Regulations & frameworks
Compliance that stands up to the regulator
Find the regime that applies to you and see how we help you meet it. Each name links to the official source.
| Regulation or framework | Region | What it covers | How we help |
|---|---|---|---|
| CERT-In directions (28 Apr 2022) cert-in.org.in | India | Incident reporting within 6 hours, 180-day log retention and time-sync obligations for service providers, intermediaries and bodies corporate. | Reporting playbooks, log and NTP design, incident readiness. |
| SEBI CSCRF sebi.gov.in | India | Cybersecurity and Cyber Resilience Framework for SEBI-regulated entities (circular of 20 Aug 2024 and later clarifications), including audit and resilience expectations. | Gap assessment, control mapping, SOC monitoring, audit evidence. |
| RBI IT governance, risk, controls and assurance directions rbi.org.in | India | Master Direction (7 Nov 2023) on IT governance, risk, controls, assurance and business continuity for banks, NBFCs and other regulated entities. | Programme design, SOC, identity and data controls, testing. |
| DPDP Act, 2023 indiacode.nic.in | India | Digital Personal Data Protection Act and Rules: consent, data principal rights, security safeguards and breach intimation. | Data inventory, privacy programme, breach response and notification playbook. |
| Revised Schedule M (GMP), Drugs Rules 1945 cdsco.gov.inPharma & life sciencesOfficial CDSCO copy: Gazette of India Extraordinary No. 738, 28 Dec 2023 (Hindi and English PDF, 272 pages). | India | Revised good manufacturing practice requirements notified as G.S.R. 922(E) on 28 Dec 2023, including controls for computerised systems and records. | Computerised-system access control, audit trails, data integrity and validated-state security. |
| New Drugs and Clinical Trials Rules, 2019 cdsco.gov.inPharma & life sciences | India | Rules for new drugs, clinical trials, bioavailability and bioequivalence studies in India, including ethics committees and record-keeping. | Secure trial data handling, access governance, vendor and site oversight. |
Descriptions are summaries to orient you, not legal advice. Links go to the publisher's page and may change. Check the current text and any amendments before relying on a requirement. NAPSECURE is an advisory firm and does not issue certifications or regulatory approvals.
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We will map your obligations and show the shortest path to evidence.