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REGULATORY GUIDELINES FOR SAMPLING OF DRUGS, COSMETICS & MEDICAL DEVICES BY DRUGS INSPECTORS OF CENTRAL & STATE DRUG AUTHORITIES

Version 00

Central Drugs Standard Control Organization Directorate General of Health Services Ministry of Health & Family Welfare Government of India

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Index

1. Introduction
2. Sampling Plan
3. Selection of Sample
4. Selection of Sampling Location
5. Number of Samples
6. Quantity of Samples
7. Timelines
8. Database/ Monitoring
9. NSQ / Spurious Alerts
10. Testing Laboratories
11. Annexures 1-5

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1. Introduction
   Good quality medicines are essential for efficient disease management. Not of standard Quality (NSQ) and Spurious drugs can cause treatment failure and adverse reactions, increase morbidity and mortality, and contribute to the development of drug resistance. Vulnerable populations and patients with co-morbidities are at particular risk of being harmed from receiving substandard or spurious medicines. Poor-quality medicines also increase health care costs to both patients and the health system as a whole, wasting resources that could otherwise be used to benefit public health.

Drugs regulation in India is a complex process, where one side approval of new drugs, issuance of manufacturing license, wholesale license, retail license and their renewal/ retention are carried out by central and state regulatory authorities, which involves assessment of product technical documentation, inspection to ascertain manufacturers’ compliance with the principles of Good Manufacturing Practices (GMP) and approval or issuance of approval & license as per Drugs & Cosmetics Act and Rules there under. Other side it also includes post-marketing surveillance (PMS) activities, such as maintenance of Market authorization/ registration through Post approval changes (PAC) for Biologicals, regular inspections of manufacturers, wholesalers and retailers, quality control testing, pharmacovigilance, routine sampling of products from the distribution channel and implementation of regulatory actions in the event of any quality problem reported to Drug Regulatory Authorities.

In general, sampling is carried out to assess the quality of drugs, cosmetic provided to patients and generate the data that can help to formulate strategies and plans to ensure the continuous availability of good quality products in the market. Sampling also confirms that patients are receiving satisfactory products and give reassurance that the regulatory system of the country is functional, or when there is a suspicion that patients are not receiving satisfactory medicines.

The Section 22 & 23 of the Drugs & Cosmetics Act 1940 prescribes the detail procedure for samples to be taken by Drugs Inspectors of Central and State drugs control as a part of routine drugs quality surveillance. Drugs sampling are costly tasks and limitations of resources may restrict the number of samples collected, parameters tested, techniques to be used for analysis or number of Drugs Inspector & Laboratory available to conduct the sampling and analysis respectively. Therefore, it is important to optimize the use of resources by focusing on parameters that pose a higher risk to patients and apply risk analysis during planning of the sampling.

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From the past trends it is observed that there is no defined methodology for sample selection & location of sampling etc and was done randomly with the individual knowledge of Drug Inspectors. Often it was seen that sampled drugs are from big brands and collected from urban locations or sub urban locations only. The interior locations or rural distributions are not covered and thereby quality of drugs at distant user/ last user was not being assessed. Cosmetics samples were not collected in some regions. There is no centralize database of sale outlets where NSQ / Spurious product were reported, such identified outlets are to be kept for regular vigilance.

The main objective of the sampling is to check the quality & efficacy of drugs & cosmetic available in the market with their approved specifications. This involves:  Monitoring the quality of the API, Excipients and finished products of drugs, cosmetic and medical devices in all parts of the distribution chain throughout the authorised shelf-life.  Ensuring that existing control methods are satisfactory.  Investigating the Not of Standard Quality (NSQ) Product.  Identifying Unapproved Products/ Without License sales outlets.  Identifying Spurious drugs in distribution chain
 Identifying sales outlets where repetitive NSQ/ Spurious drugs are reported etc. This guideline is mainly focused to utilize available information & identified risks for selection of sample & location to cover vast variety of drugs, cosmetic and medical devices moving in the market from manufacturing facility, wholesale outlet, retail outlet, government distribution channel etc. in urban, sub-urban, and rural locations. To maintain a centralized monthly NSQ/Spurious drug list and publishing on CDSCO website to avoid their further use.

This guideline will be useful for effective surveillance for quality & efficacy of drugs & cosmetic available in the market by adopting uniform drug sampling methodology for drugs inspectors under drug regulatory authorities of state and central.

2. Sampling Plan: Each drugs inspector with consultation of his controlling authority shall prepare a sampling plan on monthly basis & annual basis for finalizing the sampling locations to cover the entire jurisdiction/ area under their office.This will avoid communication gap between the officers and optimum utilization of resource to cover the maximum territory and all kind of product category with identified risk and approached under this guidance document. Sampling plan shall include rural/ tribal areas and drugs used in areas of endemic for certain diseases, drugs for seasonal diseases etc.,

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The annual sampling plan shall be shared with their headquarters of their offices for review and to avoid any repetitive sampling of one brand and to cover maximum variety of brand/category in proposed sampling schedule.

3. Selection of sample: The selection of sample will depend on various factors, which may indicate possible higher risk to the quality of drug. The Drugs Inspectors shall draw samples of different therapeutic categories, different formulations, and different manufacturers from a one sales outlet by applying following identified risks, it is not exhaustive and is only indicative. a. Feedback/information from citizens, Healthcare professionals. Products on which efficacy information is received during interaction with Doctors/Medical Representatives / Chemists / Pharmacists / Consumers / Media /Public Domain.
   b. Sampling schedule provided by CDSCO for specific therapeutic category drugs in specific months (Yearly Joint Surprise Check schedule provided by CDSCO). c. Use of Drugs Alert of CDSCO and State Drug Authorities for detail of frequent NSQ/ Spurious drugs and their manufacturing & sales outlets. d. Seasonal changes in environmental conditions may have an influence on the quality of the medicine collected. It is possible that Spurious of antimalarial are more common during the malaria season and so on.
   e. Brands of the same product sold at different prices and aimed at different market segments. f. Drugs found procured or sold at huge discounts (in deviation to ethical market practices) g. Products with high consumption volumes. h. Products having low potency and narrow therapeutic index. i. Drugs found with tampered label. j. Products which are sold during specific seasons or pandemic. k. Information from various disease control programmes can be used like National Programs for De-worming, Universal vaccination etc. l. Drugs manufactured by new manufacturers. m. Products which are labeled / printed in suspicious manner. e.g. lack of required details, mistakes in spelling, illegible description etc. n. Drugs with poor quality of primary packing (packing that comes indirect contact with the dosage form depending on the season and Products whose packing gives rise to suspicion of being low quality. o. Products with one or more visible defects. p. Brands which appears to be same/resemblance of other well-known or established brands.

