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Government Working On A
Scheme To Strengthen Indian Medical Device Sector: Pharma
Secretary
Dr Arunish Chawla, Secretary,
Department of Pharmaceuticals, Ministry of Chemicals &
Fertilizers, Govt of India said that the PLI schemes for
medical devices sector have succeeded, and the government
is now looking at the post PLI framework.
The government approved the
Medical Devices policy a few months ago, and this new
scheme is being designed to support the industry and
reduce our import dependence going forward beyond the PLI,
he added.
The proposed scheme, he
stated will be based on 5 key components including Common
Facilities for medical devices clusters; Capacity building
and Skill Development; Marginal Investment Scheme for
reducing import dependence; focus on clinical trial
support and medical device promotion scheme.
He stated we need to bring
the policy stack together in a manner that enables India
to achieve the vision of Viksit Bharat by 2047. Dr Chawla
further urged the industry to invest more in clinical
trials. Highlighting the importance of skilled manpower
required in the medical devices sector, Dr Chawla said,
Across the industry, there is a shortage of technical
manpower, particularly medical engineers.
To address this gap, we have
partnered with the relevant skill development council in
the industry to support both the training and development
of technicians and medical engineers.
(https://www.business-standard.com)
Aug 22 2024
CDSCO
Mandates GMP Compliance For Sterile Equipment
Manufacturers
This move marks a significant
shift, as GMP compliance was previously required only for
drug manufacturers.
The Central Drugs Standard
Control Organization (CDSCO) has directed manufacturers of
sterile equipment to adhere to Schedule M of the Drugs and
Cosmetics Rules, aligning with Good Manufacturing
Practices (GMP) standards as outlined by the World Health
Organization (WHO). This move marks a significant shift,
as GMP compliance was previously required only for drug
manufacturers.
The inclusion of sterile
equipment under GMP guidelines is crucial given the
expanding Indian market for these products. The new
regulations aim to ensure higher quality standards for
various sterile items, including surgical instruments,
forceps, biopsy tools, eye equipment, and injectables.
“The revised GMP notification
published last December covers all pharmaceutical items
and specifies requirements for different product types,
such as sterile products, biologicals, and ophthalmic
solutions,” an official explained.
In addition to general
requirements, companies must now follow WHO guidelines,
regularly conducting self-assessments and addressing
compliance gaps to meet international standards.
The government had previously
revised Schedule M of the Drugs and Cosmetics Rules in
December 2023 to tighten GMP norms, particularly impacting
micro, small, and medium enterprises (MSMEs). According to
the guidelines announced in July 2023, companies with
annual turnovers exceeding Rs 2.5 billion must
comply within six months, while those with lower turnovers
have a 12-month period.
This update follows a
government inspection revealing significant GMP lapses,
including infrastructural issues and poor documentation.
This action is partly in response to incidents involving
Indian cough syrups linked to child deaths in Gambia and
Uzbekistan.
(https://ipfonline.com/news/detail/articles)
Aug 14,24
DoP To Launch Scheme For
Common Facilities In State-Supported Medical Device Parks:
DoP Secretary
In a significant development,
the Department of Pharmaceuticals (DoP) is planning to
introduce a new scheme aimed at providing common
facilities for medical device parks or clusters that have
been exclusively established with the financial support of
respective state governments, according to Dr. Arunish
Chawla, DoP secretary.
This initiative coincides with the Government of Gujarat's
recent allocation of Rs. 250 crore for a state-of-the-art
medical device park at Nagalpar, near Rajkot. Spread
across 336 acres, this park is distinguished as
India’s first medical device park funded solely by a state
budget, without relying on the central government's
financial grant of Rs. 250 crore. The park is expected to
commence operations by the end of 2025.
Conceived as a commercially
and economically viable project, the Nagalpar medical
device park is projected to attract an investment of USD
100-150 million over the next three years.
"The park is estimated to
host around 400 medical device companies. The land has
been allocated, and the first phase of construction has
begun. Nagalpar, being an engineering hub, offers a
strategic location for the park, promising good returns on
investment. It will facilitate R&D, testing,
manufacturing, training, and incubation for medical device
companies," stated Dr H G Koshia, commissioner of the
Gujarat Food and Drug Control Administration (FDCA).
The Gujarat Industrial
Development Corporation (GIDC) has started the process of
setting up the medical device park at Nagalpar to boost
medical device manufacturing in the state.
To reduce import dependence
and encourage domestic manufacturing of drugs and medical
devices, the Indian government has implemented various
measures. Under the “Promotion of Medical Devices Parks”
scheme, financial assistance of Rs. 100 crore each has
been approved for Uttar Pradesh, Tamil Nadu, Madhya
Pradesh, and Himachal Pradesh to establish common
facilities in their medical device parks.
The production linked
incentive (PLI) scheme, with a financial outlay of Rs.
3,420 crore, aims to boost domestic manufacturing of
medical devices. Running from FY 2020-21 to FY 2027-28,
this scheme offers financial incentives to selected
companies at the rate of 5 per cent of incremental sales
of medical devices made in India, covering four target
segments, for a period of five years.
(https://www.pharmabiz.com)
July 3, 2024
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