Latest news with #ScheduleM
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.
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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
News18
01-05-2025
- Health
- News18
Few Pharma Firms Apply For Schedule M Extension After Seeking More Time; Govt Urges Urgent Action
Small and Medium Pharma Manufacturers Association told News18 that firms lack financial resources to upgrade their facilities and government should give them 2-3 years instead of 1 Despite being granted the extension that small and medium drugmakers had asked for, most pharmaceutical companies have still not applied to delay compliance with Schedule M or revised drug manufacturing rules, News18 has learnt. The central government has shown concern over the trend and asked firms to act quickly. Quality concerns Following allegations levelled over the quality of made-in-India drugs by multiple countries, including the World Health Organization, in 2023, the central government updated the Good Manufacturing Practices (GMP) under Schedule M of the Drugs Rules, 1945. Many micro, small, and medium-sized (MSME) drug companies — those with a turnover of less than Rs 250 crore — asked for more time to meet these new standards, as the move requires both investment and time. Considering the industry's request, the government issued a new order in February 2025, allowing eligible companies to apply for an extension until December 31, 2025. To get this extension, companies had to submit an application and a plan for upgrading their facilities within three months. However, according to the letter seen by News18, Punya Salila Srivastava, secretary at the union ministry of health and family welfare, despite this support and multiple reminders—including official letters and a review meeting at the Central Drugs Standard Control Organisation (CDSCO)—very few companies have applied. ' … as per the data available, very few firms have submitted their application requesting extension of timelines for implementation of revised Schedule M," said the letter, dated April 30. Srivastava, who has sent the letter to the health secretaries, special chief secretaries, and principal secretaries of all states and union territories, has now asked state drug regulators and industry associations to take this matter seriously. 'It is requested to issue necessary directions to the state drug regulators and pharmaceutical manufacturers in your state/UT to take up the issue on priority … within the stipulated time and submit the application for extension on the ONDLS portal," the letter said. The union health secretary has highlighted that compliance with revised drug laws is 'critical" for the quality and safety of medicines manufactured in India. 'By taking necessary action together, I am sure we can ensure safety, quality and efficacy of drugs. To this effect, compliance with the necessary provisions of the Revised Good Manufacturing Practices (GMP) under Schedule-M is critical," she said in the letter. Handholding, financial support and more time needed: Pharma association Nipun Jain, chairman, Small and Medium Pharma Manufacturers Association, told News18, 'Small and medium pharmaceutical companies lack the financial resources to upgrade their facilities to meet the new standards. Rather than pushing us out of business in the name of aligning with global norms, the government should support and guide us through training and assistance to help us meet these standards. We request that the government reconsider the decision to extend the deadline to two to three years, along with extending financial support to the industry." He referred to the letter written by his association in January, which urged the health ministry for a 'condition-free" timeframe of two to three years for implementing Schedule M. Similarly, RSS affiliate Laghu Udyog Bharati (LUB) told News18 that the demand for an extension of the deadline was extended when their lobby requested the union health minister JP Nadda. 'On the request of Laghu Udyog Bharati, Hon'ble Health Minister JP Nadda extended the implementation of Revised schedule M guidelines up to 31st Dec 2025 for below 250 crore turnover MSME companies," said LUB in a statement. However, Ghanshyam Ojha, all-India president of LUB, said, 'We demanded a blanket extension as every small company has to invest Rs 4 crore to Rs 10 crore in plant upgradation for Revised Schedule M certifications." Ojha mentioned how drugmakers are struggling with the 'gap analysis of every plant" and facing technical difficulties in several steps. 'Small and medium enterprises are in panic and are trying hard to comply with new norms," he said while adding that the drugmakers will request the union health ministry to consider their request to give the industry more time. According to government data, there are around 10,500 manufacturing units in the country, of which at least 8,500 are in the category of micro, small, and medium enterprises (MSME). Of these, 2,000 are approved by the World Health Organization certified as WHO-GMP (Good Manufacturing Practices). tags : drug manufacturing medicine Location : New Delhi, India, India First Published: May 01, 2025, 17:58 IST News india Few Pharma Firms Apply For Schedule M Extension After Seeking More Time; Govt Urges Urgent Action
