Regulatory & GMP advisory · India and export markets
Pharmaceutical Regulatory Compliance Consultation for Indian Manufacturers and Exporters
Practical compliance support for facilities working towards Revised Schedule M, WHO-GMP, USFDA, MHRA, EU GMP and PIC/S expectations — gap assessment, licensing, documentation, validation and inspection readiness, delivered by a working QA and regulatory affairs practitioner rather than a generalist consulting desk.
Why this matters now
The Revised Schedule M transition window has closed
Revised Schedule M was notified on 28 December 2023 and published in the Gazette of India on 5 January 2024. Manufacturers above the ₹250 crore turnover threshold were required to comply within six months. Micro, small and medium manufacturers at or below that threshold could apply through Form A on the ONDLS portal for an extension to 31 December 2025, with the effective implementation date set at 1 January 2026.
State inspections are already running
In a directive dated 7 November 2025, the Drugs Controller General of India asked all state and union territory drug controllers to inspect manufacturing units that had applied for the extension, submit monthly reports on observations and action taken, and initiate strict action against units found non-compliant with Revised Schedule M.
For a facility that is still part-way through upgradation, the practical question has changed. It is no longer whether an inspection will happen, but whether the documentation, qualification files and quality system will hold up when it does. Our CDSCO Schedule M compliance dashboard tracks the clause structure in detail.
Start here
Regulatory compliance assessment request
Give us enough detail to be useful. The more precisely you describe the facility, the target market and the current documentation position, the more specific the preliminary direction we can send back.
After you submit
What comes back to you
- An assessment of which frameworks genuinely apply to your product and market, and which ones you can set aside for now.
- The likely licensing route under the Drugs and Cosmetics Rules, 1945, including which licence forms fit your dosage forms.
- A first read on the documentation and qualification gaps that typically hold up an inspection in your category.
- A realistic view of sequence and effort, stated as ranges rather than a fixed promise.
Scope note
What we do not claim
No consultant can guarantee a licence, a certificate or a clean inspection. Outcomes depend on product category, target market, facility condition, documentation quality and the licensing authority's own assessment. We work on readiness and evidence, which is the part that is actually within your control.
Services
Core compliance services
Each engagement is scoped against a single question: what stands between this facility and the standard it needs to meet. The work below is delivered as documents, protocols and reviewed evidence — not advisory notes.
Assessment
Compliance gap assessment
A clause-level review of the quality system, premises, utilities, documentation and processes against the standard you are targeting.
- Facility and layout review
- QMS and documentation audit
- Gap register with priority ranking
- Costed remediation sequence
India
Revised Schedule M upgradation
Mapping the current facility against the 2023 revision and building the upgradation plan the licensing authority expects to see.
- Pharmaceutical Quality System build
- Quality Risk Management framework
- Product Quality Review structure
- Computerised system and data integrity controls
Licensing
CDSCO and state licensing support
Working out which licence you actually need before anything is filed, then preparing the file so it survives scrutiny.
- Form 25 and Form 28 manufacturing licences
- Form 25A and Form 28A loan licences
- Form 28B manufacture for export
- Form 20B and 21B wholesale licences
Export
WHO-GMP and COPP
Preparing the site for the CDSCO inspection that leads to a WHO-GMP certificate and Certificate of Pharmaceutical Product for your export markets.
- Site Master File preparation
- Pre-inspection readiness review
- Product-wise COPP documentation
- Observation response support
United States
USFDA readiness
Aligning the plant with 21 CFR Parts 210 and 211 and the data integrity expectations of Part 11, ahead of an inspection or a filing.
- cGMP gap analysis
- Data integrity and audit trail review
- Mock inspection with observation log
- Form 483 and warning letter CAPA support
United Kingdom
MHRA and UK route
Working out the correct UK entry route for an Indian site, and preparing the plant for assessment against UK GMP as set out in the Orange Guide.
- UK GMP gap review
- Annex 1, 11, 15 and 16 alignment
- QP and MIA holder interface preparation
- Documentation pack for UK partners
Europe
EU GMP and PIC/S alignment
Bringing the site up to EudraLex Volume 4 expectations, which is also the practical bridge to most PIC/S participating authorities.
