Latest news with #DepartmentofPharmaceuticals
News18
6 days ago
- Health
- News18
'Can Activate Malware, Bugs': Govt To Probe Security Risks From Chinese Medical Devices
China is the second-largest exporter of medical devices to India at around Rs 11,506 crore in 2023-24, less than US, which exported devices worth Rs 12,552 crore the same year Amid rising national security concerns, the government is investigating Chinese IoT-enabled medical devices in remote areas, fearing they could leak sensitive health data and compromise defence interests, News18 has learnt. A concern was raised during a meeting chaired by Union commerce and industry minister Piyush Goyal, flagging potential national security and data privacy risks. The ministry has ordered an examination into the growing use of Chinese IoT-enabled medical devices in remote Indian health facilities. An official document reviewed by News18 outlines concerns over the potential misuse of data by Chinese firms, particularly through medical imaging and monitoring devices. These devices, which are now being widely used in rural healthcare settings, have been identified as potential conduits for surveillance and unauthorised data access. 'Deployment of Chinese medical devices in remote areas raises patient data security concerns… Concern expressed was that the population health data can be misused by Chinese firms (using Chinese-owned medical devices, especially IoT-enabled imaging and monitoring equipment, which are increasingly being installed in remote Indian health facilities)," according to the minutes of the meeting held on July 2. According to an official who was part of the meeting, 'the concern was discussed with the minister, as it is very easy to insert malware or bugs into the medical devices while exporting. Any hostile nation can play this trick and activate malware or bugs in those devices whenever they want". 'We must understand that such incidents can put thousands of patients using those devices under severe distress. Hence, we need to scrutinise the devices which are coming from hostile nations. The ministry has decided to take this matter seriously and will go deep into it," he said, requesting anonymity. The commerce ministry has proposed that relevant data be shared with ministries, including the Department of Pharmaceuticals (DoP), Department for Promotion of Industry and Internal Trade (DPIIT) and the Ministry of Health and Family Welfare (MoHFW) for further scrutiny. Presence of Chinese Medical Devices in India According to industry data, India continues to rely heavily on Chinese imports for a wide range of medical devices, particularly in critical and high-volume categories. China is the second-largest exporter of medical devices to India, which stood around Rs 11,506 crore in 2023-24, slightly less than the US, which exported devices worth Rs 12,552 crore in the same year. Some of the top medical equipment imported from China includes patient monitoring systems, diagnostic imaging machines (like ultrasound and CT scanners), in-vitro diagnostic (IVD) kits, oxygen concentrators, surgical instruments, thermometers, orthopaedic implants, and disposable items like syringes and needles. Leading Chinese companies dominating this space include Mindray, United Imaging, Yuwell and Sinocare. These firms, often offering competitively priced technology, have gained strong market presence in India, especially in Tier-II and rural health settings. The document also highlights transfer pricing violations by Chinese firms, pushing for stronger enforcement through anti-dumping measures and quality control orders (QCOs). The National Pharmaceutical Pricing Authority (NPPA) has been tasked with examining this issue, in consultation with agencies like BIS and CBIC. First Published: July 17, 2025, 10:49 IST Disclaimer: Comments reflect users' views, not News18's. Please keep discussions respectful and constructive. Abusive, defamatory, or illegal comments will be removed. News18 may disable any comment at its discretion. By posting, you agree to our Terms of Use and Privacy Policy.
