Glenmark Pharma's North Carolina facility gets five U.S. FDA observations

The U.S. Food and Drug Administration (FDA) has issued a Form 483 with five observations to Glenmark Pharmaceuticals' manufacturing facility in Monroe, North Carolina, U.S.
The observations were issued at the end of GMP inspection of facility from June 9-17, the company said in a filing on Wednesday. All the observations are procedural in nature and not related to data integrity. The company said it will work in close collaboration with the regulator to address them and respond to within the stipulated timeline.

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Centre extends deadline for revised Schedule M implementation for small, medium pharmas

Time of India

2 hours ago

Time of India

Centre extends deadline for revised Schedule M implementation for small, medium pharmas

Mysuru: The Union govt has extended the deadline for implementing the revised Schedule M–Good Manufacturing Practices (GMP)–for small and medium pharmaceutical enterprises (SMEs) with an annual turnover of Rs 250 crore or less, until the end of this year, said Khalid Ahmed Khan, deputy drug controller and president of the Indian Pharmaceutical Association (IPA), Karnataka state branch. He was speaking at the inauguration of a national conference on 'Enhancing Pharmaceutical Quality Assurance through Good Manufacturing Practices (GMP)' and a special session on the Revamped Pharmaceutical Technology Upgradation Assistance Scheme. The event was organised by the PHD Chamber of Commerce and Industry (PHDCCI) health committee in association with the department of pharmaceuticals, Union ministry of chemicals and fertilizers, JSS Academy of Higher Education and Research (JSS AHER) and the IPA Mysuru branch, at the JSS College of Pharmacy on Wednesday. Khan noted that due to the financial burden involved in implementing the revised quality framework, MSME firms were granted time until Dec 2025 to comply. "Firms with turnover above Rs 250 crore, as well as all newly established plants, are required to adopt the revised Schedule M immediately. These guidelines are aligned with WHO and international standards and emphasise total quality management and robust pharmaceutical systems," he added. Khan stressed the importance of leadership and a quality-driven mindset in the pharmaceutical sector. "Even if you're not in a leadership position, you can influence those who are. Without quality, neither the industry nor its workforce can sustain," he said. Dr H Basavana Gowdappa, VC, JSS AHER, commended the department of pharmaceuticals for launching the RPTUAS and urged the industry to treat GMP not as a regulation but a fundamental responsibility. Amaresh Tumbagi, former drug controller of Karnataka, outlined the inspection mechanisms under the revised Schedule M and how regulatory processes have evolved. Dr Pramod Kumar TM, principal, JSS College of Pharmacy, provided insights into current industry regulations and compliance requirements. Jatin Nagpal, joint secretary, PHDCCI, Dharmendra Kumar Yadav, under secretary, department of pharmaceuticals, Yashwant Shinde, manager, SIDBI and Dr Savitha RS, secretary, IPA Mysuru local branch were also present.

With no upgradation plan, several small drug companies may shut operations

Time of India

7 hours ago

Time of India

With no upgradation plan, several small drug companies may shut operations

New Delhi: Thousands of pharmaceutical companies in the micro, small and medium enterprise (MSME) sector face the grim prospect of closure, having passed the May-end deadline for submitting plans to the government for upgrading their manufacturing facilities. Only a fraction of such units, 1,700 out of an estimated 6,000, have submitted plans for upgradation as per the newly-notified Good Manufacturing Practices ( GMP ), people in the know told ET. Industry executives said they anticipate many units to shut down and thousands of job losses as these units struggle with high costs needed to make the necessary infrastructure improvements. The government, meanwhile, is likely to initiate site audits and kick-off regulatory action against those not complying with the new standards, the people said. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like 혈압, 혈당, 고지혈로 고민이 많으신 분들만 읽어주세요. 메디셜 더 읽기 Undo Experts noted that if the government takes stringent action, it may cause drug shortages in areas like cancer, where there are fewer manufacturing units. Live Events "Next few months will see a lot of small sector units getting closed, resulting in increased unemployment. The upgradation requirement to Schedule M has created challenges for small and medium units potentially leading to closures and unemployment," said an industry executive, raising concerns about the future of these units. Some executives believe that 'stop production notices' will be issued to units not complying with the newly-notified standards, which may inflate drug prices. "These units require hand holding by the government and if they do not get further support, then production will stop, resulting in escalation of drug prices," a second executive said. Health ministry officials however stressed that sufficient time has been given to the industry for complying with the new norms. Earlier the ministry had received several representations from pharma associations with annual revenues of less than '250 crore for extension of timeline for the implementation of revised Schedule M. Schedule M of the Drugs and Cosmetics Act outlines quality standards for pharma products. To address their concerns, in February, the ministry issued another notification for extension of implementation of revised Schedule M whereby manufacturers with less than Rs 250 crore revenues were required to file an application to the Central License Approving Authority within three months, along with the plan of upgradation.

The Hindu

9 hours ago

The Hindu