- Annex 1 contamination control strategy
- Cleanroom classification review
- Qualified Person expectations briefing
- Supporting technical documentation
Documentation
SOP and documentation systems
Building the document set that the quality system rests on, written for the way your plant actually runs.
- SOP suite with revision control
- Master formula, BMR and BPR templates
- Specifications and test procedures
- Training matrix and records
Validation
Validation and qualification
Protocols and reports for equipment, utilities, processes, cleaning and analytical methods, in the sequence an auditor expects.
- Validation Master Plan
- DQ, IQ, OQ and PQ protocols
- HVAC, water and compressed air qualification
- Cleaning and process validation
Inspection
Mock audit and inspection readiness
A full dry run conducted the way a regulator would run it, with a written observation report and a closure plan.
- Pre-audit document review
- Floor walk and personnel interviews
- Observation report with risk grading
- CAPA drafting and effectiveness checks
Registration
Export dossiers and registration
Compiling and reviewing product registration files for the markets you are entering, in the format the receiving authority accepts.
- CTD and eCTD structure review
- Drug Master File support
- Country-specific registration files
- Free sale and legalisation paperwork
People
GMP training
Role-specific training for production, QC, QA, engineering and warehouse teams, with effectiveness checks that stand up in an audit.
- Induction and refresher GMP modules
- Data integrity and ALCOA+ training
- Deviation and CAPA investigation skills
- Behaviour during a regulatory inspection
Related reading: WHO-GMP compared with USFDA compliance · USFDA approval roadmap for Indian formulation plants · SOP library
Framework explorer
Regulatory frameworks we work against
Select a framework to see what it governs, who it applies to, and the work involved. Ten frameworks, described the way they affect an Indian manufacturing site rather than as a glossary.
Revised Schedule M, Drugs and Cosmetics Rules, 1945
Mandatory in IndiaIndia's GMP requirement, revised by notification of 28 December 2023 and published in the Gazette on 5 January 2024. It moves Indian GMP substantially closer to WHO-GMP and EU GMP by introducing a formal Pharmaceutical Quality System, Quality Risk Management, Product Quality Review, computerised system validation and data integrity discipline.
Applies to: every licensed drug manufacturing unit in India, with no remaining transition period for units that took the MSME extension.
Typical work: clause-wise gap register, upgradation plan, PQS and QRM documentation, PQR structure, revised layouts, and closure evidence for the state inspection. See the Schedule M compliance dashboard.
CDSCO and state licensing
India · statutoryManufacturing licences in India are issued by state licensing authorities, with the Central Licence Approving Authority involved for certain categories. Which form applies depends on the drug schedule and whether you own the premises or manufacture on a loan licence.
Common routes: Form 25 for drugs other than those in Schedules C, C(1) and X; Form 28 for Schedule C and C(1) drugs; Form 25A and Form 28A for the corresponding loan licences; Form 28B for manufacture meant for export. New drug approvals now run under the New Drugs and Clinical Trials Rules, 2019, which replaced the older Form 44 route.
Typical work: licence route selection, premises and equipment adequacy, technical staff qualification checks, product list drafting and file preparation.
WHO-GMP and Certificate of Pharmaceutical Product
Export enablerWHO good manufacturing practice for pharmaceutical products is the reference text most importing regulators recognise. In India the WHO-GMP certificate and the COPP are issued following a CDSCO inspection of the site.
Applies to: manufacturers exporting to markets that ask for a COPP under the WHO Certification Scheme, which covers much of Africa, South-East Asia, Latin America and the CIS.
Typical work: Site Master File, validation and qualification file completion, environmental monitoring trend data, stability data review and pre-inspection readiness.
USFDA current Good Manufacturing Practice
United StatesEnforced under 21 CFR Parts 210 and 211 for finished pharmaceuticals, with ICH Q7 applied to active pharmaceutical ingredients. Non-compliance is a legal matter, not an administrative one, and inspection findings are issued on Form 483, escalating to warning letters and import alerts.
Applies to: any site manufacturing product intended for the US market, including API and intermediate suppliers referenced in a filing.
Typical work: cGMP gap analysis, mock inspection, laboratory control and OOS investigation review, and CAPA construction. See the USFDA inspection readiness guide and warning letter CAPA blueprint.
