Building a pharma cleanroom in Hyderabad: site, utilities and approvals.

A cleanroom project is decided before the first panel arrives

A pharma cleanroom in Hyderabad succeeds or fails on three early decisions: the site, the utility plan and the order of approvals. Get them right and the room has a fair chance of holding its grade through a monsoon, a generator changeover and an inspection. Get them wrong and even a well-built room can end up on a plot that cannot dispose of its effluent, or with a licence file that does not match what was built.

Hyderabad gives pharma projects real advantages, including an established life sciences cluster and specialist suppliers. It also brings local constraints that a generic cleanroom guide will not mention. Where you build affects how effluent leaves the site, and which authorities you deal with.

This guide is for promoters, project heads and quality teams planning a new facility or converting an existing building. It focuses on the decisions to make before you tender. For the air system itself, read our guide to cleanroom HVAC design and validation.

Choosing the right site in Hyderabad

Start by checking whether the site can legally and practically support your product, not by comparing land prices. A cheaper plot can cost more if effluent must be tankered a long way, or the estate cannot support expansion.

Three local land issues to check

The ORR is becoming a planning question. Telangana’s HILT policy seeks to convert industrial land within the Outer Ring Road and move industries beyond it. It has been described as voluntary and is facing High Court scrutiny. If your site is inside the ORR, ask how the policy could affect neighbouring uses, expansion and long-term value.

Do not plan around Pharma City until you hold allotment documents. The state announced a shift to pharma villages in 2024. In May 2026, the Industries Minister was reported as saying Pharma City had not been cancelled and that a Life Sciences Park would use the land. Treat its timing and status as unsettled.

Check estate history for API work. A public-interest case led the Supreme Court to ban new or expanded bulk drug units in the Patancheru-Bollaram estate, according to a 2015 Down To Earth report. Have counsel confirm the current position before buying land there for API production.

Site due diligence checklist

• Written confirmation of permitted land use and product category.
• Title, lease and allotment conditions, including any limits on subletting or expansion.
• Soil report, flood and drainage levels, and neighbouring dust or chemical sources.
• Available power, with feeder arrangements and a realistic connection route.
• Reliable water source and quality data for your treatment plant.
• A named effluent route, with its capacity and acceptance limits.
• Room for utilities, tanks, loading, fire access and a later production block.

Hyderabad’s Zone II seismic classification lowers one risk, but it does not settle vibration or foundation design. Sensitive equipment still needs site-specific assessment.

Designing the building around the cleanroom

The product sets the design, so write a room data sheet for every room before you fix the building dimensions. Each sheet should record the process, product exposure, grade, temperature and humidity limits, pressure relationships, and movement of people and materials.

Revised Schedule M has applied to all manufacturers since 1 January 2026. Its requirements differ by product type:

• Sterile products. Part II sets four grades of clean area, A to D. It gives about 10 to 15 Pa as guidance between adjacent rooms of different grades.
• Oral solid dosage. Part VIII has no grade table of its own. It focuses on a pressure cascade that keeps dust contained, with limits set for each facility.
• Highly sensitising or biological products. Some need dedicated, self-contained facilities, which can mean separate air handling as well as separate rooms.

These choices then shape the building in four ways:

• Flow. Arrange rooms in a logical order for materials and people, with airlocks and pass boxes where the risk calls for them.
• Height and service zones. Allow space for ducts, HEPA housings, pipework and maintenance before fixing the roof or slab level.
• Structure. Size slabs and foundations for process equipment, tanks and plant, and isolate vibration where equipment requires it.
• Envelope. Use smooth, cleanable surfaces, and detail every joint and penetration so the room can hold pressure.

Converting a shed can work well, but the old fabric rarely becomes the clean boundary. A room-in-room enclosure is often a better approach. Our guide to the industrial shed explains why the building shell becomes part of the engineering control.

Coordinate fire design from the start. Fire, ventilation and GMP requirements can pull in different directions, especially around partitions, fresh air and smoke control. Bringing all disciplines into one BIM model helps find those conflicts before drawings are frozen.

