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Business Standard
4 days ago
- Business
- Business Standard
MSME pharma firms ask for financial, regulatory help in GMP, NSQ compliance
Several pharmaceutical companies and associations raised concerns over the regulatory and financial issues faced by small and medium units in complying with good manufacturing practices (GMP) during a consultation with NITI Aayog on Monday. According to people in the know, MSME pharma players have asked the drug regulator for Rs 50 crore in handholding support and a further extension for complying with revised Schedule M, which outlines GMP for pharmaceutical units. This request comes after small units with an annual turnover of less than or equal to Rs 250 crore were granted a one-year extension to comply with the revised Schedule M. However, all units under this criterion were required to submit a gap analysis plan to the Central Drugs Standard Control Organisation (CDSCO) by May 30 to qualify for the extension. According to industry insiders, only 1,600 units out of 8,500 MSME pharma units have submitted the plan to the drug regulator. Several groups, such as the Confederation of Indian Pharmaceutical Industry (CIPI), have previously written letters to the CDSCO and the Union Health Secretary, requesting an extension of the deadline for submitting gap analysis plans to August. According to industry sources who attended the meeting, Drug Controller General of India (DCGI) Rajeev Singh Raghuvanshi stated that there would be no relaxation in the enforcement of GMP. '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,' an executive added. A group of pharmaceutical associations has also endorsed a GMP-linked support scheme and the establishment of common quality assurance infrastructure for MSME pharma clusters. This comes amid rising concerns over the increase in the number of "Not of Standard Quality" (NSQ) drug alerts. An executive noted that the DCGI outlined a stricter protocol for handling NSQ cases, with companies now facing license suspension after a two-week showcause notice. Reinstatement of such companies will only be considered after a satisfactory Corrective and Preventive Action (CAPA) review. Industry representatives also highlighted the issue of poor educational standards in pharmacy colleges, which may result in technically underqualified personnel unable to handle drug inspectors during audits. Representatives for CIPI also proposed the setting up of financial support for equipping the MSME industry with infrastructure to conduct stability studies, helping to reduce incidents of NSQ. Other issues discussed included quality-linked pricing and procurement, as well as strengthening post-marketing surveillance and pharmacovigilance. Commenting on the issue, Nikkhil K. Masurkar, Chief Executive Officer (CEO) of Mumbai-based Entod Pharmaceuticals, said that NITI Aayog's call for a quality overhaul is both timely and necessary. 'While India has made remarkable strides as a global pharma hub, maintaining consistent, internationally acceptable quality standards remains a key challenge, especially among MSME companies,' he added.
Time of India
5 days ago
- Business
- Time of India
Sun Pharma says working towards full regulatory resolution at 3 plants facing USFDA action
Drug major Sun Pharmaceutical Industries aims to bolster compliance across its manufacturing operations and work towards achieving full regulatory resolution at the three facilities facing USFDA action, according to Chairman and MD Dilip Shanghvi. In his address to shareholders in its annual report for 2024-25, Shanghvi said the company is facing US Food and Drug Administration (USFDA) compliance-related issues at three of its facilities. The company is facing an import alert for the Halol facility and also is in receipt of non-compliance letter for the Mohali facility , he stated. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Shape your journey in the unforgiving desert world of Arrakis! Shop Now Undo Additionally, the company's Dadra facility was accorded an Official Action Indicated (OAI) status in FY24, he noted. "We have completed the implementation of Corrective and Preventive Action (CAPA) in the Halol facility, which is currently awaiting USFDA inspection, and we are in the process of implementing CAPA at the Mohali and Dadra facilities," he added. Live Events Besides these three, all facilities remain compliant with global regulatory standards, including those of the US FDA, Shanghvi said. On the business front, he noted the company expects its R&D investment to be in the range of 6-8 per cent of sales in the current financial year, with enhanced focus on speciality products. The company aims to expand its product pipeline of global speciality products, he added. "Our R&D spend in FY26 is likely to be in the range of 6-8 per cent of sales, with increased spending expected on speciality products," Shanghvi stated. The Mumbai-based drug major invested USD 154 million on speciality products R&D in FY25. Sun Pharma reported consolidated revenues of Rs 52,041 crore in FY25, with the share of global speciality business increasing from 18 per cent in FY24 to 20 per cent in FY25 sales. The company sells speciality products like Ilumya, Winlevi, Cequa and Odomzo across markets. "We anticipate mid to high single-digit consolidated topline growth in FY26, and expect our global speciality business to continue on its growth path," Shanghvi said. Elaborating on the focus areas, he said the company plans to prepare the business for potential disruptions arising from tariffs and geopolitical issues. The company would also continue to focus on cost and operational efficiency, he added.
