Latest news with #CDSCO
The Hindu
a day ago
- Health
- The Hindu
RSS arm seeks clarity on draft guidelines on biosimilars
Swadeshi Jagran Manch (SJM), economic wing of the Rashtriya Swayamsewak Sangh (RSS), urged the Central Drugs Standard Control Organisation (CDSCO), the apex drug regulatory authority, to bring more clarity in its draft guidelines to ensure production of high-quality and cost-effective biosimilars in the country. In a letter to the Director General of CDSCO, SJM sought safeguards for the Indian industry from 'international pressures for regulations' that favour multi-national pharma companies. The CDSCO had recently issued the 2025 draft guidelines on similar biologics, also called biosimilars. 'Though the draft guidelines represent a pivotal advancement in making affordable, life-saving biosimilars accessible to millions of Indians suffering from chronic and life-threatening conditions such as cancer, diabetes, and autoimmune disorders it requires more clarity and direction,' the SJM letter reads. The SJM appreciated the draft guidelines for embracing the '3Rs principle' (replacement, reduction, refinement) as it reflects India's commitment to ethical scientific practices and alignment with global standards for animal welfare. Modern technologies, including in-vitro assays, organ-on-chip models, and computational simulations, provide robust, accurate, and humane alternatives to confirm the safety and biosimilarity of these drugs, it said. 'These methods are often faster and more precise than animal studies, reducing both ethical concerns and development costs,' it added. The organisation, however, noted that the guidelines stipulating that it will be the discretion of the CDSCO to decide whether a requirement of 'additional non-clinical in vivo animal studies' should be waived or not, poses a 'risk' of increasing biosimilar development cost. This provision goes against the practices of the leading regulatory authorities in other countries, it added. 'Prominent regulatory authorities like the UK MHRA, European Medicine Agency (EMA) Health Canada, and USFDA have either eliminated or phased out mandatory animal testing for biosimilars,' SJM said, adding its recommendation that waiving animal studies entirely when comprehensive laboratory tests demonstrate high similarity between a biosimilar and its reference product. Recently, civil societies, in a letter to CDSCO on the draft guidelines on biosimilars, has urged that there is an urgent need to eliminate unnecessary animal studies, and establish clear conditions for requiring comparative clinical trials for affordable biosimilars without compromising safety and efficacy. According to the SJM, the draft guidelines' provision to waive certain clinical trials when biosimilarity is established through analytical and functional studies is a forward-thinking measure, saying this approach can significantly reduce development costs and expedite market entry, which is critical for patients awaiting affordable treatments. However, the lack of explicit criteria in the guidelines for when waivers are permitted introduces ambiguity, potentially leading to inconsistent application and delays as well as 'room for corrupt practices', it said, stressing the need to establish 'clear conditions' for conduct of clinical trials.
Time of India
2 days ago
- Business
- Time of India
DRI Mumbai seizes 160 tonnes of substandard Chinese toys, counterfeit cosmetics worth Rs 6.5 crore
Mumbai: In a major crackdown on smuggling of substandard goods, the Directorate of Revenue Intelligence (DRI), Mumbai zonal unit, seized 160 metric tonnes of illegally imported Chinese toys, counterfeit cosmetics, and unbranded shoes, valued at over ₹6.5 crore. Based on specific intelligence, DRI officers identified 10 containers at Mundra Port, Hazira Port, Kandla SEZ, and ICD Piyala (Faridabad). These containers, fraudulently declared as decorative items, keychains, and pencil boxes, were found concealed with large quantities of toys, cosmetics, and footwear. The toys were imported without mandatory BIS certification, violating the Foreign Trade Policy and Toys (Quality Control) Order, 2020. Counterfeit cosmetics infringed Intellectual Property Rights (Imported Goods) Enforcement Rules, 2007, and lacked required CDSCO licenses. The unbranded shoes also breached the Footwear (Quality Control) Order, 2024. You Can Also Check: Mumbai AQI | Weather in Mumbai | Bank Holidays in Mumbai | Public Holidays in Mumbai
Time of India
3 days ago
- 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
3 days ago
- 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
3 days ago
- 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.
