How the new bill could change the game

Government’s new Drugs and Medical Devices Bill will regulate Sowa-Rigpa (ancient form of holistic healthcare), homeopathy and online sale of drugs, and propose tougher penalties for death in clinical trials, among other provisions. first reported in September the government’s decision to form a group to draft laws on drugs, cosmetics and medical devices under India’s Drug Controller General, VG Somani. .

The draft law, uploaded on the Ministry of Health website, invites suggestions, comments and objections from the public and stakeholders within 45 days from the date of publication of the notice (July 8) .

Until now, medical devices have been treated on an equal footing with medicines, and there have been no separate rules to regulate the sale, manufacture, distribution or clinical trials of such devices in the country.

“The Drugs and Cosmetics Act 1940 is pre-independence legislation enacted by the Central Legislative Assembly. Reviewing outdated laws and updating existing laws is an ongoing process to adapt to new requirements and adapt to new technologies,” the ministry said.

The government has stressed the need to review outdated laws and “periodically repeal and amend laws” for which the bill was introduced in parliament, according to the ministry.

“In line with the recommendations of the Committee, the Ministry of Health and Family Welfare, Government of India is proposing a New Drugs, Medical Devices and Cosmetics Bill, 2022 to keep pace with the evolving needs, the ‘Time and Technology.’

A separate chapter on AYUSH

For the first time, the bill includes a separate chapter for AYUSH medicines, which proposes to regulate Sowa-Rigpa and homeopathy while the existing law only regulates Ayurveda, Unani and Siddha medicines and cosmetics.

Unofficially referred to as “pseudo-science”, AYUSH therapies and medications have often been criticized due to lack of scientific evidence.

Now the bill proposes to establish a scientific research council to support the regulatory authority on advances used to develop innovative medicines from Ayurveda, Siddha, Sowa-Rigpa, Unani and homeopathy, their safety and efficacy, the manufacture of devices and other related matters. .

He also said that central and state governments should encourage the use of modern science and technology to develop innovative medicines and devices in Ayurveda, Siddha, Sowa-Rigpa or Unani.

Online sale of drugs

Although the regulation of online pharmacies or online sales of drugs is a long overdue decision, the bill does not have a separate chapter or detailed regulations to drive the growth of online pharmacies in India. Discussions to regulate the online sale of drugs have been going on for at least six years.

Instead, the bill suggests that the central government formulate rules to regulate online pharmacies.

It also mentions that “no one shall sell, store, display or offer for sale, or distribute, by himself or by any other person on his behalf, any medicine by online mode, except under and in accordance with a license or an authorization so issued, as may be prescribed.

It also prohibits such sales for the category of medical devices.

New definitions

The 83-page draft includes several new definitions. For example, it explains the meaning of a “bioavailability study” as a study to assess the rate and extent to which the active drug is absorbed from a pharmaceutical formulation and becomes available in the systemic circulation or the availability of the drug at the site of action. .

Likewise, several other terms, commonly used in today’s context, include bioequivalence study, over-the-counter drugs, medical device, medical device manager, predicate device, among others.

For example, a new drug was explained comprehensively in five points. In the first, it describes the new medicine as “a medicine, including an active pharmaceutical ingredient or a plant protection medicine, which has not been used in the country to a significant extent, except in accordance with the provisions of the law and the rules derived from it, under the conditions specified in the labeling thereof and has not been approved as safe and effective by the Central Licensing Authority with respect to its claims.

Medical devices are no longer equal to drugs

Until now, there was no separate official definition of medical devices as they were treated on an equal footing with drugs. In the draft, a comprehensive definition of medical devices has been proposed.

“Any device, including an instrument, appliance, appliance, implant, material or other item, whether used alone or in combination, including software or an accessory, intended by its manufacturer to be used especially for humans or animals, which do not achieve their intended primary action in or on the human body or animals by any pharmacological, immunological or metabolic means, but which may aid in its intended function by such means to one or more specific ends…”

The bill also proposes medical device testing centers modeled on state and central drug labs.

Tougher penalties in clinical trials

Penalties for carrying out clinical trials have been increased. The draft also proposes that any person (sponsor, clinical research organization, any other organization or investigator) who fails to provide the required medical care or compensation be liable to a prison sentence of up to one year or a fine which cannot be less than twice the amount of the compensation.

In addition, in the event of death during the clinical trial, attributable to the drug under study or due to its participation in this trial, the company must indemnify the legal heir of the participant.

Under current law, there is no provision to impose harsher penalties such as imprisonment for non-compensation of clinical trial participants.

Formation of the new advisory council

In the second chapter, the bill proposes to form a separate Drugs Technical Advisory Board (DTAB) and a separate Medical Devices Technical Advisory Board (MDTAB) which would advise the central and state governments on technical matters relating to medicines and cosmetics related to the implementation of this law. and other functions.

It is proposed that the council be made up of several members, including the chairman of the director general of health services and the secretary member of the comptroller general of medicines. A similar proposal has been drafted by the MDTAB.

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