Latest news with #CentralDrugsStandardControlOrganisation
Mint
4 days ago
- Business
- Mint
India's drug regulator moves import approvals online to boost transparency and cut delays
India's apex drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has moved the approval process for importing drugs entirely online, aiming to improve transparency, accountability, and the ease of doing business. This reform applies to drugs imported in bulk for non-medicinal purposes— also known as 'dual-use' drugs— commonly used in sectors such as pharmaceuticals, food, and animal feed, according to the two officials and documents reviewed by Mint. Also read: India unveils first formal rules for drug approval panels in regulatory overhaul One-year NOC, fewer renewals The new dual use system, launched on the SUGAM Portal, introduces a one-year No Objection Certificate (NOC) for approved importers. This move reduces the administrative burden of frequent renewals. 'CDSCO to further enhance 'ease of doing business' has streamlined the process of issuing Dual Use NOC for drugs imported in bulk for non-medicinal use through SUGAM Portal. Further to reduce the compliance burden, CDSCO has initiated an issue of one-year NOC, subject to prescribed conditions for such drugs," said Drugs Controller General of India, in a circular to stakeholders. The process involves an initial online application for registration and NOC from the CDSCO zonal office, followed by the approval for release of consignments from the ports. In addition, the applicants will be able to track the use of imported materials in the supply chain to ensure greater accountability. Two-phase process The new system is designed to provide a hassle-free experience for importers. The process is divided into two main phases: Phase I (step 1): This involves an online application for registration and NOC from the CDSCO's zonal or sub-zonal office. The registration process, which began on 5 August 2025, requires applicants to submit a prescribed checklist of documents, including address proof, an undertaking form, and a valid ID for the authorised person. The grant of a Dual Use NOC is verified by the concerned zonal or sub-zonal office and may be issued within seven working days of the application. Phase II (step 2): After receiving a valid Dual Use NOC from the zonal or sub-zonal office, the applicant must submit documents online to the port office at the time of import for the release of consignments. Also read: Centre to rope in states to enforce drug quality norms Enhanced traceability A key innovation in the system is the Supply Chain Module, which allows real-time tracking of each import consignment. Data submitted during import is verified by port offices. The system also includes a reconciliation module, open throughout the NOC's validity, to monitor repetitive consignment releases. Approved applications and updates will be visible to zonal, sub-zonal, and port offices on the SUGAM portal, ensuring inter-agency coordination and oversight. 'It is for ease of doing business. Earlier it was a physical application, now it is a digital system. It will create easy traceability and help build a national database," the first official aware of the matter said. The new online Dual Use System on the SUGAM Portal will become live on 31 August 2025. Starting 1 September 2025, only users who are registered and approved by the CDSCO as Dual Use NOC traders or actual manufacturers will be permitted to apply for Dual Use NOCs on the new portal. Legal compliance The system aims to ensure uniform implementation of Rule 43 of the Drugs and Cosmetics Rules, 1945, which governs bulk drug imports for non-medicinal purposes. All applications will be subject to technical review by the Deputy Drugs Controller (India) of the concerned zones. Also read: Centre to deregulate household antiseptic sales 'For the pharmaceutical and related industries, this new system is a game-changer. Earlier, the process was so cumbersome and time taking. Now, this online system having a unified platform will reduce the time and effort required to secure permissions, make it more efficient," said the second official.
The Print
30-07-2025
- Health
- The Print
India's draft guidelines on biosimilar drugs can make treatments more accessible, affordable
In India, healthcare affordability is a critical issue, and biosimilars can play a pivotal role in making advanced therapies accessible to a broader population. India's dynamic pharmaceutical ecosystem positions the country to become a global leader in biosimilar production. The government has initiated multiple policy reforms and introduced capacity building initiatives in the form of National Biopharma Mission (NBM) and the Production Linked Incentive (PLI) scheme to boost domestic biosimilar production. But significant obstacles remain concerning regulatory policies and market accessibility. Hence, promoting safe, efficacious, and affordable biosimilars requires a comprehensive strategy — one that not only encourages innovation through research and development, but also streamlines the regulatory processes and ensures rigorous quality standards. Biosimilars present a vital opportunity to increase patients' access to biological therapies and reduce the burden on healthcare systems. Although biosimilar drugs are hailed as a pathway for providing better access to expensive and unaffordable drugs, their production is fraught with hurdles, including high cost and regulatory barriers. Unlike conventional generic medicines, bringing a biosimilar drug to the market requires substantial scientific expertise, advanced technological capabilities, and a robust regulatory apparatus. These challenges have hindered the pace of biosimilar development and limited their adoption and uptake globally. Biologic drugs have become the cornerstone of medical treatment, offering therapies for a number of diseases. Unlike traditional medicines that offer a one-size-fits-all approach, many biologics have a very targeted approach to disease management and treatment. These transformative therapies have altered the treatment landscape for multiple diseases, including cancer and autoimmune disorders. Biosimilars are biological products that are highly similar to approved reference or innovator drugs, with no clinically meaningful differences in terms of safety, purity, and potency. Limitations India has emerged as the global frontrunner in the commercialisation and approval of biosimilars. The country approved its first biosimilar in 2000, well ahead of similar regulatory action in Western markets — the European Union approved the first biosimilar in 2006, while the US approved nearly 10 years later in 2015. The formulation of the Central Drugs Standard Control Organisation (CDSCO) biosimilar evaluation process in 2012 and revision of the guidelines in 2016 provided the much needed regulatory rigour and accelerated the pace of