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Business Standard
08-07-2025
- 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
07-07-2025
- 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.
Business Upturn
04-07-2025
- Business
- Business Upturn
Shilpa Medicare subsidiary clears GMP inspection from ANVISA with no major observations
By Aman Shukla Published on July 4, 2025, 16:10 IST Shilpa Medicare Limited announced that its wholly owned subsidiary, Shilpa Pharma Lifesciences Limited (Unit-1), has successfully completed a Good Manufacturing Practice (GMP) inspection conducted by the Brazilian regulatory authority, ANVISA. In the exchange filing, the company shared, 'This is to inform you that the Shilpa Medicare Limited's 100% subsidiary, Shilpa Pharma Lifesciences Limited, Unit-1 has successfully completed GMP inspection from Brazilian regulatory authority, ANVISA. ' The inspection took place from June 30 to July 4, 2025, and concluded with no critical or major observations—a key milestone for the company's global regulatory compliance. Only minor procedural observations and recommendations were noted, which were discussed during the course of the audit. Shilpa Medicare stated that it remains committed to maintaining the highest quality and regulatory standards. The company will submit a Corrective and Preventive Action (CAPA) plan to address the minor points raised, within the stipulated timelines set by the agency. This successful outcome reinforces Shilpa's position in regulated markets and supports its ongoing efforts to expand its international presence, particularly in Latin America. Ahmedabad Plane Crash Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
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Business Standard
26-06-2025
- Health
- Business Standard
Drugmakers may lose product licence if govt labs flag quality failures
The Health Ministry is working with states to allow immediate suspension of licences for drugs declared substandard by labs, following a key recommendation from Drugs Technical Advisory Board Rimjhim Singh New Delhi The Ministry of Health is planning strict action against pharmaceutical companies if their medicines fail quality checks. The ministry is in talks with state authorities to allow immediate suspension of licences for drugs found to be 'Not of Standard Quality' (NSQ) by government laboratories, according to a report by The Economic Times. This move aims to ensure consistent drug quality and safeguard public health, especially after several cases of substandard medicines were reported across the country. Recommendation of drug advisory board The proposed action follows the recommendation of the Drugs Technical Advisory Board (DTAB), the apex body advising the Central Drugs Standard Control Organisation (CDSCO). The board, in its recent meeting, underlined the need for quick regulatory intervention once a drug is declared NSQ, the news report said. 'The board noted that it is very important that once a drug is declared NSQ, the license of such product shall be suspended immediately in public interest unless a satisfactory corrective action and preventive action (CAPA) is submitted by such manufactures. After detailed deliberation, DTAB recommended the appropriate amendment in the Drug Rules in this regard and the suspension product licence should be revoked only after root cause analysis and corresponding CAPA has been implemented,' said the minutes of the meeting. The CDSCO is currently holding discussions with pharmaceutical industry associations, many of which have raised objections to the proposed rule. 'The health ministry and the CDSCO is taking a step forward by taking views of the states and pharma bodies as it would require a notification,' said a senior government official, as quoted by The Economic Times. Pharma industry voices concerns Pharmaceutical industry representatives argue that NSQ declarations can stem from technical issues rather than deliberate negligence. The Federation of Pharma Entrepreneurs (FOPE) noted in its submission, 'NSQ is a global phenomenon, and most of the time, it is due to technical issues without any wrongful intent.' Industry groups also highlighted potential shortcomings in government laboratory practices. 'This has been a long-standing concern. It is also necessary that the NSQ investigation includes a review of records and data from government testing laboratories, as well as GLP compliance by the Drugs Inspector,' said a member of one such lobby group, as quoted by The Economic Times. Industry demands robust review and recall mechanisms Drugmakers emphasise that rather than immediately suspending licences, the focus should be on strengthening the drug recall mechanism and conducting thorough investigations before action is taken. FOPE has also called for a detailed impact assessment of the proposed rules. 'We fear it may lead to malpractices in the profession, and genuine manufacturers with investments of hundreds of crores in plant setup, product development, technical team development, brand development, business development, and goodwill, may be adversely impacted if actions like the suspension of product permission are taken without proper investigation,' the group said. Novo Nordisk launches Wegovy in India Danish drugmaker Novo Nordisk on Tuesday launched its weight-loss injection Wegovy in India. The once-a-week injectable, already available in the US and Europe, will reach Indian pharmacies by the end of June. Wegovy contains semaglutide, a compound that mimics a natural hormone to help control appetite, reduce cravings, and promote fullness — making it easier for users to adopt healthier habits. Approved for long-term weight management, it also lowers heart-related risks in overweight or obese individuals. Clinical trials suggest that around one in three users may lose up to 20 per cent of their body weight in just over a year, when combined with diet and exercise. In India, Wegovy is recommended for adults with a BMI of 30 or above, or over 27 with health issues like diabetes or high blood pressure. It is administered once weekly with a pre-filled pen, and the dose increases gradually. Monthly prices range from ₹17,345 to ₹26,015 depending on the dosage.
Time of India
25-06-2025
- Health
- Time of India
Pharma companies may lose licence if drugs fail tests
Drugmakers will have to face strict government action if their products fail quality parameters and are declared as substandard. The punitive measure is being proposed by the health ministry during ongoing discussions with states to ensure quality drug production and safeguard public health. The ministry is looking to issue a notification shortly that will mandate immediate suspension of product licences of companies found producing 'not of standard quality' (NSQ) drugs by government laboratories, officials said. The Central Drugs Standard Control Organisation ( CDSCO ) on its part has been deliberating the matter with pharma lobby groups that have raised objections. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Victoria Principal Is Almost 75, See Her Now Reportingly Undo Earlier, the government's technical advisory board on drugs, which is part of CDSCO, had approved taking swift action against such manufacturers. Live Events "The board noted that it is very important that once a drug is declared NSQ, the license of such product shall be suspended immediately in public interest unless a satisfactory corrective action and preventive action (CAPA) is submitted by such manufactures. After detailed deliberation, DTAB recommended for the appropriate amendment in the Drug Rules in this regard and the suspension product licence should be revoked only after root cause analysis and corresponding CAPA has been implemented," according to the minutes of a board meeting of the technical advisory body. "The health ministry and the CDSCO is taking a step forward by taking views of the states and pharma bodies as it would require a notification," said a government official on the condition of anonymity. However, the pharma lobby groups have raised objections and given representations. NSQ, "is a global phenomenon, and most of the time, it is due to technical issues without any wrongful intent," the Federation of Pharma Entrepreneurs (FOPE) said in its representation. In a recent meeting, pharma lobby groups also pointed out that many government testing laboratories are facing challenges in following the current standards. "This has been a long-standing concern. It is also necessary that the NSQ investigation includes a review of records and data from government testing laboratories, as well as GLP compliance by the Drugs Inspector," a member of a lobby group opined. "It has been found that in many cases, samples declared NSQ by government labs, when challenged and tested by CDL Kolkata, have been declared as Standard Quality by CDL Kolkata, which is an appellate laboratory," the person said. Drug makers also emphasised that more than suspending licenses, it is crucial to strengthen the "recall mechanism". FOPE urged a proper impact analysis given the sensitivity of the matter. "We fear it may lead to malpractices in the profession, and genuine manufacturers with investments of hundreds of crores in plant setup, product development, technical team development, brand development, business development, and goodwill, may be adversely impacted if actions like the suspension of product permission are taken without proper investigation," the lobby group said.
