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Government proposes e-pharmacy regulation and trial mishap fines in new law

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Peeyush Ghalot
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(Photo Courtesy: - Lexplosion)

In an effort to regulate e-pharmacies and medical devices for the first time, the government has put out a new law that includes jail as a penalty for failure to compensate victims of damage or death that occurred during clinical trials for both medications and medical devices. The proposed Novel Pharmaceuticals, Medical Devices and Cosmetics Bill, 2022, which seeks to replace the present Drugs and Cosmetics Act of 1940, also includes provisions for the execution of clinical studies for new medications and medical devices. The New Drugs and Clinical Trials Rules, 2019, are a set of regulations that control, among other things, how clinical trials for novel drugs and medical devices are conducted, how trial participants are managed medically, how ethics committees are regulated, and compensation provisions for harm or death brought on by participation in clinical trials. In the draught bill's distinct chapter on AYUSH medicines, it is initially suggested that Sowa Rigpa and homoeopathy be regulated. The current law controls Ayurvedic, Unani, and Siddha medicines and cosmetics.

The public and other interested parties have 45 days from the day the notice was issued to offer recommendations, comments, and objections regarding the draught law that has been posted on the website of the Union Health Ministry. The study and update of the 1945 Drugs and Cosmetics Rules got under way in earnest in 2016. A separate Drugs Technical Advisory Board (DTAB) and Medical Devices Technical Advisory Board (MDTAB), made up of specialists from different associations, is suggested in order to provide technical advice to the national government. The official claims that appropriate increases have been made to the penalties for offences concerning the import of drugs and cosmetics. The proposed measure includes provisions for the regulation of new medication clinical trials, experimental pharmaceuticals, ethics committees, etc. The new draught law states that failure to provide the necessary medical treatment or compensation under Section 73 would result in a punishment that cannot be less than double the amount of compensation or up to one year in jail.

The current Act does not define medical devices specifically and treats them the same as pharmaceuticals. In order to better understand the stakeholders and manage the law on the topic, provisions have been incorporated in the proposed bill for the regulation of medical devices, investigational medical devices, clinical study of investigational medical devices, etc. in a separate chapter. To raise quality, consumer trust, and stakeholder expectations, a separate chapter for medical devices would approach it differently in accordance with worldwide best practises, the source said. Additionally, measures have been developed, among other things, for the categorization of medical devices according to danger and susceptibility to the human body as well as their intended use. Provisions for clinical research on experimental medical devices are included in the draught legislation. The federal government is able to waive the need for a clinical investigation in order to manufacture or import a new medical device into the nation, however only in cases of severe urgency or public health concern.

According to the new law, authorization is required in order to run an online pharmacy. No one may sell, stock, show, offer for sale, or distribute any drugs via online mode (e-pharmacy) unless they do so in accordance with a licence or authorization that has been granted in the manner that may be prescribed. Provisions enabling the central government to designate or construct medical device testing centres for the purpose of testing and evaluating medical devices for regulators and industry have been inserted into the draught law. For some minor offences, provisions have been provided for the adjudication of a punishment with a fine imposed by an adjudicating authority authorised by the various governments. The official said that this will ensure a reduced potential for litigation and a speedier resolution of minor compliance-related concerns. Every police officer is required to help a drugs control officer who requests it with an inquiry into a suspected offender under this Act, with preventing that person from escaping, or with stopping any harm that person might seek to do to the drugs control officer.

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