GMP Certification for Pharma Manufacturers (Schedule M & WHO-GMP)
Good Manufacturing Practices under the revised Schedule M of the Drugs Rules, 1945 now apply to every licensed drug manufacturer in India, large or small. Exporters also need a WHO-GMP certificate and a Certificate of Pharmaceutical Product (CoPP) for most overseas markets. We prepare the file, submit it and follow up with the regulators until the certificate is issued.
What it is
Good Manufacturing Practices (GMP) are the rules that make sure every batch of a medicine is made the same way, in a clean and controlled plant, with records that prove it. In India, GMP is not a voluntary badge. It is a condition of your drug manufacturing licence.
The standard sits in Schedule M of the Drugs Rules, 1945, made under the Drugs and Cosmetics Act, 1940. The Ministry of Health and Family Welfare replaced the old Schedule M through G.S.R. 922(E) dated 28 December 2023. The revised Schedule M is titled “Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products”. It adds a pharmaceutical quality system, quality risk management, product quality review, equipment qualification and validation, and computerised systems.
“GMP certification” usually means one of two things. The first is a GMP certificate from your State Licensing Authority confirming that your plant meets Schedule M. The second is the WHO-GMP certificate and CoPP under the WHO Certification Scheme, which exporters need. That one is issued after a joint inspection by the Central Drugs Standard Control Organisation (CDSCO) and the state regulator.
Who it applies to
Every licensed drug manufacturer
Tablets, capsules, oral liquids, injectables, ointments or APIs: it makes no difference. If you hold a drug manufacturing licence under the Drugs Rules, revised Schedule M applies to your site.
MSME units under ₹250 crore turnover
Small and medium units got extra time to upgrade, up to 31 December 2025, if they filed an upgradation plan in Form A. That window has closed. Compliance is mandatory from 1 January 2026.
Exporters of medicines
Many importing countries ask for a CoPP in the WHO format before they register your product. You need WHO-GMP for that, along with an active Import Export Code.
Why it matters
Keep your licence safe
Schedule M compliance is a licence condition. A unit that fails inspection can face suspension or cancellation of its manufacturing licence by the licensing authority.
Be ready when inspectors arrive
In November 2025 CDSCO asked state drug controllers to start inspections of units that had not sought an extension, plan inspections for the rest from 1 January 2026, and send monthly compliance reports.
Clear the way for exports
A foreign regulator uses your WHO-GMP certificate and CoPP to judge a plant it will never visit. Without them, product registration abroad stalls. Picture a Haryana tablet unit that has sold only in India and gets its first enquiry from an African distributor: the first document asked for is usually the CoPP.
Documents required
Licence and company papers
- Drug manufacturing licence and approved product list
- Company incorporation documents, PAN and GST registration
- Details of the technical staff and their approvals
- Approved plant layout
Quality system documents
- Site Master File (WHO TRS 961 format for WHO-GMP)
- List of equipment and instruments
- Layout drawings of HVAC and water systems
- SOPs, validation master plan and quality manual
Product data (for CoPP)
- Stability data for three batches (accelerated or real-time)
- Process validation for three batches of each product
- List of products already approved and those applied for
How it works
Review your licence and gaps
We check your licence, product list and existing paperwork, and work with your QA head or GMP consultant to list what the revised Schedule M still needs. Here is the catch: a plant can finish its civil work and still fail if HVAC or water systems were never re-validated afterwards.
Assemble the regulator’s file
We collect and organise the Site Master File, layouts, staff details and product data in the order the regulator expects, and flag anything missing.
Submit to the right authority
We file with the State Licensing Authority for a GMP certificate, or with the CDSCO zonal or sub-zonal office and the state for WHO-GMP and CoPP.
Close inspection observations
We schedule the inspection, track queries and help your team file the compliance report on any observations until the certificate is issued.
Timelines
Large manufacturers
Turnover above ₹250 crore: revised Schedule M applied from 28 June 2024, six months after notification.
Small and medium manufacturers
Turnover up to ₹250 crore: extended to 31 December 2025 for units that filed Form A within three months of 11 February 2025. Mandatory from 1 January 2026. CDSCO has said there will be no further extension.
WHO-GMP and CoPP
CDSCO’s target is 28 working days to scrutinise a fresh application with joint inspection, and 21 working days for additional products.
What happens if your plant is not GMP-compliant
Licence suspended or cancelled
The licensing authority can suspend or cancel a manufacturing licence for breach of its conditions, after a show-cause notice.
