CDSCO Revokes Nod for Eye Drops to Replace Glasses Due to Safety Concerns

Wednesday, 11 September 2024, 06:28

Unsafe use of eye drops has led to CDSCO revoking approval for products intended to replace glasses. Entod Pharma has failed to address safety queries satisfactorily. The company plans to contest the decision in pursuit of restoring market access.
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CDSCO Revokes Nod for Eye Drops to Replace Glasses Due to Safety Concerns

Background on CDSCO's Decision

The Drugs Controller General of India (CDSCO) has taken a crucial step by revoking approval for specific eye drops made to replace glasses. This decision arises from significant concerns over the potential for unsafe use of the product.

Reasons Behind the Revocation

  • Failure to Address Queries: Entod Pharma did not satisfactorily respond to essential safety questions posed by the regulatory body.
  • Public Safety Concerns: The continued availability of these eye drops without proper assurances could pose a risk to consumers.

Future Actions by Entod Pharma

In light of the CDSCO's decision, Entod Pharma intends to challenge the suspension of approval in hopes of reinstating their product.


This article was prepared using information from open sources in accordance with the principles of Ethical Policy. The editorial team is not responsible for absolute accuracy, as it relies on data from the sources referenced.


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