Drugs Medical Devices and Cosmetics Bill Released by India Ministry

On July 8, 2022, the Ministry of Health and Family Welfare, Government of India, initiated public consultation by releasing a draft of the Drugs, Medical Devices and Cosmetics Bill, 2022 (“Draft Bill”). This Draft Bill aims to serve as a comprehensive legal framework governing the regulation of drugs, medical devices, cosmetics, clinical trials, and online pharmacies, among other areas. Once it is officially enacted, it will replace the existing Drugs and Cosmetics Act, 1940 (“D&C Act”), which currently serves as India’s primary legislation governing drug regulation. Stakeholders and the public are invited to submit their comments on the Draft Bill until August 22, 2022, to ensure that their insights are considered in shaping the future of drug and medical device regulation in India.

The much-anticipated overhaul of the D&C Act has been in development for some time. In response to evolving needs, technological advancements, and public health concerns, the Central Government formed a dedicated committee to review existing regulations and propose a new legislative framework. This Draft Bill is a direct result of the committee’s recommendations, and it is expected that the current draft may be refined based on public feedback before it is presented to Parliament for further discussion and potential enactment, paving the way for a modernized regulatory environment.

Below, we will explore several key elements of the Draft Bill that highlight its significance in the regulatory landscape.

Enhancing the Regulation of Medical Devices for Safety and Efficacy

The Draft Bill introduces a pivotal shift by proposing the independent regulation of all medical devices, separating them from drugs. Under the existing D&C Act, only specific notified medical devices are classified and regulated as ‘drugs’. A broad definition of medical devices was announced in 2020, effectively bringing all medical devices under the Medical Device Rules, 2017 (“MDR”). The Draft Bill retains this definition while establishing a distinct framework for medical device regulation. This means that all devices which fit the defined criteria will be subject to rigorous regulatory oversight, ensuring that they meet established safety and quality standards.

In addition to defining medical devices, the Draft Bill significantly expands regulations concerning the quality of these products. It prohibits the manufacture and importation of medical devices that do not meet specified standards or are classified as misbranded, adulterated, or spurious. These measures aim to protect public health by ensuring that only safe and effective medical devices are available in the market.

To obtain marketing approval, a clinical investigation is mandated for investigational medical devices, which includes in-vitro diagnostic devices. This requirement may only be waived by the Central Licensing Authority. Unlike the MDR, which distinguishes between different categories of medical devices for safety and efficacy studies, the Draft Bill proposes a uniform regulatory framework for all classes of medical devices. It also stipulates prerequisites for obtaining permission before conducting clinical investigations and outlines the responsibilities for medical management and compensation in cases of study-related injuries or deaths. Specific penalties for non-compliance with these provisions have also been proposed, reinforcing the importance of adherence to regulatory standards.

A noteworthy aspect of the Draft Bill is the establishment of an independent regulatory framework for medical devices. In contrast to the current arrangement where drug authorities oversee medical devices, the Draft Bill envisions the creation of specialized authorities and boards dedicated to making regulatory decisions about medical devices. The proposed Medical Devices Technical Advisory Board (MDTAB) will comprise individuals with technical expertise in medical devices, including officials from various governmental departments, industry representatives, and experts in biomedical technology, biomaterials, and related disciplines. This collaborative approach aims to enhance regulatory effectiveness by leveraging specialized knowledge.

To enforce the new regulations, Medical Devices Officers will be appointed with the authority to conduct inspections, searches, and seizures. Furthermore, the Draft Bill proposes the establishment of Central and State Medical Devices Testing Centres at both levels, which will be responsible for testing and evaluating medical devices, mirroring the functions of the existing Central Medical Devices Testing Laboratory and authorized Medical Device Testing Laboratories under the MDR.

Strengthening the Regulation of Drugs with Enhanced Penalties

While the Draft Bill retains many provisions for drug regulation from the existing framework, it introduces enhanced penalties for violations, which are significantly more stringent than those currently in place. The revised penalties can include imprisonment ranging from one to ten years and fines that can reach up to fifteen lakhs. This increase in penalties reflects a commitment to ensure compliance and uphold the integrity of drug regulation in India.

Additionally, the Draft Bill outlines a new procedure for issuing improvement notices. Licensing authorities will now have the capacity to issue these notices, specifying necessary measures for compliance or directing the remediation of any existing contraventions. This provision allows licensees the opportunity to address violations proactively, rather than facing immediate punitive actions, thereby promoting a more constructive regulatory environment.

Comprehensive Regulation of AYUSH Products for Consumer Safety

The Draft Bill recognizes the importance of AYUSH products, encompassing Ayurveda, Siddha, Sowa-Rigpa, Unani, and Homeopathy. It also extends its regulatory framework to include traditional medicine systems recognized in their countries of origin, aside from allopathic medicine. This comprehensive approach to regulation is a significant departure from the D&C Act, which did not specifically categorize AYUSH medical devices and cosmetics as an independent class of products. While no new compliance measures are introduced for AYUSH medical devices and drugs in the current draft, it is expected that forthcoming rules and guidelines will further clarify these aspects.

