Drugs, Medical Devices & Cosmetic Bill 2022 ; suggestions
To,
Under
Secretary (Drugs Regulation)
Ministry
of Health and Family Welfare
Room
434, C Wing, Nirman Bhawan
New
Delhi 110011
Date:
23rd July 2022
Subject:
Submission of objections/suggestions in response to the Notification F No. X
11012/2/2021-DRS.
Respected
Sir,
Please consider this as a formal
submission of objections/submissions in response to Notification F No. X
11012/2/2021-DRS vide which the Draft of the new Drugs, Medical Devices,
Cosmetics Bill 2022 has been recommended.
This
representation is being filed by the Medico Legal Action Group (MLAG). We are a
non-profit trust at Chandigarh, formed in July 2013 by a group of doctors from
all over the country who wish to legally engage the Govt of India regarding its
various policies concerning medical profession, training, working conditions. We regularly take up such activities,
which include filing of writ petitions, public-interest litigations,
representations and RTIs to further the common goal of striving for the rights
of doctors and establishing a constant dialogue with the policy makers to
ensure proper participation from all the relevant stakeholders.
Upon perusal of the Draft
of the new Drugs, Medical Devices, Cosmetics Bill 2022, the following issues
mentioned hereinbelow are highlighted: -
1. Doctors of Modern Scientific Medicine (Allopathy)
have not
been defined as
Registered Medical Practitioners in
this draft Bill
a. Section 86(s) registered medical practitioner is
defined as: -
(i) for the
purpose of Ayurveda, Unani, Siddha, Sowa-Rigpa systems, a person holding a
qualifications granted by Universities, Boards or medical institutions
recognized under the National Commission for Indian System of Medicine Act,
2020 and enrolled the name in the register maintained by State Council and/or
National Commission for registration of an Ayurveda, Siddha, Sowa-Rigpa and
Unani practitioner medical practitioners under relevant State or Central Act;
(ii) for the purpose of Homoeopathy drugs, a person holding qualifications
granted by Universities, Boards or medical institutions recognized under the
National Commission for Homoeopathy Act, 2020 and enrolled the name in the
register maintained by State Council and/or National Commission for registration
of Homoeopathy practitioner.
b. Section
2(zk) defines over the counter drugs as:-
means drugs that
can be sold by way of retail to a consumer without prescription from a
registered medical practitioner as per the conditions and in such manner as may
be prescribed;
c. The
Bill does not provide for a definition of a registered medical practitioner,
for the purpose of Modern Scientific Medicine (Allopathy). Since there is no
definition for registered medical practitioner, the definition provided under
Chapter 5 under 86(s) is relied upon, which fails to cater to the interests of a
qualified Doctor of Modern Scientific Medicine (Allopathy).
d. Therefore,
to solve this anomaly, either the definitions provided in Section 86 should be
enlarged to include doctors prescribing Modern Scientific Medicine (Allopathy) and
the definitions should not only be for Chapter 5 but for the entire Bill; or, a
separate definition under Section 2 for registered medical practitioner must be
drafted. By doing so, the definition of registered medical practitioner shall
not only include Ayush / Ayurvedic doctors and shall also cater to doctors
prescribing Modern Scientific Medicine (Allopathy). The distinction between the
different types of
Registered Medical
Practitioners should be
ensured.
e. Another
problem that comes to light once
the definition and
distinction of RMP (Modern Scientific Medicine / Allopathy)
is not
made under different
systems of medicine
is the issue
of Doctors qualified
and registered in
one system of
medicine
stocking and selling medicine of
another system of
medicine. All RMPs should
be able to stock
and sell / dispense over the
counter medicines of
different systems of medicine. However no practitioner
of Indian System of
Medicine should be permitted
to sell or
dispense modern scientific
medicine (Allopathic) other than
the over the
counter medicines and
vice versa. Similarly
homeopathic medicines should
be stacked and
sold only by Registered Medical Practitioner of
homeopathy, Therefore, a clear distinction between various
types of RMPs
of different systems
of Medicine is necessary
as also the procedure to prescribe drugs specific
to the system and over the counter drugs, that is
applicable across the fields of Ayurveda, Homeopathy and Modern Scientific
Medicine must be laid out.
f. Further,
punishments for illegal prescription, dispensing , stocking and
sales of medicines by doctors not
registered in the
particular system of
medicine must also be provided since stocking , marketing and selling has
been equated with
manufacturing under this Bill.
g. This
shall be largely in the interests of the consumer so that any drug that is
prescribed and dispensed is being done only by a doctor
practicing in such a field.