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q. Drugs for which proper purchase/sale record is not maintained (No purchase bills/ Batch Number or Date of Manufacturing or Expiry does not tally with the bill/ proper sale record not maintained especially if it is a wholesale concern). r. Drugs that are usually sold/distributed to specific perceivably doctor attached counters and are not available in general counters. s. Products which are in supply chain from different route other than regular/ authorize supply chain of manufacturer i.e. Super Stockiest – Stockiest – Wholesaler – Retailer. t. Inter-State purchase by the whole seller or retailer and other than regular/ authorize supply chain of manufacturer.

The Drugs Inspector shall ensure that at least all the above identified risks are utilized in his sampling activities of 06 months. Further, not more than 03 samples are collected from one sale outlet and excess sampling, if any reasons shall be recorded and approved by the controlling authority.

4. Selection of Sampling Location: The sampling location can be identified by applying following approaches; it is not exhaustive and is only indicative; a. Frequent NSQ reports b. Market complaints c. Manufacturing and sales locations not yet sampled or last sampling was done more than 01 years before by state or central drugs inspector. d. Government Medical Store Depot. e. Private/Public Sector manufacturing firms. f. State, Central Government Hospitals/Institutes having local purchase by the Hospital/Institute. g. Wholesale/Retail sales premises. h. Sale outlets having operation in morning and evening hours only. i. Sales outlet located nearby school & colleges. j. Sales outlet situated at border areas of district, state, and country. k. Prevalence of the disease in region & season for which the target medicines are indicated. l. Complexity of manufacturing, m. Stability of the medicine – risk of quality deterioration under local conditions of storage, distribution and use. n. Non-Compliance of manufacturers of the target medicines with GMP principles.

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o. Complexity of distribution chain for the target medicines and likelihood of non- compliance with good distribution practices (GDP) principles and approved storage conditions during distribution and storage.

5. Number of Samples: Each Drugs Inspector shall collect samples under the provision specified in the Section 22 & 23 of the Drugs & Cosmetics Act 1940. Each Drugs Inspector shall collect at least 10 samples in a month comprising of following;
   a. 09 samples of drugs (API, Excipient and Formulations) b. 01 sample of cosmetics/ Medical Device.

6. Quantity of samples It is important that sufficient quantity of samples are collected & forwarded to laboratory so that all the parameters are tested and re-testing, if any required by laboratory before issuing of NSQ test report. The quantity of samples also varies with type of samples like API, Formulations (Tablets, Capsules, Liquid Oral, Injectable, Large Volume Parenteral, Ointment, Lotions etc), Cosmetics, medical devices etc., Please refer Annexure 1-5 for quantity required for testing of various sample product category.

Sometime, retail outlets or rural sale outlet are not having sufficient quantity for complete testing and it become challenge to divide & pack sample in four equal portions. In this situation priority shall be given for tests like identification and assay under reduced testing to rule out spurious products. In such cases the sample portion can be divided in 02 equal portion preferably both with primary/secondary labels (one portion for Government analyst and other for producing in the court) and remaining 02 portions sufficient for performing reduced testing. This information shall be recorded in respective forms under Drugs, Cosmetics & Medical Devices Rules and covering letter to respective Government Analyst, where sample is sent for testing for reduced testing i.e. identification and assay only due to non-availability of full quantity.

7. Timelines: It is important to avoid any procedure delay in testing and obtaining of test report from the laboratory, so that further use of identified NSQ products are stopped by issuing drug alert and product recall notice at the earliest for public awareness, irrespective to proceeding of Drugs Inspector as per provision under Drugs & Cosmetic Act & Rules there under. Following timelines are to be followed;

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a. The Drugs Inspector shall plan the sampling in such a way that samples are forwarded to laboratory on the same day of sampling. b. If delay happens due to transit from rural location or distant location to office, then sample shall be forwarded to laboratory by next day and not later than that.
c. The disclosure under section 18A of Drugs & Cosmetics Act & Rules there under for Name, Address, copy of purchase invoice and other particulars of the person from whom he acquired the drug or cosmetic shall be obtained during sampling to rule out the possibility of Spurious drug. Further distribution chain establishment up to manufacturer level under section 18A of Drugs and Cosmetics Act is to be completed for all samples. This will be helpful to ensure the availability of true product in the market and also to initiate quick actions for NSQ product declared by the Government Analyst. d. The Drugs Inspector shall obtain the method of analysis & reference/working standards from manufacturer for sample belongs to patent & proprietary drugs or new drugs, without waiting for communication from laboratory and shall provide to the laboratory for timely testing of the product. e. The head of state and central laboratories shall forward NSQ reports in excel sheet format as per Para 9 with copy of test report preferably before 10th of every month for uploading at CDSCO website under Drug/Device/Cosmetic NSQ Alert for vide public awareness.
f. The head of the field offices of the State and central drug authorities shall forward the monthly spurious alert as per following excel sheet format as per Para 9 for uploading at CDSCO website under Spurious Drug/Device/Cosmetic Alert for vide Public Awareness preferably before 10th of every month.

NOTE: CDSCO Drug Inspectors shall use SUGAM Lab Portal for generation of Form-17/ Form-17A/ Form-18 and forwarding through online (forms only) & offline (printed forms & samples) to the concerned laboratory.

8. Database / Monitoring: Each Drugs Inspector shall maintain data of sampling and shall submit to their controlling authority on monthly basis for execution of sampling plan. The inputs from the monthly data of sampling shall be used for planning of next month’s sampling plan. Following information are to be maintained; a. Number of samples drawn and their process completion up to test report from laboratory and chain establishment up to manufacturer level.

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b. Number of NSQs reported by laboratory and their action taken (Drugs Alert, Product Recall, Proposal to controlling Authority for Admin/Legal Action, Completed Action like Suspension /Cancellation of license, Court Cases Number etc.) c. The cases of Spurious products reported by laboratory in test report or identified under chain establishment up to manufacturer by the Drugs Inspectors and their action taken (Drugs Alert indicating all the locations, Product Recall / Seizure, Number of Arrest, Proposal to controlling Authority for Legal Action, Court Cases No.).

Each Drug Controlling office shall prepare a list on monthly basis for Wholesale/retail outlet with name of registered pharmacist and owner where Spurious products are reported/ distribution chain is broken for the provided invoice.

