The government has proposed a new bill which for the first time seeks to regulate e-pharmacies and medical devices and provides for penalties including imprisonment for failing to pay compensation for injury or death during clinical trials for both drugs and medical devices.

Also, for the first time, regulations for the conduct of clinical trials for new drugs and medical devices have been brought under the draft New Drugs, Medical Devices and Cosmetics Bill, 2022 which seeks to replace the existing Drugs and Cosmetics Act of 1940.

Currently, 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. Also, medical devices are treated as drugs and there is no separate definition for them

The draft bill has a separate chapter for AYUSH drugs which proposes to regulate Sowa Rigpa and Homeopathy for the first time. The existing act regulates Ayurveda, Unani and Siddha drugs and cosmetics. The draft bill has been put up on 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 the notice (July 8).

The work of reviewing and updating Drugs and Cosmetics Rules, 1945 was vigorously taken up in 2016. "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.

"As per recommendations of the committee, the Ministry of Health 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.

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, an official said.

It proposes the constitution of a separate Drugs Technical Advisory Board (DTAB) and Medical Devices Technical Advisory Board (MDTAB), comprising experts from various associations to advise the central government on technical matters.

The penalties for offences related to the import of drugs and cosmetics have been enhanced appropriately, the official said. The proposed bill provides for the regulation of clinical trials of new drugs, investigational new drugs, ethics committees, etc.

"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," 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. Currently, 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 such as imprisonment on the erring firms or persons for failure to provide compensation to trial participants in the clinical trial for both drugs and medical devices.

The new draft bill mentions, "Where any person permitted under subsection (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."

In the existing Act, medical devices are treated as drugs and there is no separate definition of medical devices. So in the proposed bill provisions have been made for the regulation of medical devices, investigational medical devices, clinical investigation of investigational medical devices, etc in a separate chapter with a view of better understanding of the stakeholders and administration of the law on the subject.

"Separate chapter for medical devices will give distinct treatment to it in line with international practices to boost quality, consumer confidence and expectations of the stakeholders," the official explained. Further, provisions have been made, inter alia, for risk-based classification of medical devices based on their intended use, risk and vulnerability to the human body.

"Like as for drugs, the proposed bill envisages provisions relating to clinical investigation in respect of investigational medical devices. However, in the interest of public health or extreme urgency of a medical device, the central government is empowered to waive the requirement of conducting the clinical investigation for the manufacture or import of a new medical device in the country.

"Where a participant during a clinical investigation suffers injury or death on account of his participation in such investigation, provision has been made to provide compensation and medical management to such participant," the draft said. 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.

Provisions have been made for adjudication of the penalty with a fine imposed by an adjudicating officer authorised by respective governments for certain minor offences. This will ensure lesser scope for litigation and quicker resolution of minor compliance-related issues, the official explained.

Every police officer shall be bound to assist a drugs control officer by 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.