DCC Urges State Authorities to Set Deadline for Updating Drug Details in Sugam Portal

The recommendation follows discussions with industry associations and aims to ensure compliance with drug laws across the country.

The Drugs Consultative Committee (DCC) has urged state authorities to set a deadline for pharmaceutical manufacturers to update all formulation details in the Sugam portal, a central database for drug formulations. 

The Sugam Portal is a platform introduced by the Central Drugs Standard Control Organization (CDSCO) in India. It seeks to simplify regulatory processes related to drugs, cosmetics, and medical devices. 

Through this portal, applicants can submit electronic applications, track their status, and receive real-time notifications, making interactions with the regulatory body more efficient and transparent.

The DCC's recommendation comes after observing a significant delay in updating product details despite the mandate outlined in Rule 84B of Drugs Rules, 1945. 

Manufacturers have been required to update product licenses and permissions on the Sugam portal for nearly five years. 

However, as of November 30, 2023, only a fraction of drug formulations have been uploaded and verified.

According to the DCC, out of 4,92,995 drug formulations registered on the Sugam portal, only 33,094 have been verified and approved by State Licensing Authorities (SLAs). 

This delay raises concerns for the accuracy and completeness of the database, which is essential for ensuring the safety and efficacy of pharmaceutical products.

Recommendations for Regulatory Oversight

Further, CDSCO has recommended amendments to existing rules to enforce compliance more effectively. The committee suggests that manufacturers who fail to update their data should not be permitted to sell or distribute their products. 

Additionally, the CDSCO proposes hiring appropriate agencies or manpower to verify legacy data and streamline the verification process.

Furthermore, CDSCO emphasized the importance of a comprehensive national database for monitoring and regulating drug formulations. 

Currently, disparate databases across different states create challenges in monitoring the quality, safety, and efficacy of medicines. 

Integrating these databases into a centralized platform would provide real-time information to regulatory authorities, empowering consumers and enhancing regulatory oversight.

Unified IT Platform for Regulatory Activities

The government initiated the development of a unified IT platform to streamline regulatory activities and promote ease of doing business. 

The Sugam portal's database may be integrated into this platform, facilitating seamless information exchange between regulatory authorities at the state and central levels.

The CDSCO's efforts reflect a broader push towards modernizing regulatory processes and enhancing transparency in the healthcare sector. 

By leveraging technology and enforcing compliance with existing regulations, authorities aim to strengthen the regulatory framework and safeguard public health.

In light of the evolving landscape of the pharmaceutical industry, proactive measures are essential to address emerging challenges and maintain public trust in the safety and efficacy of medicinal products. 

Collaboration between government agencies, industry stakeholders, and regulatory bodies is crucial for achieving these objectives and promoting the health and well-being of the population.