The above list shall be shared to their head office for preparation of centralized list of wholesaler / retailer outlets revealed in sale/distribution of Spurious products and to give wide publicity for public to avoid use of purchased medicine from these outlets.

9. NSQ / Spurious Alerts: The NSQ reports received from state and central laboratories shall be reported in following excel sheet format with copy of test report preferably before 10th of every month for uploading at CDSCO website under Drug/Device/Cosmetic NSQ Alert for vide public awareness.

NSQ Alert for month……… Sr. No. Product / Drug Name B. No. Manufacturing date Expiry Date Manufa ctured By NSQ Results Reported by CDSCO/ State Lab 1.

The samples identified as Spurious due to distribution chain breakage or reported by the manufacturer as Spurious shall be reported in following excel sheet format with copy of Drugs Inspector report indicating distribution chain break with manufacturer response indicating how to identify original product from reported Spurious. The head of the field offices of the State and central drug authorities shall forward the monthly spurious alert as per following excel sheet format for uploading at CDSCO website under Spurious Drug/Device/Cosmetic Alert for vide Public Awareness preferably before 10th of every month.

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Spurious Alert for month…….

Sr. No. Product / Drug Name B. No . Manufacturi ng/Expiry Date Manufact ured By as per Label Sale Outlets Involved in distribution of Spurious Drug (Name & Address of outlet with Pin code and Pharmacist Name with Registration number) Response of Original Manufacture r stating how to identify the original product from reported Spurious product Reported by CDSCO/ State/ Manufact urer 1.

1. Sampled At

4.Detail disclosed in Invoice is not verifiable due to non-existence of firm/address and supply chain broke.

11. Testing Laboratories: Detail of Notified laboratories for Drugs, Cosmetics and Medical device at central and state level is already available in Rules and notification/ letters circulated time to time.

States which are not having their own testing laboratories has notified Central Drugs Testing laboratories and Central labs are testing samples of state drugs inspectors.

In some quality complaint cases where state is neither have their own laboratory nor notified central laboratory for specific product category etc. shall request the respective CDSCO field office for sampling by the CDSCO inspector for sampling.

Recently, G.S.R 409(E) dated 2nd June, 2023-Medical Devices (Amendment) Rules, 2023 “State medical Devices Testing Laboratory” means a medical devices laboratory established or designated by the State Government under sub-rule (3) of rule 19”.
Central Medical Device Testing Laboratory (CMDTL) for testing of Medical Devices under MDR 2017. Total 6 CMDTL are notified by MOH&FW under MDR 2017 for testing of devices in the country as per S.O 2237(E) dated 1st June 2018.

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S.No Name of Laboratory
Category of medical device
1
The National Institute of Biologicals, Noida
In-Vitro Diagnostics for human Immunodeficiency virus, Hepatitis B Surface Antigen and Hepatitis C Virus, Blood Grouping sera, Glucose Test Strip, Fully Automated Analyser Based Glucose Reagent
2
The Central Drugs Testing laboratory, Chennai
Condoms
3
The Central Drugs Laboratory, Kolkata
Surgical Dressings, Surgical Cotton, Surgical Bandages, Disinfectant
4
The Regional Drugs Testing Laboratory (RDTL), Guwahati
Disposable Hypodermic Syringes, Disposable Hypodermic Needle, Disposable Perfusion Sets, I.V. Cannulae
5
The Central Drugs Testing Laboratory, Mumbai
Intra Uterine Devices (IUD) and Falope Rings
6
The Regional Drugs Testing Laboratory, Chandigarh
Disposable Hypodermic Syringes, Disposable Hypodermic Needles, Disposable Perfusion Sets, Catheters, I.V. Cannulae, Scalp Vein Set, Ligatures, Sutures, Staplers, Surgical Dressing, Umbilical Tapes.”.

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Annexure-1

Quantity of Drugs Sample Required For Complete Analysis S.No. Name of Drug Sample
Form-18 Samples
Survey Samples
1.
Tablets
100 Tablets
20 Tablets
2.
Capsules
100 Capsules
20 Capsules
3.
Syrups / Oral Liquids/ Suspensions
12 Bottles
2 Bottles
4.
Injection (Ampoule) (1-10 ml)
40 Ampoules
10 Ampoules
Injection (Ampoule ) (10-100 ml)
25 Ampoules
10 Ampoules
5.
Large Volume Parentrals ( more than 100 ml )
10 Bottles
2 Bottles
6.
Powder for injection ( Sterile)
40 Vials
5 Vials
7.
Dry Powder for Oral/ Liquid Suspension
25 Bottles
5 Bottles
8.
Oral Rehydration Salt Sachets
30 Pcs
5 Pcs
9.
API Drug
2 x 10 gm
5 gm
10.
Ointment / Creams / Paste / Gel (Non Sterile)
12 Pcs
2Pcs
Ointment / Creams / Paste / Gel (Sterile)
20pcs
5pcs
11.
Eye / Ear Drops
40 Vials/ pcs
5 Vials/ pcs
12.
Nasal Preparation
20 Vials
5 Vials
13.
Inhalers/ Spray
40 Pcs
5 Pcs
14.
Pessaries / Lozenges
60 Pcs
20 Pcs
15.
Empty Gelatine Capsules
500 Capsules
100 Capsules

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Annexure-2

Quantity of Cosmetics Sample Required For Complete Analysis

S.N
Name of Cosmetic Sample
Form-18 Samples
Survey Samples
1.
Skin Cream
3 x 50 gm
1 x 50 gm
2.
Hair Cream
3 x 50 gm
1 x 50 gm
3.
Shampoo
3 x 200 ml
1 x 200 ml
4.
Soap
3 x 150 gm
1 x 150 gm
5.
Transparent Toilet Soap
3 x 150 gm
1 x 150 gm
6.
Tooth Powder
3 x 50 gm
1 x 50 gm
7.
Shaving Cream
3 x 15 gm
1 x 15 gm
8.
Cosmetic Pencil
20 Pencils
5 Pencils
9.
Hair Dyes ( Liquid, Gel & Cream)
3 x 100 ml
1 x 100 ml
10.
Powder Hair Dyes
4 x 20 gm
1 x 20 gm
11.
Liquid Toilet Soap
3 x 100 ml
1 x 100 ml
12.
Bathing Bar
3 x 75 gm
1 x 75 gm
13.
Hair Oil
3 x 50 ml
1 x 50 ml
14.
Lipstick
15 Packs
5 Packs
15.
Nail Polish
15 Packs
5 Packs
16.
Talcum Skin powder
3 Packs
1 Packs
17.
Kajal
10 Packs
1 Packs
18.
Any other cosmetic
3 Packs
1 Packs

