How to Stay Compliant with Drugs & Cosmetics Act Using RAKT

For a blood bank under the Drugs & Cosmetics Act, Rule 122G is a licence condition, not a software checklist. It requires the licensee to maintain adequate staff, plant and premises, keep operational records, permit inspection and comply with the special conditions in Schedule F. For a licence in Form 28-C, those special conditions are in Schedule F Part XII-B, also written as Part XIIB.¹²

An inspector may ask for your current licence, select a unit from an issue or stock record, and follow that unit back through collection, testing and processing. The same inspection can include your floor plan, staff qualifications, equipment records, temperature logs and evidence that you acted on an excursion or deviation.

RAKT can produce, organise and retrieve the records that support you at inspection. It cannot make unsuitable premises adequate, ensure that a technician followed the written procedure, grant a licence or guarantee compliance. Your centre and the licence holder remain accountable for what happened on the floor and what appears in the record.

What is the Drugs & Cosmetics Act?

The Drugs & Cosmetics Act of 1940 is the parent law governing drugs in India.³ The detailed licensing and operational requirements for blood banks appear in the Drugs and Cosmetics Rules, 1945, particularly Part XII-B of the Rules and Schedule F Part XII-B.⁴²

For blood banks specifically, this framework covers operations from donor screening and blood collection through testing, processing, storage, labelling, issue and the records that support transfusion traceability. Medical devices and biological products are also regulated within the wider statutory framework, but Rule 122G should be read with the conditions attached to your particular blood-centre licence.

In practical terms, the framework requires:

• Proper licensing and approvals for the activities carried out at your centre
• Detailed documentation of all activities required by the Rules and your approved procedures
• Safe storage conditions, suitable premises and required equipment
• Accurate labeling and expiration tracking
• Clear traceability from donor to recipient and back again

Non-compliance can result in regulatory action, including suspension of operations or cancellation of the relevant licence after the process set out in Rule 122-I.⁵

The legal map: Act, Rules, licence and operating standard

If your inspection file treats the Act, the Rules, Form 28-C and Schedule F as interchangeable documents, staff will struggle to find the requirement behind a checklist item. Use this map to identify which instrument answers which question.

Start each internal checklist item with this hierarchy. For example, a generic line saying records maintained gives your technician no retrieval test. A useful line identifies Rule 122G or Schedule F Part XIIB, names the register or worksheet, assigns its custodian and records the applicable retention trigger.

What Rule 122G requires from your blood centre

Rule 122G sets the conditions attached to licences in Form 28-C and Form 28-E. Form 28-C concerns operation of a blood bank and processing of whole human blood into components. Form 28-E applies to the manufacture of blood products, with Schedule F Part XII-C supplying the corresponding special conditions.⁴¹

For a Form 28-C centre, Rule 122G and Schedule F Part XIIB work together. Rule 122G supplies the general licence conditions. Schedule F supplies the detailed operational standard against which your premises, staff, equipment, records and processes can be examined.

• Staff, plant and premises: You must provide and maintain what is adequate for the licensed operation.
• Operational records: Rule 122G requires records for processing whole human blood, components and, where applicable, manufacturing blood products.
• Inspection access: An Inspector appointed under the Act may inspect the premises, plant, processes, testing arrangements and records, with or without prior notice.
• Changes: Keep the licensing correspondence and approvals supporting changes to expert staff, premises, equipment, plant or the licensed scope.
• Continuing compliance: Receiving Form 28-C does not close the exercise. The conditions continue throughout the licence period.

Rule 122G states that the operational records it identifies must be kept for five years from the date of manufacture. Schedule F Part XIIB separately requires relevant records to be preserved for not less than five years from the date of the last entry.¹²

Those are different starting events. Build your retention schedule record by record, and do not delete a record until every applicable period has ended. If an issue register remains active after the unit’s manufacture date, the last-entry wording matters. Your retention schedule should name the record, its owner, the triggering event and the destruction date; the specialised blood bank record-retention guide gives your records team a more detailed register-by-register check.

Schedule F Part XIIB covers more than records

An electronic register can support the records requirement. It cannot satisfy the physical requirements in Schedule F Part XIIB. An inspector can still find that the centre lacks the prescribed accommodation, separation of work areas, qualified staff, functioning equipment or controlled storage conditions.

