New Delhi: Drugmakers who want to increase the timeline for the implementation of schedule should analyze the gap and file an application with the drug regulator, giving details of their strategy to comply with improved product standards.
“Small and medium producers with turnover of less than ₹ 250 crore less than ₹ 250 crore can demand an expansion of the deadline by submitting a plan of upgrades within three months,” the DRA Drug Regulatory Authority said.
“These companies have to comply with the revised schedule as per the plan submitted by them,” a senior official told ET.
As per the instructions, the director, proprietor or partner of the company will have to submit a gap analysis and give an initiative to start upgrades within three months from the date of application. The submission should also be appropriate for the required period that they want to comply with the requirements.
According to ET, Tuesday’s instruction gave time to comply with the revised schedule to small drug companies by December 31 this year. The application should be submitted to the Central License Allowed Power.
Drug rules will be amended to extend time for the second year.
The improved schedule outlines strict quality standards for M-J production, which was notified in January last year. When the units with annual turnover had to be followed from July 1, 2023, the implementation date for MSME was January 1 this year.
However, MSMESS sought more time to make the necessary changes to their production processes.
The ministry then proposed to extend the deadline for MSME and issued a draft notification. In this regard, he invited public comments by January 11.
“The feedback was integrated, and the final draft was sent to the legal affairs department for investigation,” a person cited above told ET.
The country’s pharma lobby groups were demanding a two -year expansion within the deadline, saying that more time is needed to improve infrastructure, increase manpower and training.
Federation Far F Pt Pharma entrepreneurs (FOPOs) wrote the drug controller in search of the expansion of notification implementation.