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Annexure-3

Quantity of Vaccine Sample Required For Complete Analysis

S.N
Name of Vaccine Sample
Form-18 Samples
1.
Antitoxin / Anti Serum
10 ml x 10 vials / ampoules
1 ml x 50 vials / ampoules
2.
Anti-Snake Venom Serum / Anti Rabies Serum
10 ml x 5 vials / ampoules
5 ml x 10 vials / ampoules
3.
Bacterial Vaccine BCG
10 dose x 50 vials / ampoules/PFS
5 dose x 20 vials / ampoules
10 dose x 10 vials / ampoules
20 dose x 10 vials
10/20 dose x 40 vials
4.
Viral Vaccine OPV
1 dose x 50 vials/ampoules/PFS
5 doses x 20 vials/ ampoules
10 doses x 10 vials/ampoules
20 doses x 20 vials
5.
Blood Products
3 containers of 50 ml above
5 vials of 10 ml each
10 vials of 2 ml each
25 vials of 2 ml each
50 vials of 1 ml each
6.
Surgical Sutures
50 Strands

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Annexure-4 QUANTITY OF BIOLOGICAL/ Medical Devices SAMPLES (*Note: List is for reference purpose only, however please check website of NIB, Noida for current information)
NEW CODE PRODUCT NAME QUANTITY REQUIRED/ BATCH TESTING RETAINED A.1.1 Glucose Reagent- Open Ended Chemistry 500 ml or 1000 Tests with accessories Nil A.1.2 Glucose Reagent- Closed Chemisty System 1000 Tests or Reagent quantity enough for use over 25 working days vis-a-vis on-board shelf life of Reagent with accessories Nil A.2 Blood Glucose Test Strips 1200 Test Strips with accessories 350 Test Strips with accessories A.3 Glucometer Device 10 Nos. with accessories 02 Nos. with accessories B.1 ABD Pad 140 Tests 60 Tests B.2 ABO confirmation card 144 Tests 72 Tests B.3 ABO Rh Typing Card 144 Tests 72 Tests B.4 Anti D (Verification of Weak D by IAT) 2 vials 1 vial B.5 **Anti Kpb Reagent 2 vials 1 vial B.6 Anti-A (Bulk) 1vial 1 vial B.7 Anti-A (Concentrate Bulk) 1vial 1 vial B.8 **Anti-A /B / D /K / control ABO card 144 Tests 72 Tests B.9 Anti-A Monoclonal 2 vials 1 vial B.10 Anti-A1 (Lectin) 2 vials 1 vial B.11 Anti-AB (Monoclonal) 2 vials 1 vial B.12 Anti-B ( Concentrate Bulk) 1 vials 1 vial B.13 Anti-B (Bulk) 1 vials 1 vial B.14 Anti-B (Monoclonal) 2 vials 1 vial B.15 **Anti-Cw Reagent 2 vials 1 vial B.16 Anti-D ( RH1) (Totem) 2 vials 1 vial B.17 Anti-D (IgG) Monoclonal 2 vials 1 vial B.18 Anti-D (IgM) Monoclonal 2 vials 1 vial B.19 Anti-D (IgM)( Bulk) 1vial 1vial B.20 Anti-D (IgM) (Concentrate Bulk) 1vial 1 vial B.21 Anti-D (IgM+IgG) (Bulk) 1vial 1 vial B.22 Anti-D (IgM+IgG) (Concentrate Bulk) 1vial 1 vial B.23 Anti-D (IgM+IgG) Monoclonal 2 vials 1 vial

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B.24 **Anti-Fya Reagent 2 vials 1 vial B.25 **Anti-Fyb Reagent 2 vials 1 vial B.26 Anti-H (Lectin) 2 vials 1 vial B.27 Anti-Human Globulin 2 vials 1 vial B.28 **Anti-Jka Reagent 2 vials 1 vial B.29 **Anti-Jkb Reagent 2 vials 1 vial B.30 **Anti-k Reagent 2 vials 1 vial B.31 **Anti-K Reagent 2 vials 1 vial B.32 **Anti-Kpa Reagent 2 vials 1 vial B.33 **Anti-Lea Reagent 2 vials 1 vial B.34 **Anti-Leb Reagent 2 vials 1 vial B.35 **Anti-M Reagent 2 vials 1 vial B.36 **Anti-N Reagent 2 vials 1 vial B.37 **Anti-Pi Reagent 2 vials 1 vial B.38 **Anti-s Reagent 2 vials 1 vial B.39 **Anti-S Reagent 2 vials 1 vial B.40 Blood Grouping Cards 144 Tests 72 Tests B.41 Blood Grouping Rapid Card Test 144 Tests 72 Tests B.42 Bovine Serum Albumin 2 vials 1 vial B.43 CombiPack ABD Monoclonal Antibody 2 combipack 1 combipack B.44 **Gel Card Anti-M 144 Tests 72 Tests B.45 **Gel Card Anti-N 144 Tests 72 Tests B.46 Gel Card Anti-A1 (Lectin) 144 Tests 72 Tests B.47 **Gel Card Antigen Profile I 144 Tests 72 Tests B.48 **Gel Card Antigen Profile II 144 Tests 72 Tests B.49 **Gel Card Antigen Profile III 144 Tests 72 Tests B.50 Gel Card Anti-H (Lectin) 144 Tests 72 Tests B.51 Gel card for Direct Anti Globulin test 144 Tests 72 Tests B.52 *Gel card for new born 144 Tests 72 Tests B.53 Gel Card forward & reverse grouping 144 Tests 72 Tests B.54 Gel Card forward grouping 144 Tests 72 Tests B.55 Gel Card Rh Subgroups 144 Tests 72 Tests B.56 *Gel Cards ABO/Rh for Newborns DVI Neg/Pos 144 Tests 72 Tests B.57 Gel Cards Anti- A/B/AB/DVI Pos/ DVI Neg/Ctl 144 Tests 72 Tests B.58 Gel Cards Anti-A/B/D/Rh subgroups 144 Tests 72 Tests B.59 **Gel Cards Anti-Cw 144 Tests 72 Tests B.60 Gel Cards Anti-D (Human) 144 Tests 72 Tests B.61 Gel Cards Anti-DVI 144 Tests 72 Tests B.62 **Gel Cards Anti Fya 144 Tests 72 Tests B.63 **Gel Cards Anti Fyb 144 Tests 72 Tests

