INDIA Law and Practice Contributed by: Malathi Lakshmikumaran, Vindhya S Mani, Pallaash Shankhdhar and Khushi Lokwani, Lakshmikumaran & Sridharan Attorneys
Lakshmikumaran & Sridharan Attorneys
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Tel: +91 (11) 4606 3300 Fax: +91 (11) 4129 9899 Email: Lsdel@lakshmisri.com Web: lkslaw.com
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation The Drugs and Cosmetics Act, 1940 (DCA) regulates the import, manufacture and distribution of medical devices in India, and the sale of drugs and cosmetics, ensuring their safety, quality and efficacy. Pursuant to the DCA, various rules have been notified periodi- cally to govern the manufacture, sale and regulation of pharmaceutical products and medical devices. The relevant rules are as follows. • The Drugs and Cosmetics Rules, 1945 (DCR) give detailed procedures regarding implementing the DCA, including requirements for licensing, packag- ing and labelling, manufacturing conditions, and rules governing the import of both drugs and medi- cal devices. Recent amendments to these Rules have introduced measures such as QR code‑based traceability and stricter controls on blood banks and contract manufacturing. • The Medical Devices Rules, 2017 (MDR) provide a complete framework for regulating medical devices at every stage of their life cycle. They cover manu- facturing, import, quality standards, labelling, sales and clinical investigations. The rules also promote transparency and efficiency by permitting electron- ic applications through the online SUGAM portal. • The New Drugs and Clinical Trials Rules, 2019 (NDCT Rules) were implemented to promote increased clinical trials by streamlining approvals, reducing timelines and creating a transparent regu-
latory framework. The rules broadened the defini- tion of “new drug” to cover novel products like vaccines and stem cell therapies, and allowed for waivers of novel drugs that have been approved in certain countries (eg, the United States, the Euro- pean Union, the United Kingdom). It also mandated registration and periodic training for ethics commit- tees, and established mechanisms for compensa- tion for trial-related injuries or death. In addition to the above, there are multiple ancillary pieces of legislation and codes governing various aspects of pharmaceuticals and medical devices, including the following. • The Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS Act) controls the cultivation, manufacture, possession, purchase, transport, storage, sale and use of “narcotic drugs” (including coca leaf, cannabis, opium, poppy straw and other manufactured drugs) and narcotic substances for medical, scientific and industrial purposes. The framework imposes strict controls and severe pen- alties for non‑compliance or misuse. • The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (DMRA) controls and regulates drug advertising, banning ads for reme- dies claiming magical cures, and making such pro- motions a cognisable offence in order to prevent the exploitation of superstition, covering magic, human sacrifice and false cures for ailments. It
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