Regulatory intelligence · Pharmaceuticals · Medical devices · Cosmetics

Every answer carries its section number.

ComplyNex is a citation-grounded AI platform for Indian regulatory compliance — the Drugs and Cosmetics Act and Rules, the Medical Devices Rules 2017, DPCO 2013, and import–export procedure — built so that every output can be traced to the exact statutory provision it came from.

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⚠ AI DRAFT — VERIFY AGAINST ORIGINAL SOURCE BEFORE USE

Query: Can a retail pharmacy sell a Schedule H drug without a prescription?

No. Schedule H drugs may be sold by retail only against the prescription of a Registered Medical Practitioner, and the supply must be recorded in the manner prescribed.

Rule 65(9)(a), Drugs and Cosmetics Rules, 1945 "…substances specified in Schedule H … shall not be sold by retail except on and in accordance with the prescription of a Registered Medical Practitioner…"
Citation machine-verified ✓Law as on: 02 Jul 2026

Built for the regulated side of the industry.

Compliance teams spend hours locating the precise provision behind a licensing condition, a labelling requirement, or a pricing obligation — and the cost of citing the wrong one is measured in show-cause notices, detained consignments, and stalled approvals. ComplyNex is designed for the people who carry that responsibility.

PHARMA

Manufacturers & marketers

Licensing conditions, Schedule M compliance, labelling under Rules 96–97, Schedule H/H1/X obligations, and DPCO pricing — answered with the governing provision quoted alongside.

DEVICES

Medical device companies

Classification, registration, and licensing pathways under the Medical Devices Rules 2017, including the obligations that differ by risk class and by licence type.

COSMETICS

Cosmetics manufacturers & importers

Registration, labelling, and prohibited-ingredient requirements under the Cosmetics Rules 2020, traced to the exact rule and schedule entry.

IMPORT · EXPORT

Importers & exporters

Import licensing and registration certificates, port-office procedure, export NOCs, and the documentation each consignment must carry — with the provision behind every requirement.

DISTRIBUTION

Wholesalers & distributors

Sale-licence conditions, purchase and sale record requirements, cold-chain and storage obligations, and the compliance expected at inspection.

ADVISORY

Consultants & legal teams

A research assistant that drafts with citations and refuses to invent them — built for professionals whose opinions must survive scrutiny.

Built for work where "roughly right" is not an option.

General-purpose AI models guess. In regulatory practice, a wrong section number in a compliance opinion is not a small error. ComplyNex is designed around six disciplines that generic AI tools do not have.

Verified output

Machine-checked citations

Before an answer is shown, every quoted provision is automatically compared against the source text in the corpus. If a citation cannot be verified, the answer is blocked — accuracy enforced by software, not by promise.

Amendment-aware corpus

Point-in-time law

Compliance questions are often judged by the law as it stood on a particular date. The corpus tracks amendment history, so the platform can answer against the law as on a specific date — not only today's text.

Multi-hop reasoning

Cross-statute analysis

Regulatory questions rarely live in one section. The platform reasons across the Act, its Rules, schedules, price-control orders, and procedural guidance to assemble complete, cited answers.

Deterministic calculation

DPCO arithmetic by calculator, not guesswork

Ceiling-price and margin computations under DPCO 2013 are performed by a fixed calculation engine and only explained by the AI — so the arithmetic is exact, every time.

Honest refusal

Knows what it doesn't know

When the corpus does not cover a question, the platform says so instead of inventing an answer — a behaviour tested explicitly in every evaluation round.

Measured quality

Benchmarked, not vibe-checked

Performance is scored against a growing, graded test set of real Indian regulatory questions — from schedule classification to price computation to compliance drafting.

The corpus. Sourced from official publications, deduplicated, and version-tracked:

Drugs & Cosmetics Act, 1940 Drugs & Cosmetics Rules, 1945 Medical Devices Rules, 2017 Cosmetics Rules, 2020 DPCO 2013 / NPPA orders Indian Pharmacopoeia 2022 CDSCO guidance & circulars State DCA procedures Case law

Validated before it was built out.

Before committing to infrastructure, the platform's retrieval-and-reasoning design was validated in a structured pilot against real regulatory documents and a graded test set.

8 / 8test questions answered correctly, with citations, in the Phase 0 validation pilot
  • Multi-hop legal reasoning across the Act, Rules, and schedules
  • DPCO 2013 ceiling-price calculation performed correctly
  • High-stakes compliance drafting with a mandatory verification header
  • Correct refusal on a question outside the loaded corpus — no fabricated citation
Assistive by design. ComplyNex output is a draft for a qualified professional, never a substitute for one. Every generated document carries a verification header, and the platform is built for human-in-the-loop review at every step. It does not provide legal advice.

Company

ComplyNex Technologies is an early-stage Indian company building applied AI for regulatory compliance across pharmaceuticals, medical devices, and cosmetics. The platform is designed and evaluated against the practical realities of Indian regulation — statute, price control, quality standards, and procedure — with domain expertise at the centre of corpus curation and evaluation design. It is engineered for on-premise deployment, so a client's compliance questions and documents never leave the client's own infrastructure.

Contact

For pilot programmes, partnerships, or programme enquiries:

uday@complynex.in