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B.64 **Gel Cards Anti Jka 144 Tests 72 Tests B.65 **Gel Cards Anti Jkb 144 Tests 72 Tests B.66 **Gel Cards Anti K 144 Tests 72 Tests B.67 **Gel Cards Anti-k 144 Tests 72 Tests B.68 **Gel Cards Anti-Kpa 144 Tests 72 Tests B.69 **Gel Cards Anti-Kpb 144 Tests 72 Tests B.70 **Gel Cards Anti-Lea 144 Tests 72 Tests B.71 **Gel Cards Anti-Leb 144 Tests 72 Tests B.72 **Gel Cards Anti-Lua 144 Tests 72 Tests B.73 **Gel Cards Anti-Lub 144 Tests 72 Tests B.74 **Gel Cards Anti-Pi 144 Tests 72 Tests B.75 **Gel Cards Anti-S 144 Tests 72 Tests B.76 **Gel Cards Anti s 144 Tests 72 Tests B.77 Gel Cards Crossmatch Testing (CT) 144 Tests 72 Tests B.78 Gel Cards Neutral 144 Tests 72 Tests B.79 **Gel Cards Rh subgroups + Cw + K 144 Tests 72 Tests B.80 **Gel Cards Rh subgroups + K 144 Tests 72 Tests B.81 Gel Cards Type + Screen 144 Tests 72 Tests B.82 Microplate for forward & Reverse grouping 144 Tests 72 Tests B.83 *Newborn casette for AntiA/AntiB/ Anti AB/ Anti D/ Control / Anti IgG 144 Tests 72 Tests B.84 Sera/Gel Card for AHG & C3d 144 Tests 72 Tests B.85 Gel cards for Anti-A, B, DVI- /Enzyme/AHG 144 Tests 72 Tests B.86 Gel cards for DAT Anti-IgG- Dilution 144 Tests 72 Tests B.87 Gel cards for LISS/ Coombs + Enzyme Test 144 Tests 72 Tests B.88 Gel cards for DC-Screening I 144 Tests 72 Tests B.89 Gel cards for Reverse Grouping with Antibody Screening 144 Tests 72 Tests B.90 Anti-Human Globulin IgG 2 vials 1 vial B.91 Anti-Human Globulin C3d 2 vials 1 vial B.92 Rh Phenotype Card with Anti-D 144 Tests 72 Tests B.93 Gel card for ABO/Rh for Patients 144 Tests 72 Tests B.94 **Anti-Lua Reagent 2 vials 1 vial B.95 **Anti-Lub Reagent 2 vials 1 vial B.96 Starter pack for preparing Coombs Control Cells 2 Pack 1 Pack B.97 Gel Card for DC Screening II 144 Tests 72 Tests B.98 Gel Card for ABO Sub Grouping 144 Tests 72 Tests C.1 Anti HBc IgM CLIA 150 Tests 150 Tests C.2 Anti HBc IgM ELFA 150 Tests 150 Tests

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C.3 Anti HBc IgM ELISA 96 Tests x 02 Kits 96 Tests x 02 Kits C.4 HBe Ag CLIA 150 Tests 150 Tests C.5 HBe Ag ELFA 150 Tests 150 Tests C.6 HBe Ag ELISA 96 Tests x 02 Kits 96 Tests x 02 Kits C.7 Anti HBs CLIA/HBs Ab CLIA 150 Tests 150 Tests C.8 Anti HBs ELFA/HBs Ab ELFA 150 Tests 150 Tests C.9 Anti HBs ELISA/HBs Ab ELISA 96 Tests x 02 Kits 96 Tests x 02 Kits C.10 Anti-HBe CLIA/ HBe Ab CLIA 150 Tests 150 Tests C.11 Anti-HBe ELFA/ HBe Ab ELFA 150 Tests 150 Tests C.12 Anti-HBe ELISA/ HBe Ab ELISA 96 Tests x 02 Kits 96 Tests x 02 Kits C.14 Dengue IgM ELISA 96 Tests x 02 Kits 96 Tests x 02 Kits C.15 HBc IgM CLIA 150 Tests 150 Tests C.16 HBc IgM ELFA 150 Tests 150 Tests C.17 HBc IgM ELISA 96 Tests x 02 Kits 96 Tests x 02 Kits C.18 HBc Total CLIA/ Anti HBc Total CLIA 150 Tests 150 Tests C.19 HBc Total ELFA / Anti HBc Total ELFA 150 Tests 150 Tests C.20 HBc Total ELISA/ Anti HBc Total ELISA 96 Tests x 02 Kits 96 Tests x 02 Kits C.21 HBe Ag-Ab CLIA 250 Tests 250 Tests C.22 HBe Ag-Ab ELFA 250 Tests 250 Tests C.23 HBe Ag-Ab ELISA 96 Tests x 03 Kits 96 Tests x 03 Kits C.24.1 HBsAg CLIA 700 Tests 700 Tests C.24.2 400 Tests 400 Tests C.25.1 HBsAg ELFA 700 Tests 700 Tests C.25.2 400 Tests 400 Tests C.26.1 HBsAg ELISA 96 Tests x 07 Kits 96 Tests x 07 Kits C.26.2 96 Tests x 04 Kits 96 Tests x 04 Kits C.27 HBsAg Confirmatory ELISA* 100 Tests 100 Tests C.28.1 HBsAg Rapid (Strip/Cassette) {Lateral Flow (Immunochromatogr aphy)} 600 Tests 600 Tests C.28.2 250 Tests 250 Tests C.29.1 HCV Ab CLIA 700 Tests 700 Tests C.29.2 400 Tests 400 Tests C.30.1 HCV Ab ELFA 700 Tests 700 Tests C.30.2 400 Tests 400 Tests C.31.1 HCV Ab ELISA 96 Tests x 07 Kits 96 Tests x 07 Kits C.31.2 96 Tests x 04 Kits 96 Tests x 04 Kits C.32 HCV Ab Confirmatory/ Supplemental Rapid 100 Tests 100 Tests C.33.1 HCV Ab Rapid (Strip/Cassette) {Lateral Flow (Immunochromatogr aphy)} 600 Tests 600 Tests C.33.2 250 Tests 250 Tests