As with the D&C Act, the regulatory authorities overseeing AYUSH products will remain distinct from those governing pharmaceutical drugs. The Draft Bill continues to recognize the AYUSH Technical Advisory Board and introduces new advisory boards comprising experts in the field, such as the Drugs, Medical Devices and Cosmetics Consultative Committee for AYUSH Drugs, the Scientific Research Board, and plant boards at both national and state levels. The establishment of these advisory bodies aligns with the government’s recent initiatives to promote and support the AYUSH industry.

Regulating Clinical Trials to Enhance Research Integrity

The Draft Bill incorporates pivotal aspects from the New Drug and Clinical Trial Rules, 2019 (“CT Rules”), which will now fall under the parent legislation. This inclusion is crucial as it establishes mandatory requirements for sponsors to obtain prior permission before conducting clinical trials and mandates medical management and compensation for trial-related injuries or fatalities. Specific penalties for violations of these provisions have also been introduced, highlighting the importance of ethical conduct in clinical research.

However, a significant concern regarding clinical trials arises from the Draft Bill’s lack of clarity on the status of academic trials and biomedical research. Currently, the CT Rules explicitly exclude these studies from regulatory compliance. The absence of explicit exemptions in the Draft Bill raises questions about the potential implications for academic research and the autonomy of educational institutions in conducting essential studies.

Establishing Regulatory Framework for Online Pharmacies

Despite the burgeoning market for online medicine sales in India, there currently exist no direct regulations governing the sale of medications over the internet. The government previously attempted to introduce draft E-pharmacy Rules in 2018, but these were never enacted. The Draft Bill addresses this regulatory gap by mandating that licenses be required for the sale of drugs and medical devices online. While the current draft does not include specific compliance measures for online pharmacies, it allows the Central Government to develop rules to regulate this burgeoning sector further, ensuring that consumer safety is prioritized in online transactions.

Establishing Independent Regulatory Bodies for Effective Oversight

To facilitate effective enforcement, the authorities governing drugs, medical devices, and AYUSH products will operate independently. While this approach is commendable, it is important to note that there are no restrictions preventing Central or State governments from assigning existing drug inspectors to oversee medical devices and AYUSH products. This overlap could potentially undermine the Draft Bill’s objective of independent regulation, which aims to account for the unique characteristics and challenges faced by each industry.

In addition, the Draft Bill establishes a new body—the Drugs, Medical Devices and Cosmetics Consultative Committee (DMDCCC)—which will be chaired by the Drugs Controller General of India. This committee aims to advise both Central and State governments, as well as the Drug Technical Advisory Board (DTAB) and the Medical Devices Technical Advisory Board (MDTAB), on matters to ensure uniformity in the administration of drug and medical device regulations across the country.

Introducing Stricter Offences and Penalties to Uphold Regulatory Integrity

The Draft Bill retains all offences from the D&C Act but proposes stricter penalties for violations. It introduces specific penalties for conducting clinical trials or clinical investigations without the necessary permissions, failing to provide compensation, neglecting to pay financial penalties imposed by adjudicating officers, and for submitting misleading information. This increase in accountability demonstrates a strong commitment to upholding the integrity of the regulatory framework.

Interestingly, the Draft Bill empowers police officers to assist authorized officers in investigating violations. While this collaboration is a step forward, the potential extension of investigation powers to include arrests raises concerns about the possibility of excessive authority being exercised without appropriate checks and balances.

Ensuring Continuity of Current Regulations During Transition

Transitional provisions within the Draft Bill ensure the continuity of existing rules, regulations, and notifications established under the D&C Act. Consequently, rules such as the Drugs and Cosmetics Rules, 1945, MDR, CT Rules, and Cosmetics Rules, 2020 will remain in effect to complement the Draft Bill until new regulations are introduced. This approach is essential to provide clarity and stability during the transition phase.

Moreover, the Draft Bill preserves the operations of the D&C Act to a limited extent, encompassing:

• Any rights, privileges, obligations, or liabilities accrued under the D&C Act;

• Any penalties, forfeitures, or punishments incurred for offences committed against the D&C Act and its orders;

• Any investigations or remedies concerning such penalties, forfeitures, or punishments, which can be instituted, continued, or enforced as per the D&C Act;

• Licenses issued under the D&C Act will remain valid until their expiry date, as if they were issued under the provisions of the Draft Bill;

• Courts can take cognizance of offences under the D&C Act for up to three years following the commencement of the Draft Bill.

Evaluating the Draft Bill: Strengths and Weaknesses

The revamping of the D&C Act is a positive development that has been long awaited. The clear distinction between the regulation of allopathic drugs, cosmetics, AYUSH products, and medical devices eliminates the confusion and uncertainties that have plagued the industry under the previous framework.

