Medical devices & e-pharmacies to come under… Leave a comment

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The government has introduced a new bill that seeks to regulate e-pharmacies, medical devices and impose penalties.

The bill also includes provisions for imprisonment and failure to pay compensation for losses incurred during clinical trials for drugs and medical devices.

The New Drugs and Clinical Trials Rules, 2019, govern the conduct of clinical trials for new drugs and medical devices as well as the provisions for compensation for injury or death resulting from participation in clinical trials, medical management of trial participants, and regulation of ethics committees, among other aspects. 

In addition, for the first time, regulations for the conduct of clinical trials for new pharmaceuticals and medical devices have been included in the draft – “Drug, Medical Devices, and Cosmetics Bill, 2022” which intends to replace the current “Drugs and Cosmetics Act of 1940”. 

All of these clauses, according to an official, are already part of the Rules, but the bill now includes them.

The Union Health Ministry’s website has displayed the draft bill, and within that space, the public and other stakeholders are encouraged to offer recommendations, comments, and complaints within 45 days from the date of issue of the notice (July 8).

The Drug and Cosmetics Rules, 1945 were put under review in 2016 and thus the need for comprehensive legislation was felt. In order to draft the New Drugs, Cosmetics, and Medical Devices Bill, a committee was established.

“Drug, Medical Devices and Cosmetics Bill, 2022 is in order to keep pace with changing needs, times, and technology,” the ministry said.

A number of new definitions and provisions are included in the draft bill, including those relating to bioequivalence study, bioavailability study, clinical trials, clinical investigations, controlling authorities, manufacturers, medical devices, new drugs, over-the-counter (OTC) drugs, adulterated cosmetics, etc. for greater clarity, effective functioning, and implementation, an official stated.

Furthermore, there is no distinct definition for medical devices; they are just regarded the same as medications.

A separate Drugs Technical Advisory Board (DTAB) and Medical Devices Technical Advisory Board (MDTAB), comprising experts from different associations, is proposed in order to provide technical advice to the central government.

The proposed bill includes provisions for the regulation of new medication clinical trials, experimental pharmaceuticals, ethics committees, etc. According to the official, the sanctions for offences involving the import of pharmaceuticals and cosmetics have been adequately increased.

The draft did state that, “However, in the interest of public health or extreme urgency of drugs, the central government is empowered to make provisions for Central Licensing Authority to waive the requirement of conducting a clinical trial for manufacture or import of new drugs or investigational new drugs in the country,” 

“Where a participant during a clinical trial suffers injury or death on account of his participation in such investigation, provision has been made to provide compensation and medical management to such participants,” it stated.

The draft bill also has a separate chapter on AYUSH drugs, which suggested Sowa Rigpa and homeopathy be regulated. 

However, there is no mechanism in the current regulations to inflict sanctions, such as jail, on the guilty companies or individuals for failing to compensate trial participants in clinical trials for both pharmaceuticals and medical devices.

The revised draft bill states that failure to provide the necessary medical management or compensation under Section 73 will result in imprisonment for any individual authorised under Sub-section (1) of Section 72, which “shall be punishable with imprisonment which may extend to one year or with fine which shall not be less than twice the amount of compensation.”

“No person shall himself or by any other person on his behalf sell, or stock or exhibit or offer for sale, or distribute, any drug by online mode (e-pharmacy) except under and in accordance with a licence or permission issued in such manner as may be prescribed,” the draft said.


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