve months from the date of publication of these rules. |

## Annexure referred to in reply to part (a) of the LOK SABHA UNSTARRED Q. No. 1988 for answer on 06.12.2024 raised by Shri Rajesh Ranjan and Dr. Amar Singh regarding Supply of Medicines to Jan Aushadhi Kendras

|   S. No. | Name of the Manufacturer                       | Category   |
|----------|------------------------------------------------|------------|
|        1 | Aculife Healthcare Pvt. Ltd.                   | Private    |
|        2 | Admac Lifesciences                             | Private    |
|        3 | Aegis Lifesceiences Private Limited            | Private    |
|        4 | Affy Parenterals                               | Private    |
|        5 | Agio Pharmaceuticals Ltd.                      | Private    |
|        6 | Aishwarya Healthcare                           | Private    |
|        7 | Ak Health Tech Private Limited                 | Private    |
|        8 | Akums Drugs &Pharmaceuticals Limited (Plant-1) | Private    |
|        9 | All Heavens Exim                               | Private    |
|       10 | Amkay Products Pvt. Ltd.                       | Private    |
|       11 | Andhra Pradesh Medtech Zone Limited            | SPSU       |
|       12 | Asoj Soft Caps Pvt. Ltd                        | Private    |
|       13 | Bajaj Healthcare Limited                       | Private    |
|       14 | Bal Pharma Ltd.                                | Private    |
|       15 | Bdr Pharmaceuticals International Pvt. Ltd.    | Private    |
|       16 | Bharat Parentral Ltd                           | Private    |
|       17 | Bharti Milk Foods Pvt Ltd                      | Private    |
|       18 | Biocon Biologics Limited                       | Private    |
|       19 | Biodeal Pharmaceuticals Limited                | Private    |
|       20 | Biogenix Inc Pvt. Ltd.                         | Private    |
|       21 | Biological E Limited                           | Private    |
|       22 | Brisk Surgicals Cotton Limited                 | Private    |
|       23 | Briyosis Soft Caps Private Limited             | Private    |
|       24 | Cadila Pharmaceuticals Ltd.                    | Private    |
|       25 | Care Medical Devices Limited                   | Private    |
|       26 | Centaur Pharmaceuticals Pvt. Ltd.              | Private    |
|       27 | Centurion Remedies Pvt. Ltd.                   | Private    |
|       28 | Cian Healthcare Pvt. Ltd.                      | Private    |
|       29 | Cipco Pharmaceuticals                          | Private    |
|       30 | Cipla Limited                                  | Private    |
|       31 | Cmg Biotech Pvt. Ltd.                          | Private    |
|       32 | Concept Pharmaceuticals Ltd                    | Private    |
|       33 | Consern Pharma Ltd.                            | Private    |
|       34 | Continental Milkose (India) Limited            | Private    |
|       35 | Coral Laboratories Ltd                         | Private    |
|       36 | Crescenzia Wellness Private Limited            | Private    |

|   37 | Cupid Limited                                       | Private   |
|------|-----------------------------------------------------|-----------|
|   38 | Daffodills Pharmaceuticals Ltd.                     | Private   |
|   39 | Divine Laboratories Pvt Ltd                         | Private   |
|   40 | Dynamic Techno Medicals Private Limited             | Private   |
|   41 | East African (India) Overseas                       | Private   |
|   42 | Elnova Pharma                                       | Private   |
|   43 | Eris Lifesciences Limited                           | Private   |
|   44 | Eskag Pharma Pvt.Ltd                                | Private   |
|   45 | Essenzaa Nutrition Pvt. Ltd.                        | Private   |
|   46 | Eucare Pharmaceuticals Pvt Ltd                      | Private   |
|   47 | Fdc Limited                                         | Private   |
|   48 | Fertin India Private Limited                        | Private   |
|   49 | Geno Pharmaceuticals Pvt Ltd                        | Private   |
|   50 | Gentech Healthcare Pvt. Ltd.                        | Private   |
|   51 | Globela Pharma Pvt. Ltd.                            | Private   |
|   52 | Gls Pharma Ltd                                      | Private   |
|   53 | Gnosis Pharmaceuticals Pvt Ltd                      | Private   |
|   54 | Hab Pharmaceuticals &Research Ltd.                  | Private   |
|   55 | Halewood Laboratories Pvt. Ltd.                     | Private   |
|   56 | Haseeb Pharmaceuticals Pvt. Ltd.                    | Private   |
|   57 | Health Biotech Limited                              | Private   |
|   58 | Healthium Medtech Limited                           | Private   |
|   59 | Healthy Life Pharma Pvt. Ltd.                       | Private   |
|   60 | Hetero Healthcare Limited                           | Private   |
|   61 | Hi Care Gloves Pvt Ltd                              | Private   |
|   62 | Hindustan Antibiotics Ltd                           | CPSU      |
|   63 | Hindustan Laboratories Limited                      | Private   |
|   64 | Imperial Medcare Private Limited                    | Private   |
|   65 | Indian Medicines Pharmaceutical Corporation Limited | CPSU      |
|   66 | Innova Captab Limited                               | Private   |
|   67 | Innovative Linen Co. Pvt. Ltd.                      | Private   |
|   68 | Integrated Laboratories Pvt. Ltd.                   | Private   |
|   69 | Inventia Healthcare Limited                         | Private   |
|   70 | Iscon Surgicals Ltd.                                | Private   |
|   71 | J Duncan Healthcare Pvt Ltd                         | Private   |
|   72 | Jajoo Surgicals Pvt. Ltd.                           | Private   |
|   73 | K.A.Enterprises                                     | Private   |
|   74 | K.S. Surgical Pvt. Ltd.                             | Private   |
|   75 | Kag Industries                                      | Private   |
|   76 | Karnataka Antibiotics And Pharmaceuticals Limited   | CPSU      |
|   77 | Kms Manufacturing Company                           | Private   |
|   78 | Laborate Pharmaceuticals India Limited              | Private   |
|   79 | Lark Laboratories (India) Ltd.                      | Private   |

