A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY
Our 32nd Year of Publication
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Aimed & Regulatory Update

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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