Latest news with #QCOs
Time of India
2 days ago
- Business
- Time of India
License overload, inconsistent regulations hurting healthcare businesses: NATHEALTH
New Delhi: Calling for a complete overhaul of the existing regulatory and licensing framework in India, industry representative NATHEALTH flagged that the country's 'complex regulatory structure is creating compliance bottlenecks for the healthcare sector and preventing ease of doing business.' In a meeting with the Niti Aayog members, the lobby group presented a whitepaper highlighting that, healthcare industry is one of the 'top three' regulated sectors in India, where 60 per cent of regulations are decentralized, thereby leading to complexity of compliance due to lack of standardization. The white ciphered co-authored by EY covers three sectors in healthcare viz hospitals, diagnostics and medtech and underlines that businesses operating under these segments face multiple or numerous licensing requirements and are struggling with a highly dynamic and changing regulatory landscape with little or no transition time. Speaking to media after their meeting with Niti Aayog, Ameera Shah, President, NATHEALTH, said, 'Under the white paper we have highlighted that regulatory standards vary frequently across different states, and there is often a lack of clarity regarding these regulations.' 'Among the segments, there are variations, with diagnostics being less regulated, while hospitals and medtech face much stricter regulations,' Shah added. Sharing the MedTech-related concerns raised during the meeting, Himanshu Baid, Vice President, NATHEALTH, said, 'Being classified as drugs, MedTech products are overregulated and at the meet we highlighted the Quality Control Orders (QCOs), which are hampering the manufacturing of medical devices in the country.' 'We also highlighted issues such as the overlap between government departments and labeling challenges, where we are regulated by both the CDSCO and the Ministry of Consumer Affairs, " Baid added. On Niti Aayog's response, Baid apprised, 'NITI was very receptive to the issues raised, and we will meet again in about eight weeks with concrete solutions and for further discussions.' Secondly Niti Aayog shares NATHEALTH's view that there should be a separate Act for medical devices, he added. As per Shah, the whitepaper shared with the government policy think tanks includes a total of 70 regulatory and licensing challenges of which 12 have highlighted as the 'top challenges which require urgent attention.' For hospitals the whitepaper outlines issues like state registrations for medical practitioners leading to multiple UIN generations and administrative burden, Licensing of blood banks required for central and state licensing authorities, among several others. Similarly for the other two segments diagnsotics and MedTech it includes Lack of standardization in clinical establishment regulations across states, different licensing authorities based on activity and class of device leading to multiple registrations and delays. Besides these issues the papers includes two long standing agnostics issues related to the restriction on hospital building heights that is stated to reduce the number of hospitals bed capacity and concerns over stringent penalties imposed in case of failure to obtain or renew consent in a timely manner. Among its key recommendations, the whitepaper features short, medium and long term suggestions for addressing them including single window clearance, adoption of global standards–ISO and embracing digitization— health records, signatures. 'We seek government support to address these hurdles, which will help the sector grow faster and improve patient access,' Shah noted.
Mint
6 days ago
- Business
- Mint
India eases quality control norms on key chemicals imported from the US, China
The Centre has withdrawn quality control orders (QCOs) for three key industrial chemicals: acetic acid, methanol, and aniline to ease compliance burdens for domestic manufacturers, said a 23 July notification. These chemicals are critical inputs for sectors such as pharmaceuticals, textiles, dyes and intermediates, paints, adhesives, and agrochemicals. These QCOs, originally issued in August 2019, mandated that manufacturers and importers of these chemicals obtain Bureau of Indian Standards (BIS) certification to sell their products in the Indian market. India sources significant quantities of acetic acid and aniline from China and the US, while methanol is primarily imported from Gulf countries. With the withdrawal of QCOs—a form of non-tariff barrier that mandates strict compliance for both domestic and imported goods—these chemicals will no longer require compliance with compulsory BIS standards, thereby removing a layer of regulatory control that many in the industry viewed as restrictive and costly. Mint reported on 13 December 2024 that the government may ease stringent quality control rules, criticized by local manufacturers and seen as a potential trigger for supply shortages. 'The move is seen as a softening of the government's stance to support manufacturing, in contrast to its broader push to tighten quality controls across sectors,' a senior executive from a chemical manufacturing company said on the condition of anonymity. The decision, taken after consultations with the BIS, comes at a time when protectionist barriers are rising globally, and India itself is subjecting a wide range of domestic and imported goods to closer scrutiny. A nationwide exercise to improve product standards, involving 37 ministries, is currently underway, Mint reported on 10 February 2025. As part of the government's ongoing quality enforcement drive, over 1,500 products are expected to be brought under stringent BIS quality norms by the end of 2025-26. A total of 758 products are still regulated through QCOs. In 2023, India imported acetic acid worth around $12 million from the US, compared to that worth over $186 million from China, according to data from the World Integrated Trade Solution (WITS). Similarly, India sourced aniline and its salts worth around $2.79 million from the US, while imports of the same from China stood at $21.6 million during the same period. The withdrawal of QCOs on key industrial chemicals will offer much-needed breathing space to small and medium enterprises that were struggling with certification costs and supply disruptions, said Vinod Kumar, president of the India SME Forum. 'For many SMEs, especially those dependent on imported raw materials, the mandatory BIS compliance was becoming a bottleneck. This move will help ease sourcing constraints and reduce compliance burdens, allowing them to focus on manufacturing and competitiveness,' Kumar said. 'It's a welcome move that will help boost the manufacturing of chemicals in India,' said Kalyan Goswami, director general of the Agro Chem Federation of India (ACFI). 'Easing regulatory burdens will support domestic players and enhance competitiveness,' he said. India's exports of chemical and allied products stood at $130.73 billion in 2022-23, which declined to $108.59 billion in 2023-24.
