Pharmaceutical & Drug Regulatory Advisory

Overview

India's pharmaceutical regulatory framework — governed by the Drugs and Cosmetics Act 1940, New Drugs and Clinical Trials Rules 2019, Drug Prices Control Order 2013, and CDSCO (Central Drugs Standard Control Organisation) guidelines — is among the most complex regulatory regimes in the world. For pharmaceutical manufacturers, importers, distributors, and clinical research organisations operating in Delhi NCR, regulatory compliance is a continuous operational requirement, not a one-time approval exercise. Corpus Juris Legal advises pharmaceutical companies, medical device manufacturers, and clinical research organisations on all aspects of drug regulatory law. Our practice covers new drug approval applications, manufacturing licence advisory under Schedule M GMP requirements, drug import licensing, Schedule H and H1 prescription drug compliance, clinical trial authorisation under the New Drugs and Clinical Trials Rules 2019, and CDSCO inspection response. For medical devices, we advise on Class A through D device registration and the Medical Devices Rules 2017. On drug pricing, we advise pharmaceutical companies on National Pharmaceutical Pricing Authority (NPPA) price control obligations under the Drug Prices Control Order 2013 — ceiling price notifications, overcharging recovery proceedings, and price revision applications. For pharmaceutical transactions — licensing agreements, contract manufacturing arrangements, and M&A — we advise on regulatory approvals required for business transfers and change of ownership. Regulatory litigation before the High Court for challenge of CDSCO decisions, product ban orders, and drug approval rejections is also within our practice.

Key Service Components

• ◆New Drug Approval (NDA) and clinical trial authorisation advisory
• ◆Manufacturing licence application and Schedule M GMP compliance
• ◆CDSCO inspection response and regulatory query management
• ◆Drug import licence and foreign manufacturer registration
• ◆Medical Devices Rules 2017 — Class A/B/C/D device registration
• ◆NPPA drug pricing compliance — DPCO 2013 ceiling price and overcharging
• ◆Clinical Trial Rules 2019 compliance for CROs and sponsors
• ◆Pharmacovigilance and adverse drug reaction reporting obligations
• ◆Contract manufacturing agreement and technology transfer licensing
• ◆High Court pharmaceutical regulatory litigation and CDSCO order challenge

Our Approach

We maintain a dedicated pharmaceutical regulatory practice that tracks CDSCO guidance, Drug Technical Advisory Board decisions, and High Court pharmaceutical jurisprudence. Every advisory mandate begins with a current regulatory position assessment against the specific product and licence category.

Other Regulatory & Compliance Services