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News18
08-07-2025
- Business
- News18
NITI Aayog Calls For Quality Overhaul In Pharma, Industry Flags Challenges
Last Updated: Concerns raised included the increasing number of Not of Standard Quality drug alerts, workforce issues and unsustainable drug pricing policies In a high-level consultation led by NITI Aayog on Monday, leading pharmaceutical industry bodies raised pressing concerns over drug quality, regulatory enforcement, and systemic gaps in technical manpower and infrastructure. The meeting, chaired by Dr VK Paul (Member, Health), was aimed at aligning India's pharmaceutical standards with global benchmarks. Held at NITI Aayog headquarters, the central focus was to assess the challenges hampering the production of high-quality, globally acceptable pharmaceutical products, and to chart a strategy for reform. The Niti Aayog, in its invite, mentioned that it aims to discuss the challenges in producing high-quality medicines while also upholding the title of pharmacy to the world. 'A rigorous focus on quality is also essential to ensure patient safety and trust in public health in the domestic market. With a strong network of over 3,000 pharmaceutical companies and approximately 10,500 manufacturing units across the country, it is essential to invest in and uphold the highest quality standards for pharmaceuticals," highlighted the letter sent to various industry associations, including Indian Pharmaceutical Alliance (IPA), Indian Drug Manufacturers' Association (IDMA), Laghu Udyog Bharati, Bulk Drug Manufacturers Association (India), Organisation of Pharmaceutical Producers of India (OPPI), Federation of Pharma Entrepreneurs (FOPE) among others. Industry Flags NSQ and Workforce Issues One of the dominant concerns raised was the increasing number of Not of Standard Quality (NSQ) drug alerts. Industry representatives pointed to poor educational standards in pharmacy colleges, which, they said, result in technically under-qualified personnel who are unable to handle the drug inspectors coming for audit. 'The industry highlighted that the gap in technical competence is directly impacting manufacturing quality," an industry official told News18, requesting anonymity. Representatives from the Confederation of Indian Pharmaceutical Industry (CIPI) highlighted the structural and financial constraints faced by MSMEs, especially in conducting stability studies, a critical requirement for ensuring drug quality. They urged the government to provide financial support for MSMEs to build necessary infrastructure, arguing that this could significantly reduce NSQ cases. The industry also advocated for exclusive engagement meetings between policymakers and MSME associations to address deep-rooted, sector-specific issues that are often overlooked in broader policy discussions. In a strong counter-point, RSS-led Laghu Udyog Bharati challenged the narrative that MSMEs are primarily responsible for quality failures. 'US FDA failure by large corporations is generally overlooked in India and small deviations by micro, small and medium enterprises (MSMEs) are given more attention. This has created a bad image of the MSME industry. Big pharma companies are facing product recalls on a regular basis but no one talks about them," Dr Rajesh Gupta, who represents Laghu Udyog Bharati and supports MSME industry, said. 'The myth of 'Brand Bharat' created by large corporations ignores the fact that MSMEs manufacture and sell 97.3 per cent of India's drugs. Yet, only 2.64 per cent are NSQ-declared, and often with no reported harm to patients," Gupta told Newa18, mentioning that he presented the same argument before the government officials in the meeting. Drug Pricing Pressures: Quality vs Affordability Concerns were also raised around the unsustainable drug pricing policies of the price watchdog, National Pharmaceutical Pricing Authority. Industry participants cautioned the government that low price ceilings have made it unviable for manufacturers to produce quality formulations. As an example, they cited cotrimoxazole, an essential antibiotic, which has reportedly vanished from the domestic market due to pricing stress. 'Government wants us to upgrade quality standards and we will do that. But that comes at a cost. We are investing in technology as well as a skilled workforce. While investments are increasing, we are not allowed to increase prices of products. Hence, we are being pushed to discontinue products," said an industry official part of the meeting. Regulator's Firm Stand on GMP and Accountability Drug Controller General of India Dr Rajeev Singh Raghuvanshi, as per industry sources who were part of the meeting, gave a clear message to the industry, saying: 'There will be no relaxation in enforcement of GMP (Good Manufacturing Practices)." 'Emphasising accountability, he outlined a stricter protocol for handling NSQ cases—companies would now face license suspension after a two-week show-cause notice—with reinstatement only upon satisfactory Corrective and Preventive Action (CAPA) review," said the official quoted above. 