Latest news with #ScheduleM


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."


Time of India
18-06-2025
- Business
- 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.


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.


Time of India
08-05-2025
- Business
- Time of India
New Schedule M rules: Most drug companies not yet ready for upgrade
With the revised Schedule M deadline approaching, only a fraction of small and medium pharmaceutical companies have submitted facility upgrade plans. The health ministry, concerned about the slow response, has urged state health secretaries to engage with local drugmakers. This aims to ensure broader compliance with the updated quality standards outlined in Schedule M of the Drugs and Cosmetics Act. Tired of too many ads? Remove Ads Only a small number of pharmaceutical companies have submitted plans for upgradation of facilities even as a revised deadline for implementation of revised Schedule M ends on Monday. Health ministry officials said out of about 10,000 medium and small manufacturing enterprises, just about 100 have submitted secretary Punya Salila Srivastava has now written to state health secretaries, asking them to issue necessary directions to state drug regulators to discuss the matter with drugmakers in their own M of the Drugs and Cosmetics Act outlines quality standards for pharmaceutical February, the ministry issued a notification extending the deadline for implementing revised Schedule M, whereby manufacturers with revenues of less than ₹250 crore were required to submit applications to the Central License Approving Authority within three months, along with their upgradation plans "However, as per the data available, very few firms have submitted their application requesting extension of timelines for implementation of revised Schedule M," said the health secretary in her letter to states.
&w=3840&q=100)

Business Standard
06-05-2025
- Business
- Business Standard
Schedule M rollout may face delay as MSMEs seek more time for upgrade
Small drugmakers seek a three-month extension to submit GMP compliance plans under revised Schedule M, raising concerns about delays in national rollout Premium Sanket Koul Delhi Listen to This Article Small and medium-sized drugmakers have asked the Centre to extend the 10 May 2025 deadline to submit upgradation plans in line with the revised Schedule M by another three months, with experts raising concerns that further extensions could delay overall implementation. This comes after the government, in February this year, granted small drug manufacturers with an annual turnover of less than Rs 250 crore a one-year extension to comply with the revised Schedule M, which specifies good manufacturing practices (GMPs) to ensure the quality of drugs made in the country. However, stakeholders were required to submit an upgradation plan within