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DoP
Releases Draft Uniform Code For Medical Devices Marketing
Practices
The Department of
Pharmaceuticals (DoP) has released the draft Uniform Code
for Medical Device Marketing Practices (UCMDMP), a
voluntary code laying standards for promotion, marketing
and sales of the medical devices prohibiting distribution
of gifts or benefits to healthcare professionals (HCPs),
but allowing “modest, appropriate educational items” and
“brand recall items” worth less than Rs. 1,000
occasionally.
The draft has been published
after consultation with the industry and is open for wider
stakeholder consultation. The feedback has to be sent to
the department by not later than April 15, 2022.
The marketing practices of
the Medical Device sector has been voluntarily regulated
by the Uniform Code for Pharmaceuticals Marketing
Practices (UCPMP), which prohibits the pharma companies or
their agents from giving gifts, peculiarly advantages or
benefits in kind offered or promised to persons qualified
to prescribe or supply drugs or offer gifts for the
personal benefit of HCPs and family members - both
immediate and extended - such as tickets to entertainment
events.
The Code for Medical Devices,
however, elaborates the kind of gifts that will not be
allowed and those which can be permitted. No gifts,
peculiarly advantages or benefits in kind shall be
supplied, offered or promised to persons qualified to use,
prescribe or supply medical devices, by medical devices
company or any of its agents and
gifts for the personal benefit of HCPs and family members
such as tickets to entertainment events shall not be
offered or provided, under the UCMDMP.
However, companies may
occasionally provide modest, appropriate educational items
to HCPs that benefit patients or serve a genuine
educational function for HCPs. Educational items can
include, but are not limited to, product manuals and
anatomical models.
“Hence, companies can supply
medical education materials like books including e-books,
and subscription to online portals (that can help download
the materials for medical education and knowledge
dissemination), anatomical models, bone/animal models,
manuals and small products/educational material related to
the training/Continued Medical Education (CME) in
hospitals or in clinic training, to HCPs or institutions,”
said the draft Code. Companies should maintain adequate
records to support any expenses on these educational
materials.
Also, companies may
occasionally provide modest, appropriate brand recall
items/brand reminders, which are customary business
courtesies and are reasonable in value and frequency.
However, the value of such brand recall items or brand
reminders shall not exceed Rs. 1,000 and the companies
shall maintain proper documentation on the expense
incurred on such brand reminders, it said.
While at present it is a
voluntary code, the government may consider making it a
statutory code if it has not been implemented effectively
by the industry associations and companies, it said.
Unlike the UCPMP published by
the DoP in 2014, the Code for Medical Devices industry
also has provisions for the company to collaborate with
the HCPs and engage in activities including providing
consulting services, conducting clinical studies and doing
research, participate in company conducted training and
education including continued medical education, product
training’s, business meetings, webinars etc. However, such
engagements shall not be conditional upon any obligation
for the HCPs to use, recommend,
promote or purchase products of the company.
Companies can directly or in
collaboration with health care professionals or certain
third parties conduct educational activities, product or
procedure training programmes for inservice team of the
hospitals on safe and effective use of the medical
technologies, products and procedures, company’s
promotional event such as seminar, conference of meeting
for launch of a new product or technology or promoting an
existing product or technology amongst HCPs. The broad
categories of training and
educational programmes also include continued medical
education activities sponsored or funded by the company
conducted by third parties including organisations
controlled by a HCP, HCPs Association, event companies or
any other entity for the purpose of group learning and
skill upgradation for HCPs.
HCPs may participate in these
programmes either as a faculty or training or proctor or
as a delegate or trainee. In all these events, the HCPs as
faculty/trainer/proctor can be provided with modest meals,
travel reimbursement, hotel stay and honorariums for
lectures, and HCPs as delegates or trainees can be
provided with modest meals. For delegates and trainees,
travel reimbursement and hotel stay are allowed if it is a
company organised product and procedure training
programmes or in-service programme, while it is not
allowed for company conducted promotional programmes or
third party conducted CME sponsored by companies for peer
learning. Companies may also provide educational grants to
training institutions and to other third-party entities in
support of their legitimate scientific, educational and
training programmes.
All the Medical Device
Manufacturer Associations in India will have the Code
uploaded on their website, and once a complaint is lodged
and the Association receives the information from which it
appears that a company may have contravened the code, the
managing director or chief executive or equivalent of the
company or authorised persons of the company concerned
will be requested to investigate, take corrective actions
and provide a response to the matters of complaint to the
Association. The Association shall
send the details of such complaints and status on a
quarterly basis to the National Pharmaceutical Pricing
Authority (NPPA). If the company is a member in multiple
associations, the association that receives the complaint
first shall communicate with the company and the company
shall not be responsible to report to any other
association.
In the UCPMP, the
Associations were advised to form an ethics committee to
look into the complaints and the penalty provisions
include suspending or expelling the company from the
Association, reprimanding the company and publishing
details of that reprimand, and provisions for the
committee to ask the company to recover the items from the
concerned persons.
http://pharmabiz.com/NewsDetails.aspx?aid=147483&sid=1
Govt
Amends Rules To Allow Import License For Devices With
Certificate Of Sale From UK, Without Clinical
Investigation
The ministry of health and
family welfare has issued final notification amending the
rules related to the grant of import license for the
medical devices, to allow products with a free sale
certificate from the drug regulator of the United Kingdom
also to be issued import license in the country without
clinical investigation. The amendment is by adding the
United Kingdom also to the list of nations including the
United States of America, which are currently allowed to
import under this provision.
The amendment, namely Medical
Devices (2nd Amendment) Rules, 2022, was notified after
the objections and suggestions received from the public
and stakeholders were considered, said the Ministry.
The amendment says that in
the Medical Devices Rules, 2017, in the rule 35, in
sub-rule (3), for the words “or the United States of
America”, the words “United Kingdom or the United States
of America” shall be substituted.
The Rule 36 of the Medical
Devices Rules is regarding the requirements for the grant
of import licence, wherein it says that after the
examination of documents furnished with the application
and on the basis of the inspection report, if inspection
has been carried out, the Central Licensing Authority may,
on being satisfied, grant licence in Form MD-15 or, may
reject such application for which reasons shall be
recorded in writing within a period of nine months from
the date of application.
Under the sub-rule (3), it
stipulates that where, a free sale certificate has already
been issued in respect of any medical device by the
national regulatory authority or other competent authority
of any of the countries, namely Australia, Canada, Japan,
European Union Countries or the United States of America,
a licence shall be granted as per the provisions, without
carrying out clinical investigation. It is to this
provision, the amendment adds the name of the United
Kingdom.
When the medical device is
imported from countries other than those referred to in
sub-rule (3), the licence in case of Class C and Class D
medical devices may be granted after its safety and
effectiveness has been established through clinical
investigation in India as specified under provision of
Chapter VII of these rules,
according to the Medical Devices Rules.
A draft amendment was
proposed and published on December 10, 2021, in the
Gazette of India, after consultation with the Drugs
Technical Advisory Board for information of all persons
likely to be affected. The Ministry also issued notice
that the draft amendment shall be taken into consideration
on or after the expiry of a period of 45 days from the
date on which copies of the Gazette of India containing
these draft rules are made available to the public.
http://pharmabiz.com/NewsDetails.aspx?aid=146257&sid=1
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