India.com
09-07-2025
- Business
- India.com
India's Pharma War Zone: How Delhi's Bulk Drug Push Is Rattling China
New Delhi: The heat is rising in India's pharmaceutical backrooms. Quiet factories. Long shifts. New chemical reactors humming across Himachal, Gujarat and Telangana. Something has shifted. China, long the uncontested supplier of India's drug ingredients, is suddenly nervous. Its prices are falling. Fast. Some slashed by 50%. This is no coincidence. The trigger? India's Rs 6,940 crore Production-Linked Incentive (PLI) scheme. Launched in March 2020, it was a shot across the bow. And the target: reduce dependence on Chinese Active Pharmaceutical Ingredients (APIs). By December 2024, 48 domestic API projects were sanctioned. Of these, 34 are already operational. Together, they cover 25 key drug molecules. The investment so far? Rs 4,254 crore. But the Chinese are not backing down quietly. They are throwing prices into free fall. Landed costs of certain APIs from China have collapsed far deeper than Indian prices. Take Atorvastatin, used in cholesterol pills, for instance. Indian API prices fell 17% to Rs 10,000 per kg. China pushed it down to Rs 8,000 per kg. That is a 33% crash. Let's understand with another example of Ofloxacin, a broad-spectrum antibiotic. Indian prices dropped from Rs 3,200 to Rs 2,700. China? Rs 2,100. Down 30% in a year. This is price war, not coincidence. Bhavin Mukund Mehta, director of the Kilitch Drugs and Vice Chairman of Pharmexcil, minced no words, 'Even though the PLI has helped reduce the prices of domestically-produced APIs, the Chinese players are undercutting the competition in specific product categories to retain their market share.' Behind the scenes, policymakers are reviewing the PLI's next phase. They are asked industry insiders for help. The mission is to stop China's dumping spree, push for stronger local production and close the gaping supply chain hole exposed during COVID. The Department of Pharmaceuticals is now asking – can India stand on its own chemical legs and can it stop the bleed from Beijing's pricing games? The pressure is on. China still supplies around 70% of India's API imports. India imports about 50% of its total bulk drug needs. That is the strategic choke point the PLI is aiming to break. The scheme covers the production period from FY23 to FY29. But the impact is already being felt. Jatish Sheth, secretary general of the Confederation of Indian Pharmaceutical Industry, sees this as China's last stand. 'It is an expected move from the Chinese exporters to bring down the bulk drugs prices. While their focus is to retain the market share, we believe that this is a temporary phenomenon. We do not expect the Chinese players to keep selling the drugs at such low prices for too long.' He is betting on patience. Indian drugmakers are playing the long game. With new infrastructure, newer molecules and tighter government support, the tide could soon turn. But for now, it is a staring contest across lab benches and import docks. On one side, old Chinese dominance. On the other, rising Indian ambition backed by billions. And in between? A market worth tens of billions and the chemical backbone of the world's pharmacy.
Hans India
06-07-2025
- Business
- Hans India
Pharma sector set for 11% YoY growth in Q1FY26 driven by global momentum: Report
Pharmaceutical companies in India are projected to deliver an 11% year-on-year (YoY) growth in both sales and EBITDA for the first quarter of FY26, according to a recent report by Kotak Institutional Equities. The growth is expected to be driven by sustained momentum across key international markets, despite slightly muted domestic demand in April and March. The hospital segment is also expected to shine with a robust 17% YoY increase in sales and EBITDA, attributed to increased patient footfalls, capacity expansions through new bed additions, and a modest improvement in Average Revenue Per Occupied Bed (ARPOB). Diagnostics players are forecast to see a 14% growth in sales, fueled by higher volumes, an improved service mix, and mergers and acquisitions activity. The Indian pharmaceutical market was valued at USD 50 billion in FY24, with domestic consumption contributing USD 23.5 billion and exports accounting for USD 26.5 billion. India continues to hold its place as the world's third-largest pharmaceutical producer by volume and 14th by value. The industry's portfolio spans generic and bulk drugs, OTC products, vaccines, biosimilars, and biologics. As per the National Accounts Statistics 2024, published by the Ministry of Statistics and Programme Implementation, the pharmaceutical sector's total output stood at ₹4.56 lakh crore for FY23 at constant prices, with ₹1.75 lakh crore as value added. With over 9.25 lakh people employed in the sector during FY23, the Indian government has been actively promoting pharmaceutical innovation. The Department of Pharmaceuticals has set up seven National Institutes of Pharmaceutical Education and Research (NIPERs) to foster advanced research and academic excellence. To accelerate innovation, the department has also rolled out the National Policy on R&D and Innovation in the Pharma-MedTech Sector, aimed at nurturing an entrepreneurial ecosystem and positioning India as a global leader in drug discovery and medical device development.