approvals. With 135 approved products as of January 2025, spanning across various therapeutic areas, India has surpassed both the US and Europe. Though India has built a robust domestic biosimilar market, its international presence and the ability to lower prices as compared to small molecule generics remains limited. One of the major reasons has been the inability to align with the scientific and technological advancement happening globally. The changes in the stances of global regulatory bodies signal a potential evolution in the biosimilar landscape and present an opportunity for Indian regulators to align their regulations with those of the UK, EU, and Canada. These global regulatory changes, coupled with the impending biosimilar void, provide a golden opportunity for Indian biosimilar manufacturers to remove the high investment barrier and expand their footprint globally. Reflecting a shift in the biosimilar landscape and global regulatory alignments, the CDSCO released its draft revised Guidelines on Similar Biologics in May 2025. These updated guidelines seek to align India's regulatory approach with established frameworks, specifically the WHO Technical Report Series No. 1043, European Medicines Agency (EMA), and the US Food and Drug Administration (FDA) frameworks. Some of the key changes in the draft guidelines include an increased focus on strengthening the analytical and structural characterisation and in-vitro comparability of biosimilars. Additionally, the guidelines also emphasise on following the principle of 3Rs (Replace, Reduce, Refine) for animal studies, allowing conditional waivers for clinical efficacy studies, and advancing interchangeability practices. Though the focus on 3Rs reflect India's commitment to ethical science and global standards that prioritise animal welfare, it still allows for animal studies in some cases and also leaves the discretion to the licensing authorities. Many of the international developed regulatory bodies like the UK's Medicines and Healthcare products Regulatory Agency, EMA, Health Canada, and USFDA have increasingly shifted away from animal testing and moved to non-animal models. In a ground breaking development, the USFDA has even decided to phase out animal testing for development of products like monoclonal antibodies. But the CDSCO's draft guidelines allowing conditional waivers in place of a complete waiver for animal testing can lead to increased ambiguity, which will increase cost for biosimilar manufacturers and delay access to affordable biosimilars. Also read: India's top students wanted to be doctors. Not anymore A historic opportunity In terms of waiver for clinical trials, there is an increasing shift in the global paradigm in countries like the UK, EU, and Canada where clinical efficacy studies are regarded as an exception rather than a rule for regulatory approval of biosimilars. These changes do not reflect a radical break, but show decades of scientific and regulatory experience with product approvals and data evidence. These jurisdictions have embraced more nuanced approaches and established clear science-driven criteria for when clinical trials will be truly necessary. Health Canada draft guidelines have moved further by requiring the clinical trial sponsor (biosimilar manufacturer) to provide rationale for conducting clinical trials. In contrast, Indian guidelines grant considerable discretion to the licensing authority, without delineating scenarios where such trials will be required. This lack of clarity not only risks regulatory arbitrariness, but will also inflate development costs. India stands at a critical junction of biosimilar innovation. Amidst rapid advancements in its scientific prowess, policy shifts, and an evolving regulatory landscape, it is well-positioned to spearhead advancements in producing affordable biosimilars. The 2025 Draft Guidelines on Similar Biologics offer a historic opportunity to advance India's healthcare system. By removing persisting ambiguities in animal studies, clarifying conditions for clinical trials, and prioritising affordability, it will not only provide the much needed impetus to India's biosimilar industry but can also make biosimilars more accessible and reinforce India's leadership in affordable medicine. Chetali Rao is a Senior Scientific Researcher and Legal Advisor at Third World Network. Views are personal. (Edited by Aamaan Alam Khan)
Time of India
29-07-2025
- Business
- Time of India
India-UK trade pact to ease market access for domestic medical devices into Britain
New Delhi: The India-UK trade pact has incorporated a mutual recognition agreement framework to facilitate smoother entry of medical devices certified by domestic regulatory agencies into the British market, an official said on Tuesday. The framework will help Indian manufacturers expand market share in the UK vis-a-vis its global competitors like China, Brazil, and Vietnam who face non-preferential duty. "The free trade agreement includes a mutual recognition agreement framework allowing medical devices certified by the Central Drugs Standard Control Organisation (CDSCO) or the Indian Certification of Medical Devices (ICMED) to access the UK market more freely," the official said. Medical devices and instruments will be exported to the UK at zero tariffs, down from the current duty range of 2 per cent to 6 per cent, benefiting Indian manufacturers of surgical and diagnostic equipment. The UK medical devices market was valued at USD 32 billion in 2024 and is projected to reach USD 69 billion by 2035, growing at a CAGR of 7.19 per cent, representing a significant opportunity for Indian medical device manufacturers, the official said. A bilateral regulatory cooperation framework will also be pursued between CDSCO and MHRA (Medicines and Healthcare products Regulatory Agency) potentially taking the form of a Mutual Recognition Agreement (MRA). "The agreement will incorporate provisions for joint inspections, data sharing, harmonization of technical documentation, and training programmes between Indian and UK regulators, which will help build confidence and trust in each other's regulatory frameworks, thereby enhancing market access for our exports," the official said. India remains committed to a fair, balanced, and mutually beneficial agreement and is engaging with the UK to consider pathways for regulatory cooperation, including recognition of CDSCO approvals. Further to prevent routing of third country goods via the UK into India, there are provisions for strong Rules of Origin (RoO) in the comprehensive economic and trade agreement, which define the origin of a product and determine whether it qualifies for preferential tariffs. The combination of rigorous RoO, digital certificate of origin systems, and customs monitoring will ensure that only legitimate products -- made or significantly transformed in the FTA partner -- benefit from tariff concessions.
