1Assistant Professor, Brainware University, Kolkata. Email: prodpitabarman@yahoo.com
2Assistant Professor, School of Management Studies, CGC University, Mohali -140307 (PB). Email: artianmolsingh@gmail.com
3Doctoral Candidate, Panjab University. Email: charu051197@gmail.com
4Dean Students' Welfare, IMS Law College, Noida. Email: deansw@imsnoida.com
5Assistant Professor, Vivekananda Institute of Professional Studies (VIPS) Technical Campus. Email: drshalinibhartiya@gmail.com
6Professor, Faculty of Law, Swami Vivekanand Subharti University, Meerut, UP (India)-250005. Email: premchandra1979@gmail.com
India's pharmaceutical industry, ranked third globally by volume and thirteenth by value, occupies a pivotal position in the global supply of generic medicines, vaccines, and advanced drug formulations. The rapid emergence of novel drug delivery technologies — encompassing nanoparticle-based systems, liposomal carriers, transdermal patches, implantable devices, targeted biological therapies, and controlled-release oral formulations — has fundamentally transformed the therapeutic landscape while simultaneously generating profound regulatory challenges. The Central Drugs Standard Control Organisation (CDSCO), operating under the Drugs and Cosmetics Act of 1940 and its 1945 Rules, constitutes the primary regulatory authority governing the approval, manufacture, and post-market surveillance of pharmaceutical products in India. However, the existing legislative and regulatory architecture was conceived primarily for conventional dosage forms and is increasingly strained by the complexity and novelty of advanced drug delivery systems (DDS). This paper provides a comprehensive examination of the intersection between contemporary drug delivery technologies and the regulatory compliance framework under Indian pharmaceutical law. It critically analyses the adequacy of current legislative provisions — including Schedule M (Good Manufacturing Practices), the New Drugs and Clinical Trials Rules 2019, and the Biological Drugs Regulation — in addressing the safety, efficacy, and quality requirements of novel DDS. The paper further evaluates the institutional capacity of CDSCO, the evolving role of the Indian Pharmacopoeia Commission, and the alignment of Indian regulatory standards with international benchmarks set by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The paper concludes by identifying critical regulatory gaps and proposing systemic reforms necessary to enable India to sustain its position as a global pharmaceutical leader while ensuring robust patient safety.
Keywords: drug delivery systems, CDSCO, Indian pharmaceutical law, Drugs and Cosmetics Act, New Drugs and Clinical Trials Rules 2019, nanoparticle drug delivery, regulatory compliance, Good Manufacturing Practices.
How to cite this article: Barman P, Rani A, Grover C, Goyal GP, Bhartiya S, Chandra P. Drug Delivery Technologies and Regulatory Compliance Under Indian Pharmaceutical Laws. Int J Drug Deliv Technol. 2026;16(15s): 16-25. DOI: 10.25258/ijddt.16.15s.3
Source of support: Nil.
Conflict of interest: None