PESO Requirements for Pharma Facilities
Three parts of a pharmaceutical site typically attract PESO requirements, and they are assessed under different rules.
Solvent storage
The most common trigger. Under the Petroleum Rules, 2002, materials are classified by flash point, and PESO’s published list brings hexane, toluene and benzene into scope directly. Acetone, ethyl alcohol and methyl alcohol arrive via the Inflammable Substance Act, 1952 and also require a licence under the Petroleum Rules.
Pressure vessels
Unfired pressure vessels and bulk gas storage fall under the SMPV(U) Rules, 2016. This reaches reactors, receivers, cryogenic tanks and nitrogen installations depending on their specification and service.
Industrial gases
Cylinder possession, filling and storage fall under the Gas Cylinder Rules, 2016. Pharma sites often hold a mixed cylinder inventory — nitrogen, hydrogen, oxygen and speciality gases — without having assessed it as a licensing question.
Hazardous area electricals
Electrical equipment in classified areas under the Petroleum Rules requires approval from the Chief Controller of Explosives. Zone classification governs which protection types are permitted.
Petroleum Class A
Below 23°CHexane, benzene, toluene, naphtha. The Inflammable Substance Act, 1952 also brings acetone, ethyl alcohol and methyl alcohol under the Petroleum Rules.
Petroleum Class B
23°C to below 65°CDiesel (HSD), kerosene (SKO) and mineral turpentine. Usually held as utility or captive fuel stock rather than process input.
Petroleum Class C
65°C to below 93°CFurnace oil and light diesel oil — typically boiler and thermic fluid heater feedstock.
Hazardous Material Storage for Pharma
Pharma solvent storage has a characteristic that creates licensing drift: it scales with campaigns. A facility running a new product for six months may hold a solvent it has never held before, in a yard licensed for a different inventory.
The situations that most often require attention:
- New block commissioning. A new production or R&D building with its own solvent handling, added to a site with an existing licence covering only the original yard.
- Solvent recovery. Recovery and distillation sections change both the quantities held and where they are held.
- Campaign-driven inventory changes. New materials introduced into an existing licensed storage area.
- Capacity increase. Additional tankage ahead of a scale-up, where the licensed quantity no longer covers the intended holding.
- Warehouse reorganisation. Drum storage relocated within the site without the drawing being revisited.
Scope note. PESO licensing sits alongside, not inside, your pharmaceutical regulatory obligations. It does not replace or overlap with Drug Department requirements, and our practice does not extend to Drug Department, GPCB or CPCB matters.
Documents & Application Process
PESO has moved to a paperless process, with applications routed through the National Single Window System. PESO’s published document on disposal timelines states that online applications are auto-inwarded four times a day and are to be processed within 21 days. Read that figure for what it is — a departmental processing timeline, not a promise of when your licence arrives. Elapsed time is governed almost entirely by how often the file goes back for clarification.
Typically required
- Company constitution and incorporation documents
- Authorisation for the signatory
- Plot allotment, lease or occupancy proof
- Site plan, key plan and layout drawing
- Solvent list with classification, flash point and quantity
- Tank and vessel schedules with capacities and construction details
- Fabrication and test certificates
- Safety and test certificates by a recognised competent person
- Existing licence with approved drawing, for renewal or amendment
The pharma-specific difficulty
Documentation on a pharma site is usually excellent — but it is organised around quality systems, not around licensing. The solvent list exists in a purchasing system, the tank details in an engineering file, and the site drawing in a projects folder, each maintained by a different team to a different revision.
Assembling a PESO application means reconciling those three into one consistent picture. Where they disagree, that disagreement will surface during scrutiny rather than staying internal.
Inspection & Compliance
Where the licence category calls for a site visit, preparation is a reconciliation exercise rather than a cleaning exercise.
- A tank or vessel relocated during construction, never reflected in the approved drawing
- Stored quantities that have crept above the licensed figure
- Safety fittings replaced with a different make or specification
- Electrical equipment in a classified area whose approval status nobody has checked
- Distances on the drawing that do not survive a tape measure
- A site team that has never seen the drawing filed on their behalf
On pharma sites one additional issue is common: the person who prepared the application and the person who will meet the inspecting officer are frequently from different departments and have never compared notes. Brief the site team on what was filed before the visit, not during it.
What a consultant can and cannot do. We prepare the file, brief your site team and draft replies to departmental observations. We have no role in how an inspection is conducted and no influence over its outcome. A One Consultant is a private consultancy — not a government body, and not appointed or authorised by one. Our practice does not extend to GPCB, CPCB or Drug Department matters.
