Licences Required for a Pharmaceutical Business in India

Licences and registrations to plan for

• Planning stage
  Udyam registration

  Used to establish your enterprise size, which matters for several pharma schemes and for how Revised Schedule M timelines were applied to small units.

• Before construction
  Building plan approval

  Pharma plants need sanctioned layouts, and the drug inspector checks the premises against the design requirements of Schedule M.

• Before installing machinery
  Pollution consent (CTE / CTO)

  Bulk drug and intermediate manufacture is generally treated as a high-pollution category, while formulation is classified differently. Confirm your category with the state board.

• Before occupation
  Fire NOC

  Solvent storage and process areas raise fire risk, so state fire services examine the plant closely.

• Before production
  Factory licence

  A manufacturing plant meeting the Code threshold needs a factory licence before it starts production.

• Before production or trading
  Drug licence (manufacturing, wholesale, retail)

  The core approval. Manufacture requires a manufacturing licence from the State Licensing Authority, while trading requires a wholesale or retail sale licence.

• Before operation
  Hazardous waste authorisation

  Solvent residues, spent catalysts and expired or off-spec drugs can fall under hazardous waste rules, so the plant needs authorisation and a disposal route.

• Before borewell use
  Groundwater NOC

  Water-intensive formulation and API units that extract groundwater need CGWA permission.

• Before first sale
  GST registration

  Needed for sales and input tax credit. Medicines are taxed at rates that were rationalised in September 2025, so check the rate for each product.

• On hiring
  EPF and ESIC

  Employer registrations apply once the plant employs workers above the coverage limits.

• Before first shipment
  Import Export Code

  Required for exporting finished formulations or importing APIs and excipients.

• Before launch
  Trademark registration

  Brand names in pharma are checked for similarity to existing marks, and drug authorities also scrutinise confusing names.

• After licensing
  ISO and quality certifications

  Voluntary, but buyers and tenders often ask for ISO and for WHO-GMP evidence in addition to licence compliance.

Understanding who licenses what

Under the Drugs and Cosmetics Rules, 1945 the state Licensing Authority grants manufacturing licences for most drugs and all sale licences, while the Central Drugs Standard Control Organisation (CDSCO) approves new drugs, medical devices, imports and clinical trials. A formulation plant therefore typically deals with its state drugs control department for the licence, and with CDSCO for product-specific permissions such as test licences or new drug approval.

Three licence routes exist for a manufacturer. An own-manufacture licence is for a unit with its own premises and plant. A loan licence lets you use another licensee's facility, and both parties remain responsible for compliance. A repacking licence covers repackaging of bulk drugs. Your choice affects capital cost, timelines and the inspection you face.

Revised Schedule M: the compliance deadline has passed

Revised Schedule M, notified as G.S.R. 922(E) on 28 December 2023, replaced the old Good Manufacturing Practices schedule with a quality-system-based standard covering pharmaceutical quality systems, quality risk management, product quality review, validation, and stronger documentation and equipment requirements. Units with turnover above ₹250 crore had to comply from mid-2024.

Smaller units that submitted an upgrade plan to CDSCO received an extension under G.S.R. 127(E) dated 11 February 2025, which ended on 31 December 2025. From 1 January 2026 all manufacturers are expected to comply. A directive from the Drugs Controller General in November 2025 signalled strict enforcement. If you are applying for a fresh licence or renewal now, plan the plant to the revised standard from day one, because inspectors will assess against it.

Our dates come from a secondary compliance tracker and press reports, and we could not open the gazette text directly. Check the CDSCO website before you rely on the dates for a legal decision.

The roadmap: order of approvals

For a new formulation unit the usual order is below. Retail and wholesale businesses skip the plant-related steps.

• Fix the entity and register for PAN, GST and Udyam. A company or LLP must name a competent person and a technical team, while partnership and proprietary firms name the proprietor or partner responsible.
• Obtain land use clearance, building plan approval and a layout designed to the Revised Schedule M zones for production, quality control, storage and utilities.
• Apply for pollution Consent to Establish and, if needed, groundwater permission before you install equipment.
• Appoint qualified technical staff. Rules require a manufacturing chemist and an analytical chemist with prescribed qualifications and experience, and the inspector will check their credentials.
• Apply to the State Licensing Authority for the manufacturing licence with the site master file, plant layout, equipment list and staff details. An inspection by a joint team follows before grant.
• Obtain Consent to Operate, fire NOC and the factory licence, then start validation batches.
• For wholesale or retail sale, apply separately for the sale licence. A retail pharmacy needs a registered pharmacist, and a wholesale licence needs a competent person with qualifying experience.
• If you plan exports, apply for the IEC and consider a WHO-GMP certificate or Certificate of Pharmaceutical Product for the markets that ask for it.

WHO-GMP and other quality certificates

WHO-GMP is not a licence. It is a certification of compliance with World Health Organization good manufacturing practice, issued in India through CDSCO and state authorities after inspection. Importing countries, institutional buyers and tenders often require it, and a plant built to Revised Schedule M is much closer to it than before. Treat it as a market-access document rather than a legal precondition for selling in India.

Other quality marks, such as ISO 9001 and ISO 13485 for devices, are voluntary but frequently requested by buyers.

Delhi, Uttar Pradesh and Haryana: where applications go

Delhi: The Drugs Control Department of the Government of NCT of Delhi licenses sale premises and manufacturing. It publishes its own forms and fee schedules on its website. Delhi has very few manufacturing plants given land use rules, so most applicants are wholesalers, retailers and loan-licence holders.

Uttar Pradesh: The Food Safety and Drug Administration is the licensing authority. UP has a large wholesale and retail market in cities such as Lucknow, Kanpur, Agra and Noida, and manufacturing clusters in Ghaziabad and Noida. Industrial approvals run through the Nivesh Mitra portal.

Haryana: The state Drugs Control organisation licenses manufacturers and sale outlets, and Haryana has important manufacturing clusters in Panchkula, Faridabad and Gurugram. Plants obtain pollution consent from HSPCB and fire clearance from the Haryana Fire Service.

Practices on inspections and query handling differ across these offices, so ask your local consultant or the department which formats and annexures they currently use.

Recurring compliance for a licensed pharma unit

• Licence retention: drug licences are generally perpetual in form but need a licence retention fee at periodic intervals, with a late-payment charge if you miss it. Confirm the cycle and fee in your state's current notification.
• Records and quality: batch manufacturing records, stability data, complaint and recall records, self-inspection and training logs under Schedule M.
• Pricing: if you sell scheduled formulations, price-control compliance with the National Pharmaceutical Pricing Authority applies, including price lists and returns.
• Pharmacovigilance and sampling: samples are drawn by drug inspectors and any not-of-standard-quality finding leads to prosecution and possibly suspension.
• Taxes and labour: monthly GST, PF and ESIC, TDS, annual returns, and the factory, pollution and hazardous waste filings described on our manufacturing page.
• Sale premises: display of licence, a pharmacist on duty at retail and purchase and sale invoices with batch numbers.

Pitfalls that delay pharma approvals

• Staff qualification gaps. Applications fail when the chemist's experience certificate does not meet the rule or the person is employed elsewhere.
• Premises not matching the layout filed. Inspectors compare the actual rooms, areas and flow with the drawing.
• Treating Revised Schedule M as a later upgrade. Retrofitting after inspection is slower and costlier than designing for it.
• Selling beyond the licence category. A licence for particular drug classes does not authorise others, and Schedule H or X sales need extra safeguards.
• Loan licence disputes. The principal and the host both carry liability, so the agreement and quality responsibilities must be clear.

Frequently asked questions

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