The recent New Drugs, Medical Devices and Cosmetics Bill, 2022 (“the Bill”) seeks to replace the Drugs and Cosmetic Act, 1940 (“the Act”). The Bill might mark the beginning of a new era of medical and drug regulation in the country due to its extensive scope to include the control of medical devices in the Bill. For the first time, it has tried to incorporate the regulation of telemedicine and the adoption of new technology in the field of medicine. The inclusion of regulation for the clinical trials and investigation of drugs and medical devices is one of the key features of the Bill.
While the Bill has tried to incorporate various aspects of medical regulation and has emphasised the use of technology to keep pace with the changing times and technological developments around the world, it has still fallen short on various grounds of medical development in India. This article aims to critically analyse the Bill and suggest the necessary reforms.
Decoding the New Drugs, Medical Devices and Cosmetics Bill, 2022
The New Drugs, Medical Devices and Cosmetic Bill, 2022 has brought in several commendable changes. In 2018, the government published e-pharmacies rules, but they were not implemented. The inclusion of online pharmacies in the Bill and making a concrete law for regulating online pharmacies was the need of the hour especially due to the COVID-19 pandemic, which increased people’s dependency on online sources for several basic necessities, which also led to an increased demand for telemedicine. However, the absence of concrete law in this area made it very difficult to proceed against the cases of violations.
Several instances of people buying medicines from e-pharmacies without prescription can still be seen today, with a concerning fact being that many e-pharmacies do not have the requisite licenses to sell medicines online. This can be seen by the exponential rise in the sale of fever drugs during the pandemic. Section 41(2) of the Bill clearly specifies that no person can sell, or distribute any drug via online mode except in accordance with a licence or permission issued in such manner as may be prescribed. If implanted properly, the licensing policy for online pharmacies would be a very progressive step toward the development of legitimate online pharmacies in India. However, the proposed licensing system needs to be properly implemented and regulated. If not, it could lead to an increase in corruption and lobbying for pharmacy licenses.
The other change brought in the Bill is the greater legal recognition of Ayurveda. Section 87 of the Bill proposes the establishment of a scientific research board for the development and innovation in Ayurveda, Siddha, Sowa-Rigpa, Unani and Homeopathy. This is to ensure safety and efficacy in making these medicines, and this is for the first time that a Bill in India is catering to protecting and regulating the segment under AYUSH through the use of technology and modern science. These aspects of the Bill for promoting Make in India by fostering innovation in traditional medicine, which has been a part of the Indian culture for centuries. Even though the Bill has incorporated various provisions for developing the medical sector in India, several ambiguities in the draft might deviate from its intended purpose and hamper the developmental process.
The Bill has laid the procedure for clinical trials and has imported some features from New Drug and Clinical Trial Rules, 2019. Under Section 72 of the Bill, it is mandatory for the sponsors to obtain permission from the central licencing authority in order to conduct the clinical trial. The companies need to seek approval from the apex drug regulator to conduct the preliminary trial; these provisions are missing in the present Bill. The legislation further specifies penalties and compensation in case of violation of these provisions. Section 73 of the Bill specifies that in case of the death of the participant during the trial process, their legal heir should be awarded with compensation. Failure to provide with the same will be considered as a punishable offence and will lead to imprisonment or a fine.
The provision is progressive, but it is not enough. It has some major gaps and loopholes which need to be ratified to make it a progressive legislation than a regressive legislation. For instance, provisions for fining pharmaceutical companies are weak. Due to their enormous economic resources, fines for violating the Bill are nominal and can be easily paid by the companies, minimizing the deterring effect of the rules which the Bill seeks to implement. However, provisions for imprisonment might deter violation of rules, but their effectiveness remains to be seen once the Bill comes in force. The other provisions that the Bill misses out on are, firstly, the academic trials and biomedical research is exempted from the purview of the Bill. Secondly, the Bill is silent on the post-treatment formalities/ surveillance, such as follow-ups, and lastly, there is no provision in the Bill for recalling the drugs or devices in case of any issue or default.
Moreover, the Bill needs to carefully define the investigation and punishment process, due to Sections 50 and 135 authorising the police to investigate matters and take the necessary action if the Drugs Control Officers or Medical Device officers demand it. This may lead to the use of excessive power by the police due to their involvement, and also due to the power of investigation extending to the power of arrest. The Bill doesn’t provide any standard operating guidelines for the investigation procedure or for the compounding of offences.
The other features on which the Bill is silent are the provisions related to the distinction between regulation by the centre and state authorities. Neither has it provided any concrete mechanism for their functioning. The Bill has also not offered any procedure for the use of drugs in case of a public health emergency and has not clarified the process to safeguard high-risk medicines. Lastly, the rules related to the Drug Control Officer recruitment are unclear. This can be corrected by establishing a robust procedure structure and using a reliable mechanism to ensure if the Bill is fair in its implementation and making sure it reaches out to those who would genuinely benefit from it.
The amendment to the 1940 Bill is definitely a welcome step. In the era of technology and modern science, the development and regulations of e-pharmacies and telemedicine are commendable. However, for the Bill to be progressive in its implementation, the ambiguities need to be ratified to make it of better quality and boost the medical industry in India.
This piece has been authored by our Junior Analyst, Nishka Kapoor and was co-ordinated by our Editor, Ajinkya Pacharaney.