Schedule F Part XIIB specifies a minimum area of 100 square metres for a blood bank, with an additional 50 square metres where blood components are prepared. It also identifies the work areas needed for activities such as registration and medical examination, collection, testing, component preparation, washing and sterilisation, storage, records and donor rest or refreshment.²

Use the Schedule against your approved floor plan and actual workflow. A room name on a drawing does not help if staff routinely perform an incompatible activity there or stored files make the area unusable.

Walk through the premises with the approved plan before an inspection. Confirm that the activity performed in each area matches the plan, required equipment is present and usable, and records can identify who checked cleaning, maintenance or temperature control. Photographing a compliant room once does not establish its condition on the day an inspector enters.

Records to have ready at inspection

Start with one unit identifier and retrieve the complete chain. An inspector should be able to move from donor selection and collection to testing, component preparation, storage, issue and the recipient record, then trace the same chain in reverse.²

Keep the records connected. If you can produce an issue entry but cannot retrieve its testing worksheet, the software has found one document rather than demonstrated end-to-end traceability.

Expect the inspector to test an exception as well as a normal unit. For a deferred donor, show the examination and deferral entry and demonstrate that the same person could not return inside the recorded deferral period without the system or register exposing the earlier decision. For a temperature excursion, retrieve the reading, alarm or observation, affected inventory, review, action and authorisation as one file.

A discarded or expired unit provides another useful test. Your stock record, discard entry and component history should agree on the identifier, status, date and responsible user. If one screen still shows the unit as available, retrieval has exposed an inventory-control failure before an inspector does.

Run the same sample through your blood bank compliance checklist. Record who performed the check, which unit identifiers were selected, what could not be retrieved and when the gap was closed.

What an inspector may ask you to demonstrate

An inspection request is often concrete. Prepare your team to answer with the underlying file, not a presentation assembled separately from the source records.

• Show the licensed scope: Produce Form 28-C and match each activity being performed to the current licence and licensing correspondence.
• Show who was authorised: Retrieve the qualification, appointment, training, duty allocation and signature record for the person attached to the selected entry.
• Trace this unit: Follow one identifier from donor registration to issue or discard, including testing and every component created from the collection.
• Explain this exception: Connect an excursion, alarm, adverse event or deviation to the affected units, review and corrective action.
• Show that this equipment was fit for use: Produce its status, maintenance and calibration records for the date on which the selected activity occurred.
• Retrieve an older record: Demonstrate that a record inside the applicable five-year clock remains legible, complete and connected to its supporting entries.

Assign an owner to each file before the inspection. When nobody knows whether calibration records sit with engineering, quality or the laboratory, the delay itself shows that your document control has not been tested.

Common Compliance Challenges for Blood Banks

Staying compliant can be difficult when processes are manual or outdated. The usual inspection failures are concrete:

• Manual record-keeping: Paper logs are prone to errors and loss. A missing page can break the chain for every unit recorded on it.
• Lack of traceability: Tracking each unit from donor to patient manually is time-consuming, particularly when testing and issue use different identifiers.
• Regulatory reporting: Preparing reports for licensing authorities often takes hours when the source entries sit in separate registers.
• Staff accountability: It is hard to establish who performed which task and when if staff share logins or leave signatures blank.
• Storage oversight: Missed expiry dates or incorrect temperatures can lead to waste, regulatory findings and, where enforcement follows, penalties.

These failures can affect your compliance status and patient safety. Software helps only when your staff enter complete information under controlled access and someone reviews the exceptions.

How RAKT Helps You Stay Compliant

RAKT is a blood bank management system used by 200+ blood centres across India. It is built around Indian blood-centre workflows, including donor registration, camp management, component separation, inventory, crossmatch and compliance records.⁶ It can support evidence for the Drugs & Cosmetics Act and Rules, but the software itself is not a statutory approval.

Automated Record-Keeping

RAKT is designed to securely store donor details, blood inventory data, transfusion records, testing entries and more. Automated record-keeping makes retrieval easier, but “audit-ready at all times” still depends on your staff completing each required field and correcting discrepancies under an approved process.

Real-Time Inventory Tracking

You can see what is in stock, which units are about to expire and what storage conditions have been recorded. Alerts can flag an approaching expiry or an entered temperature outside configured limits. Your centre must still use suitable equipment, verify the reading and document the action taken.

Easy Regulatory Reporting

With just a few clicks, RAKT can generate configured operational reports from the data your team has entered. Review every output before submission to the authorities; automatically formatted does not necessarily mean complete or ready for submission.