The Draft Bill primarily emphasizes the regulation of medical devices as a distinct category, recognizing the necessity for specialized governing authorities with relevant technical expertise. This aspect is commendable, as it aligns regulatory oversight with industry needs. However, it is crucial for the MDR to be updated accordingly to ensure consistency with the Draft Bill. The medical device industry has been on the verge of achieving regulatory stability since the 2020 revamp. If the Draft Bill is passed without clear transitional provisions that align it with the MDR, it could create a state of uncertainty within the industry.

Industry stakeholders had anticipated that the Draft Bill might clarify the regulation of software as a medical device, refurbished medical devices, and compensation mechanisms for medical devices. Unfortunately, the Draft Bill does not address these vital areas, leaving many questions unanswered.

The inclusion of provisions regarding clinical trials and investigations within the Draft Bill is a significant advancement, legitimizing the requirements established in the CT Rules and MDR. However, the lack of clarity regarding the status of academic studies not seeking marketing approval remains a concern. Furthermore, the Draft Bill does not provide guidance on post-marketing surveillance and the recall process for drugs and devices, which are critical components of effective regulatory oversight.

Charting the Path Forward: Future Implications of the Draft Bill

The Draft Bill represents a crucial step towards reimagining the regulatory landscape for drugs and cosmetics in India. While it aims to overhaul the existing D&C Act, many aspects remain largely consistent with current legislation. Despite retaining elements of the prior law, the Draft Bill’s enhancements, omissions, and overall intent have the potential to significantly improve the quality of products, instill consumer confidence, and meet stakeholder expectations. The industry is hopeful that this Draft Bill will usher in a new era of regulation for the pharmaceutical and medical device sectors in India, fostering innovation and safeguarding public health.

References and Further Reading

¹ Draft of the Drugs, Medical Devices and Cosmetics Bill, 2022, available at:

https://main.mohfw.gov.in/newshighlights-97 (last accessed on August 17, 2022).

² Under the current regime, the scope of the D&C Act is restricted to only those medical devices which are notified by the Government from time to time as “drugs.” On February 11, 2020, a broad definition of medical devices was notified, effectively bringing all medical devices in India within the ambit of the D&C Act. The Central Drugs and Standards Control Organisation has issued a series of classification notices from July 2021 to notify specific medical devices and assign risk classification. The Medical Device Rules, 2017 supplement the D&C Act, and elaborate on safety and quality standards while prescribing the licensing regime for medical devices in India.

³ Clause 3(zd) of the Draft Bill defines ‘medical device’ as “(a) all devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of- (i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder; (ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability; (iii) investigation, replacement or modification or support of the anatomy or of a physiological process; (iv) supporting or sustaining life; (v) disinfection of medical devices; (vi) control of conception; (b) in-vitro diagnostic device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination thereof intended to be used for examination and providing information for medical or diagnostic purposes by means of examination of specimens derived from the human bodies or animals.”

⁴ Clause 126, Draft Bill.

⁵ Clause 127, Draft Bill.

⁶ Clause 128, Draft Bill.

⁷ Clause 129, Draft Bill.

⁸ Previously, the definitions and provisions applicable to misbranded, adulterated, and spurious drugs were applicable to medical devices as well by virtue of medical devices being drugs for the purpose of regulation. The Draft Bill provisions specific conditions with respect to medical devices.

⁹ Clause 139, Draft Bill.

¹⁰ Clause 139, Draft Bill.

¹¹ Clause 142, Draft Bill.

¹² Clauses 144, 145, and 146, Draft Bill.

¹³ Clause 6, Draft Bill.

¹⁴ Clause 134, Draft Bill.

¹⁵ Clauses 10 and 91, Draft Bill.

¹⁶ Clause 67, Draft Bill.

¹⁷ Clause 86(x), Draft Bill.

¹⁸ Clause 87, Draft Bill.

¹⁹ Clause 88, Draft Bill.

²⁰ Clause 89, Draft Bill.

²¹ Clause 72, Draft Bill.

²² Clause 73, Draft Bill.

²³ Clauses 79, 80, and 81, Draft Bill.

²⁴ Academic trials and biomedical research are not governed under the CT Rules and instead must comply with the Guidelines for Biomedical and Health Research involving Human Participants, 2017, issued by the Indian Council for Medical Research.

²⁵ The draft amendment to the Drugs and Cosmetic Rules, 1945 published by the Ministry of Health and Family Welfare on August 28, 2018.

²⁶ Clauses 41, 102, and 140, Draft Bill.

²⁷ Clauses 83 and 159, Draft Bill.

²⁸ Clause 11, Draft Bill.

²⁹ Clauses 79 and 144, Draft Bill.

³⁰ Clauses 81 and 146, Draft Bill.

³¹ Clause 156, Draft Bill.

³² Clause 169, Draft Bill.

³³ Clauses 50 and 135, Draft Bill.

³⁴ Clause 184 and 185, Draft Bill.

³⁵ On February 11, 2020, the Ministry of Health and Family Welfare published two notifications. The cumulative effect of these two notifications is that all medical devices were brought under the fold of quality and safety regulation from April 1, 2020. Available at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTU0OA==;

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTU0OQ== (last accessed on August 17, 2022).

Varsha Rajesh contributed to this article.