21 CFR Part 11 and data integrity
Electronic recordsSets the conditions under which electronic records and electronic signatures are accepted in place of paper. In practice this is where a large share of inspection observations originate: shared logins, disabled audit trails, unreviewed metadata and results that cannot be traced back to raw data.
Applies to: any computerised system that generates or holds GMP data, from HPLC software to the ERP and the building management system.
Typical work: system inventory and risk classification, audit trail review procedure, user access matrix, backup and archival controls, and ALCOA+ training.
MHRA and the UK route
United KingdomThe Medicines and Healthcare products Regulatory Agency is the competent authority for Great Britain under the Human Medicines Regulations 2012. Post-Brexit, UK GMP is a modified version of EU GMP Parts I and II, published in the MHRA Orange Guide.
Point of correction: MHRA does not issue a GMP licence directly to an Indian manufacturing site. UK market access runs through a UK-based Manufacturer's or Importer's Authorisation holder and a Qualified Person who certifies each batch. Your site is assessed as part of that supply chain, and may be inspected by MHRA.
Typical work: UK GMP gap review, Annex 1, 11, 15 and 16 alignment, technical agreement drafting and the documentation pack your UK partner's QP will ask for. Background: MHRA guidelines for quality manufacturers.
EU GMP, EudraLex Volume 4
European UnionThe GMP requirements applying to medicinal products for human and veterinary use in the EU, structured as Part I for finished products, Part II for active substances and a set of annexes. A GMP certificate is issued by an EEA competent authority following inspection.
Current pressure point: the 2022 revision of Annex 1 on sterile products, which requires a documented Contamination Control Strategy rather than a set of isolated controls.
Typical work: Contamination Control Strategy authoring, cleanroom classification and monitoring review, aseptic process simulation design, and technical documentation for the marketing authorisation holder.
PIC/S
Voluntary alignmentThe Pharmaceutical Inspection Co-operation Scheme harmonises GMP inspection standards across its participating authorities. Its GMP guide is closely aligned with EU GMP, and its data integrity guidance is widely used as a reference by inspectors well beyond its membership.
Position for India: India is not a PIC/S participating authority, so alignment is voluntary. It is nevertheless the most efficient single target if you are preparing for several regulated markets at once, because it overlaps heavily with EU, UK and Australian expectations.
Typical work: gap assessment against the PIC/S GMP guide, data integrity maturity review and inspection simulation.
ICH guidelines
Technical basisICH guidelines supply the technical reasoning that most GMP frameworks now assume. Q7 covers API manufacture, Q8 pharmaceutical development, Q9 quality risk management, Q10 the pharmaceutical quality system, and Q1A(R2) stability testing.
Why it matters: Revised Schedule M and EU GMP both expect risk-based decisions and a lifecycle view. If your justifications are not written in that language, they read as assertions rather than evidence.
Typical work: risk assessment methodology, stability protocol design, development report structuring and specification justification.
ISO 14644 cleanroom classification
Facility designThe international standard for classifying air cleanliness by particle concentration, used alongside the Grade A to D classification that GMP frameworks apply. Classification, monitoring and requalification intervals all follow from it.
Where it bites: most facility disputes at inspection are not about the certificate itself but about sample point justification, at-rest versus in-operation states, and recovery testing after an HVAC change.
Typical work: classification strategy, HVAC qualification review, environmental monitoring programme design and requalification scheduling. Costing a new build? Use the pharma plant setup cost calculator.
Coverage
Industries we serve
The quality system logic carries across regulated manufacturing, but the statute, the licensing authority and the inspection focus change. These are the segments we work in.
Pharmaceuticals
Human formulations and APIs under the Drugs and Cosmetics Act, 1940 and Rules, 1945.
Veterinary
Veterinary formulations, with dedicated area and cross-contamination expectations.
Ayurvedic / AYUSH
Schedule T GMP, AYUSH licensing and shelf-life substantiation.
Cosmetics
Cosmetics Rules, 2020, registration and ISO 22716 alignment.
Medical devices
Medical Devices Rules, 2017, risk classification and ISO 13485 systems.
Nutraceuticals
FSSAI health supplement regulations and label claim substantiation.
Food processing
FSSAI Schedule 4, HACCP and hygiene rating readiness.
Biotech
Biologicals and biosimilars, with CDSCO and biosafety interfaces.
