Latest news with #NotofStandardQuality
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
News18
04-07-2025
- Health
- News18
Small Drugmakers Supplying Medicines In Rural Areas Under Scrutiny; Centre Calls For Crackdown
Central Drugs Standard Control Organisation has conducted over 1,000 Risk-Based Inspections across the country and asked states/UTs to continue acting after finding non-compliance. Small pharmaceutical companies, especially those supplying medicines in rural areas, have come under regulatory scrutiny, with the Drug Controller General of India (DCGI) directing state officials to closely monitor their activities and ensure accountability. The DCGI has asked states, via state licensing authorities (SLAs) to take strict action against any such marketers found violating quality standards under the Drugs and Cosmetics Rules, 1945. The move comes amid growing concerns over the quality and compliance practices of certain small-scale players in the drug distribution chain. The apex drug regulatory agency has also called for stricter action against the repeated manufacture of spurious and Not of Standard Quality (NSQ) drugs and asked states to keep CDSCO informed of any regulatory actions taken. 'We are still awaiting response on Schedule M compliance and most small players are unable to cope up with quality scrutiny. The government is convinced that without proper oversight, these companies pose a risk to medicine safety in under-served regions," a senior government official privy to the development told News18. The official added that the apex regulatory authority, Central Drugs Standard Control Organisation (CDSCO) has conducted over 1,000 Risk-Based Inspections (RBIs) across the country. 'These inspections have been key in identifying non-compliance among drug manufacturers and strengthening the surveillance framework." The first is adoption of revised Schedule M. The DCGI has asked state officials to begin enforcing updated Good Manufacturing Practice norms for drug production units. Also, it has asked to fix new drug licensing gaps as state licensing officials have been asked to refrain from issuing product licences without proper permissions from DCGI. The officials have also been instructed 'Post risk based inspections action." The states and UTs have been urged to act on the findings and recommendations that emerge from inspections. CDSCO has informed officials to comply with '84AB" in which details of all drug makers and product details must be uploaded and verified on the central online portal to ensure traceability. Also, the state officials will work on building testing lab capacity which has been flagged as a 'critical need."
New Indian Express
01-06-2025
- Health
- New Indian Express
Bengaluru Chemists' body seeks crackdown on fake medicines
BENGALURU: The Bangalore District Chemists and Druggists Association (BDCDA) has urged Chief Minister Siddaramaiah to constitute a high-level enforcement task force headed by senior IPS officers to tackle the growing threat of counterfeit medicines. The association said the proposed task force, involving officers from the Karnataka Food Safety and Drug Administration department (FDA), must be empowered to carry out state-wide raids, seizures, and arrests of those involved in the fake drug trade, which it described as 'a form of national public health terrorism.' BDCDA acknowledged and appreciated the government's recent move to develop a software for the recall of Not of Standard Quality (NSQ) drugs — a first-of-its-kind initiative in India. However, it emphasised that this only addresses a limited part of the much bigger issue of counterfeit and spurious drugs in circulation, particularly in the post-Covid period, when their prevalence has reportedly surged by 50%. Citing Parliamentary Standing Committee findings and recent trends, the association warned that counterfeit medicines were infiltrating the market due to lax enforcement, lenient laws, and growing consumer preference for discounted drugs. A key bottleneck, according to BDCDA, is the shortage of drug inspectors. Only eight out of 12 sanctioned posts in the state are filled, making surveillance against fake drugs extremely difficult. To address this, it reiterated the need for an IPS-led multi-agency team that could plug enforcement gaps and ensure strong punishment for offenders.
