CDSCO was asked to create a roadmap with timetables for reaching global standards in its designated activities. At a high-level review meeting on drug and cosmetic regulations on Wednesday, Union Health Minister J P Nadda urged authorities to emphasize the need of developing world-class regulatory systems and ensuring openness in operations.
“For India to match our global reputation as the ‘Pharmacy of the World’, we need to have a world-class regulatory framework that matches our scale of operations and international expectations,” Nadda stated when the meeting took place.
CDSCO was instructed to develop a road map with timeframes for meeting global standards in its defined activities.
Union Health Minister J P Nadda urged authorities on Wednesday to underline the need of creating world-class regulatory mechanisms and guaranteeing operational transparency.
“For India to match our global reputation as the ‘Pharmacy of the World’, we need to have a world-class regulatory framework that matches our scale of operations and international expectations,” Nadda said before the conference..
This comes as the government begins to work on the correct implementation of the updated Schedule M, which incorporates GMP criteria to assure the production of quality medications.
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The updated Schedule M includes several key modifications, including the implementation of a pharmaceutical quality system (PQS), quality risk management (QRM), product quality review (PQR), equipment qualification and validation, and a computerized storage system for all drug goods.
Nadda further added that CDSCO must maintain open lines of communication with the pharmaceutical and medical device industries in order to hear their concerns and assist them in meeting quality requirements.
“Our focus should be on inventing systems that make it easier for the drug industry to conduct business while adhering to regulatory standards. For this, CDSCO must be a user-friendly organisation with cutting-edge facilities that satisfy global standards,” Nadda stressed during the conference.
Noting that the states are a vital component of the regulatory value chain, Nadda advised officials to work in tandem with the state regulatory bodies to strengthen their skills and capacities, as well as encourage them to align with the central government’s quality requirements.
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