Diagnosis
Common compliance challenges
Most enquiries arrive with one of these problems already in progress. If you recognise your situation here, the assessment form is the fastest route to a specific answer.
Licence application stuck
The file has been filed but queries keep returning. Usually a mismatch between the product list, the approved layout and the technical staff qualifications on record.
Form 483 observations open
Observations issued and the response window is short. The response quality and the credibility of the CAPA matter more than the speed of the reply.
Documentation does not exist
The plant runs well but the paperwork trails behind practice. Retrospective documentation is visible to any experienced inspector and creates a worse problem than the gap it hides.
Validation gaps
Equipment qualified once at installation and never requalified, cleaning validation without worst-case justification, or a Validation Master Plan that no longer matches the plant.
Schedule M readiness
Partial upgradation with the transition period already over, and a state inspection expected. Sequencing the remaining work matters more than attempting everything at once.
Export approval blocked
A buyer or importing regulator has asked for a COPP, a WHO-GMP certificate or a registration file that the site cannot currently support.
CAPA that does not close
The same deviation recurs under different reference numbers. Almost always a root cause analysis problem rather than an execution problem.
Data integrity findings
Shared logins, audit trails switched off, or laboratory data that cannot be reconciled with raw instrument records.
New plant designed wrongly
Layout frozen and construction started before GMP flows were checked. Correcting material and personnel flow after the shell is up is the most expensive mistake in plant setup. Related: plant acquisition due diligence checklist.
Engagement
How the work runs, end to end
Eight stages. Not every engagement needs all of them — a gap assessment can stop at stage three, and a CAPA engagement may start at stage six.
Output
What you receive
Deliverables
Documents you can put in front of an inspector
- Gap analysis report — clause reference, finding, risk grade and evidence reviewed.
- Compliance roadmap — sequenced actions with owners and realistic durations.
- SOP templates — drafted for your processes, not generic forms.
- Validation and qualification templates — VMP, DQ, IQ, OQ, PQ protocols and report formats.
- CAPA report — root cause analysis, actions and effectiveness check design.
- Audit checklist — the checklist used in the mock audit, left with you for self-inspection.
- Inspection readiness report — open items, residual risk and front room arrangements.
- Training plan — role-wise matrix with content, frequency and effectiveness checks.
Documentation expertise
Document types routinely prepared or reviewed
The quality system is only as good as the documents that carry it. These are the record types we build, correct and defend during inspections.
Self-assessment
Inspection readiness check
Tick what your facility can evidence today, with documents, not intent. Nothing is stored or transmitted — the list resets when you reload the page.
Readiness signal
0 / 8Start ticking to see an indicative reading. This is a self-assessment prompt, not a compliance rating.
Why Laafon
What you are actually buying
Manufacturing experience
Advice grounded in how a plant runs on a bad day, not only how it reads in a guideline.
QA and QC practitioners
Work led by people who have held quality responsibility, signed batches and faced inspectors.
Practical implementation
Documents written to be used by your team, in language your operators can follow.
Plant setup experience
GMP flows checked at design stage, when corrections still cost drawings rather than concrete.
Regulatory documentation
Licence files, registration dossiers and technical documents prepared to survive review.
End-to-end support
From first gap assessment through to post-approval maintenance, with one point of accountability.
Audit readiness
Mock inspections run to the standard being targeted, with findings graded by real risk.
Pan-India coverage
Work delivered across major manufacturing belts including Himachal Pradesh, Uttarakhand, Gujarat, Sikkim and Telangana.
Who you work with
The person behind the advice
Darshan Singh
Founder · Laafon Galaxy Pharmaceuticals
Twenty-three years in pharmaceutical quality assurance, quality control and drug regulatory affairs. The work has run across formulation manufacturing, quality systems, documentation and licensing — which is why the advice on this page is written in terms of what a plant can evidence rather than what a guideline says in the abstract.
Areas of practice: quality assurance and quality management systems; quality control and laboratory compliance; drug regulatory affairs and licensing; GMP facility planning and plant setup; third-party and loan licence manufacturing; inspection readiness and CAPA.
