Industry solution
Schedule M, CDSCO and every export market at once
- 3,900+
- pharma and device obligations
- Per-site
- Schedule M gap tracking
- Continuous
- inspection-readiness evidence
Sector pressures
What makes pharma compliance hard
Revised Schedule M is a capital programme
Upgraded GMP requirements covering pharmaceutical quality systems, qualification and validation, and computerised systems require plant investment, not documentation.
Dual Central and state drug administration
Manufacturing licences are issued by state drug controllers while approvals for new drugs and devices sit with CDSCO, and the two do not always align in interpretation.
Medical device rules keep expanding scope
Progressive notification has brought all devices under licensing, with class-based requirements and registration obligations catching companies that never considered themselves device makers.
Environmental scrutiny on API manufacturing
Effluent standards, zero liquid discharge expectations and hazardous waste obligations are enforced tightly on bulk drug clusters.
Coverage
Key instruments we track in depth for this sector
A representative sample, not the full list. Depth varies by jurisdiction and we will tell you exactly where it sits for your markets before you buy.
| Instrument | Jurisdiction | What it drives |
|---|---|---|
| Drugs and Cosmetics Act, 1940 + Rules | Central + State | Manufacturing and sale licensing, revised Schedule M |
| New Drugs and Clinical Trials Rules, 2019 | Central | Trial approval, ethics committee, compensation, reporting |
| Medical Device Rules, 2017 | Central | Classification, licensing, registration, materiovigilance |
| DPCO / NPPA | Central | Price control, ceiling prices, price revision intimation |
| Bio-Medical Waste Rules, 2016 | Central + State | Authorisation, segregation, annual reporting |
| Narcotic Drugs and Psychotropic Substances Act | Central + State | Controlled substance handling and record keeping |
| DPDP Act, 2023 | Central | Patient and trial subject data, consent and breach duties |
Use cases
How teams in this sector use Regulens
Schedule M readiness tracking
Decompose the revised schedule into unit-level obligations with current state, gap and remediation owner per manufacturing site.
Licence and product registration inventory
Every manufacturing, sale and product licence with validity, conditions and renewal lead time in one register.
Price control monitoring
Track NPPA ceiling price notifications against your product master and flag SKUs requiring price revision.
Inspection readiness
Maintain a continuously current evidence pack rather than assembling one under inspection notice.
“Schedule M was treated as a quality project until someone asked which of our fourteen units were actually compliant and by when. Nobody could answer without a three-week exercise.”
Other sectors
Not quite your industry?
See it scoped to a pharma footprint
We configure your legal entities, licences and jurisdictions and run live intelligence for two weeks. You compare it against what your team actually caught in the same period.