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C.34 HCV Ab RIBA 100 Tests 100 Tests C.35 HCV Ab Confirmatory Western Blot 100 Tests 100 Tests C.36.1 HCV Ag-Ab ELFA 700 Tests 700 Tests C.36.2 400 Tests 400 Tests C.37.1 HCV Ag-Ab ELISA 96 Tests x 07 Kits 96 Tests x 07 Kits C.37.2 96 Tests x 04 Kits 96 Tests x 04 Kits C.38.1 HIV 1&2 Ab CLIA 700 Tests 700 Tests C.38.2 400 Tests 400 Tests C.39.1 HIV 1&2 Ab ELFA 700 Tests 700 Tests C.39.2 400 Tests 400 Tests C.40.1 HIV 1&2 Ab ELISA 96 Tests x 07 Kits 96 Tests x 07 Kits C.40.2 96 Tests x 04 Kits 96 Tests x 04 Kits C.41 HIV 1&2 Ab Confirmatory/ HIV 1& 2 Ab Supplemental Rapid 100 Tests 100 Tests C.42.1 HIV 1&2 Ab Rapid (Strip/Cassette ) {Lateral Flow (Immunochromatogr aphy)} 600 Tests 600 Tests C.42.2 250 Tests 250 Tests C.43 HIV 1&2 Ab Confirmatory Western Blot 100 Tests 100 Tests C.46.1 HIV Ag-Ab CLIA 700 Tests 700 Tests C.46.2 400 Tests 400 Tests C.47.1 HIV Ag-Ab ELFA 700 Tests 700 Tests C.47.2 400 Tests 400 Tests C.48.1 HIV Ag-Ab ELISA 96 Tests x 07 Kits 96 Tests x 07 Kits C.48.2 96 Tests x 04 Kits 96 Tests x 04 Kits C.49.1 HIV Ag-Ab Rapid (Strip/Cassette) {Lateral Flow (Immunochromatogr aphy)} 600 Tests 600 Tests C.49.2 250 Tests 250 Tests C.50.1 HIV TP Combo Rapid 700 Tests 700 Tests C.50.2 350 Tests 350 Tests C.51.1 HIV,HCV Combo Rapid 700 Tests 700 Tests C.51.2 350 Tests 350 Tests C.52.1 HIV,HCV,HBV Combo Rapid 800 Tests 800 Tests C.52.2 450 Tests 450 Tests C.54 Paclitaxel for HIV, HBsAg, HCV 01 Vial 01 Vial C.55 Human Plasma/ Plasma Pool for Fractionation as per IP 03 Vials x 05 ml 03 Vials x 05 ml C.56 Syphilis CLIA 300 Tests 300 Tests C.57 Syphilis ELISA 96Tests x 03 Kits 96Tests x 03 Kits C.58 Syphilis Rapid (Strip/Cassette) {Lateral Flow (Immunochromatogr 250 Tests 250 Tests

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aphy)} C.59 Syphilis RPR 250 Tests 250 Tests C.60 Syphilis TPHA 250 Tests 250 Tests #C.61 Infection diagnostic test for HBV (Qualitative) 36 Tests 36 Tests #C.62 Infection diagnostic test for HCV (Qualitative) 36 Tests 36 Tests #C.63 Infection diagnostic test for HIV-1 (Qualitative) 98 Tests 98 Tests #C.64 Blood donor Screening multiplex (HBV, HCV & HIV) Test (Qualitative) 146 Tests 146 Tests #C.65 Viral load monitoring Kit for HBV 24 Tests 24 Tests #C.66 Viral load monitoring Kit for HCV 24 Tests 24 Tests #C.67 Viral load monitoring Kit for HIV-1 76 Tests 76 Tests C.69.1 HIV, HCV, Syphilis and HBsAg Combo Rapid (Device having Four individual sample addition wells) 600 Tests 600 Tests C.69.2 250 Tests 250 Tests C.70.1 HIV 1&2 Ab Rapid (Strip/Cassette) {Vertical Flow (Immunofiltration)} 600 Tests 600 Tests C.70.2 250 Tests 250 Tests C.71.1 HIV 1+2 (Immunodot Test/ Dot Immuno Assay) 600 Tests 600 Tests C.71.2 250 Tests 250 Tests C.72.1 HIV Ag-Ab Rapid (Strip/Cassette) {Vertical Flow(Immunofiltration)} 600 Tests 600 Tests C.72.2 250 Tests 250 Tests C.73.1 HCV Ab Rapid (Strip/Cassette) {Vertical Flow (Immunofiltration)} 600 Tests 600 Tests C.73.2 250 Tests 250 Tests C.74 HBsAg Confirmatory CLIA** 100 Tests 100 Tests D.1.1 Anti-D Immunoglobulin for Intravenous use 110 vials 60 vials D.1.2 55 vials 30 vials D.2.1 Anti-D (Rho) Immunoglobulin (Intramuscular) 50 vials 25 vials D.2.2 100 vials 50 vials D.3 Anti-Inhibitor Coagulant 10 vials 05 vials

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Complex D.5.1 Hepatitis B Immunoglobulin (Intramuscular) 70 vials 40 vials D.5.2 33 vials 25 vials D.5.3 18 vials 12 vials D.5.4 Hepatitis B Immunoglobulin (subcutaneous) 70 vials 50 vials D.6.1 Hepatitis B Immunoglobulin (Intravenous) 110 vials 60 vials D.6.2 55 vials 30 vials D.6.3 05 vials 02 vials D.7 Human Albumin 04 Bottles 02 Bottles D.8 Human Coagulation Factor - IX 06 vials 04 vials D.9 Human Coagulation Factor - IX (recombinant) 06 vials 02 vials D.10.1 Human Coagulation Factor - VIII (Dried Human Antihaemophilic Fraction) 08 vials 04 vials D.10.2 Human Coagulation Factor - VIII (without vWF) (Dried Human Antihaemophilic Fraction) D.11 Human Normal Immunoglobulin (IM) 10 vials 05 vials D.12 Human Normal Immunoglobulin (Intramuscular) (Bulk) 04 Bottles 02 Bottles D.13.1 Human Normal Immunoglobulin for Intravenous use 03 Bottles 02 Bottles D.13.2 10 Bottles 08 Bottles D.13.3 03 Bottles 02 Bottles D.14 Human Plasma Protein Fraction 04 Bottles 02 Bottles D.15 Human Prothrombin Complex (PTC) 10 Bottles 05 Bottles D.16 Human Normal/Specific Immunoglobulin (IV) (Bulk) 03 Bottles 03 Bottles D.17 Rabies Immunoglobulin 20 vials 10 vials D.18 Human Coagulation Factor-VIII (recombinant) 06 vials 02 vials D.19 Tetanus Immunoglobulin (Intramuscular) 50 vials 25 vials D.20 Tetanus Immunoglobulin (Intramuscular) (Bulk) 04 Bottles 02 Bottles D.21 Human Fibrinogen 05 vials 02 vials