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Business Standard
16-07-2025
- Business
- Business Standard
BIS seizes uncertified consumer goods in raid at Amazon hub in Vijayawada
BIS Vijayawada Director Prem Sajani Patnala said the raid was part of an ongoing effort to identify and stop the circulation of products that do not comply New Delhi The Bureau of Indian Standards (BIS) Vijayawada carried out a raid at Amazon's warehouse in Kandrika, located in Andhra Pradesh's NTR district, and seized a large stock of uncertified consumer goods. These included electronics, kitchenware, toys, ceiling fans, footwear, and more, according to an official statement released on Wednesday. The enforcement operation took place on July 15. BIS Vijayawada Director Prem Sajani Patnala said the raid was part of an ongoing effort to identify and stop the circulation of products that do not comply with Quality Control Orders (QCOs). 'Based on actionable intelligence and digital tracking, it was discovered that several e-commerce platforms are helping sell and distribute uncertified and potentially dangerous goods,' the press note said. BIS is currently running a nationwide campaign to stop the sale of non-compliant products. Violation of BIS Act, 2016 Patnala confirmed that the seized items did not have the required BIS certification or registration under the Compulsory Registration Scheme. This is a violation of Section 17 of the BIS Act, 2016, which bars the sale, display, or storage of goods without the proper standard mark. Unsafe goods promoted via e-commerce She stated that these platforms "are enabling the circulation of uncertified and unsafe goods". Patnala also explained that the seized items would either be destroyed, scrapped, or made unusable, depending on the category. "For example, BIS drills holes in cookers, stoves, and steel products. Gold is melted, but only after court approval", she said. She also revealed that many sellers listed on e-commerce sites provide fake or non-traceable addresses, often linked to residential areas. Holding platforms accountable "We thought we had to catch hold of the platform, they will lead us to the actual manufacturer," she said. BIS has now decided to hold e-commerce companies directly accountable. 'Everyone making a profit should be made responsible,' she added. Previous actions of BIS against e-commerce platforms This is not the first raid. This action follows recent similar raids on Flipkart, E-Kart, and Meesho in Krishna district. On March 20, 2025, BIS found multiple items lacking mandatory certification during recent raids in various warehouses of e-commerce platforms Amazon and Flipkart. Speaking on this, the government body said it took this step in a bid to enhance consumer safety from potentially hazardous products. Raids were conducted in a series at Amazon and Flipkart warehouses in Gurgaon, Lucknow, and Delhi, and more than 7,000 substandard items, including electric water heaters, toys, blenders, bottles, and speakers that were found to be without the BIS standard mark, were seized. On March 26, 2025, BIS conducted a search and seizure operation at a warehouse of Amazon located in Airport City, Shamshabad, for violation of the provisions. Here, it seized 2,783 "uncertified" consumer products. These products were estimated to be worth more than Rs 50 lakhs, as per BIS.