Do not place Form 27D, 28C, and others into one bucket called “reports required by law.” The applicable blood-bank application is Form 27-C and the resulting licence is Form 28-C. Form 27-D concerns a different manufacturing application, while Form 27-E and Form 28-E concern blood products. These forms belong to the licensing process rather than routine monthly operational reporting.⁴

Built-In Alerts and Validations

RAKT can warn you about potential compliance issues, such as missing donor information or improperly labeled units, before the record proceeds. A validation catches the condition it was configured to detect. It cannot confirm that the label was physically attached to the correct bag.

Staff Activity Logs

Staff activity logs can show who updated inventory, who performed testing and who issued which unit. Give each user an individual account and review privileged changes. A timestamp under a shared login does not establish which technician performed the task.

End-to-End Traceability: A Core Requirement

A core requirement of Schedule F Part XIIB is traceability. Your records should connect the donor, collection, testing, components, storage and issue to the recipient, and allow the chain to be followed in reverse.²

RAKT can tag and track every unit through donor registration, testing, storage, issue and transfusion records. Full traceability is achieved only when each hand-off is recorded against the same unit identifier. If an adverse event occurs, a complete chain helps your team trace the source immediately and begin the required review, potentially saving time and saving lives.

Here is a quick example. A donor gives blood on July 1st. The unit is tested, stored under controlled conditions and issued on July 5th to a recipient. With RAKT, every recorded step from collection to transfusion can be logged, timestamped and traceable. If the July 5th issue was entered without the recipient identifier, the chain remains incomplete regardless of the other timestamps.

Staying Ready for Inspections and Audits

No one enjoys surprise inspections, but Rule 122G allows an Inspector to enter with or without prior notice.¹ Keep your data organised and up to date, then test retrieval before the inspector arrives.

Use one recent unit, one expired or discarded unit and one older unit still inside the retention period. For each one, you should be able to:

• Instantly generate compliance reports from completed source records
• Show temperature logs and expiry records
• Provide digital logs of all staff activity
• Maintain version control and data history
• Retrieve the linked donor, testing, inventory, issue and exception records

Fast retrieval can mean less stress and more confidence during audits. Quicker clearance remains the inspector’s or assessment team’s decision; a dashboard cannot replace verification of the underlying records, premises and practice.

Write down the result of every retrieval drill. A list of missing worksheets, duplicate identifiers or unreviewed exceptions gives your team a corrective-action file. A verbal assurance that the record can probably be found gives the inspector nothing to verify.

Peace of Mind with NABH and NBTC Alignment

The Drugs and Cosmetics Rules, NABH and NBTC are separate sources of requirements. NABH, the National Accreditation Board for Hospitals & Healthcare Providers, accredits blood centres under its assessment programme.⁷ It does not certify blood-bank software. NBTC, the National Blood Transfusion Council, issues national guidance.⁸

RAKT can support records used for NABH and NBTC review alongside statutory licence records. The linked overview brings all regulatory requirements into one discussion, but your team should retain the source and version behind each checklist item. Combining evidence in one place does not merge the authority of the Drugs and Cosmetics Rules, NABH standards and NBTC guidelines.

Conclusion: Compliance Made Simple with RAKT

Compliance with the Drugs & Cosmetics Act is not just about ticking boxes. For your centre, it means maintaining the Form 28-C licence conditions in Rule 122G, meeting the premises and operational requirements in Schedule F Part XIIB, and producing a complete traceable record when an inspector selects a unit.

RAKT automates parts of the paperwork, highlights configured errors and missed deadlines, and keeps records easier to retrieve. Your blood bank remains responsible for adequate staff, premises, equipment, actual practice and the accuracy of every entry. That division lets software handle the hard parts it can genuinely support while your team focuses on safe operations and saving lives. Sign up now!

Sources

1. Drugs and Cosmetics Rules, 1945, Rule 122G cdsco.gov.in
2. Drugs and Cosmetics Rules, 1945, Schedule F Part XIIB cdsco.gov.in
3. Drugs and Cosmetics Act, 1940 indiacode.nic.in
4. Drugs and Cosmetics Rules, 1945, Part XIIB cdsco.gov.in
5. Drugs and Cosmetics Rules, 1945, Rule 122-I cdsco.gov.in
6. RAKT rakt.in
7. National Accreditation Board for Hospitals & Healthcare Providers, Blood Centre Accreditation Programme nabh.co
8. Directorate General of Health Services, National Blood Transfusion Council dghs.mohfw.gov.in