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Need For Improving Pharmaceutical Laws – The Proposed Way Forward – Healthcare

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With the rising need to accommodate the new requirements and
adaptation of modern technology in the pharmaceutical sector, the
draft of the ‘Drugs, Medical Devices and Cosmetics
Bill, 2022
‘ (the
Bill”) has been released by the
Ministry of Health and Family Welfare (MoHFW) on July 8, 2022,
which seeks to replace the existing archaic law under the Drugs and
Cosmetics Act of 1940 (“Act”) and the
Drugs and Cosmetic Rules 1945

The process of review of the Act gained momentum in the last few
years, and in the year 2021, the Drug Controller General of India
constituted a committee to frame the Bill, on which the MoHFW has
sought consultation and feedback from the public and stakeholders,
within a period of 45 days from the date of issue of notice (i.e.
from July 8, 2022). While the Rules have been amended a few times
in the past, it is laudable that the Bill has been introduced to
give a fillip to the existing law, by providing for a broader
coverage of an improved and a comprehensive regulatory framework
for medical devices, clinical trials and e-pharmacies, apart from
medicines and cosmetics. It is yet another attempt to enforce the
proposed provisions added to the existing law, to ensure
synchronisation with international standards as needed, and have an
improved regulatory process in place.

The Act regulates the import, manufacture, distribution, and
sale of drugs and cosmetics in India, with the primary objective to
ensure that the drugs and cosmetics sold and made available to the
public are safe and efficacious. The Act and the Rules have been
amended over a period of time in view of the vicissitudes in the
pharmaceutical industry. In furtherance to the same, the Bill has
been introduced as a step forward to include the aspects that
remain presently uncovered and to deal with the need to make the
law more stringent, considering the rapidly evolving technology in
the upstream industry of pharmaceuticals. Observing the surge in
the availability of drugs on the online platform with the
convenience offered thereby, especially during the Covid-19
pandemic, e-pharmacies are acquiring a major stake in the
pharmaceutical retail value chain in the country. Due to such
proliferation, the need to regulate e-pharmacies and have a
systematic crackdown against illegally dealing with and selling of
counterfeit and spurious drugs by medical stores and drugs
companies is increasing with each passing day. It is hoped that
enforcing the new regulations as proposed in the Bill prove to be a
constructive way forward for better regulation and addressing the
bottlenecks in the current framework.

The key highlights of the Bill are as follows:

  • The Bill proposes to expand the definitions under the Act, by
    adding certain new definitions inter alia for clinical
    trials, over-the-counter drugs, manufacturers, new drugs,
    bioavailability studies, investigational new drugs and imported
    spurious drugs, amongst others. Also, the definition of medical
    devices has been inserted separately, which, under the Act, is
    included in the definition of ‘Drugs’.

  • For regulating e-pharmacies, provisions have been introduced in
    the Bill that aim to govern the online sale of medicines, which the
    existing framework lacks dealing with and is thus prone to be
    misused with the increased market of online pharmacies offering
    drugs and virtual consultations, if not regulated. While in the
    year 2018 there was an attempt made to amend the Rules in order to
    regulate e-pharmacies, and draft rules in regard thereto were
    introduced and circulated, however, the same were not notified as
    they were considered to be deficient in dealing with the
    complexities associated with the retail by online pharmacies, and
    hence remained unenforced. To regulate this, the Bill inter
    categorically restricts ‘stocking or exhibiting or
    offering for sale, or distributing, any drug by online mode
    except under and in accordance with a licence or permission issued
    in such manner as may be prescribed thereunder
    ‘, thereby
    making the requirement of obtaining a license or permission
    mandatory for undertaking such activity.

  • Provisions have been introduced for penalty in the form of fine
    and imprisonment in case of any morbidity or mortality related to
    clinical trials or investigations.

  • In order to facilitate the smooth implementation of the Bill,
    advisory boards have been proposed to be constituted, namely the
    Drugs Technical Advisory Board (DTAB) and Medical Devices Technical
    Advisory Board (MDTAB), to comprise of such professionals and
    experts belonging to departments of medical devices, science and
    technology, biomedical, biomaterials, electronics etc., as
    prescribed under the Bill, for supporting the Central and the State
    Governments and providing technical assistance. The Bill also
    mandates the setting up of the ‘Consultative Committee on
    Drugs, Cosmetics and Medical devices’ which would advise the
    Central and State Governments, the DTAB and the MDTAB on any matter
    concerning the administration of the Bill and the rules made

  • The Bill also provides for setting up of ‘Medical Devices
    Testing Centres’ for testing and evaluation of medical
    devices and carrying out such other functions as may be prescribed,
    at both, Central and State levels.

  • Another crucial provision in the Bill pertaining to the power
    to regulate or restrict the import of drugs in public interest, if
    the drug is essential to meet the requirements of an emergency due
    to epidemic or natural calamities.

  • An Ayurveda, Siddha, Sowa-Rigpa, Unani, Homeopathy Drugs,
    Medical Devices and Cosmetics Consultative Committee has been
    proposed to be constituted along with a Scientific Research Board
    for supporting on the scientific advances used for developing,
    innovative drugs of Ayurveda, Siddha, Sowa-Rigpa, Unani and
    Homoeopathy, their safety and efficacy, devices and other such
    related matters. Also, provisions for import of Ayurveda, Siddha,
    Sowa-Rigpa, Unani and Homoeopathy drugs and cosmetics have been
    inserted in the Bill.

To conclude, while the Bill aims to provide an impetus to the
existing pre-independence legislation and to meet the need for
staying abreast with the ever-changing technology, it is yet to be
seen how the new legislation would practically be welcomed and
prove to be beneficial for accelerating the growth of the sunrise
sector of the medical devices industry of India by enhancing its
regulatory framework. It is hoped that the changes that the Bill
proposes to bring, cater to the increasing need of addressing the
inadequacy of the existing law and monitoring additional avenues of
retail and other aspects in the pharmaceutical sector, which will
go a long way in facilitating the ease of doing business in

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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