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Business Standard
27-06-2025
- Business
- Business Standard
Govt, industry hold talk on issues over marketing code for medical devices
Medical device industry representatives have raised concerns with the Department of Pharmaceuticals (DoP) over certain provisions under the recently notified Uniform Code for Marketing Practices for Medical Devices (UDMPMD), during a meeting held on Thursday. The new code seeks to curb unethical marketing practices in the medical devices industry by barring medical representatives and device companies from using inducements or subterfuge to access healthcare professionals. The meeting follows an advisory by the Director General of Health Services (DGHS), directing all government-run hospitals to prohibit medical representatives from directly meeting doctors. While medtech associations and the DoP did not respond to queries sent by Business Standard till the time of going to print, sources indicated that companies flagged concerns related to continuing medical education (CME) necessary to train practitioners on their devices. The UDMPMD mandates full disclosure of details related to the distribution of evaluation samples (provided to give hands-on experience) and all expenses incurred on CME and training through conferences, workshops and seminars. 'The particulars are to be filled on an ongoing basis and mandatorily within two months of the end of every financial year on the UCPMP portal of the department, within the time limit fixed for submitting self-declaration by the executive head of the company,' the DoP notification on the code states. Industry sources added that several companies had sought DoP approval for overseas training programmes, which under the UDMPMD is only allowed under special circumstances. 'Some 20 to 25 companies had applied for the approval, but all have been rejected for one reason or another,' said a person familiar with the matter. In a notification dated September 6, 2024, the DoP directed medical device associations to constitute a three- to five-member Ethics Committee for Marketing Practices in Medical Devices (ECMPMD), chaired by their chief executive officer (CEO), and to set up a dedicated portal on their websites. With the centralised portal not yet operational, the DoP has instructed companies to upload the required information on their India websites—something many multinational corporations (MNCs) may not have in place. 'The portal is expected to be ready in the next three to six months,' an official aware of the developments said.
Mint
24-06-2025
- Business
- Mint
India boost to pharma & medtech R&D with ₹5,000 cr portal
New Delhi: The Department of Pharmaceuticals has launched an online portal for a ₹ 5,000-crore scheme it says will support innovation in pharma and medical technology. PRIP, or the Promotion of Research and Innovation in Pharma MedTech Sector, promises to make it easier to submit applications to develop novel technologies in medicine, including medical devices and drugs for communicable, non-communicable diseases and rare disease. The government is concerned about the tiny levels of domestic R&D spending, compared with many other nations, despite India being a global leader in generic drug production. While the US and China spend $60 billion and $20 billion on pharmaceutical R&D respectively, India's expenditure is only around $3 billion. PRIP aims to bridge this gap and foster a culture of research and innovation in the pharma and medtech industry. The scheme has two main components. First, strengthening research infrastructure: This involves setting up Centres of Excellence (CoEs) in the seven existing National Institutes of Pharmaceutical Education & Research (NIPERs). Second, Promoting Research in Pharma & MedTech: This component offers direct financial assistance to companies and projects for both in-house R&D and academic collaborations. It covers six priority areas, including drug discovery and development, medical devices, stem cell therapy, medicines for rare diseases and treatment for drug-resistant patients. "With the PRIP portal now live, the government is making it simple for pharma companies, medtech firms, and even startups to register and elevate their research and development capabilities," explained an official. As planned under the scheme, bigger companies can seek funding of up to ₹ 125 crore while startups can secure up to ₹ 1 crore over a period of five years, based on their milestones, the official said. India's pharmaceutical market is a global force, valued at $50 billion. While domestic consumption stands at $23.5 billion, exports contribute a significant $26.5 billion. India is the world's third-largest pharmaceutical market by volume and 14th by value of production. Over half its exports reach highly developed markets like the US, EU, and Japan, which have a high threshold on quality. Sheetal Arora, promoter and CEO of Mankind Pharma, emphasized the transformative potential of the PRIP scheme. "The new PRIP portal is a game-changer for Indian pharma. This ₹ 5,000-crore investment is exactly the boost we need as we're on the verge of massive growth. India already leads the world in generic medicines, providing 20% of the global supply. But PRIP helps us shift towards innovation, potentially bringing in another ₹ 17,000 crore for R&D by FY28. This will truly sharpen our competitive edge. The timing couldn't be better. With many major drugs losing patent protection by 2030, companies that invest in new molecules and top-tier research now will be future leaders. What's most exciting is that PRIP supports both innovation and affordable healthcare.' Arora added that PRIP supports both innovation and affordable healthcare. 'This perfectly fits India's goal of being a global innovation hub while also making medicines accessible worldwide. PRIP isn't just about money; it's about empowering Indian pharma to build a strong, self-reliant future where innovation benefits everyone,' she said.