2. RMPs
of Modern Scientific Medicine (Allopathy)
should not be required to acquire a drug
license in order
to maintain a Pharmacy
for their patients
a. Section
41 - Prohibition of manufacture and sale of drugs and cosmetics–
(1) Save as
otherwise provided in sub-section (5), no person shall himself or by any other
person on his behalf,- (a) manufacture for sale or distribution, or sell,
stock, exhibit, offer for sale or distribute, any,- (i) drug which is not of
standard quality, or is misbranded, adulterated or spurious; (ii) cosmetic
which is not of standard quality, or is misbranded, adulterated or spurious;
(iii) proprietary medicine, unless there is displayed, on the label or
container thereof the true formula or list of active ingredients contained in
it together with the quantities thereof, in such manner as may be prescribed;
(iv) drug which by means of any statement, design or device accompanying it or
by any other means, purports or claims to prevent, cure or mitigate any such
disease or ailment, or to have any such other effect as may be prescribed; (v)
cosmetic containing any ingredient which may render it unsafe or harmful for
use under the directions indicated or recommended; (vi) drug or cosmetic, in
contravention of any of the provisions of this Chapter or any rule made
thereunder; (vii) drug which purports or claims to prevent, mitigate, cure or
convey that the same may prevent, mitigate or cure such diseases or ailments as
may be prescribed or procure or assist to procure miscarriage in woman; (b)
sell, stock, exhibit or offer for sale or distribute, any drug or cosmetic
which has been imported or manufactured in contravention of any of the
provisions of this Act or any rule made there under; (c) manufacture for sale
or for
distribution, or sell, or stock or exhibit or offer for sale, or distribute,
any drug or cosmetic, except under and in accordance with a license issued by
the State Licensing Authority in such form and manner as may be prescribed:
Provided that nothing in this section shall apply to the manufacture of small
quantities of any drug for the purposes of examination, test or analysis:
Provided further that the Central Government may, after consultation with the
Board, by notification, permit, subject to any condition specified in the
notification, the manufacture for sale or for distribution, sale, stocking or
exhibiting or offering for sale or distribution of any drug or class of drugs
not being of standard quality.
(2) 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 except under and in
accordance with a license or permission issued in such manner as may be
prescribed.
(3) No person
shall manufacture for sale of any new drug except in accordance with the
permission or approval issued by Central Licensing Authority in such manner as
may be prescribed.
(4) The Central
Licensing Authority may, in public interest, abbreviate, defer or waive off
such pre-clinical and clinical data requirements for approval of such new drug,
relating to life threatening or serious diseases or rare diseases or diseases
of special relevance to the country, in such manner as may be prescribed.
(5)
Notwithstanding anything contained in sub-section (1), on and from the
commencement of this Act, no licence in respect of manufacture for sale or for
distribution of drugs specified in the Third Schedule shall be issued by the
State Licensing Authority without the approval of Central License Approving
Authority in the manner as may be prescribed: Provided that the Central License
Approving Authority may issue directions to the State Licensing Authority in
respect of any of the drugs included in the Third Schedule and such direction
shall be binding.
(6) The Central
Government may, by notification, amend the Third Schedule so as to insert
therein or omit there from categories of drugs.
b. Section
2(zb)“manufacture”: -
(a) in relation
to any drug or any cosmetic, except human blood and its components, includes
any process or part of a process for making, altering, ornamenting, finishing,
labelling, packing, breaking up or otherwise treating or adopting any drug or
cosmetic with a view to sell or distribute or stock but does not include the
compounding or dispensing of any drug, or the packing of any drug or cosmetic
in the ordinary course of retail business; (b)in relation to human blood and
its components includes any process of collection, processing, separation,
storage, labelling, packing and testing for its use or distribution for
transfusion in human beings; (c) in relation to medical device, includes any
process for designing, making, assembling, configuring, finishing, packing,
sterilizing, labelling, or adapting with a view to sell or distribute or stock
but does not include assembling or adapting a device already approved for use
for an individual patient by registered medical practitioner;
c.
Upon perusal of the above-mentioned sections, all persons manufacturing
and selling drugs shall require a license. However, upon further examination
and by reading it with Section 2(zb) which defines ‘manufacture’, it implies
that a doctor prescribing general medicines, shall also require the same. While
the saving grace under Section 2(zb) is that ‘in the ordinary course of
business’ is exempted, but the same needs more clarification. For example, a
qualified doctor prescribing or dispensing medicine shall not need to acquire a
drug license if he dispenses medicine only to his own patients but he will
require a drug license if from his establishment, he not only sells the
medicines he prescribes to his patients , but also sells them to outside patients,
if they have a proper prescription by another doctor. Similarly for Small and
medium healthcare establishments Hospitals (SMHCE) with less than 20 beds there
should be no need for drug license to run a pharmacy as long as medicine /
equipment / cosmetics are sold only to patients being treated in the establishment
and the sale of drug / medical equipment
and cosmetics to outside patients is not done.
d.
