|
DTAB ratifies extension of timeline for revised Schedule M implementation for MSMEs
|
|
Gireesh Babu, New Delhi
May 07 , 2025
|
|
|
The DTAB has ratified the notification issued by the Centre in February, extending the timeline for implementation of the revised Schedule M manufacturing standards for manufacturers having turnover less than Rs. 250 crore.
The notification was issued on February 11, 2025, following requests from the industry to allow more time for the small and medium industry to implement the revised Schedule M standards notified in December 2023, based on certain conditions.
The meeting of the Board, held on April 24, 2025, was apprised about the notification and after deliberation, it has ratified the said notification, said the DTAB minutes.
The Union ministry of health and family welfare has issued the final notification in February, extending the deadline for implementation of the revised Schedule M manufacturing standards to one more year for the micro, small and medium (MSME) units which apply for extension within three months from the time of notification.
While the decision to extend the timeline came as a relief to many MSMEs, they raised objections to the draft notification, especially against the conditions including that they should submit an application in a prescribed format with the Central License Approving Authority (CLAA) while issuing manufacturing license is under the purview of State Licensing Authorities.
A section of the industry also said that it is difficult to adhere to the conditions in the application form, such as detailing gap analysis and giving an undertaking to complete the upgradation within the deadline of December 31, 2025.
The Ministry, in its final notification, has said that the objections and suggestions received from the public on the draft rules have been considered by the Central government.
According to the final notification, the rule will be amended to add a provision to the existing condition that the small and medium manufacturers should comply with the revised Schedule M norms in 12 months from the date of publication of the rules.
The revised GMP standards, on par with the international manufacturing quality standards, were initially notified in December, 2023, mandating compliance of the revised standards by pharma units above Rs. 250 crore turnover in six months and units below Rs. 250 crore turnover in 12 months from the date of notification.
The latest amendment to the Rules, adds the proviso, “Provided that the small and medium manufacturers with turnover less than two hundred and fifty crores may seek extension of the timeline for implementation and for that purpose shall make an application to the Central Licence Approving Authority in Form ‘A’ annexed to this notification, within a period of three months from the date of publication of this notification, along with a plan of upgradation and for such manufacturers, the timeline for implementation shall be extended till 31st day of December, 2025.”
It has also provided Form A, the application for seeking extension of compliance with revised Good Manufacturing Practices (GMP), under Schedule M of the Drugs Rules, 1945.
According to the form A, the units which apply for extension of deadline have to submit the details of section-wise gap analysis and plans and strategies for compliance with the revised GMP based on the gap analysis, in three months from the final notification. The extension of time for implementation of the plan has to be not beyond December 31, 2025, which was January 1, 2026 in the draft notification.
The applicants should also provide justification of time required for compliance and the management should submit an undertaking that they propose to initiate upgradation within three months from the date of application and will comply with the revised Schedule M requirements as per the plan submitted in the application.
The gap analysis has to be on various sections including the plant, equipment, lab equipment, HVAC system, utilities, technical staff, documentation and others.
The Ministry, in its draft notification has said that the decision to extend the timeline was following representations from various industry associations representing pharma MSME sector for extension. The main reasons for seeking extension are time to arrange finances for upgradation and time for implementation of the required changes, it added.
At the time of issuing the draft notification for the amendment the Ministry said that Central Drugs Standard Control Organisation (CDSCO) has inspected over 800 manufacturing units and 252 public testing labs for ensuring standards.
The revised Schedule M, for which the draft was issued in the year 2018, has major additional features compared to the previous Schedule M standards, including standards for Pharmaceutical Quality System (PQS), Quality Risk Management (QRM), Product Quality Review (PQR), qualification and validation, establishment of system to recall the defective products, self inspection team and quality audit, supplier audit and approval, stability studies, among others.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|