If you manufacture drugs, pharmaceuticals, Ayurvedic products, or cosmetics in India, GMP compliance is a legal requirement — not a certification you opt into. Your drug licence from CDSCO/State Drug Authority is conditional on maintaining GMP. There is no separate "GMP certificate" for domestic compliance — GMP is verified by drug inspectors during routine inspections.
Legal
Drug licence conditional on GMP compliance
Inspected
Drug inspectors can visit unannounced
WHO GMP
Required for export to regulated markets
Your company manufactures regulated products and GMP compliance is part of your daily work. GMP means every step of production is documented, every material is traceable, and every batch can be recalled if needed. Your job is to follow written SOPs and record what you actually did — not what you were supposed to do.
SOP
Written procedure for every manufacturing step
BMR
Batch Manufacturing Record for every batch
ALCOA+
Data must be attributable, legible, contemporaneous, original
Quick reference. GMP in India: Schedule M (Drugs & Cosmetics Act 1940) for allopathic drugs, revised 2023. Ayush GMP under Drugs & Cosmetics Act Schedule E1. WHO GMP (TRS 986 Annex 2) for export. CDSCO oversees central licensing; State Drug Authorities oversee state licensing. WHO PQ required for UN procurement.
Schedule M
Pharma GMP, revised 2023
Ayush GMP
Schedule E1
WHO TRS 986
Export market GMP reference
Good Manufacturing Practice (GMP) is a set of principles and procedures ensuring products are consistently produced and controlled to quality standards. In India, GMP for pharmaceuticals is defined by Schedule M of the Drugs and Cosmetics Act 1940, revised most recently in 2023 to align more closely with WHO GMP guidelines.
1940
Drugs & Cosmetics Act
Schedule M
GMP requirements for pharma
2023
Schedule M revised
Mandatory for all licensed drug manufacturers in IndiaSchedule M under Drugs & Cosmetics Act for pharmaceuticalsSeparate GMP guidelines for Ayush, food, and cosmetics
What’s on this page
01 —What it isUnderstanding GMP
Every licensed drug and pharmaceutical manufacturer in India must comply with GMP. It is not optional.
GMP (Good Manufacturing Practice) defines the minimum standards for manufacturing drugs, pharmaceuticals, Ayurvedic formulations, and cosmetics. In India, GMP compliance is a condition of your manufacturing licence — not a separate certification you apply for.
For pharmaceutical manufacturers, GMP requirements are defined in Schedule M of the Drugs and Cosmetics Act 1940. The 2023 revision tightened requirements significantly, bringing Schedule M closer to WHO GMP standards. For Ayush products, Schedule E1 of the same Act applies.
For export to regulated markets — the EU, USA, Japan, WHO procurement — manufacturers must additionally comply with WHO GMP guidelines (TRS 986 Annex 2) or the equivalent standards of the importing country's regulator.
GMP compliance ≠ GMP certificate. For domestic drug manufacturing, GMP is verified by State Drug Authority or CDSCO inspectors during routine or triggered inspections. There is no application for a "GMP certificate" for domestic compliance. For export or WHO prequalification, a separate WHO GMP certificate or regulatory inspection is required.
👥 Illustrative case — details changed for confidentiality
A large pharmacy chain asked for GMP certification proof before extending distribution to their national network. The manufacturer held a valid drug licence but no formal GMP certification.
The challenge
Their batch manufacturing records were maintained on paper — inconsistently. Dispensing records, in-process QC, and final release were recorded in separate registers by different teams. No consolidated batch record existed.
Where Clicarity came in
They had deployed Clicarity to track production jobs. Every batch was a job with stages configured for dispensing, granulation, compression, QC, and release. Custom fields at each stage captured what the GMP batch record requires. When their consultant reviewed the Clicarity records for the last 3 months, all the key data points were there — by batch, by stage, by person.
The result
GMP certification achieved within 5 months. Pharmacy chain distribution agreement signed.
We already had most of the data. It just wasn't in one place. Clicarity gave us the consolidated batch record we were missing.
Ayurvedic, Siddha, Unani, and Homeopathic product manufacturers
Cosmetics manufacturers (under D&C Act)
Exporters supplying to WHO-prequalified procurement
∼ Also consider
Food supplement manufacturers seeking WHO GMP for export
Medical device manufacturers (separate MDR 2017 regulations apply)
— Different framework applies
Food manufacturers — FSSAI and HACCP are the applicable requirements
Non-drug consumer products — other product-specific standards apply
03 —What it requiresWhat is checked
What a drug inspector checks — and what must be in your records.