Therefore, this aspect needs clarification such that a distinction must
made between the professional dispensing medicines / medical equipment and
cosmetics to his own patients versus maintaining an open shop where anyone (even outside
patients) can purchase from.
3. Relation
between manufacturer and branding
a. Section
2(zc)“manufacturer”: -
means a person
who himself manufactures drug, cosmetic or medical device and includes any
other person who undertakes such manufacturing activity on his behalf.
b. Section
2(zb)“manufacture”-
(a) in relation
to any drug or any cosmetic, except human blood and its components, includes
any process or part of a process for making, altering, ornamenting, finishing,
labelling, packing, breaking up or otherwise treating or adopting any drug or
cosmetic with a view to sell or distribute or stock but does not include the
compounding or dispensing of any drug, or the packing of any drug or cosmetic
in the ordinary course of retail business; (b)in relation to human blood and
its components includes any process of collection, processing, separation,
storage, labelling, packing and testing for its use or distribution for
transfusion in human beings; (c) in relation to medical device, includes any
process for designing, making, assembling, configuring, finishing, packing,
sterilizing, labelling, or adapting with a view to sell or distribute or stock
but does not include assembling or adapting a device already approved for use
for an individual patient by registered medical practitioner; and
expressions ‘marketed by’ or ‘promoted by’ or any other similar expression
claimed on the label of drug shall be construed as manufacture.
c. Upon
reading Section 2(zb) and 2(zc) together, it implies that marketers and
promoters are also treated as manufacturers. Multiple fly by the night
companies get drugs manufactured at a facility or at multiple facilities and market
them with their own brand names. While from the point of view of onus, it seems
worthwhile to hold the marketers and promoters of manufactured medicines
responsible, but in practical terms, this creates a logistical nightmare of the
doctors.
d. This
is because, there is a plethora of “manufacturers” in the market,
who are selling through different promoters and marketers. In reality, a doctor
shall now have to choose from prescribing a single medicine manufactured by a single
manufacturer but sold as 100 different brand names at different prices.
e. Therefore,
the solution to the same is that the ones who do not manufacture any medicine
themselves, should not be allowed to sell medicines / medical equipment or
cosmetics. Or, if manufacturers do sell the medicines through promoters and
marketers, such numbers should at thevery least be restricted and limited.
f. This
shall also inspire market forces and ultimately enable only the best medicines
on the market to survive and in turn benefit the consumer.
4. Pricing
of medicines
a. Another
subset of the problem mentioned above, that arises through a non-distinction
between promoter and manufacturer is that generally when a medicine is made, it
is sometimes sold by the same company on a different price/brand name to
different consumers. This is done to satisfy large corporate customers with large
discounts on MRP who then bill their patients at MRP making unhealthy profits.
The same company also promotes the same drug in open market with a different brand
name but with a reasonable pricing because market forces would not permit exorbitant
pricing / MRP as is done for corporate hospitals. In principle no company should
be permitted to manufacture and market one drug with different brand names and different
pricing since this results in cheating of
the consumer.
b. Therefore,
there is a need for more scrutinization on the agreements signed by
manufacturers with promoters and marketers so that there is a bar on selling
medicines under different names to cater to large and small audience subsets.
This can only be executed through a stringent system of checks and balances by
the Drugs Controller General, India.
Therefore,
to summarize:
1.
Doctors prescribing or dispensing or selling Modern Scientific Medicine
(Allopathy) have not been defined as Registered Medical Practitioners in this
Bill. Section 2 and Section 86 must be amended accordingly so as to provide for
their interests.
2.
Clarity must be provided in the Act to a exempt a RMP from requiring a drug license to maintain a
pharmacy to provide medicines to his own patients unless and until he operates
an open shop;
3.
The current definition of manufacturers includes promoters and marketers, which
shall only lead to a plethora of market players that shall in turn make the
prescription of medicines a logistical nightmare for the doctors;
4.
Regulation and scrutinization of manufacturers to ensure fair market pricing
and bar on one manufacturer selling of
same medicines with different names
and different prices.
In
light of the above-mentioned objections and suggestions, we request you to take
them into consideration immediately. Further, we would request you
to afford us
an opportunity for
personal hearing in
the matter.
Thanking
you.
Regards
Dr.
Neeraj Nagpal
Convenor
and Managing Trustee
Medicos
Legal Action Group
Office:
SCO 1066-1067,Aerodale Market, New Sunny Enclave, Sector 123, Mohali 140301
Mob:
+91 9888207176, 9465109935, 9478082176
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