'He also expressed disappointment with the role of pharma manufacturing associations, urging them to take more responsibility in ensuring that member units uphold quality norms." top videos View all In the ongoing debate between Indian Pharmacopoeia (IP) and WHO-GMP, the DCGI clarified that the two should be seen as parallel and non-conflicting systems. Overall, Gupta and other industry representatives who attended the meeting told News18 that senior government officials, including DCGI and Dr Paul listened attentively to their concerns. The officials were described as patient and receptive, urging the industry to submit their queries in writing for further consideration. 'Everyone was considerate and gave us ample time to present our concerns," Gupta from LBU said. tags : niti aayog pharma sector VK Paul Location : New Delhi, India, India First Published: July 08, 2025, 10:06 IST News india NITI Aayog Calls For Quality Overhaul In Pharma, Industry Flags Challenges
Time of India
23-05-2025
- Business
- Time of India
Waive risk-based inspections, urges MSME pharma body
Synopsis Laghu Udyog Bharati requests the government to waive risk-based inspections for companies upgrading their facilities. The association seeks an extension for Schedule M implementation for smaller firms. Concerns arise over inspections being conducted like raids. LUB highlights the role of MSMEs in supplying medicines during Covid. They request special attention for manufacturers with less than Rupees 50 crore turnover.
Economic Times
14-05-2025
- Health
- Economic Times
RSS-affiliated body urges Centre to scrap mandatory cough syrup export tests
Laghu Udyog Bharati (LUB) has appealed to the government to eliminate mandatory pre-export testing for cough syrups, citing delays and increased costs for small-scale manufacturers. This request follows the implementation of compulsory testing after reports linked India-made syrups to fatalities in Gambia. Tired of too many ads? Remove Ads Tired of too many ads? Remove Ads New Delhi: RSS affiliate Laghu Udyog Bharati (LUB), which supports the small-scale industry, has urged the government to drop the requirement of compulsory testing of cough syrups at a government-approved laboratory before exports, stating that it leads to delays and increased made the testing compulsory following reports that linked the death of several children in Gambia to "made in India" cough syrups."For the manufacturers and exporters, these are areas of concern as it results in potential delays and increased costs, particularly for export shipments," LUB all India general secretary Om Prakash Gupta wrote in a letter dated May 10 to union health minister JP Nadda He requested the minister to "provide a viable solution" addressing the concerns of the pharma to the LUB, the testing procedure often takes 45 days and the testing fee of '25,000 per batch is "quite hefty".It also sought exemption from testing for exporters of other syrups, suspensions, dry syrups, tablets, injections and infusions as there had been no critical complaints in the past two May 2023, the Directorate General of Foreign Trade notified that for exports, cough syrup manufacturers must produce a certificate of analysis from a government-approved followed incidents where India-made cough syrups imported into Gambia were allegedly found to be contaminated with diethylene glycol and ethylene glycol, resulting in an acute kidney injury cluster among children.
Time of India
14-05-2025
- Health
- Time of India
RSS-affiliated body urges Centre to scrap mandatory cough syrup export tests
New Delhi: RSS affiliate Laghu Udyog Bharati (LUB), which supports the small-scale industry, has urged the government to drop the requirement of compulsory testing of cough syrups at a government-approved laboratory before exports, stating that it leads to delays and increased cost. India made the testing compulsory following reports that linked the death of several children in Gambia to "made in India" cough syrups. "For the manufacturers and exporters, these are areas of concern as it results in potential delays and increased costs, particularly for export shipments," LUB all India general secretary Om Prakash Gupta wrote in a letter dated May 10 to union health minister JP Nadda . He requested the minister to "provide a viable solution" addressing the concerns of the pharma industry. According to the LUB, the testing procedure often takes 45 days and the testing fee of '25,000 per batch is "quite hefty". Live Events It also sought exemption from testing for exporters of other syrups, suspensions, dry syrups, tablets, injections and infusions as there had been no critical complaints in the past two years. In May 2023, the Directorate General of Foreign Trade notified that for exports, cough syrup manufacturers must produce a certificate of analysis from a government-approved laboratory. This followed incidents where India-made cough syrups imported into Gambia were allegedly found to be contaminated with diethylene glycol and ethylene glycol, resulting in an acute kidney injury cluster among children.
