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Aiming to regulate e-pharmacies and medical devices, the government proposed a new bill, which will also provide for penalties including imprisonment for failing to pay compensation for injury or death during clinical trials for both drugs and medical devices.

This is for the first time that such a proposal being mulled by the government. Also, under the draft New Drugs, Medical Devices and Cosmetics Bill, 2022, regulations for conduct of clinical trials for new drugs and medical devices have been brought, seeking to replace the existing Drugs and Cosmetics Act of 1940.

As per the current norms, the conduct of clinical trials for new drugs and medical devices and the provisions for compensation for injury or death on account of participation in clinical trials, medical management of the trial participants and regulation of ethics committee etc are regulated under the New Drugs and Clinical Trials Rules, 2019. The medical devices are treated as drugs and there is no separate definition of them.

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However, for the first time ever, the draft bill has a separate chapter for AYUSH drugs which proposes to regulate Sowa Rigpa and Homeopathy. The existing act regulates Ayurveda, Unani and Siddha drugs and cosmetics.

The new draft bill has been put up in the Union health ministry's website and suggestions, comments and objections from the public and stakeholders have been sought within 45 days from the date of issue of notice, i.e. 8 July.

"In light of recommendations of the central government and the felt need to have comprehensive legislation, a committee was constituted for framing the New Drugs, Cosmetics and Medical Devices Bill," the ministry said.

"As per recommendations of the committee, the Ministry of Health a proposes a draft New Drugs, Medical Devices and Cosmetics Bill, 2022 in order to keep pace with changing needs, times, and technology," the ministry said.

In the draft bill, several The draft bill introduces various new definitions or provisions like bioequivalence study, bioavailability study, clinical trial, clinical investigation, controlling authority, manufacturer, medical device, new drugs, over the-counter (OTC) drugs, adulterated cosmetics, etc. for more clarity and smooth functioning and implementation have been added.

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Also, the bill proposes for the constitution of a separate Drugs Technical Advisory Board (DTAB) and Medical Devices Technical Advisory Board (MDTAB), which will comprise experts from various associations to advise the central government in technical matters.

"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 clinical trial for manufacture or import of a new drugs or investigational new drugs in the country," the draft read.

"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.

Though all these provisions are there in the Rules but now it has been proposed in the bill, the official said.But in the existing rules there is no provision to impose penalties.

The new draft bill mentions, "Where any person permitted under sub-section (1) of section 72 fails to provide the required medical management or compensation under section 73, 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."

Under the new bill, permission has to be taken to operate an e-pharmacy.

"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.

In the draft bill, provisions have been incorporated to designate or establish medical device testing centres by the central government for testing and evaluation of medical devices for regulators and industry.

Among other things, every police officer shall be bound to assist a drugs control officer demanding his assistance in the investigation and preventing the escape of any person who is suspected to commit an offence under this Act or in the prevention of any injury attempted by the person to be committed against the drugs control officer, according to the draft bill.

With PTI inputs. 

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