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In relief to thousands of micro, small and medium pharma units in the country, the Union ministry of health has taken steps to extend the deadline for implementation of the revised Schedule M manufacturing standards to one more year for those units which apply for an extension.
A draft notification has been issued by the Ministry on January 4, to bring in changes to the notification issued in December 2023, which mandated compliance by units above Rs. 250 crore turnover in six months and units below Rs. 250 crore turnover in one year from the date of notification.
The draft amendment provides for small and medium manufacturers with turnover of below Rs. 250 crore to seek extension of the timeline for implementation. These units shall make an application to the Central License Approving Authority in a form provided with the notification within a period of three months from the notification, along with the plan of upgradation.
"For such manufacturers the deadline for implementation shall be extended till December 31, 2025," said the draft amendment.
It has also provided Form A, the application for grant of extension of compliance with revised Good Manufacturing Standards, under Schedule M of the Drugs Rules, 1945.
"Whereas, the timeline of twelve months was provided for implementation of the provisions in respect of small and medium manufacturers having turnover of Rs. 250 crore or less which is expiring shortly. And several representations have been received from various associations to extend this timeline to enable small and medium scale manufacturers to comply with the provisions of revised Schedule M," said the Ministry while issuing the draft notification.
As reported earlier, the industry has repeatedly requested extension of the deadline for micro, small and medium units, raising concerns over the future of a majority of these units which are not in a position to comply with the standards within a short timeframe.
The revised Schedule M was notified by the Union ministry of health and family welfare in December 28, 2023, with major changes in the manufacturing standards for drugs manufactured in the country, on par with the international standards.
"States like Punjab has been facing disadvantages compared to the tax haven states till 2017, and even after that the competition has been stiff with limited room for the industry to focus on more investments," said Jagdeep Singh, president of Punjab Drug Manufacturers Association (PDMA).
He said that only about 15-20 of the total 150 units in Punjab might have upgraded to the revised manufacturing standards. If the regulation is implemented without any extension in deadline, it would wipe out a majority of the micro and small units, not only in Punjab, but across the country, he averred.
"The turnover benchmark of Rs. 250 crore stipulated for Schedule M means the existence of around 8,000 Micro and Small Enterprises (MSEs) has been ignored," he said earlier.
The Association has also repeatedly urged the Prime Minister through letters to extend the timeline for the micro and small units to comply with the revised standards and also urged the government to look into improving other facilities including availability of potable water, qualified manpower for the industry, among others.
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.
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