CDSCO issues caution against manufacture and sale of unapproved drugs
The Hindu
CDSCO warns against unapproved drugs, specifically "New Drugs", citing examples of Meropenem and Disodium EDTA.
The Central Drugs Standard Control Organisation (CDSCO) has cautioned against the manufacture and sale of unapproved drugs specifically warning against drugs falling under the category of “New Drugs”.
The organisation citing the example of drugs – Meropenem (antibacterial agent) and Disodium EDTA (to treat calcium overload) – noted that they have got information that some manufacturers are involved in manufacturing/marketing of unapproved drugs which CDSCO does not yet approve.
In its communication to all zonal/sub-zonal offices of CDSCO and the Indian Drugs/Pharmaceutical Association forum, it said that no new drug shall be manufactured for sale unless the licensing authority approves it and additionally a person who intends to manufacture a new drug in the form of Active pharmaceutical ingredients (API) or Pharmaceutical formulation – as the case may be for sale or distribution – shall make an application for grant of permission to the central licensing authority as per the specifications.
CDSCO has now directed that all manufacturers be made aware of the two drugs – Meropenem and Disodium EDTA. “The matter should be conveyed to all manufacturers and the product permission granted by these drugs should be cancelled,’’ it noted.
Explore the necessity, types, challenges, and potential of bioremediation in India for environmental restoration and public health.
Researchers in India uncover genetic factors linked to early oral cancer onset in tobacco chewers, enhancing cancer prediction and prevention.
Mahindra’s XEV 9S is a modern, family-focused electric SUV with premium design, a spacious tech-rich cabin, refined performance and advanced safety features. Discover variants, pricing and real-world impressions in our detailed review.
Samantha interview: On pickleball, her battles with a rare autoimmune condition and learnings
Experience the thrilling Akkulam Glass Bridge in Thiruvananthapuram, offering stunning views and adventure activities for all ages.
Climate scientists and advocates long held an optimistic belief that once impacts became undeniable, people and governments would act. This overestimated our collective response capacity while underestimating our psychological tendency to normalise, says Rachit Dubey, assistant professor at the department of communication, University of California.
Indian astronaut Shubhanshu Shukla predicts a transformative decade for India’s space exploration and international collaboration.