NDTV
29-07-2025
- Business
- NDTV
India-UK Trade Deal To Ease Access For Domestic Medical Devices In Britain
New Delhi: The India-UK trade pact has incorporated a mutual recognition agreement framework to facilitate smoother entry of medical devices certified by domestic regulatory agencies into the British market, an official said on Tuesday. The framework will help Indian manufacturers expand market share in the UK vis-a-vis its global competitors like China, Brazil, and Vietnam who face non-preferential duty. "The free trade agreement includes a mutual recognition agreement framework allowing medical devices certified by the Central Drugs Standard Control Organisation (CDSCO) or the Indian Certification of Medical Devices (ICMED) to access the UK market more freely," the official said. Medical devices and instruments will be exported to the UK at zero tariffs, down from the current duty range of 2 per cent to 6 per cent, benefiting Indian manufacturers of surgical and diagnostic equipment. The UK medical devices market was valued at USD 32 billion in 2024 and is projected to reach USD 69 billion by 2035, growing at a CAGR of 7.19 per cent, representing a significant opportunity for Indian medical device manufacturers, the official said. A bilateral regulatory cooperation framework will also be pursued between CDSCO and MHRA (Medicines and Healthcare products Regulatory Agency) potentially taking the form of a Mutual Recognition Agreement (MRA). "The agreement will incorporate provisions for joint inspections, data sharing, harmonization of technical documentation, and training programmes between Indian and UK regulators, which will help build confidence and trust in each other's regulatory frameworks, thereby enhancing market access for our exports," the official said. India remains committed to a fair, balanced, and mutually beneficial agreement and is engaging with the UK to consider pathways for regulatory cooperation, including recognition of CDSCO approvals. Further to prevent routing of third country goods via the UK into India, there are provisions for strong Rules of Origin (RoO) in the comprehensive economic and trade agreement, which define the origin of a product and determine whether it qualifies for preferential tariffs. The combination of rigorous RoO, digital certificate of origin systems, and customs monitoring will ensure that only legitimate products -- made or significantly transformed in the FTA partner -- benefit from tariff concessions.
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Business Standard
29-07-2025
- Business
- Business Standard
India-UK trade deal boosts access for Indian medical devices in Britain
The India-UK trade pact has incorporated a mutual recognition agreement framework to facilitate smoother entry of medical devices certified by domestic regulatory agencies into the British market, an official said on Tuesday. The framework will help Indian manufacturers expand market share in the UK vis-a-vis its global competitors like China, Brazil, and Vietnam who face non-preferential duty. "The free trade agreement includes a mutual recognition agreement framework allowing medical devices certified by the Central Drugs Standard Control Organisation (CDSCO) or the Indian Certification of Medical Devices (ICMED) to access the UK market more freely," the official said. Medical devices and instruments will be exported to the UK at zero tariffs, down from the current duty range of 2 per cent to 6 per cent, benefiting Indian manufacturers of surgical and diagnostic equipment. The UK medical devices market was valued at USD 32 billion in 2024 and is projected to reach USD 69 billion by 2035, growing at a CAGR of 7.19 per cent, representing a significant opportunity for Indian medical device manufacturers, the official said. A bilateral regulatory cooperation framework will also be pursued between CDSCO and MHRA (Medicines and Healthcare products Regulatory Agency) potentially taking the form of a Mutual Recognition Agreement (MRA). "The agreement will incorporate provisions for joint inspections, data sharing, harmonization of technical documentation, and training programmes between Indian and UK regulators, which will help build confidence and trust in each other's regulatory frameworks, thereby enhancing market access for our exports," the official said. India remains committed to a fair, balanced, and mutually beneficial agreement and is engaging with the UK to consider pathways for regulatory cooperation, including recognition of CDSCO approvals. Further to prevent routing of third country goods via the UK into India, there are provisions for strong Rules of Origin (RoO) in the comprehensive economic and trade agreement, which define the origin of a product and determine whether it qualifies for preferential tariffs. The combination of rigorous RoO, digital certificate of origin systems, and customs monitoring will ensure that only legitimate products -- made or significantly transformed in the FTA partner -- benefit from tariff concessions.
