DCC asks SLAs to set deadline for manufacturers to add product details to Sugam portal
The Drugs Consultative Committee (DCC), the advisory committee of the Central government to advise the Central and state governments on matters that require uniform implementation of drug laws across the country, has recommended to all the States to set a deadline for the manufacturing companies to upload all the formulation details in the Sugam portal, after conducting discussions with the industry associations.
The DCC’s recommendation comes in the backdrop of a report, submitted by a committee constituted by the Central Drugs Standard Control Organisation (CDSCO), on November 30, 2023 to prepare a comprehensive National Drugs Database of drug formulations manufactured and marketed in the country.
DCC observed that the manufacturers have not updated the details of all the products in the Sugam database even though almost five years have passed after mandating manufacturers to update details of product licenses and permissions in the portal as required under Rule 84B of Drugs Rules, 1945.
As on November 30, 2023, the manufacturers have uploaded data of total 4,92,995 drug formulations on the Sugam portal out of which 1,75,337 formulations are with brand name and 3,17,658 formulations are without brand name, observed the DCC. However, out 4,91,527 drugs formulations, only 33,094 have been verified and approved by the State Licensing Authorities (SLA) so far. Out of the 33,094 formulations, 18,978 are with brand name and 14,116 are without brand name.
Also, 2,706 drugs formulations, out of which 1,838 are with brand name and 868 are without brand name, have been verified and rejected by the SLA so far, observed the 63rd DCC meeting held on January 30, 2024.
The CDSCO’s Committee recommended the government to consider amendment of Rules to incorporate suitable provision so that in case any manufacturer of any drug does not upload and update the data as per the requirements, the manufacturer cannot sell or distribute the said product.
The details of the drug formulations in the database of the Sugam portal should be verified and approved by the respective State Drugs Control Authorities at the earliest before its use, it advised. For verification of the legacy data, the committee recommended that the government may consider hiring of appropriate agency/manpower for coordinating with the State Drug Authorities for carrying out this exercise.
The drug database should be used in strengthening, streamlining the regulatory as well as healthcare system in many aspects as mentioned in the committee report. The State Drugs Control Authorities should regularly direct the manufacturers under their jurisdiction to upload the data on real time basis as per the requirements.
The government has initiated the process for creation of a unified IT platform for all regulatory activities, to assess regulatory capacity across the States and Centre, to promote Ease of Doing Business. The database created under the Sugam portal may be considered for integration with the database under the unified IT platform as and when the platform is implemented, it added.
The drug regulator has been working on a unified IT platform after observing that under the Drugs & Cosmetics Act, 1940 and Rules, different authorities have different responsibilities and the data of the drugs manufactured, sold and distributed is present in different forms under the custody of multiple regulatory authorities, which in turn leads to a need for a central database of the drugs.
CDSCO formed the committee after observing that there is no comprehensive national database which provides details of medicines available in the country. A comprehensive database is crucial not only to empower consumers but also to improve the monitoring mechanism for ensuring quality, safety and efficacy of drugs. At the moment, many states have their own databases on different software platforms and all that data needs to be integrated into a centralised database which will provide near real-time and comprehensive information to the authorities.
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