Drugs, Medical Devices and Cosmetics Bill, 2023

Introduction

The Drugs and Cosmetics Act, 1940 (the "Drugs Act") is intended to be replaced by the Drugs, Medical Devices and Cosmetics Bill, 2023 (the "Drugs Bill") as the legislation governing the production, marketing, and distribution of pharmaceuticals, medical devices, and cosmetics. The Drugs Bill seeks to adjust to the evolving medical product market, taking into account technological advancements, a growing global emphasis on health and drugs, and other factors. We have examined the main components of the Drugs Bill in this update.
The Drugs, Medical Devices and Cosmetics Bill, 2023 was put up on public domain in July last year seeking feedback from stakeholders. It has been revised and sent for inter-ministerial consultation

Medical gadgets are considered a distinct category and need to be approved before being sold.

The Drugs Act regarded medical devices as a subclass of "drugs," and both categories of products were subject to the same legal framework. However, the need to handle medical devices as a separate category is evident due to their increasing sophistication and technological advancement, and the medications Bill governs them differently from medications.

• The Drugs Bill defines "medical devices" more broadly, encompassing all kinds of apparatus and software for illness management and diagnosis, such as implants, assistive technology devices for the disabled, life support systems, disinfection tools, reagents, conception control devices, in-vitro kits, apparatus and equipment, etc. These gadgets have been categorised according to risk.


• A new "Medical Devices Technical Advisory Board" has been suggested by the Central Government. Its duties will be similar to those of the Drugs Technical Advisory Board, with the aim of advising the government on technical matters pertaining to medical devices. This board will include representatives from the Department of Health, the Department of Atomic Energy, the Department of Science and Technology, the Ministry of Electronics, the Defense Research and Development Organization, and specialists in the domains of biomedical, biomaterial, and polymer technologies.


• To test and assess medical devices, Central and State Medical Device Testing Centers will be established, modeling themselves after Central and State Drug Laboratories.

The framework known as AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy) has been expanded in scope.

Several key changes have been made to the AYUSH framework to make it more comprehensive.

• The reach of the Drugs Act was restricted to Unani, Siddha, and Ayurvedic medication. The Drugs Bill broadens the definition to cover homeopathy and Sowa-Rigpa. Additionally, the pharmaceuticals Bill establishes two (2) categories for pharmaceuticals produced in accordance with these medical systems. The term "drugs" refers to the first group, which includes drugs recognized by authoritative books or official pharmacopoeias; on the other hand, the term "innovative drug" describes pharmaceuticals manufactured from natural substances that are not mentioned in the corresponding authoritative literature. It is suggested that distinct boards be established to supervise every class of pharmaceuticals falling under the purview of AYUSH.
  

  Although it is a positive start to include other traditional medicine practices in the regulatory purview, establishing a distinct category for novel medications under the traditional medicine framework might lead to certain issues. These medications are essentially new formulations because the concept of innovative drugs covers medications made with natural components that are not listed in the corresponding authoritative literature. Misselling incidents could result from the uncertainty around the effectiveness of these novel treatments in comparison to chemical drugs. Because of this, it might be preferable to regulate their development, production, and distribution similarly to how conventional medications are handled.

• Concerning medicinal plants, a different National Medicinal Plant Board will have jurisdiction. An additional Scientific Research Board will be established to encourage the application of contemporary science and technology in the creation of novel AYUSH medications and to support an interdisciplinary approach.



Clinical trials and Clinical investigations

The medications Act did not control clinical trials for medications or clinical investigations for medical devices, despite the fact that they were governed by the New Drugs and Clinical Trials Rules, 2019 (the "NDCT Rules") and the Medical Devices Rules, 2017 (the "Devices Rules"), respectively. The Drugs Bill intends to offer a more comprehensive framework than the one that is currently in place by attempting to include the components that are not covered by the Drugs Act. In accordance with the NDCT Rules and Devices Rules, the Drugs Bill reiterates the following requirements: obtaining approval from the Central Licensing Authority before beginning trials or investigations; offering medical care and compensation to participants who suffer negative effects from the trial or investigation; etc.

Regulation of e-pharmacies

The Drugs Bill gives the central government the power to make rules about how to sell medicines online. This is because e-pharmacies are growing fast in India and need to be regulated. The Drugs Bill also says that no one can sell, stock, show, offer for sale, or give away any medicines online without a license or permission. This is important because unregulated e-pharmacies could sell prescription medicines in a way that is not safe.

Penalties

Due to the belief that the sanctions outlined in the Drugs Act, particularly the amount of monetary penalties, are insufficient. As a result, harsher financial penalties have been implemented, including fines of up to INR1,500,000 (roughly US$18,217) or three times the value of the drugs seized, as well as life in prison in certain cases (importing or producing subpar, adulterated, or spurious drugs that are likely to cause death or grievous bodily harm). The consumer (or heirs in the event of death) shall receive the fine amount if the drug has a negative effect on them.

Other miscellaneous changes

Certain other miscellaneous changes are proposed in the Drugs Bill. These include:

• In an emergency resulting from an epidemic or other natural disaster that serves the public interest, the Central Government is authorized to control or prohibit the import of necessary medications.
• The list of substances whose manufacturing is forbidden now includes medications that cause miscarriages
• "Drugs Control Officers," who are appointed as "Inspectors" under the Drugs Act, are empowered to issue "Improvement Notices" to licensees (those who have been granted permission to manufacture drugs or devices) in the event that they violate any of the Drugs Bill's provisions. They may also outline the steps that the licensee must take to ensure compliance. The license could be fully revoked, suspended, or applied just to certain drugs or devices if compliance is not achieved.

Conclusion

The Drugs Bill is an important step in the right direction towards revamping India's current drug and cosmetics regulatory framework, which hasn't kept up with the many changes brought about by technological innovation. The urgent need for a comprehensive framework that can accommodate the advancements in contemporary healthcare is addressed by the Drugs Bill. Additionally, and this is particularly beneficial to the business, the Drugs Bill has established autonomous governing bodies with specific competence and emphasizes varied and compartmentalized control.This legislation signifies a progressive move towards updating the legal and regulatory framework of the pharmaceutical sector to keep pace with technological advancements. It underscores the importance of regular scrutiny and modernization of antiquated laws.

~Neha Chaudhary, Pursuing LLB, IP University Delhi