1
Premises and equipment meeting Schedule M standards
Manufacturing facility layout, clean room standards, HVAC, water system, and equipment must meet the specifications in Schedule M.
E.g. Separate areas for dispensing, manufacturing, packing. Air handling units with appropriate filtration for product category.Most common gap: Facility modified after inspection without notifying the licensing authority.
2
Written SOPs for every manufacturing and QC step
A Standard Operating Procedure for every step of manufacturing, testing, cleaning, and calibration. SOPs must be current, approved, and available to staff at the point of use.
E.g. SOP for dispensing raw materials: steps, responsible person, double-check requirement, documentation format.Most common gap: SOPs exist but are outdated, or staff are following different practices.
3
Batch Manufacturing Records (BMRs)
A complete, contemporaneous record for every production batch: materials used, quantities, equipment, operators, in-process results, and final release.
E.g. Every weighing step: material name, AR number, quantity required, quantity dispensed, dispensed by, checked by.Most common gap: BMRs incomplete or filled in after the fact. ALCOA+ principles required — Attributable, Legible, Contemporaneous, Original, Accurate.
4
Raw material testing and release records
Every raw material must be tested and formally released before use. Certificate of Analysis (COA) from supplier plus in-house confirmatory testing.
E.g. AR number assigned, test report completed, material released by QC with signature and date.
5
Calibration and qualification records
All manufacturing and testing equipment calibrated, and critical equipment formally qualified (IQ/OQ/PQ for new equipment).
E.g. Dissolution tester calibrated monthly. HPLC qualified. Records maintained with next-due dates.
6
Change control and deviation records
Any change to a product, process, or facility managed through a formal change control procedure. Any deviation from a procedure investigated and documented.
E.g. If a batch deviated from the SOP at any step: deviation report raised, root cause identified, CAPA documented.
7
Product recall procedure
A written, tested procedure for recalling a product from the market. Must be capable of reaching all distributed batches within defined timeframes.
What inspectors really check
A drug inspector inspects the facility, reviews BMRs for recent batches, checks that SOPs match actual practice, and verifies calibration records. "Show me the BMR for your last 3 batches" is the standard first request. Missing or incomplete BMRs are the most common GMP failure.
Gap analysis checklist — tick what you already have
Schedule M premises requirements met for your product category
Layout, clean room grade, HVAC, water system.
SOPs written for every manufacturing and QC step — current and approved
Version-controlled. Accessible at point of use.
Batch Manufacturing Records completed for every batch
Contemporaneous. ALCOA+ compliant.
All raw materials tested and released with AR numbers
COA on file. In-house confirmation test completed.
All equipment calibrated with current certificates
Next-due dates tracked. No expired calibrations.
Change control procedure documented
All process or facility changes managed through it.
Deviation procedure documented
All deviations investigated and CAPAs closed.
Product recall procedure written and tested
Last recall drill documented.
0 of 8 complete
04 —Official bodyWho certifies in India
Who issues this in India — and how to verify it.
For domestic pharmaceutical manufacturing, GMP compliance is verified by CDSCO (Central Drugs Standard Control Organisation) for central licences and by State Drug Authorities for state manufacturing licences.
For export and WHO prequalification, WHO GMP inspection is conducted by WHO or a national regulatory authority from the importing country.
For WHO GMP certificates (required for supplying UN agencies and many regulated markets), the process involves a WHO inspector or an authorised national authority inspecting your facility. CDSCO coordinates WHO GMP inspections for Indian manufacturers.
CDSCO — Central Drugs Standard Control Organisation
Central drug licensing and regulatory authority. Schedule M published here.
Audit your facility against Schedule M requirements for your product category.
Step 2
Write and implement SOPs
SOPs for every step. Train all staff. Record training.
Step 3
Begin batch records
BMR for every batch from today. ALCOA+ compliant.
Step 4
Drug licence / renewal
Apply for or renew your manufacturing licence with CDSCO or State Drug Authority.
Step 5
Facility inspection
Licensing authority inspects facility and reviews records before issuing or renewing licence.
WHO GMP
Separate process
If exporting to regulated markets, engage CDSCO for WHO GMP inspection process.
▶Where to begin: Use the checklist in Section 3 to assess your readiness before contacting any CB.
Domestic GMP
Licence-linked
GMP compliance verified at drug licence inspection. Not a separate certification process.
WHO GMP certificate
Required for export
Needed for EU, USA, WHO procurement. Involves WHO or partner authority inspection.
Schedule M revised
2023
Significant tightening of requirements in the 2023 revision. Verify current requirements.
Batch records
Permanent
BMRs must be retained for specified periods after expiry date of batch.