|   80 | Legency Remedies Pvt Ltd               | Private   |
|------|----------------------------------------|-----------|
|   81 | Logos Pharma                           | Private   |
|   82 | Lokbeta Pharmaceuticals (I) Pvt Ltd    | Private   |
|   83 | Lupin Ltd.                             | Private   |
|   84 | MDHygiene Pvt. Ltd                     | Private   |
|   85 | Maan Pharmaceuticals Ltd               | Private   |
|   86 | Macleods Pharmaceuticals Limited       | Private   |
|   87 | Macsur Pharmaa (India) Private Ltd     | Private   |
|   88 | Mahalaxmi Malt Products Pvt. Ltd.      | Private   |
|   89 | Malik Lifesciences Private Limited     | Private   |
|   90 | Mancare Laboratories Pvt. Ltd.         | Private   |
|   91 | Mankind Pharma Limited                 | Private   |
|   92 | Marc Laboratories Limited              | Private   |
|   93 | Martin And Brown Biosciences Pvt. Ltd. | Private   |
|   94 | Maruti Meditech Pvt Ltd                | Private   |
|   95 | Mascot Health Series Pvt. Ltd          | Private   |
|   96 | Matins Healthcare Pvt Ltd              | Private   |
|   97 | Maxtar Bio-Genics                      | Private   |
|   98 | Med Manor Organics Pvt. Ltd.           | Private   |
|   99 | Medevis Rubplast India Private Ltd     | Private   |
|  100 | Medipol Pharmaceuticals India Pvt Ltd  | Private   |
|  101 | Mepromax Lifesciences Pvt Ltd          | Private   |
|  102 | Merril Pharma Pvt. Ltd.                | Private   |
|  103 | Mformillet Foods Private Limited       | Private   |
|  104 | Mgrm Medicare Pvt. Ltd.                | Private   |
|  105 | Micron Pharmaceuticals                 | Private   |
|  106 | Micropure Parenterals Pvt Ltd          | Private   |
|  107 | Midas Care Pharmaceuticals Pvt. Ltd.   | Private   |
|  108 | Mj Biopharm Pvt Ltd                    | Private   |
|  109 | Modern Laboratories                    | Private   |
|  110 | Morepen Laboratories Limited           | Private   |
|  111 | Msn Laboratories Private Limited       | Private   |
|  112 | Multani Pharmaceuticals Ltd            | Private   |
|  113 | Nandani Medical Laboratories Pvt. Ltd. | Private   |
|  114 | Nanz Medscience Pharma Pvt. Ltd.       | Private   |
|  115 | Naprod Life Sciences Pvt. Ltd          | Private   |
|  116 | Naulakha Industries                    | Private   |
|  117 | Navkar Lifesciences                    | Private   |
|  118 | Nem Laboratories Private Limited       | Private   |
|  119 | Nutrizo Advancis Healthcare Pvt Ltd    | Private   |
|  120 | Om Sai Pharma Pack                     | Private   |
|  121 | Omega Pharma                           | Private   |
|  122 | Optimus Pharma Pvt. Ltd.               | Private   |

