CDSCO must maintain a registry of all Brand Name of Drugs: Dr BR Jagashetty

In conclusion, the creation of a comprehensive brand name registry by the CDSCO is a crucial step towards addressing the issue of LASA medicines in India.

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Brand Name
Picture: Pixabay
Former National Adviser (Drugs Control) to MoHFW, GOI & CDSCO |
Former State Drugs Controller, FDA Karnataka |
Presently working as Legal Consultant for Pharma field |
Email ID: jagashetty@gmail.com
Dr. Bharatesh R Jagashetty

Last Updated on August 27, 2024 by The Health Master

Brand Name

Brand Name: The increasing prevalence of Look Alike & Sound Alike (LASA) medicines in the Indian market poses a significant threat to patient safety.

These medications, often similar in appearance and pronunciation, can lead to medication errors and adverse health outcomes.

To address this issue, Dr. B.R. Jagashetty, a former National Adviser to the Ministry of Health and Family Welfare, has urged the Central Drugs Standard Control Organisation (CDSCO) to establish a comprehensive registry of all branded drugs.

The Importance of a Brand Name Registry

A brand name registry would serve as a valuable tool for healthcare professionals and patients alike.

By providing a centralized database of all approved brand names, it would help to:

  • Avoid confusion: Prevent medication errors by differentiating between LASA drugs.
  • Enhance patient safety: Reduce the risk of adverse health outcomes associated with incorrect medication use.
  • Improve drug regulation: Facilitate better oversight of pharmaceutical branding and marketing practices.

CDSCO’s Role in Establishing the Registry

To create a comprehensive brand name registry, Dr. Jagashetty recommends the following steps:

  • Dedicated wing: Establish a specialized unit within CDSCO to handle brand marketing and registration matters.
  • Data collection: Begin collecting information on all brand names and their corresponding compositions available in the market.
  • Fee structure: Implement a system of fees for brand name approvals and inquiries, similar to the framework used under the MRTP Act and the Consumer Protection Act.

Addressing Regulatory Inconsistencies

Dr. Jagashetty also highlights the need to clarify and streamline existing regulations related to brand name approvals.

He suggests:

  • Withdrawal of 33P direction: Revoke the direction issued under section 33P of the Drugs and Cosmetics Act, which restricts the grant of brand names.
  • Fee enhancement: Implement the previously announced fee increase for additional product approvals to generate revenue for state exchequers.
  • Standardization of drug names: Ensure that drug names accurately reflect their generic composition rather than brand names.

Benefits of a Brand Name Registry

The establishment of a brand name registry would offer numerous benefits, including:

  • Improved patient outcomes: Reduced risk of medication errors and adverse events.
  • Enhanced transparency: Greater clarity in drug prescribing and dispensing.
  • Better drug regulation: Improved oversight of pharmaceutical branding and marketing practices.

In conclusion, the creation of a comprehensive brand name registry by the CDSCO is a crucial step towards addressing the issue of LASA medicines in India.

By providing a centralized database of approved brand names, this registry can significantly enhance patient safety, improve drug regulation, and protect consumer interests.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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