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Medical devices industry
asks govt to define and bring clarity on online sale of
devices in New Drugs Bill, 2022
The medical devices industry
in the country has sought the Centre to define online and
offline mode of sale, provide more clarity on the
regulations that are binding the online sales and
suggested inclusion of online medical devices players
under the Uniform Code for Medical Devices Marketing
Practices (UCMDMP).
The Association of Indian
Medical Device Industry (AiMeD), in its feedback to the
government on the draft New Drugs, Medical Devices and
Cosmetics (NDMDC) Bill, 2022, has said that there needs
more clarity to some of the sections which points on
regulations related to online sales of medical devices.
For instance, in the Section
130 (4) of the draft, where it discusses prohibition of
import or manufacture and sale of medical devices, the
government intends to make regulations that no person
shall himself or by any other person on his behalf sale,
distribute or offer for sale the medical devices by online
method, as may be prescribed, for which a license or
permission is required to be obtained from the licensing
authority, except under and in accordance with such
license or permission subject to such exemptions and
conditions and in such form and manner as may be
prescribed.
“We would suggest defining what is Online and Offline Mode
for greater clarity and understanding of all stakeholders
from a policy maker/regulatory perspective,” said the
Association.
“Both Methods of Sale are totally different and
communities' health and well being is compromised with
sale/delivery formats which have no clarity,” it added.
Under the Section 158 (z) of the draft, where it discusses
the powers of the Central Government to make rules for the
Chapter VI related to medical devices after consultation
with or on recommendation of the Medical Devices Technical
Advisory Board and subject to previous publication, the
government has powers to prescribe the manner of
regulating online sale or distribution or offer for sale
of the medical device.
“We would like that better clarity is provided on the
following: Whether online players in medical devices are
also covered under Consumer Protection (Ecommerce Rules),
2020 under Consumer Protection Act 2019? Whether they are
also subject to Medical Device Regulation?,” said the
Association.
The online players are also covered under IT Act and this
means the online businesses will be subject to multiple
regulations and all acts have to be cross referenced for
better clarity to protect consumer safety.
Communities, consumers are often under the impression that
online businesses are strictly regulated and all
regulatory, licensing aspects are already addressed. Food
Safety Standards and Regulations Authority can be referred
to as FSSAI has brought all Online FBOs under strict
regulatory mechanism with well defined Regulatory
specification, it added.
Besides, the Association also suggested that the online
players should also be brought under the marketing code of
conduct.
“Marketing Code of Conduct (UCMDMP) should include the
Marketing Code of Conduct for Online players based on the
Consumers Protection (ecommerce rules) 2020, released by
the ministry of consumer affairs under the Consumer
Protection Act 2019. Basic Marketing Code of Conduct is
defined for online players under the said rules,” it
added.
As reported earlier, the Association also sought the
Centre to include software or an accessory to the
definition of In-vitro diagnostics device which is
referred to in the Section 3 (zd)(b) of the draft Bill.
http://www.pharmabiz.com/NewsDetails.aspx?aid=153165&sid=1
September 12, 2022
DoC approves setting up of
separate Export Promotion Council for Medical Devices
The Department of Commerce (DoC)
has approved setting up a separate Export Promotion
Council (EPC) for the medical devices sector under the
administrative control of the Department of
Pharmaceuticals to help exporters in promoting their
products in international markets. The medical devices
industry welcomed the move and the strategic step will go
a long way in accelerating the exports of medical devices
from India.
The creation of the EPC for medical devices is approved by
the DoC with one time waiver of the condition in
guidelines on the subject, stipulating creation of an
Export Promotion Forum initially, before its upgradation
as EPC.
The Council will be headquartered in YEIDA, Greater Noida,
Uttar Pradesh with regional offices in Andhra Pradesh (in
AMTZ, Visakhapatnam) and Telangana (in Hyderabad). The
headquarters will be set up with initial funding of Rs. 3
crore, in free office space of around 5,000 swift area at
the upcoming Medical Devices Park Common Facility Centre
in Greater Noida, and required secretarial staff to run
the Council.
The Regional Office at Visakhapatnam is expected to be set
up in a period of one year, by the end of 2023, and the
regional office at Hyderabad will be set up in a period of
three years, by 2025. The office space, manpower and other
requirements for the regional offices has to be fulfilled
by the respective State Governments, said an Office
Memorandum from the DoC.
The Council’s administration and management will be
through the Committee of Administration with elected and
nominated members. The nominated members shall be from
Department of Pharmaceuticals, Department of Commerce,
Department for Promotion of Industry and Internal Trade (DPIIT),
ministry of health and family welfare, Central Drugs
Standard Control Organisation (CDSCO), chief executive
officers or managing directors of major medical device
clusters or parks especially, including the MD of Andhra
Pradesh MedTech Zone and chief executive officer of
Hyderabad Pharma City etc.
Commenting on the initiative, Rajiv Nath, forum
coordinator of Association of Indian Medical Device
Industry (AiMeD) said, “It's a great news, a big boost to
Indian Medical Devices Manufacturing. The long sought and
requested Medical Devices Exports Promotion Council is
finally sanctioned to be created under the aegis of DoP,
Government of India. This strategic step will go a long
way in accelerating the exports and manufacturing growth
of the medical devices sector.”
India currently exports Rs. 23,766 crore (2021-22) of
medical devices up from previous year Rs. 19,736 crore.
However, with almost 80 per cent of the medical devices
demand in the country is met through imports, the
government and the industry are looking at various methods
to improve domestic manufacturing and increase the exports
from the country.
The Office Memorandum further states that the chairman and
vice chairman of the Council shall be elected from members
who are manufacturers or processors of medical devices and
other members, including from merchant exporters, shall
not be eligible for the post. While the final decision on
the jurisdiction will be taken by the CoA, the office in
Visakhapatnam is expected to have jurisdiction over Andhra
Pradesh, Orissa, Tamil Nadu and Chhattisgarh, the office
in Hyderabad will have jurisdiction over the States of
Telangana, Karnataka, Kerala and Maharashtra. The
headquarters will serve the requirements of the member
exports pan India till the regional facilities come up.
The entire range of medical devices goods and services
could be broadly qualified into sub-groups named as
panels, such as disposables, consumables, orthopaedic
implants, IVD equipment and reagents and surgical
instruments. There would also be panels for policy
advocacy, technology upgradation and transfer and
start-ups.
“The proposed council shall, inter alia, help exporters in
promoting their products in international markets, through
various promotional activities including organising/participating
in international trade fairs, buyer-seller meets, RBSM in
India, etc., in line with the Foreign Trade Policy (FTP)
of India,” said the Office Memorandum. The Council may
also organise awareness programmes for dissemination of
information regarding assistance available for the MSME
exporters under various government schemes. EEPC India
will provide assistance and guidance to the new Council in
discharge of its function for a period of five years.
Nath said, “The Exports Promotion Council for Medical
Devices will help bring in coordinated inter-ministerial
policy measures for unleashing the huge export potential
and investment potential of over Rs. 80,000 crore for
manufacturing medical devices for the global market in
India’s quest to be one of top 5 preferred supplier base
of medical devices worldwide and we are thankful to the
minister of commerce and industry in taking this
initiative to help realise our Prime Minister’s vision.”
http://www.pharmabiz.com/NewsDetails.aspx?aid=153404&sid=1
September 23, 2022
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