India's Pharma Regulatory Landscape —
Complex. Evolving. High-Stakes.
In India, the pharma sector is principally governed by the Drugs & Cosmetics Act, 1940, D&C Rules, 1945, Medical Device Rules, 2017, and the Drugs Price Control Order, 2013. Even though the pharma industry has transformed dramatically over the last few decades, the pre-independence legislation continues to largely govern the manufacture, distribution, and sale of drugs in India.
The multiple piecemeal amendments to the D&C Act, D&C Rules, and the Medical Devices Rules, 2017, have made Drugs Laws an open minefield — especially since violation of the regulatory regime invites penal consequences for manufacturers, distributors, and Directors alike.
India experienced the fastest growth rate for pharmaceuticals and medical devices in the last decade, and the regulatory regime is becoming increasingly complex. Juris and Justice provides its expertise to some of the largest pharmaceutical and medical device companies operating in the Indian market.
Key Legislation & Regulatory Framework
D&C Act, 1940 & Rules, 1945
Primary legislation governing manufacture, distribution and sale of drugs and cosmetics in India.
Medical Devices Rules, 2017
Comprehensive framework for regulation of medical devices including notified devices classified as drugs.
DPCO, 2013 (NPPA)
Price control regime with wide powers to NPPA — monitoring scheduled and non-scheduled formulations.
Legal Metrology Act, 2009
Compliance requirements for labelling, packaging, and declarations on pharmaceutical products.
How We Can Help You
Juris and Justice provides comprehensive legal services to clients from the pharma/medical device sector and healthcare, including:
DPCO Compliance & Pricing Advisory
Advisory on strategising and compliance requirements for manufacture, sale, distribution, marketing, and import of drugs/medical devices — including pricing and other issues for scheduled/non-scheduled formulations under DPCO, 2013.
Regulatory Compliance Services
Compliance and regulatory services regarding labelling, cosmetics, and pharmaceuticals under the Legal Metrology Act, 2009, Drugs and Cosmetics Act, 1940, Medical Devices Rules, 2017, and DPCO, 2013, among others.
DCGI, CDSCO & NPPA Proceedings
Advisory and assistance in handling proceedings initiated by regulatory authorities including DCGI, CDSCO, NPPA, and State Drug Controllers — from obtaining approvals and testing to responding to show-cause notices.
Pharma Litigation & Price Control Challenges
Handling litigation including challenge to regulatory action, challenge to Price Control Orders before the Review Authority (NPPA), District Courts, High Courts, and the Supreme Court of India.
Pharma Due Diligence
Conducting comprehensive due diligence of a client's business in relation to its compliance structure vis-à-vis the D&C Act, MDR 2017, DPCO 2013, and LM Act, 2009, among others — critical for M&A transactions in the sector.
Regulatory Authorities We Deal With
Facing a pharma regulatory issue?
Get specialised legal guidance — confidential, no-obligation consultation.