Section-wise Overview & Key Details

• Ensure proper packaging to avoid spillage or contamination.
• Coordinate with logistics providers early for cold chain requirements.
• Strictly adhere to delivery timelines specified.

• Manufacturer / OEM registration with valid licenses.
• Product certifications and test reports.
• Evidence of compliance with local and international standards.
• Active GeM profile validation for MSME status (if applicable).

Final Words

This is a strategic procurement opportunity for suppliers in the biochemical diagnostics field, offering a chance to establish a consistent supply relationship with Indian Railways. Participation can open doorways to wider government and institutional contracts. Bidders are advised to thoroughly review specifications, comply with all statutory and regulatory mandates, and prepare comprehensive documentation to maximize their chances of winning.

# SEO-Optimized FAQs

Q1: How to participate in Indian Railways biochemistry reagent kit tender in 2025?
To participate, bidders need to register on the GeM portal, ensure compliance with all relevant regulations such as the Drugs and Cosmetics Act, 1940, and Medical Device Rules, 2017. The bid involves submitting documents like manufacturing licenses, product certifications, and experience reports. Bidders should carefully review the technical specifications, particularly compatibility with XL-640 systems and packaging standards. The process involves detailed application, fee payment, and document upload. Small businesses, especially MSEs, can leverage purchase preferences if they meet the criteria and validate their credentials online. For a smoother registration process, visit https://tenderai.in/services/gem-profile-registration.
Timing and adherence to bid schedules are crucial given the bid end date of July 28, 2025.

Q2: What are the eligibility criteria for supplying biochemistry reagent kits to Indian Railways?
Manufacturers and OEMs holding valid licenses under the Drugs and Cosmetics Act, 1940, and Medical Device Rules, 2017, are eligible. Resellers or traders must demonstrate regulatory compliance and valid certifications. Bidders need to submit documentary evidence of their manufacturing licenses, product quality tests, and certifications. MSEs are encouraged to participate under the purchase preference policy, requiring valid Udyam Registration and online credential validation. The bidder must also confirm compatible packaging and technical specifications, such as reagents suitable for XL-640 systems. For detailed eligibility steps, visit the GeM portal and review the specific bid conditions.

Q3: How can small and medium enterprises benefit from this Indian Railways tender for biochemistry kits?
MSEs can avail purchase preferences provided they possess valid Udyam Registration and have their credentials validated online via the GeM portal. They must be the manufacturer or OEM of the offered product; resellers or traders are excluded from preference benefits. The policy allows MSEs quoting within 15% above L1 to match the lowest bid and secure up to 25% of the ordered quantity, enhancing their market share. To ensure eligibility, MSEs should maintain valid registration, provide proper documentation, and align with specified technical parameters. For assistance, visit https://tenderai.in/services/gem-profile-registration.
This policy aims to promote use of indigenous products and support small Indian suppliers.

Q4: What are the technical specifications for the biochemistry reagent kits required in this tender?
The kits must be serum-based RF (Rheumatoid Factor) testing kits, compatible with XL-640 and XL 1000 systems. The product should be a system pack containing 1 x 22 ml / 5.5 ml reagents, specifically formulated for immunoturbidometry tests. The reagents must be free of calibrators and controls, which are not provided. Technical adherence includes compatibility with specified analyzers, barrier-free packaging, and precise reagent volume. The kits must meet regulatory standards under the Drugs and Cosmetics Act, 1940, and Medical Device Rules, 2017, ensuring safety, efficacy, and quality. For detailed specifications, check the tender documentation and ensure compliance before submission.

Q5: What is the delivery timeline for the supply of biochemistry reagent kits in this tender?
The specified delivery period is within 45 days from the date of official order receipt. Bidders should factor in manufacturing lead times, packaging, inspection, and logistical arrangements to meet this deadline. Proactive coordination with logistics providers and adherence to the specified delivery address at Chittaranjan Locomotive Works is essential. Bidders are encouraged to plan inventory, production, and shipping well in advance for seamless fulfillment. Timely delivery is critical for successful contract completion and future procurement opportunities.

Q6: How does the bidding process evaluate offers for Indian Railways biochemistry reagent kits?
The evaluation is based on "Total value wise evaluation," assessing the total bid price for the complete quantity. Bidders must ensure their pricing aligns with regulatory price caps, and all documents supporting technical compliance are submitted accurately. The bidder offering the most competitive price and conforming to specifications will be preferred. MSE benefits can influence evaluation if the bidder qualifies and provides the required certifications. The process involves initial screening, technical compliance review, and financial evaluation, culminating in a formal award to the suitable bidder.

Q7: What documents are mandatory for bid submission in this tender?
Mandatory documents include current manufacturing licenses, product certifications confirming compliance with Indian standards, relevant test reports, and proof of technical capabilities. Resellers must also submit authorization certificates from OEMs. MSMEs should upload valid Udyam Registration. Additionally, bidders must provide details of past supply experience and certifications validating their legal and regulatory standing. All submissions should be uploaded in digital format through the GeM portal before the bid deadline. Missing critical documents can lead to disqualification.

Q8: How can I ensure my biochemistry reagent kit complies with all regulatory and technical standards?
Ensure your product is registered under the Drugs and Cosmetics Act, 1940, and meets Medical Device Rules, 2017. Certification from authorized testing laboratories confirming reagent compatibility, safety, and efficacy is essential. Maintain proper documentation of manufacturing processes, quality control tests, and certificates of compliance. Keep abreast of updates to applicable standards and submit all updated certificates during bid submission. Regularly consult official guidelines and consider third-party audits for validation. For professional assistance, visit https://tenderai.in/services/gem-profile-registration.

Q9: What are the key logistics considerations for supplying biochemistry kits to Indian Railways?
Ensure packaging safeguards reagent integrity, especially regarding temperature sensitivity. Coordinate with logistics providers to maintain cold chain logistics if required. Deliver to Chittaranjan Locomotive Works within the stipulated 45-day window. Prepare transportation documents, inspection certificates, and track shipment statuses. Maintaining regular communication with the consignee ensures smooth acceptance and quick clearance. Planning logistics in advance minimizes delays and ensures on-time delivery.

Q10: How do I verify the authenticity of the licenses and certifications required in this tender?
Verify licenses through official government portals or authorized certification bodies. Cross-check the validity, expiry dates, and scope of licenses such as the Medical Device License issued under the Drugs and Cosmetics Act, 1940. Ensure test reports are from recognized laboratories with accreditation from agencies like NABL. Reseller and distributor certifications should be authenticated with OEM verification. Maintaining digital copies and updating records regularly improves credibility during evaluation.

Please ensure full compliance with tender specifications and legal requirements for successful participation. For expert assistance at every stage, explore https://tenderai.in/services/gem-profile-registration and other TenderAI services.