Overview
Two different things get called “GMP” in India and they are not the same product. Revised Schedule M, under the Drugs Rules, is a condition of your manufacturing licence — every pharmaceutical unit has to meet it. WHO-GMP certification is a separate, voluntary certificate CDSCO issues after a factory audit, aimed at exporters and tenders that ask for it by name. A unit can be fully licensed under Schedule M and still not hold WHO-GMP. Treating Schedule M as optional because “we’re not exporting” is the dangerous mistake right now.
For MSME pharma manufacturers (turnover under ₹250 crore), the extension window closed on 31 December 2025. CDSCO set that as the hard line for roughly 1,470 units that had taken the earlier extension, and said publicly there would be no further extensions. State and UT drug controllers are now inspecting and filing monthly reports; a unit found non-compliant faces strict action, including licence suspension. If your upgradation documentation isn’t already filed, this is the item that can stop production.
On the voluntary side, India has around 10,500 pharma units, roughly 8,500 of them MSME, and only about 2,000 MSME units currently hold WHO-GMP certification. That gap is the honest baseline for anyone selling WHO-GMP as routine — CDSCO issues it only after its own factory audit, not on a consultant’s say-so. We prepare the application and audit-readiness file; CDSCO decides.
The same family covers cosmetics and Ayurvedic manufacturing, briefly. Cosmetics GMP runs on a Form COS-7 self-declaration against the Seventh Schedule, followed by a State inspection within 30 days of licensing — a schedule reviewers routinely compare to ISO 22716, the international cosmetics GMP standard, not a replacement for it. Ayurvedic, Siddha and Unani manufacturers work to Schedule T under Rule 157, with the certificate on Form 26E-I generally valid for five years. Different rule, different form, same underlying discipline: premises, process control and batch records that hold up to inspection.
Who it’s for
- MSME pharma manufacturers (turnover under ₹250 crore) still closing gaps against revised Schedule M past the 31 December 2025 deadline
- Units under state/UT drug-controller inspection or monthly reporting who need documentation defensible now
- Manufacturers pursuing voluntary WHO-GMP certification for export markets or tenders that ask for it
- Cosmetics manufacturers preparing a Form COS-7 self-declaration ahead of the post-licensing site inspection
- Ayurvedic, Siddha or Unani (ASU) manufacturers preparing a first Schedule T application or a Form 26E-I renewal
Eligibility & requirements
- Revised Schedule M is a mandatory licence condition — not an optional certificate you can defer
- The MSME deadline was 31 December 2025; CDSCO has stated no further extensions for the roughly 1,470 units that had already taken one
- State and UT drug controllers are inspecting and filing monthly reports; non-compliance can lead to licence suspension
- WHO-GMP is separate and voluntary, issued by CDSCO after its own factory audit — not automatic once you hold a manufacturing licence
- Only around 2,000 of India’s ~8,500 MSME pharma units currently hold WHO-GMP, out of roughly 10,500 units nationally
- Cosmetics manufacturers self-declare GMP on Form COS-7 against the Seventh Schedule and face a site inspection within 30 days of licensing
- ASU manufacturers work to Schedule T under Rule 157, with the certificate on Form 26E-I generally valid for five years
How CapEasy handles it
- Confirm which track applies — Schedule M, voluntary WHO-GMP, cosmetics COS-7, or Ayurvedic Schedule T — the authority differs for each
- Section-wise gap analysis against revised Schedule M: premises, plant and equipment, quality systems and documentation
- Upgradation documentation for whatever the gap analysis flags — the physical work is the unit’s; we structure the file that has to survive inspection
- For MSME units short of the deadline, prepare the compliance filing and undertaking for the authority ahead of the next inspection
- For WHO-GMP, prepare the application and audit-readiness file CDSCO expects, without implying the outcome is ours to promise
- For cosmetics, prepare the Form COS-7 file against the Seventh Schedule and ISO 22716 practice, ready for inspection
- For ASU manufacturers, prepare the Schedule T file for a first Form 26E-I application or the five-year renewal
- Set up a cadence so monthly reporting stays routine, not a scramble
Documents you’ll typically need
- Current manufacturing licence and any extension undertaking filed with CDSCO or the State Authority
- Site layout, plant and equipment specifications, and existing SOPs
- Quality records — batch records, validation protocols, deviation and CAPA logs
- Turnover documentation if reporting as an MSME under the ₹250 crore threshold
- For cosmetics: existing licence and product formulation/master records
- For ASU manufacturers: current Schedule T records and the prior Form 26E-I certificate, if renewing
CapEasy is a private consultancy and is not affiliated with any government authority. We help you assess eligibility and prepare and file your application; eligibility and approval depend on your specifics and the relevant department’s discretion.