Planning utilities for Hyderabad conditions

Utilities should be sized from the room data sheets and the process, then checked against what the site can really supply. In a GMP plant, supporting utilities must be qualified along with the premises and equipment, so they belong in the design basis from the start.

Power failure is a design case

A power interruption can collapse a pressure cascade, so decide what must keep running and how the rooms recover. Test that sequence during qualification, including the changeover to generators.

Effluent can shape the whole site

A Telangana pollution board report on the Polepally SEZ shows how specific these conditions can be. Formulation units there were directed to send pre-treated effluent to a common treatment plant at Patancheru, and to avoid discharge inside or outside their premises.

Consent conditions in that report also covered above-ground effluent storage, first-flush rainwater tanks and metering, with seven days of storage required in some cases. Each of these items needs plot space, access and capacity, which is why you should consider them before fixing the layout.

API projects may face stricter requirements. In a 2024 report, the board said bulk drug units generating more than 25 KLD of effluent must provide Zero Liquid Discharge. Check the current limits for your exact product and site.

Which approvals does a pharma cleanroom need in Telangana?

Most projects need land and building, pollution, factory, fire, electrical and drug licensing approvals. New units can use TG-iPASS as a single window for several of them, but you still need one team managing how they fit together.

Four details that are easy to miss

Your product decides the drug licensing route. Large-volume parenterals, sera, vaccines and r-DNA products use Form 27D and Form 28D, with CDSCO acting as central approving authority for LVPs. CDSCO’s published inspection records show joint CDSCO and state teams conducting such inspections. Its LVP guidance also recommends applying only when the premises are largely ready, because an unfinished site cannot receive a final inspection. Plan that route from day one.

Do not assume your pollution category. CPCB has told the National Green Tribunal that pharmaceutical industries fall in the Red category. A joint committee in the Polepally case treated formulation units there as Orange. Get the category confirmed for your specific activity.

Factory rules are in transition. The OSH Code has set the factory threshold at 20 workers with power since November 2025. As of August 2026, Telangana’s state rules were reported as still in draft, with licensing running through the existing system. Check the current position before filing.

A fire NOC does not end at occupancy. The Telangana department’s FAQ requires annual renewal after the Occupancy NOC, with an inspection of whether systems are being maintained. Draft amendments to the Fire Service Act were also out for comment when that guidance was published.

Published service timelines help, but they are not project durations. Fire’s 60-day decision period, the Code’s 30-day factory plan disposal and DCA’s 14 working days all depend on a complete file. Construction, utilities and qualification still have to be ready behind it.

Project sequence: from site to production

Run the building programme and the approvals programme as one plan. The exact order changes by product and site, but this sequence shows where each stream depends on the other.

The design stage carries the most risk, because the same drawings feed the consent, fire, factory and drug licensing files. If the room layout changes after that point, check every affected filing and qualification document. Schedule M also expects significant changes to be qualified and validated, so control changes from the start.

Common mistakes on Hyderabad cleanroom projects

Most expensive problems start before construction. Watch for these six:

• Buying land before confirming the effluent route. A plot can look right on paper and still leave no workable disposal plan.
• Designing for the licence but not the fire file. Partitions, smoke control and solvent stores must work with the GMP layout.
• Leaving too little height. Ducts, HEPA housings and maintenance access need space that a low shed may not have.
• Treating monsoon conditions as an afterthought. A room can hold in a dry month and drift when outdoor moisture rises.
• Testing normal operation only. Generator changeover and recovery need to be tested, not assumed.
• Letting drawings and records drift apart. Inspectors compare the approved layout, the validation file and the room in front of them.

Planning a pharma cleanroom in Hyderabad?

Start with a short feasibility review of your product, site, utility demand and approvals. Finding a problem at this stage costs far less than finding it after the layout is frozen.

Prana Build Tech is an engineering-led builder based in Jubilee Hills, Hyderabad. We are not a specialist sterile-suite contractor with a long list of validated cleanrooms, and we say so plainly. We bring integrated BIM coordination, independent inspection and disciplined site execution, and we would bring in specialist HVAC and validation expertise where a project calls for it.