Time of India
16-07-2025
- Business
- Time of India
Over 25 categories of uncertified goods seized in BIS raid on e-commerce firms
The Bureau of Indian Standards (BIS) on Tuesday said it had seized a large consignment of uncertified consumer products from e-commerce platforms Flipkart , E-Kart , and Meesho in Krishna district, Andhra Pradesh, emphasising that several platforms are "facilitating the sale and distribution of hazardous goods". The BIS is conducting a nationwide enforcement campaign to curb the sale of non-certified and unsafe products that violate provisions of the Quality Control Orders (QCOs). As part of this drive, the BIS Vijayawada branch carried out a raid on July 14 at Mustabad village in Gannavaram mandal, targeting the three platforms, an official press release said. "The BIS Vijayawada Branch Office conducted a major raid on prominent e-commerce platforms-Flipkart, E-Kart, and Meesho. During the operation, officials seized a large consignment comprising over 25 categories of consumer products," said Prem Sajani Patnala, Director & Head, BIS Vijayawada. The seized products included electronics, LED bulbs, toys, and table fans-all in violation of Section 17 of the BIS Act, 2016, Patnala said. Based on actionable intelligence and digital surveillance, it was found that several e-commerce platforms are enabling the sale of uncertified and potentially hazardous products, the release added. These items, lacking valid BIS certification , were being sold in violation of mandatory QCOs and relevant provisions of the BIS Act, posing serious risks to consumer health and safety , Patnala said. Section 17 of the BIS Act prohibits the sale, storage, or display of goods without the standard mark, while Section 29(3) provides for imprisonment of up to three years and fines up to Rs 10 lakh, or up to ten times the value of the seized goods. In applicable cases, violations under Section 79(2)(c) of the Information Technology Act, 2000, and Rule 3(b)(iv) & (v) of the IT (Intermediary Guidelines and Digital Media Ethics Code) Rules, 2021, will also be invoked for failure to exercise due diligence by the platforms, Patnala added. With over 800 products falling under mandatory BIS certification, all such goods must bear standard marks-such as ISI, CRS, Hallmark, or relevant system marks-and be sold only by licensed entities. Manufacture, storage, or sale of uncertified goods is punishable under law. Patnala urged consumers to use the BIS Care app to verify certification details and report misuse of BIS marks, assuring that BIS will continue proactive enforcement and consumer outreach efforts.
Hans India
11-07-2025
- Business
- Hans India
BIS stresses on quality standards for 'Made in India' products
Vijayawada: The Bureau of Indian Standards (BIS) is intensifying its focus on ensuring that both domestically manufactured goods and imported products adhere to Indian quality standards, said A Ramalingeswara Raju, additional director of the department of industries. Speaking at an 'Industrial Meet' held here on Thursday, organised by BIS in collaboration with the department of industries and the Federation of Small and Medium Enterprises India (FSME), Ramalingeswara Raju highlighted the significant presence of 1.6 million MSMEs and 1,100 large-scale industries in Andhra Pradesh. He noted that a large number of small industries often hesitate to obtain BIS certification due to perceived high costs, despite its crucial role in exporting goods. 'In the evolving landscape, obtaining certification has become much easier,' Ramalingeswara Raju stated, adding that both central and state governments are providing subsidies to help MSMEs acquire BIS certification. Prem Sajini Patnala, BIS director, emphasised that BIS is the sole authority for setting standards in India. She clarified that BIS certification is mandatory for the manufacturing, storage, and sale of products within the country. Currently, 816 product categories require compulsory BIS certification. Additionally, products from other countries must also obtain BIS certification to be sold in India. Patnala further stated that BIS conducts inspections twice annually and will carry out raids based on complaints. She urged consumers to use the BIS Care app to file complaints if a product's quality control details appear online fewer than two times. Notably, a recent decision at the first state-level meeting on standardisation, chaired by the AP Chief Secretary, mandated the inclusion of Indian standards in the State government's procurement policy. K L N Prakash Rao, chairman of FSME, highlighted that the presence of a BIS mark serves as proof of a product's assured quality. 'Today, everyone's interest in quality has increased. Implementing the BIS mark has the potential to enhance product quality,' he remarked. Ventkatrao, joint director of the industries, reiterated the importance of the BIS mark for MSMEs in the state to achieve global growth. He also confirmed the availability of central and state government subsidies for BIS mark certification. Deputy director Vivek Reddy delivered a comprehensive presentation covering BIS activities, how to download Indian standards, the application process for BIS licenses, Quality Control Orders (QCOs), the BIS Care app, Standards Watch, and BIS's hand-holding initiatives for MSMEs. Over 100 industry representatives attended the meeting with the BIS Director addressing their questions during the session.