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D.22 Human Normal Immunoglobulin (IgG) (subcutaneous administration) 04 bottles 02 Bottles D.23.1 Fibrin Sealant Kit 06 Kits 02 Kits D.23.2 Fibrin Sealant Kit (without F- XIII) D.23.3 Fibrin Sealant Kit (without Fibrinogen) D.24 Anti-T Lymphocyte Immunoglobulin for Human Use, Animal (lyophilized) 10 vials 10 vials D.25 Antihemophilic Factor VIII (Recombinant PEGylated) 10 vials 10 vials D.26 Anti-D Immunoglobulin (Intramuscular) Freeze Dried 50 vials 25 vials E.1 Heparin Sodium injection 08 vials 06 vials E.2 Human Chorionic Gonadotropin (HCG) Bulk 0.2g x 1 vial & 5mg x 5 vials *Sample is required in separate vials containing quantity as mentioned above Nil E.3.1 Human Chorionic Gonadotropin (HCG) injection 08 vials 06 vials E.3.2 10 vials 07 vials E.4 Menotropin (Human Menopausal Gonadotropin) Bulk 2mg x 4 vials, 4mg x 1 vial & 5mg x 2 vials *Sample is required in separate vials containing quantity as mentioned above Nil *E.5.1 Menotropin (Human Menopausal Gonadotropin) injection 17 vials 14 vials *E.5.2 14 vials 14 vials *E.5.3 12 vials 10 vials *E.5.4 12 vials 10 vials E.6.1 Enoxaparin Sodium Injection 20 vials 20 vials E.6.2 18 vials 18 vials E.7.1 Recombinant Human Growth Hormone/Somatropin injection 12 vials 10 vials E.7.2 E.7.3 E.7.4 E.7.5 E.7.6 E.7.7 12 PFS/Vial 10 PFS/Vial E.8. Recombinant Streptokinase injection 12 vials 10 vials E.9 Recombinant Human 10 PFS 10 PFS

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Follicle Stimulating Hormone Injection 10 vials 10 vials E.10 Streptokinase Bulk 25mg x 3 vials, 5mg x 5 vials, 10mg x 2 vials & 15mg x 1 vial *Sample is required in separate vials containing quantity as mentioned above Nil

• E.11.1 Streptokinase injection 10 vials 08 vials
• E.11.2 09 vials 08 vials

E.12.1 Tenecteplase for

injection (TNK-TPA) 6 vials 2 vials

E.12.2

6 vials 2 vials

E.12.3

6 vials 2 vials E.13 Urofollitropin Bulk 5mg x 3 vials & 2mg x 2 vials *Sample is required in separate vials containing quantity as mentioned above Nil

E.14.1 Urofollitropin injection

11 vials 08 vials

E.14.2

11 vials 08 vials E.15 Urokinase Bulk/Final 05mg x 8 vials *Sample is required in separate vials containing quantity as mentioned above Nil

E.16

Urokinase injection 11 vials 08 vials

E. 17

Elaprase Injection 04 vials 04 vials

E.18

VPRIV Injection 06 vials 06 vials

E. 19

Replagal Injection 04 vials 04 vials E.20 Human C1-Esterase Inhibitor 13 vials 08 vials F.1.1 Biphasic Isophane Insulin (25/75) 25 10 F.1.2 Biphasic Isophane Insulin (25/75) 15 10 F.1.3 Biphasic Isophane Insulin (30/70) 25 10 F.1.4 Biphasic Isophane Insulin (30/70) 15 10 F.1.5 Biphasic Isophane Insulin (50/50) 25 10 F.1.6 Biphasic Isophane Insulin (50/50) 15 10 F.2 Dulaglutide 25 5 F.3 Exenatide 25 5 F.4.1 Filgrastim Injection (rh. GCSF) 15 5 F.4.2 15 10 F.5 Insulin Aspart bulk 2g x 2 aliquotes Nil F.6.1 Insulin Aspart 25 10 F.6.2 15 10 F.7.1 Insulin Aspart & Insulin aspart protamine suspension Mixed in 30/70 mix 25 10

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F.7.2 Insulin Aspart & Insulin aspart protamine suspension Mixed in 50/50 mix 25 10 F.8 Insulin Degludec 20 10 F.9 Insulin Degludec / Insulin Aspart 30 10 F.10 Insulin Detemir 20 10 F.11.1 Insulin Glargine 25 10 F.11.2 25 10 F.11.3 15 10 F.12.1 Insulin Glulisine 25 10 F.12.2 15 10 F.13 Insulin Lispro bulk 2g x 2 aliquotes Nil F.14.1 Insulin Lispro 25 10 F.14.2 15 10 F.15.1 Insulin Lispro & Insulin Lispro Protamine Suspension (Mixed in 25/75 Mix) 25 10 F.15.2 Insulin Lispro & Insulin Lispro Protamine Suspension Mixed in 50/50 Mix 25 10 F.16 Interferon alpha 2b injection 15 10 F.17.1 Isophane insulin (NPH) 25 10 F.17.2 15 10 F.18 Liraglutide (Glucagon like Peptide-1) 20 10 F.19 Peg Filgrastim Injection (PegGCSF) 20 5 F.20 Peg Interferon alpha 2b inj 15 10 F.21 Peg Interferon Beta 1a inj 25 5 F.22 rh – Insulin bulk 2g x 2 aliquotes Nil F.23 rh- Erythropoietin bulk 2g x 2 aliquotes Nil F.24.1 rh. Erythropoietin injection 15 5 F.24.2 20 5 F.25 rh. Interferon beta 1a Injection 30 5 F.26.1 Soluble insulin (Regular) 25 10 F.26.2 15 10 F.27 Teriparatide (rh. Para Thyroid Hormone- PTH) 15 10 F.28 Xultophy (Liraglutide & Degludec) 30 10 F.29 Peg Erythropoietin 20 10 F.30.1 Peg Interferon Beta 1a inj 30 5 F.30.2 30 5 F.31 Insulin Glargine Bulk 2g x 2 aliquotes Nil F.32 Recombinant interferon beta 1b injection 250 µg/ ml 20 vials 5 vials F.33 Darbepoetin Alpha Injection 25 vials 5 vials H.1 Cell Culture Rabies vaccine 21 vials 10 vials H.2.1 Hepatitis A