Renewal & Amendments
Renewal timing varies by rule set, and misinformation circulates freely here. A documented example: under the SMPV(U) Rules, licences are granted or renewed for a maximum of three years ending 31st March, and the last date for receipt of a renewal application at the renewing office is 2nd March of the expiry year. Other rule sets carry their own validity periods and cut-off dates — check yours against your licence document rather than assuming the SMPV position applies.
Pharma facilities change more often than their licences do. Amendment becomes relevant when a new solvent enters a licensed area, tankage is added, a new block changes the site layout, or a vessel is installed or replaced. Filing the amendment at the time of the change keeps the renewal routine.
If your group is acquiring a Gujarat facility, note that under the SMPV(U) Rules a licence cannot be transferred between companies — the new occupier applies fresh. Existing approvals are something to verify during due diligence, not something you inherit automatically.
Support Across Gujarat Pharma Hubs
Ahmedabad and Sanand
Formulation and API manufacturing with a high rate of new-block commissioning, where the licensing question usually arrives with the project rather than the plant.
Vadodara
Established API and intermediate manufacturing, often with layered expansions on older installations and drawings that need rebuilding rather than updating.
Ankleshwar and Panoli
API and pharma intermediate units sharing an estate with heavy chemical manufacturing. Solvent handling is intensive and plot constraints make layout questions sharper.
Vapi and the Valsad belt
Intermediates and speciality manufacturing on constrained plots. Our office is at GIDC Char Rasta in Vapi.
Our client list includes Sun Pharma, Zentiva and Alchemie Finechem alongside chemical manufacturers.
Why Use a PESO Consultant
The value is concentrated at the start, in deciding what applies, and at the end, in making sure the file survives scrutiny. The middle is administration.
- Assessment before paperwork. A written view on which rule sets reach your site and why, built from your solvent list and equipment schedule.
- Reconciliation across departments. Bringing purchasing, engineering and projects records into one consistent application.
- Drawing preparation. Site plans and layouts prepared to rule requirements and verified against the plant as it stands.
- Multiple rule sets handled together. Solvent tankage, pressure vessels and cylinders assessed as one exercise rather than three disconnected ones.
- Renewal and amendment tracking. Different rule sets carry different cut-off dates.
We do not guarantee approval and have no influence over departmental decisions. What we commit to is an accurate file and a clear account of where things stand.
Pharma PESO FAQs
Does a pharmaceutical company need a PESO licence?
It depends on what the facility holds and operates. Bulk solvent storage, unfired pressure vessels and gas cylinder inventories are the three usual triggers, assessed under the Petroleum Rules, the SMPV(U) Rules and the Gas Cylinder Rules respectively. A formulation unit with no bulk solvent storage and no regulated vessels may have no requirement.
Which solvents used in API manufacturing fall under PESO rules?
PESO’s published list of petroleum requiring a licence includes hexane, toluene, benzene and xylene. Acetone, ethyl alcohol and methyl alcohol fall under the Inflammable Substance Act, 1952 and also require a licence under the Petroleum Rules. Classification by flash point then determines the applicable class.
Is PESO licensing connected to our Drug Department approvals?
No. They are separate frameworks administered by different authorities, and one does not satisfy the other. Nothing in a GMP or Drug Department audit will identify a PESO gap. Our practice does not extend to Drug Department, GPCB or CPCB matters.
We are commissioning a new block. When should we start?
At the design stage, before equipment is ordered. Storage positions, distances and electrical area classification are far cheaper to address on a drawing than after installation. Waiting until commissioning is the most common and most expensive sequencing error.
Do our nitrogen and hydrogen installations need approval?
Bulk gas storage and unfired pressure vessels fall under the SMPV(U) Rules, 2016, and cylinder possession, filling and storage under the Gas Cylinder Rules, 2016. Whether a particular installation is covered depends on its specification, contents and service.
We introduced a new solvent into an existing yard. Does that matter?
Potentially yes. If the material is not covered by your licensed particulars, the licence no longer describes your operation and an amendment may be needed. This is worth reviewing whenever a campaign brings in a material the site has not previously held.
Can one application cover solvents, vessels and cylinders together?
No — they fall under different rule sets with different forms, drawings and renewal dates. They can and should be assessed together, but they are filed separately.
How long does the process take?
PESO’s published timeline states that online applications through the National Single Window System are processed within 21 days, with applications auto-inwarded four times a day. That is a departmental processing timeline rather than a guaranteed date, and query cycles extend it.