Questions
Frequently asked questions
It follows from the markets you intend to sell in, not the other way round. Revised Schedule M is mandatory for every licensed unit in India regardless of export plans. WHO-GMP and a COPP open most emerging markets. USFDA, MHRA and EU GMP are separate, heavier commitments justified only by a specific commercial reason. We map this at the discovery stage so effort is not spent on a standard you do not need.
The transition period ended for MSME manufacturers who took the extension, with 1 January 2026 as the effective implementation date, and CDSCO has directed state drug controllers to inspect those units and report monthly. The practical response is to sequence the remaining work by inspection risk rather than by cost, get the documentation and qualification files defensible first, and be able to show a controlled, evidenced upgradation plan when the inspector arrives.
No, and any consultant who says otherwise is describing something that does not exist. MHRA does not issue a manufacturing licence to a site outside the UK. UK supply runs through a UK-based Manufacturer's or Importer's Authorisation holder whose Qualified Person certifies each batch, and your site is assessed as part of that chain. What we do is prepare the plant against UK GMP as set out in the Orange Guide, and build the documentation your UK partner will require.
It depends entirely on the starting position. A facility with a functioning quality system and current qualification files may need six to twelve weeks of focused work. A facility where documentation has fallen behind practice, or where utilities were never properly qualified, takes considerably longer because the evidence has to be generated over time and cannot be created retrospectively. We give a range after the gap assessment, not before it.
Yes, drafted against the framework you are targeting and adapted to your processes, equipment and product range. Generic documents downloaded and adopted without adaptation are one of the more reliable ways to fail an inspection, because the procedure will not describe what the plant actually does. Our public SOP library shows the structure we work to.
Yes. The response window is short, so the priority is a credible root cause analysis, a corrective and preventive action plan with named owners and dates, and interim controls that can be evidenced immediately. The quality of that first response strongly influences whether the matter escalates. Our warning letter and CAPA guide sets out the approach in detail.
It depends on the drug schedule and whether you own the premises. Form 25 covers manufacture of drugs other than those in Schedules C, C(1) and X; Form 28 covers Schedule C and C(1) drugs; Form 25A and Form 28A are the loan licence equivalents; Form 28B covers manufacture intended for export. Wholesale activity runs on Form 20B and Form 21B. New drug approvals now fall under the New Drugs and Clinical Trials Rules, 2019.
Yes — veterinary, Ayurvedic and AYUSH, cosmetics, medical devices, nutraceuticals, food processing and biotech. The quality system principles carry across, but the governing rules and the licensing authority differ, so the scope is set against the statute that actually applies to your product.
Both, depending on the task. Documentation, dossier review, protocol drafting and CAPA construction work well remotely. Gap assessments, mock audits and facility flow reviews need a site visit, because the findings that matter usually come from watching the plant run rather than reading about it.
No. No consultant can, and a guarantee of that kind should be treated as a warning sign. Outcomes depend on facility condition, documentation history, product category, the target market and the assessing authority's own judgement. What can be committed to is the readiness work: closing identified gaps, generating defensible evidence and rehearsing the inspection.
Next step
Tell us where the facility stands today
Send the details and you will receive a preliminary compliance direction — the frameworks that apply, the likely licence route and the gaps worth closing first. If a site visit is the sensible next step, we will say so.
This page describes advisory services. It is not legal advice and does not create a regulatory obligation or entitlement. Regulatory requirements change; verify current requirements with CDSCO, your state licensing authority or the relevant foreign regulator before acting. Related pages: all services · third-party manufacturing · PCD pharma franchise · pharma plants for sale · contact.
Sources for dates and requirements cited above
- Revised Schedule M, Drugs and Cosmetics Rules, 1945 — notified 28 December 2023, Gazette of India 5 January 2024.
- Drugs (Amendment) Rules, 2025 — extension route for manufacturers with turnover at or below ₹250 crore, compliance date 31 December 2025, effective implementation 1 January 2026.
- Directive of the Drugs Controller General of India dated 7 November 2025 to state and union territory drug controllers on Revised Schedule M inspections and monthly reporting.
- 21 CFR Parts 210 and 211; 21 CFR Part 11 — US Food and Drug Administration.
- Human Medicines Regulations 2012 and the MHRA Orange Guide — Medicines and Healthcare products Regulatory Agency, United Kingdom.
- EudraLex Volume 4, EU GMP Parts I and II with annexes, including the 2022 revision of Annex 1.