Legislative History:
The Drugs and Cosmetics Amendment Bill, 2022 was introduced in the Lok Sabha on July 8, 2022. The bill seeks to amend the Drugs and Cosmetics Act, of 1940, to consolidate and update the law relating to the import, manufacture, distribution and sale of drugs, medical devices and cosmetics. The bill also introduces new provisions for clinical trials and investigations of investigational medical devices.
The bill was referred to the Parliamentary Standing Committee on Health and Family Welfare for scrutiny. The committee submitted its report on the bill on August 22, 2022. The report recommended several amendments to the bill, including provisions for a new regulatory body for medical devices, stricter penalties for violations of the law, and increased transparency in the drug approval process.
The bill was again introduced in the Lok Sabha on September 13, 2022, with the amendments recommended by the parliamentary committee. The bill was then passed by the Lok Sabha on September 20, 2022. The bill is currently pending in the Rajya Sabha.
Introduction
The healthcare and medical device sectors in India have grown appreciably in the last decade. India is said to be known as the indigenous medical device industry which is valued at 250 crores and contributing to only 6% of India’s total healthcare sector. The Indian medical device industry is Asia’s 4th largest and the medical technology sector in India is projected to reach US$ 50 billion by 2025 and currently pegged at US$ 10 billion.
The current regulatory structure is blemished by barriers such as a lack of regulatory environment, rules or regulations & guidelines, low penetration, high capital investment and lack of active participation from the government. Hence, regulatory bodies have acknowledged the need to frame guidelines & regulatory approval processes and for quality benchmarks on par with global standards.
In July 2022, the Ministry of Health and Family Welfare released a draft of the Drugs, Medical Devices and Cosmetics Bill, 2022 (“the bill”) to review, replace and modernise the obsolescent Drugs and Cosmetics Act, 1940 where the Ministry has been persistently reviewing and streamlining the rules to further accommodate the changes and to adopt the new technology. The Ministry of Health and Family Welfare formed an 8-member committee headed by the Drug Controller General of India, Mr V.G. Somani for framing the draft bill, which is now put on the website of the ministry for recommendations and suggestions from the public in general and stakeholders.
The bill aims to ensure and provide comprehensive legislation to regulate that the medical products sold in India are safe, effective and conform to prescribed quality standards to the individuals. The other objectives are enumerated as under:
- To amend and consolidate the law relating to the import, manufacture, distribution and sale of drugs, medical devices and cosmetics
- To ensure the quality, safety, efficacy, performance and clinical trial of new drugs and clinical investigation of investigational medical devices
- To ensure that drugs, cosmetics and medical devices sold in India are reliable, efficient, and conform to quality requirements
- To adapt to the modern-day technological and medicinal breakthroughs
- To boost domestic manufacturing of medical devices and attract huge investments in India in healthcare centres.
The regulation of all retail channels as proposed in the bill becomes, even more, determining after recent raids by the Special Task Force (STF) in Uttarakhand resulted in the seizure of fake drugs worth crores, which are:
- The bill has expanded to include and regulate e-pharmacies, medical devices and the conduct of clinical trials of drugs and medical devices. It also includes a section on Ayurveda, Siddha, Sowa Rigpa, Unani and Homeopathy drugs.
- During Pandemic, the increasing online sale of medicines and medical devices which will now get restricted i.e. the sale, stocking, distribution or exhibition of any drug by online mode (e-pharmacy) except under and in accordance with a licence or permission.
The WHO declared monkeypox as a public health emergency of international concern, one level below a pandemic, even as COVID cases once again surged past the daily 1000 mark in some states of India. The bill will have to carefully balance these headwinds facing the healthcare sector and protect the interests of the society at large.
Key Highlights of Drugs, Medical Devices and Cosmetics Bill, 2022
Some of the key regulations proposed in this Bill include:
- Online pharmacies: The Bill has for the first time introduced a regulatory mechanism for the online sale of drugs and cosmetics, making it mandatory for every person who stocks, exhibits, sells or distributes any drugs through online mode to obtain a license or permission from the Authority, though there are no clear guidelines on the procedures for acquiring a license, nonetheless Section 83(2)(l) mentions that Central government would make rules prescribing the manner for regulation and restriction for online mode of sale of medicines.
- Medical devices:
a) Today millions of patients depend on medical device-based treatment for the management and diagnosis of several diseases. The quality and safety of the device depend upon the regulatory guidelines.
b) The Bill establishes a distinct definition for medical devices. The Bill also proposes to constitute a separate Medical Devices Technical Advisory Board to advise the government on technical matters about medical devices, which shall include officials from the various Government Departments and experts nominated by the government from the field of medical devices industry.
c) The Bill prohibits the manufacture, import, or distribution of medical devices that are not in conformity with the prescribed standards of quality, safety, and performance. And makes it mandatory to obtain permission from the Central Licensing Authority for conducting any clinical investigation of medical devices on human participants.
d) Furthermore, provisions relating to compensation and medical treatment in case of injury or death of a person participating in the clinical investigation of any investigational medical device have been provided. It also allows the Central Licensing Authority to waive the requirement of conducting a clinical investigation for the manufacture or import of a new medical device in the public interest. - Ayush products: The current Drugs and Cosmetics Act only regulates Ayurveda, Unani, and Siddha drugs and cosmetics, the bill proposes to include and regulate Sowa Rigpa, Homeopathy, and Traditional Medicines as Ayush Products. The Bill proposes to constitute an Ayurveda, Siddha, Sowa-Rigpa, Unani, and Homeopathy Drugs, Medical Devices, and Cosmetics Consultative Committee to advise both the State and Central Government to secure uniformity throughout India for regulation of AYUSH Drugs, Medical Devices, and Cosmetics.
- Clinical trials and investigations: For the first-time provisions relating to clinical trials have been included under the Bill, which prohibits the conduct of a clinical trial of a new drug, investigational new drug, bioavailability or bioequivalence study of any new drug in human participants without obtaining permission from the Central Licensing Authority. Furthermore, provisions relating to compensation and medical treatment in case of injury or death of a person participating in a clinical trial or study of such a drug are also included.
- Penalty provisions: The proposed bill has replicated next to all the offences of the existing Drugs and Cosmetics Act; however, to make the punishments more stringent the bill enhances the period of imprisonment between 1-10 years which may extend to life imprisonment and amount of fine up to Rs. 15 lakhs for any contravention of provisions of the bill. Additionally, the Bill introduces penalty provisions for clinical trial and clinical investigation without permission, and for failure to provide compensation for injury or death related to clinical trial.
This article is written and submitted by Devam Krishnan during his course of internship at B&B Associates LLP. Devam is a B.A. LLB 4th year student at National University of Study and Research in Law, Ranchi.