The 2023 Schedule M revision significantly tightened requirements. If your facility was inspected before 2023, re-audit against the revised Schedule M — particularly for premises, documentation, and QC requirements.
06 —Find certified companiesHow to verify
How to find and verify certified organisations.
Licensed drug manufacturers in India are registered with CDSCO. To verify whether a specific manufacturer holds a valid drug manufacturing licence, search the CDSCO database.
How to verify: To confirm whether any organisation holds a current GMP certification, use the official register. Verify the issuing CB's accreditation at nabcb.qci.org.in.
Write a BMR template and start filling it in for every batch from today
A BMR template covering every step of your manufacturing process. Fill it in contemporaneously — during production, not after. This is the single most scrutinised document in any GMP inspection.
3
Contact CDSCO or your State Drug Authority for inspection guidance
If you are applying for a new licence or renewing, contact the licensing authority directly. For WHO GMP, engage CDSCO's international division.
Good records are the foundation. A process tracker builds them automatically.
Clicarity — Live Job Process Tracker & Bottleneck Identifier
Clicarity doesn't write your SOPs or get you GMP certified. It tracks your production batches — and that tracking builds the batch-wise records GMP requires.
GMP requires a complete Batch Manufacturing Record (BMR) for every production batch — who weighed what, who operated which equipment, what the in-process test results were, and who released the batch. In Clicarity, every batch is a job. Each stage has custom fields your team fills in as they work: operator dropdown, equipment number, quantity in and out, critical process parameters. When a batch splits into different pack formats, each format is tracked independently through its own QC checks. When they rejoin at final release, the complete record of every format is preserved in one traceable batch job.
Batch number captured at job creation — every stage update linked to that specific batch, creating a consolidated record automatically.
Dispensing stage captures: material name, AR number, quantity dispensed, dispensed by, and checked by — the double-check record GMP requires for weighing.
When a batch splits into pack formats (blister, strip, bottle), each format completes its own QC checks independently before final release. Rejoin preserves the full test history.
Clicarity shows stage-wise yield — quantity in vs quantity out vs losses — supporting the process parameter monitoring GMP requires for critical manufacturing steps.
📄 Job tracked in Clicarity
#WO-6614 — Ayurvedic tablet batch — 50,000 units
Batch record opened
✎Product name
✎Batch no.
#Batch size
📅MFG date
▼Authorised by
→
Raw material weighing
✎Material name
✎AR no.
#Qty dispensed (g)
▼Dispensed by
▼Checked by
→
Granulation
#Qty in (g)
#Qty out (g)
#Loss on drying (%)
▼Operator
▼Equipment no.
→
Compression / filling
#Qty in
#Qty produced
#Rejects
▼Operator
▼Machine no.
▼ Job splits — each component tracked independently
#WO-6614-A
Blister pack — 30,000 units
#Qty to packing
▼Operator
▼Machine no.
#WO-6614-B
Strip pack — 20,000 units
#Qty to packing
▼Operator
▼Machine no.
▲
Components rejoin as #WO-6614 — complete record of every branch, every data point, every sign-off preserved.
In-process QC
▼QC analyst
#Sample size
▼Pass / Fail
✎Test report ref.
📅Date
→
Packaging & labelling
✎Label batch no.
📅Expiry date
#Qty packed
▼Operator
▼Label verified by
→
Final release
▼QC release by
📅Release date
#Qty released
✎COA ref.
Wastage tracked:▰ Granulation: loss on drying recorded — critical process parameter▰ Compression: rejects per run recorded at stage▰ Each pack format tracked through QC independently before release
ⓘ Fields and stage names are fully customisable. This illustrates a typical pharmaceutical / Ayurvedic manufacturer — GMP setup.
👥 Illustrative case — details changed for confidentiality
A large pharmacy chain asked for GMP certification proof before extending distribution to their national network. The manufacturer held a valid drug licence but no formal GMP certification.
The challenge
Their batch manufacturing records were maintained on paper — inconsistently. Dispensing records, in-process QC, and final release were recorded in separate registers by different teams. No consolidated batch record existed.
Where Clicarity came in
They had deployed Clicarity to track production jobs. Every batch was a job with stages configured for dispensing, granulation, compression, QC, and release. Custom fields at each stage captured what the GMP batch record requires. When their consultant reviewed the Clicarity records for the last 3 months, all the key data points were there — by batch, by stage, by person.
The result
GMP certification achieved within 5 months. Pharmacy chain distribution agreement signed.
We already had most of the data. It just wasn't in one place. Clicarity gave us the consolidated batch record we were missing.
Clicarity is a process tracking tool. It does not provide certification, consulting, or audit services.