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Medical Device Industry
Demands Separate Marketing Practices Code Different From Pharma Industry
As the characteristics of the medical device
industry are different from the pharmaceutical industry, the medical device
industry has sought a separate marketing practices code for the medical devices
industry.
The medical devices industry associations raised
this issue at a review meeting held by the Department of Pharmaceuticals (DoP)
on August 21, 2020, to review implementation of the Uniform Code of
Pharmaceutical Marketing Practices (UCPMP). The meeting, held through video
conferencing, was chaired byDoP secretary Dr P D Vaghela.
“The characteristics of the medical device industry
are somewhat different from the pharma industry and though the associations have
requested in earlier meetings to have a separate code for the medical devices
industry, AiMeD is in agreement with the government to start with pharma defined
code first but with some changes. Innovative and high-end medical devices such
as robotics require proper training to impart skills to users unlike drugs.
However, training can be given ethically with no lavish conferences and free
travel to exotic tourist destinations,” stated Rajiv Nath, forum coordinator,
Association of Indian Medical Device Industry (AiMeD) further adding that AiMeD
has uploaded UCPMP on its website and formed the ethics committee as well as
held meetings, invited suggestions and complaints from its members.
“Ethical marketing is being a challenge in India of
medical devices if manufacturers and importers use artificially inflated high
maximum retail price (MRP) high trade margins to induce hospitals and retailers
to push their products. We have been seeking that MRP should not be over four to
five times of import landed price or ex factory price (on which GST is charged
initially) instead of prevailing MRP that go up to 20 times," Nath further
added.
The orthopaedic implant Industry is challenged by
the co existence of hundreds unlicensed manufacturers of implants that are
allowed to market their unlicensed implant without regulatory approval which
creates an unethical and unfair marketplace, stated Anu Dureja of Siora
Surgicals and AiMeD member.
“Exorbitantly high demands for sponsorships by
doctors, hospitals has been challenging for us” stated Kanwar Sehgal of Endomed
Technologies. “These huge expenses can’t be matched by the small and midsize
segment of the medical devices industry and denies access of affordable Indian
products to Indian patients,” he explained.
The DoP secretary had asked all the associations
including medical devices to implement UCPMP. Secretary (DoP) showed his
displeasure at the status of implementation of UCPMP and exhorted all
associations to implement the code without exception. He mentioned that
suggestions can be discussed in separate meetings under JS (Policy) to be called
next week for medical Devices separately. He also asked the associations to
quote exact provisions of laws of other countries as precedence and reference
while giving suggestions in respect of UCPMP.
Despite government mandate on UCPMP and as
envisaged by DoP, details have not been uploaded related to the Ethics Committee
for Pharma Marketing Practices (ECPMP) and Apex Ethics Committee for
Pharmaceuticals Marketing Practices (AECPMP) of all the associations along with
contact number and procedure of filing complaints on the website of DoP.
To review the implementation of the voluntary UCPMP,
all the associations (Pharmaceuticals and medical devices) are requested to
provide the details of their Ethics Committee for Pharma Marketing Practices (ECPMP)
and Apex Ethics Committee for Pharmaceuticals Marketing Practices (AECPMP) along
with contact numbers and procedure of filing complaint so that the same can be
uploaded on the website of DoP.
A meeting to review the implementation of UCPMP was
held under the chairmanship of Secretary (DoP) on February 17, 2020. Secretary,
DoP enquired how many associations have uploaded the UCPMP on their website and
have formed the two Committees.
http://pharmabiz.com/NewsDetails.aspx?aid=130582&sid=1
, August 24, 2020.
COVID-19 Treatment: CDSCO
Shows Green Flag To Baxter India Oxiris Filter
Gurugram: Healthcare firm Baxter India on Tuesday
said it has received approval from the Central Drugs Standard Control
Organisation (CDSCO) for the use of its Oxiris blood purification filter for the
treatment of Covid-19 patients.
The filter is intended to be used in the critically
ill Covid-19 patients in need of blood purification where excessive inflammatory
mediators are present, Baxter India said in a statement.
"The Covid-19 cases in India have been spiralling
and putting pressure on our the healthcare system. This approval has come at a
crucial time when such filter sets are much required to ease the burden on
healthcare providers," Baxter India General Manager Ravinder Dang said.
The company hopes that the availability of Oxiris
will go a long way in fighting the Covid-19 cases in India, he added.
During blood purification therapy, the patient's
blood passes through the Oxiris filter set, where it can adsorb inflammatory
mediators, and remove fluid, electrolytes and uremic toxins, before returning
the patient's blood to the body, Baxter India said.
Baxter India is a wholly-owned subsidiary of Baxter
International Inc. It started operations in India in April 1997.
https://medicaldialogues.in/news/industry/pharma/covid-19-treatment-cdsco-shows-green-flag-to-baxter-india-oxiris-filter-67426?infinitescroll=1
, July 8, 2020
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