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

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the pre independence era, will be repealed.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
  included.




• 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
  devices.




• 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
  cosmetics.




• 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
  introduced:
  

  • 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
    authority.

  
  

  • 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
    devices.

  
  

  • 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.

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