INTRODUCTION

The Ministry of Health and Family Welfare (“MHFW”) released a draft of the Drugs, Medical Devices and Cosmetics Bill, 2022 (“Bill”)for objections, comments, and suggestions from the public and relevant stakeholders (including healthcare lawyers and life science law firms) on 8^th July 2022.¹ The objective is to replace the existing Drugs and Cosmetics Act, 1940 (“Act”) with the Bill. Primarily, the Bill introduces and amends regulations on online pharmacies, clinical testing, medical devices, Ayurveda, Sowa Rigpa, Unani and Homeopathy, which pertain to administering the healthcare sector. The Bill intends to the drugs, medical devices, and cosmetics market-related legislation in India at par with international standards. However, this move indicates that companies operating in the healthcare sector must engage with top healthcare law firms to implement robust regulatory law practices. 

KEY CHANGES FROM THE ACT

(a) Definitions

The Bill introduces multiple new definitions, including but not limited to definitions of bioavailability study, bioequivalence study, manufacturer, over-the-counter drugs, and amendments to the definition of drugs and manufacture. 

(b) E-Pharmacies

The Act does not contain any provision related to the online sale of medicines. Interestingly, the Bill has not defined ‘e-pharmacies’ or ‘online pharmacies’ under its ambit. However, the Bill provides provisions for regulating and licensing e-pharmacies in the market. Presently, licensed e-pharmacies are operating, as per convenience, leveraging themselves either as an offline pharmacy under the Act or classifying themselves as an intermediary under the Information Technology Act, 2000, which will exempt them from applying for a license. The Bill requires the Government to make rules for regulating and restricting the online sale or distribution of any drug and medical devices. This reflects the Government’s intention and plans to introduce regulations governing the e-pharmacy segment.

(c) Clinical Trials

The Bill has provided relief to the legal heirs of the participants of a clinical trial by providing them with medical management and compensation in case of injuries and death, respectively. The Bill also mandates that an ethics committee be set up to safeguard the rights, well-being, and safety of trial participants.

(d) Medical Devices

The Bill prescribes medical device centres to be set up by the Government which are meant to serve as centres for testing medical devices. The Bill has also recommended the creation of a Medical Devices Technical Advisory Board to assist the Government.

(e) Ayurveda

The Bill promotes the development of drugs and medical devices in Ayurveda, sowa rigpa, unani and homeopathy.

(f) Import of Drugs and Cosmetics

The Bill supplements the Central Government’s power to prohibit the import of drugs and cosmetics in the public interest by additionally providing the power to regulate or restrict the import of drugs and cosmetics. If a drug or cosmetic meets the requirements of an emergency arising from an epidemic or natural calamity, the import of such drug or cosmetic can be regulated or restricted in the public interest. The Bill also provides a fee for the grant of a registration certificate and license for the import of drugs and cosmetics, which could be enhanced or reduced as per notification by the Central Government.  Compared to the Act, the Bill proposes imposing stricter liabilities on contravention of the specified provisions.

COMMENTS AND ISSUES ON THE BILL

The Bill has defined ‘clinical trial’, which is relevant for testing drugs, cosmetics and medical devices. However, the definition provided under the Bill deviates significantly from the internationally accepted standard. On a similar note, the definition of medical devices fails to clarify whether apps that use software to aid the healthcare regime of an individual (period tracking apps, diabetes management apps, etc.) can be treated as medical devices under the Bill. Additionally, the Bill fails to prescribe good manufacturing practices, the standard and acceptable criteria for manufacturing, which was recently brought into the Act. Lastly, on medical device centres, the Bill does not provide any provision for setting up such centres, and its function has been left to the discretion of the Central Government. 

CONCLUSION

Healthcare lawyers in India and industry experts have noted that the Government’s implementation of the Bill has been in the pipeline for a long time. There were numerous calls from medical professionals and policymakers to amend the Act as it is a pre-independence legislation and does not take modern development in science and technology into context. On that note, it is a welcome change by the Government. However, before its implementation, the Bill requires the legislative drafters to redraft certain provisions and clarify the law concisely, addressing the loopholes and interpretational issues that require clarity.

[1] Drugs, Medical Devices and Cosmetics Bill, 2022, Accessed at:   
https://main.mohfw.gov.in/newshighlights-97.