Criminal prosecution
Section 27(d) of the Drugs and Cosmetics Act, 1940 punishes manufacture in contravention of the Act or Rules with imprisonment of one to two years and a fine of at least ₹20,000.
Lost export orders
Without a valid WHO-GMP certificate and CoPP, foreign buyers and regulators cannot register your product, and tenders that require WHO-GMP are closed to you.
Schedule M GMP vs WHO-GMP
| Point | Schedule M GMP | WHO-GMP / CoPP |
|---|---|---|
| Who needs it | Every licensed drug manufacturer in India | Manufacturers exporting to countries that ask for a CoPP |
| Legal basis | Drugs Rules, 1945 (revised Schedule M) | WHO Certification Scheme, applied by CDSCO |
| Who inspects | State Licensing Authority (with CDSCO in joint inspections) | CDSCO and State Licensing Authority jointly |
| Product-specific? | No, it covers the site | Yes, a CoPP is issued product by product |
Frequently asked questions
Is GMP certification mandatory in India?
Yes. Compliance with Schedule M of the Drugs Rules, 1945 is a condition of every drug manufacturing licence. Since the revised Schedule M (G.S.R. 922(E), 28 December 2023), large units have had to comply from 28 June 2024 and units with turnover up to ₹250 crore from 1 January 2026. A separate GMP certificate is usually requested by buyers and tenders, but the underlying compliance is not optional. We help you put the paperwork in order before the inspector arrives.
What changed in the revised Schedule M?
The revised Schedule M brings Indian GMP closer to WHO standards. It adds a pharmaceutical quality system, quality risk management, product quality review, qualification and validation of equipment, and controls for computerised systems. It is organised in 13 parts, with specific parts for biologicals, radiopharmaceuticals, phytopharmaceuticals and hormones. Most plants need new SOPs and validation records, not only civil work. A clear gap list at the start keeps the upgrade manageable.
Can an MSME pharma unit still get more time?
No. The extension to 31 December 2025 was available only to units with turnover up to ₹250 crore that filed an upgradation plan in Form A within three months of 11 February 2025. In November 2025 CDSCO told states there would be no further extension and asked them to inspect units. In practice, a small Faridabad or Bahadurgarh unit that is still mid-upgrade should finish the work and document every step, because the inspector reads records first. We can help you organise that file.
What is a CoPP?
A Certificate of Pharmaceutical Product (CoPP) is a product-wise certificate in the WHO format confirming that the product is made in a GMP-compliant plant and its licence status in India. Importing countries use it to register your medicine. In India it is issued after CDSCO and the State Licensing Authority inspect the site jointly. Once your site is cleared, adding more products is quicker. We prepare the product dossiers so the review runs smoothly.
How long does WHO-GMP certification take?
CDSCO’s published target is 28 working days to scrutinise a fresh WHO-GMP or CoPP application involving joint inspection, and 21 working days for additional products. Actual time depends on your readiness and the inspection date. Observations from the inspection must be closed before the certificate is issued. A complete file on day one is the best way to stay close to the target.
Is a joint inspection needed every time?
No. A joint inspection is needed for a first-time WHO-GMP applicant. For additional products, CDSCO’s 2020 procedure says a fresh joint inspection is not needed if the site was jointly inspected within the last two years and found compliant. Your stability and process validation data for the new products must still be in order. We track your inspection dates so you know which route applies.
What is the penalty for not following Schedule M?
Manufacturing in breach of the Drugs Rules is an offence under Section 27(d) of the Drugs and Cosmetics Act, 1940, with imprisonment of one to two years and a fine of at least ₹20,000. The licensing authority can also suspend or cancel the manufacturing licence after a show-cause notice. Most units first receive inspection observations and time to correct them. A clear, dated reply to each observation is what closes the matter.
Does Taxhint do the technical GMP work?
No. Plant upgrades, validation studies, SOP writing and testing are done by your QA team, GMP consultants and accredited laboratories. Our role is the regulatory side: applications, document files, portal filings, liaison with the State Licensing Authority and CDSCO, and ongoing licence compliance such as company and GST filings. Your technical team stays on the shop floor, and we deal with the forms and the follow-up.
What it costs
Our fee plus the government fee that applies to your case, quoted before you commit. Tell us the situation and we will price it exactly.
Ready to begin?
Send us your licence and product list, and we will tell you exactly what your GMP or WHO-GMP file needs.