20 vials

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20 vials H.2.2 12 vials 12 vials H.3.1 Hepatitits B 20 vials 20 vials H.3.2 12 vials 12 vials H.3.3 12 vials 12 vials H.4 Japanese Encephalitis Vaccine (Human) 20 vials 20 vials H.5.1 Measles Mumps & Rubella Vaccine 20 vials 20 vials H.5.2 14 vials 14 vials H.6.1 Measles Vaccine 20 vials 20 vials H.6.2 14 vials 14 vials H.7.1 Rubella vaccine 20 vials 20 vials H.7.2 14 vials 14 vials H.8 Bacillus Calmette Guerin (BCG) Vaccine 57 vials 57 vials H.9.1

Haemophilus Influenzae
Type-b- (Hib)-TT Conjugate Vaccine 55 vials 55 vials H.9.2 18 vials 18 vials H.10 Oral Cholera Vaccine 20 vials 20vials H.11 Oral Polio Vaccine 10 vials 10 vials H.12.1 COVID-19 Vaccines (Covishield, Covaxin, ZyCoV-D) 40 vials 20 vials H.12.2 10 vials 5 vials H.12.3 10 vials 5 vials H.13 Rabies Immunoglobulin (Equine) 20 vials 10 vials H.14 Human Papilloma Virus Vaccine (r-DNA) 30 vials 15 vials J.1.1 Adalimumab 10 PFS 10 PFS J.1.2 11 PFS 11 PFS J.1.3 10 PFS 10 PFS J.2.1 Bevacizumab 5 vials 5 vials J.2.2 5 vials 5 vials J.3 Etarnercept 9 PFS 9 PFS J.4 Pertuzumab 5 vials 5 vials J.5.1 Ramucirumab 5 vials 5 vials J.5.2 5 vials 5 vials J.6 Ranibizumab 16 vials 16 vials J.7.1 Rituximab 5 vials 5 vials J.7.2 5 vials 5 vials J.8.1 Trastuzumab 6 vials 6 vials J.8.2 6 vials 6 vials J.9.1 Anti-D Immunoglobulin, I.M (Monoclonal) 33 vials 33 vials J.9.2 36 vials 36 vials J.10.1 Human Hepatitis B Immunoglobulin (Intramuscular) (Monoclonal) 50 vials 50 vials J.10.2 33 vials 33 vials J.10.3 18 vials 18 vials J.10.4 13 vials 13 vials J.10.5 6 vials 6 vials J.10.6 3 vials 3 vials J.12.1 Tetanus Immunoglobulin (Monoclonal), Tetclone 33 vials 33 vials J.12.2 18 vials 18 vials J.13 Obinutuzumab 4 vials 4 vials J.14 Omalizumab 9 vials 9 vials

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J.15 Natalizumab 4 vials 4 vials J.16 Pembrolizumab 4 vials 4 vials J.17 Infliximab 10vials 10Vials J.18 Mepolizumab 10vials 10Vials J.19 Recombinant Anti Rho-D Immunoglobulin Injection 100 vials 100 vials J.20 Vedolizumab 09 vials 09 vials J.21.1 Transtuzumab Emtansine 05 vials 05 vials J.21.2 05 vials 05 vials J.22 Inotuzumab Ozogamicin (Powder for solution for infusion) 10vials 10Vials J.23.1 Denosumab 12 PFS 12 PFS J.23.2 12 vials 12 vials J.24 Benralizumab 12 PFS 12 PFS J.25.1 Durvalumab 09 vials 09 vials J.25.2 05 vials 05 vials J.26 Tocilizumab 05 vials 05 vials J.27 Cetuximab 05 vials 05 vials J.28 Brentuximab Vedotin 09 vials 09 vials J.29 Evolocumab Injection 15 PFS 15 PFS J.30 Nivolumab 09 vials 09 vials J.31 Secukinumab 15 vials 15 vials K.1 RT-PCR Kits for Diagnosis of COVID-19 (Validation) 160 Tests 160 Tests K.2 RT-PCR Kits for Diagnosis of COVID-19 (Batch Testing) 50 Tests 50 Tests K.3 RNA Extraction Kits for Diagnosis of COVID-19 (Validaton) 50 Tests 50 Tests K.4 RNA Extraction Kits for Diagnosis of COVID-19 (Batch Testing) 30 Tests 30 Tests K.5 VTM for Diagnosis of COVID-19 (Validation) 20 Tests 20 Tests K.6 VTM for Diagnosis of COVID-19 (Batch Testing) 10 Tests 10 Tests K.7 COVID Ab kit (IgG to S Protein) Rapid 250 Tests 250 Tests K.8 COVID Ab kit (IgG to S Protein) CLIA 400 Tests 400 Tests K.9 COVID Ab kit (IgG to N Protein) Rapid 250 Tests 250 Tests K.10 COVID Ab kit (IgG to N Protein) CLIA 400 Tests 400 Tests K.11 RT-LAMP Kit for Diagnosis of COVID-19 (Validation) 160 Tests 160 Tests K.12 RT-LAMP Kit for Diagnosis of COVID-19 (Batch Testing) 50 Tests 50 Tests

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Annexure-5

   Quantity required for Complete Analysis of Medical Device Samples  

S.No.
Name of Medical Device
Form-18 Samples
Survey Samples
1.
Hypodermic Syringe
50pcs
10 pcs
2.
Hypodermic Needle/Disposable Syringe Needles
50 pcs
10 pcs
3.
Infusion Set/Transfusion Set
50 pcs
10 pcs
4.
IV Cannulas
50 pcs
10 pcs
5.
Roll Bandage/Surgical Dressings
20 pcs
10 pcs
6.
Sterile Gauze Swab
50 pcs
10 pcs
7.
Surgical Suture (absorbable)
50 pcs
30 pcs
8.
Surgical Suture (Non-absorbable)
50 pcs
30 pcs
9.
Medicated Tape (Band-aid)
100 pcs
20 pcs
10.
Absorbent Cotton Wool I.P.
200gm
100gm
11.
Catheter or Ryles Tube
30 pcs
10 pcs
12.
Tubing for Micros-surgery or Endoscope
50 pcs
10 pcs
13.
Male Rubber Latex Condoms
100 pcs
100 pcs
14.
Copper T
120 pcs
20 pcs
15.
Tubal Rings
100 pcs
20 pcs
16.
Blood Bags
10bags
5bags
17.
Absorbent Sponge
50 pcs
5 pcs

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