Lok Sabha Question No. 3122 (UNSTARRED), answered on 2024-12-13
Subject: Quality and Effectiveness of CGHS Medicines
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Shri Lumbaram Choudhary

## GOVERNMENTOFINDIA MINISTRY OFHEALTH AND FAMILY WELFARE DEPARTMENTOFHEALTH AND FAMILY WELFARE

## LOK SABHA UNSTARRED QUESTION NO. 3122 TO BE ANSWERED ON 13 TH DECEMBER, 2024

## QUALITYANDEFFECTIVENESSOFCGHSMEDICINES

## 3122. SHRI LUMBARAM:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

- (a) whether Central Drug Standards Control Organisation and any other reputed or Government institution check the standards of Allopathy, Homoeopathy, Ayurvedic and Unani medicines being supplied to the beneficiaries of the CGHS Wellness Centres;
- (b) if so, the details of the sub standard medicines found during the last three years with their manufacturers along with the measures being taken to improve the quality and effectiveness of the medicines being supplied through CGHS Wellness Centres; and
- (c) if not, the reasons therefor?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILYWELFARE (SHRI PRATAPRAO JADHAV)

(a) to (c) Central Drug Standard Control Organisation (CDSCO), other reputed institutes and NABL accredited Labs, check the standards of Allopathic medicines, through the system of sample collection and subsequent lab testing.

In Homeopathy, the Homoeopathic Medical Store Depot (HMSD) ensures quality by sourcing medicines from CGHS-approved firms with lab reports from accredited labs. The Homoeopathic Medicine Inspection Team verifies compliance with Homoeopathic Pharmacopeia of India (HPI) standards. Batches failing to meet standards undergo further testing, ensuring only approved medicines are accepted.

In Ayurveda, the manufacturers supplying Ayurvedic medicines to the CGHS Ayurvedic Medical Store Depot (AMSD) are WHO-GMP/COPP or QCI certified. Each batch is tested at government-approved NABL accredited laboratories to ensure quality.

In Unani, CGHS procures GMP-certified Unani medicines and ensures quality by obtaining in-house analytical reports and quality analysis from government-approved or NABL accredited labs. These reports test for identity, purity, quality, and strength as per the Unani Pharmacopeia.

The list of substandard medicines found during last three years is annexed at Annexure . Government has taken following measures to improve quality and effectiveness of the medicines being supplied through CGHS Wellness Centers:

(i) Effective grievance system within CGHS, allowing patients to raise issues related to medicines, with prompt action taken to address and resolve their concerns.

(ii) Medical Store Organization (MSO), a central procuring agency, ensures the procurement of safe, high-quality products by mitigating risks like substandard or counterfeit goods. It involves inspections at key stages like pre-dispatch, receipt, and post-installation and are conducted by qualified personnel to verify compliance with contract specifications. Findings are documented in Inspection Reports, which are used for record-keeping and payment authorization.

(iii) Details of quality assurance of Jan Aushadhi medicines are as under:

(a) Pharmaceuticals & Medical Devices Bureau of India (PMBI) investigates product complaints and reviews control samples.

(b) Random sampling from Jan Aushadhi Kendras and warehouses is conducted, with retesting in NABL labs.

(c) Corrective and preventive actions (CAPA) are taken as necessary.

(d) PMBI has started a comparative study between branded and Jan Aushadhi generic products.

(e) Not of Standard Quality (NSQ) rate for open market medicines is 3.70%, while PMBI products maintain a rate of 0.34%.

(iv) High value restricted medicines are procured on case-to-case basis from rate contracted manufacturers who have in-house lab testing facility for products, DCGI approval and Good Manufacturing Practices (GMP) certificate, etc.

## List of substandard medicines found during last three years

|   S.No. | Medicine Name                                 | Batch No.       | Source of Procurement   | Manufacturer                         |
|---------|-----------------------------------------------|-----------------|-------------------------|--------------------------------------|
|       1 | Ramipril 5 mg                                 | RMFT901         | GMSD                    | Unicure India Ltd                    |
|       2 | Methylcobalmin 500 mcg                        | MBT904          | GMSD                    | Unicure India Ltd                    |
|       3 | Omeprazole 20 mg Cap                          | GM20126         | GMSD                    | SKYMAP PHARMACEUTICAL                |
|       4 | Enalpril 2.5 mg Tab                           | GB21079         | GMSD                    | ORTIN                                |
|       5 | Tab Lorazpam 1MG                              | TLRZ-013        | GMSD                    | Medipol Pharma India                 |
|       6 | Ranitidine 150 mg                             | NSTX 11         | GMSD                    | HAL                                  |
|       7 | Sertaline 50 mg                               | GM20105         | GMSD                    | SKYMAPPHARMA                         |
|       8 | Tab Ascorbic Acid 500mg                       | VATZ02          | GMSD                    | HAL                                  |
|       9 | Acebrophylline 100 mg                         | PF8AA04         | GMSD                    | Pure& cure health                    |
|      10 | Tab Fenofibrate 160 mg                        | MG22007         | GMSD                    | LABORATOIRES GRIFFON                 |
|      11 | Tacrolimus cream 0.03%                        | HT0203          | GMSD                    | MED MANOR ORGANICS                   |
|      12 | Tab Divalpoex Sod. 500 mg                     | PF8A019         | GMSD                    | Pure &Cure                           |
|      13 | Tab LMethyl Folate 7.5 mg                     | PF8CY03         | GMSD                    | Pure &Cure                           |
|      14 | Sy.Paracetamol                                | HVEZ01          | GMSD                    | HAL                                  |
|      15 | Gabapentin 300 mg                             | 22SIGTB467      | GMSD                    | Unicure India Ltd                    |
|      16 | Olmesartan 40 mg                              | GT221831        | GMSD                    | THEON PHARMA                         |
|      17 | Folic Acid 5 mg                               | T112005         | GMSD                    | ANG LIFESCIENCE                      |
|      18 | Rosuvastatin +Vit.D3 10+1000 IU               | 22SIGTA576      | GMSD                    | SYNOKEM PHARMA                       |
|      19 | Bromelain+Rutoside+Trypsin 180+200+96         | PF8CC12         | GMSD                    | Pure &Cure                           |
|      20 | Cetirizine Syp.                               | L042301 L042302 | GMSD                    | Bengal Chemicals Pharmaceuticals Ltd |
|      21 | Diacerein 50mg (G02023)                       | DCT1102         | GMSD                    | Unicure India Ltd                    |
|      22 | Losartan 25MG (G12047)                        | 3803821         | GMSD                    | KAPL                                 |
|      23 | Amlodipine And Perindopril 5mg + 4mg (G12169) | K2102200        | GMSD                    | INTAS                                |
|      24 | Ranitidine 150 mg                             | 0403423         | GMSD                    | KAPL                                 |
|      25 | Clopidogrel 75 mg                             | T2405299        | GMSD                    | Ribpra Formulation                   |
|      26 | Ethamsylate 500 mg                            | ELT1104         | GMSD                    | Unicure India Ltd                    |
|      27 | Fexofenadine 120 mg                           | MP9AA2303       | GMSD                    | Maxtar Boigenics                     |
|      28 | Hydroxychloroquine Sulphate 200 mg            | HCQ09E24        | GMSD                    | Bajaj Healthcare Ltd                 |
|      29 | Methylcoblamin 500 mcg                        | MBT904          | GMSD                    | Unicure India Ltd                    |

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## ANNEXURE