Latest news with #ScheduleM
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Business Standard
17-07-2025
- Business
- Business Standard
CDSCO extends COPP application deadline for pharma units to August 15
In an effort to assist pharmaceutical manufacturing units in onboarding the quality certification process, the Central Drugs Standard Control Organisation (CDSCO) has extended the deadline for submitting online applications for a WHO GMP COPP certificate by another month. A Certificate of Pharmaceutical Product (COPP) is issued to confirm that a pharmaceutical product is authorised for sale in its country of origin and manufactured in compliance with Good Manufacturing Practices (GMP). To digitise the process, the apex regulatory body had mandated last month that all manufacturing units submit WHO COPP applications online starting from 15 July 2025. This deadline has now been extended to 15 August. The extension follows reports that several pharma units have encountered difficulties in uploading documents on the government's Online National Drugs Licensing System (ONDLS) portal. In a circular dated 15 July, Drug Controller General of India (DCGI) Rajeev Singh Raghuvanshi said it had come to the organisation's attention that a number of manufacturers were still in the process of registering and uploading documents on the ONDLS platform. Commenting on the matter, Bhavin Mukund Mehta, vice-chairman of pharma export promotion body Pharmexcil, said many manufacturers—especially small and mid-sized exporters—are still aligning with digital onboarding requirements. The regulatory body had also received multiple representations from industry associations highlighting these onboarding challenges and seeking more time to complete the process. ONDLS is a single-window platform for processing applications such as the issuance of manufacturing and sales licences, GMP certificates, market standing certificates, and post-approval changes—all online. 'The extension will help provide much-needed breathing space to ensure a smooth transition,' Mehta added. Calling digitisation of regulatory processes a step in the right direction for India's pharmaceutical ecosystem, Mehta emphasised that implementation must support ease of compliance while maintaining global standards. The decision also comes at a time when small and medium-sized pharmaceutical manufacturing units—with annual turnover of less than Rs 250 crore—have been requesting a similar extension to submit gap analysis plans required to avail an extension for implementing revised Schedule M guidelines. The CDSCO had earlier instructed all eligible units to submit online applications via ONDLS to seek an extension for compliance with the updated Schedule M norms.
Fashion Value Chain
15-07-2025
- Health
- Fashion Value Chain
Medkart Champions Generic Drug Quality Amid Rising Consumer Concerns
With growing scrutiny around the quality and reliability of generic medicines in India, Medkart, Gujarat's largest generic-first pharmacy chain, is stepping forward to assure patients that affordability does not mean compromise. In response to increasing consumer concerns, the company has reinforced its Medkart Assured program-rooted in audit-based sourcing, Schedule M compliance, and continuous recertification. Medkart audit team ensuring WHO-GMP and Schedule M compliance for Assuring quality 'Price matters-but quality is non-negotiable. Medkart ensures every medicine on our shelves not only saves you money but also meets India's highest manufacturing and safety standards,' said Ankur Agarwal, Co-founder of Medkart. The Generic Dilemma: Cost vs. Confidence India's generic drug market, valued at over USD 24 billion as per Invest India, continues to face consumer trust issues domestically. A 2025 study published in the European Journal of Clinical Pharmacology reported that patients often harbour doubts about the safety and effectiveness of generics, particularly in oncology and cardiovascular segments. The study emphasizes that inconsistent communication by healthcare providers and a lack of robust manufacturer-level visibility are key barriers to trust. Moreover, WHO-backed reviews have highlighted that enforcement of quality regulations-especially in smaller manufacturing units-is uneven, contributing to a fragmented trust ecosystem. These systemic challenges, combined with low awareness and historical overreliance on branded drugs, reinforce the incorrect perception that affordability comes at the cost of efficacy. What Is Schedule M-and Why It Matters To combat this, Medkart has aligned all its procurement processes with Schedule M of the Drugs and Cosmetics Act-a stringent regulatory guideline that specifies Good Manufacturing Practices (GMP) for pharmaceutical production. Schedule M, as outlined by the Indian Pharmaceutical Alliance (Schedule M-1 Guidelines), covers standards for equipment, hygiene, storage, testing, and documentation-ensuring that every medicine manufactured is traceable and safe for consumption. Medkart Assured: Going Beyond Certification Medkarts multi-layered quality assurance process includes: Plant Audits : Medkart independently conducts regular plant audits of all partnered manufacturers to ensure international quality norms. Compulsory Dual Testing : Quality checks are run twice on all products at NABL accredited third-party labs to monitor consistency. Medkart Assured Tag: Only after passing all quality thresholds is a product marked 'Medkart Assured' in-store and online. 'We've built Medkart Assured so patients never have to choose between affordability and safety,' said Parasharan Chari, Co-founder of Medkart. 'Our commitment to Schedule M compliance, independent audits, and third-party testing gives consumers confidence that every medicine they take is backed by rigorous validation.' Raising the Bar on Public Trust In an ecosystem where trust is as important as pricing, Medkart's dual focus on education and assurance is helping reshape public opinion. The Medkart app includes a powerful Medicine-to-Medicine comparison tool, enabling users to make informed decisions with ease. Pharmacists are trained not just to dispense but to explain quality differences and clear doubts. Download With Confidence Patients deserve affordability without anxiety. Visit or download the Medkart App on-Play Store or App Store to compare medicines, upload prescriptions, and order Medkart Assured medicines-generic, yes, but never second best.
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.