|   123 | Overseas Health Care Pvt. Ltd.               | Private   |
|-------|----------------------------------------------|-----------|
|   124 | P. Bhogilal Pvt. Ltd.                        | Private   |
|   125 | Paramount Surgimed Limited                   | Private   |
|   126 | Penta Kraft                                  | Private   |
|   127 | Penta Latex Llp                              | Private   |
|   128 | Perfect Surgicare Industries Private Limited | Private   |
|   129 | Pharma Impex Laboratories Pvt. Ltd.          | Private   |
|   130 | Pharose Remedies Ltd.                        | Private   |
|   131 | Polestar Power Industries                    | Private   |
|   132 | Pontika Aerotech Ltd.                        | Private   |
|   133 | Precise Chemipharma Pvt Ltd                  | Private   |
|   134 | Preet Remedies Ltd.                          | Private   |
|   135 | Proactive Health Inc                         | Private   |
|   136 | Prochem Pharmaceuticals Pvt. Ltd.            | Private   |
|   137 | Pulse Pharma Pvt. Ltd.                       | Private   |
|   138 | Pure &Cure Healthcare Pvt. Ltd.              | Private   |
|   139 | Ravenbhel Healthcare Pvt. Ltd.               | Private   |
|   140 | Ravian Life Science Pvt. Ltd.                | Private   |
|   141 | Regent Ajanta Biotech                        | Private   |
|   142 | Reliance Formulation Pvt. Ltd.               | Private   |
|   143 | Relief Biotech Pvt. Ltd.                     | Private   |
|   144 | Renown Pharmaceuticals Pvt. Ltd.             | Private   |
|   145 | Revat Laboratories Pvt. Ltd.                 | Private   |
|   146 | Rhydburg Pharmaceuticals Limited             | Private   |
|   147 | Rivpra Formulation Pvt Ltd                   | Private   |
|   148 | Rv Lifesciences Limited                      | Private   |
|   149 | Saar Biotech Pvt. Ltd.                       | Private   |
|   150 | Sai Parenterals Limited                      | Private   |
|   151 | Saimirra Innopharm Pvt. Ltd.                 | Private   |
|   152 | Saksham Life                                 | Private   |
|   153 | Salud Care (India) Limited                   | Private   |
|   154 | Samarth Life Sciences Pvt. Ltd.              | Private   |
|   155 | Sance Laboratories Pvt. Ltd.                 | Private   |
|   156 | Savi Health Science                          | Private   |
|   157 | Sekhani Industries Private Limited           | Private   |
|   158 | Shamshree Lifesciences Limited               | Private   |
|   159 | Sharda Health Care Private Limited           | Private   |
|   160 | Shine Pharmaceuticals Ltd.                   | Private   |
|   161 | Shivalik Remedies Private Limited            | Private   |
|   162 | Shourya Hygienes                             | Private   |
|   163 | Shree Radhe Hygiene Products Pvt. Ltd.       | Private   |
|   164 | Signature Phytochemical Industries           | Private   |
|   165 | Smart Hygeia                                 | Private   |

|   166 | Smilax Healthcare Drug Company            | Private   |
|-------|-------------------------------------------|-----------|
|   167 | Spm Medicare Pvt Ltd                      | Private   |
|   168 | Sterimed Medical Devices Pvt. Ltd.        | Private   |
|   169 | Sterimed Surgicals (India) Pvt. Ltd.      | Private   |
|   170 | Suncare Formulations Pvt Ltd              | Private   |
|   171 | Sunlife Sciences                          | Private   |
|   172 | Suparshva Swabs (I) Limited               | Private   |
|   173 | Supermax Drugs &Pharmaceuticals Pvt. Ltd. | Private   |
|   174 | Susheel Yarns Pvt. Ltd.                   | Private   |
|   175 | Swear Healthcare Private Limited          | Private   |
|   176 | Swiss Garnier Life Sciences               | Private   |
|   177 | Swiss Garniers Biotech Private Limited    | Private   |
|   178 | Synmedic Laboratories                     | Private   |
|   179 | Synokem Pharmaceuticals Limited           | Private   |
|   180 | Systochem Laboratories Ltd                | Private   |
|   181 | Tablets (India) Limited                   | Private   |
|   182 | Themis Medicare Limited                   | Private   |
|   183 | Theon Pharmaceuticals Limited             | Private   |
|   184 | Tirupati Medicare Ltd.                    | Private   |
|   185 | Tmt Med Source                            | Private   |
|   186 | Ultra Drugs Pvt. Ltd. (Unit-Ii)           | Private   |
|   187 | Unicure India Ltd.                        | Private   |
|   188 | Unimarck Healthcare Ltd                   | Private   |
|   189 | Universal Prophylactic Pvt. Ltd.          | Private   |
|   190 | Vaishali Hygiene Products                 | Private   |
|   191 | Venus Remedies Limited                    | Private   |
|   192 | Vidhyasha Pharmaceutical                  | Private   |
|   193 | Vidit Healthcare                          | Private   |
|   194 | Vivimed Labs Ltd.                         | Private   |
|   195 | Wallace Pharmaceuticals Pvt Ltd           | Private   |
|   196 | Windlas Biotech Limited                   | Private   |
|   197 | Wings Biotech Llp                         | Private   |
|   198 | Wockhardt Limited                         | Private   |
|   199 | Yacca Lifesciences Pvt. Ltd.              | Private   |
|   200 | Yacca Pharmaceuticals Pvt Ltd             | Private   |
|   201 | Zee Laboratories Ltd.                     | Private   |
|   202 | Zenith Drugs Pvt. Ltd.                    | Private   |
|   203 | Zeon Lifesciences Limited,                | Private   |
|   204 | Zest Pharma                               | Private   |
|   205 | Zim Laboratories Limited                  | Private   |
|   206 | Zydus Lifesciences Limited                | Private   |