New Drugs, Medical Devices And Cosmetics Draft Bill, 2022 – Life Sciences, Biotechnology & Nanotechnology

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The Union Health Ministry has released a draft of The
Drugs, Medical Devices and Cosmetics Bill, 2022
. Once
implemented, the current Drugs and Cosmetics Act, 1940
(hereinafter referred as “D&C Act”), of
the pre independence era, will be repealed.

D&C Act presently governs the manufacture, distribution, and
import as well as efficacy, safety, and compliance of the medicines
and cosmetics sold in India with state quality standards. With
changing times technology plays a major role in drug discovery,
development, clinical trials along with the rise of e-pharmacy
portals, updating the current laws is the need of the hour. The
draft Bill intends to address such growing concerns. The major
provisions of the Bill are as below:

  • New definitions: For greater clarity,
    efficient operation, and effective implementation, the draft Bill
    adds a number of new definitions or provisions in Chapter I,
    including medical device, drug, new drugs, over-the-counter (OTC)
    drugs, cosmetics, adulterated cosmetics, bioequivalence study,
    bioavailability study, clinical trial, clinical investigation,
    controlling authority, manufacture amongst others.

  • Medical devices to be treated separately and distinct
    from Drugs
    : Currently, all medical devices are covered as
    ‘Drug’ and regulated as per Drugs & Cosmetics Act
    and Medical Devices Rules 2020. The draft Bill now intends to
    repeal the current laws and proposes a new definition for
    medical devices placing them outside the purview of
    ‘Drugs’. Also, Chapter II of the draft Bill has a
    recommendation for constitution of a Medical Devices Technical
    Advisory Board (MDTAB), separate from Drug Technical Advisory Board
    (DTAB), including specialists from various associations to
    recommend the Central Government in technical matters.

    Under the new draft Bill, provisions to name or build medical
    device testing facilities for the purpose of evaluating and testing
    medical devices for regulators and business have also been

  • Constitution of the Drugs, Medical Devices and
    Cosmetics Consultative Committee
    : To advise the Central
    Government, the State Governments, the Drugs Technical Advisory
    Board and the Medical Devices Technical Advisory Board on any
    matter and to secure uniformity in the country in the
    administration of this Act and the rules made thereunder. The Drugs
    Controller General, India (DCGI) shall be the Chairperson of the
    said Committee.

  • Chapter III deals with standards being laid down for import of
    drugs and cosmetics. Chapter IV deals with manufacture, sale and
    distribution of drugs and cosmetics and clinical trial of drugs.
    Whereas Chapter VI deals with standardising import, manufacture,
    sale and distribution and clinical investigation of medical

  • Chapter V of the draft Bill features a distinct chapter for
    Ayurvedic, Unani, and Siddha drugs and cosmetics that are currently
    covered by the D& C Act. In addition, such Chapter intends to
    regulate Sowa Rigpa and homoeopathy for the first-time including
    standardising its import, manufacture, sale, distribution and
    clinical trial of such products.

    The Central Drug Regulatory authority for Ayurveda, Siddha,
    Sowa-Rigpa, Unani and Homoeopathy drugs and cosmetics appointed by
    the Central Government shall regulate the manufacture and sale of
    such drugs and cosmetics. The Central regulatory authority shall
    also develop such infrastructure, at State level as prescribed by
    the Central Government to effectively enforce the provisions in
    this Act for the quality assurance of such drugs and

  • E-pharmacy: For the first time, a law to
    regulate highly unregulated and ever-growing space of e-pharmacies
    is planned to be introduced. The draft Bill now seeks to control
    e-pharmacies and hence it has been clearly specified that 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. However, the
    draft Bill does not mention the procedure and guidelines with
    respect to issuance of licenses of the e-pharmacies yet which may
    be laid down post consultation with the Central Government.

  • New provisions with respect to clinical trials

    • Currently Drugs and Clinical Trial Rules, 2019 are the only
      regulation in this regard. Now a separate Chapter has been included
      in the draft Bill for clinical trials and investigation. The draft
      Bill prohibits clinical trials or clinical investigations of drugs
      and medical devices without permission from the central licensing

    • The Central Government has been authorised to create measures
      for the Central Licensing Authority to forgo the necessity of
      performing clinical trials for the production or import of new
      drugs or experimental new medications in the nation in the interest
      of public health or during drug emergency period.

    • The draft Bill lays the onus of providing medical management
      for any injury arising due to the trial on the investigators.

    • The draft Bill makes provisions for compensation to
      participants or their legal heirs for injury or death suffered in
      clinical trials and investigations for drugs and medical

    • There is a new provision for imprisonment, and fine amounting
      to double the compensation amount if the compensation is not paid.
      This is seen as a welcome change as monetary compensation of few
      lakhs was not a deterrent for big companies conducting trials as of
      date whereas imprisonment might act as one.

It is relevant to note here that the Draft Bill completely
misses on provisions for recalling of drugs, cosmetics or medical
devices if found to be in violation of the provisions of law.
However, the draft Bill provides a mechanism towards regulating
online sale or distribution of medical devices, which will be a
welcome move for the industry. Though, how such sale or
distribution is tackled including tackling issues regarding sale of
counterfeits, spurious, misbranded products, along with the
intermediary liability issues that are inherent to the e-pharmacy
industry, is yet to be seen. The wait is to witness the final law
that comes into force and the impact and effectiveness with which
it may empower the authorities to enforce drug, cosmetics and
medical devices regulation in the country.

The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.

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