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The Drugs Consultative Committee (DCC), the advisory committee that advises the Central and state governments on matters related to uniform implementation of the drugs regulations, has recommended formation of a sub-committee to decide on the issues related to unapproved drugs and uniform database on approved drugs to settle the matter permanently.
The Committee was looking into a proposal for a comprehensive regulatory mechanism to stop the availability of unapproved drugs, including fixed dose combinations (FDCs), and another proposal to update the database with respect to drugs approved by CDSCO, but not reflected in the CDSCO database.
During the 69th meeting of the DCC held on June 24, it also discussed a proposal to prepare a database of drugs that were licensed by the State Licensing Authorities (SLAs) prior to September 21, 1988.
Discussing various aspects on the matter, the Committee recommended that "a sub-committee be formed to examine the issues in totality and to suggest the regulatory measures that can be taken to resolve these issues once and for all, so that a comprehensive database of approved drugs can be made, and necessary action can be taken for the prohibition of drugs that do not fall under such a database."
Further to address the issue of online submission permanently, the DCC recommended that the Drugs Rules may be amended to make submission of all applications on ONDLS in line with the Medical Device Rules, 2017, after due diligence, it added.
It also opined that the formulations not appearing either on the Central Drugs Standard Control Organisation's (CDSCO) database or listed in the Indian Pharmacopoeia 2010 or its earlier editions may be deemed as unapproved.
"The competent authority may take appropriate measures, including cancellation of the license, market withdrawal, against such unapproved products," said the Committee.
The Committee took note of various actions taken by the government, including the issuance of directions under Section 33P, etc., to resolve the issues.
However, these efforts have not translated into sustained compliance, and therefore, there is a need for a comprehensive regulatory framework to address these issues, as these unapproved drugs can pose a risk to the patients, it opined.
It may be noted that the Central Licensing Authority has been reviewing the safety and efficacy of the FDCs approved by the SLAs without the approval of the central regulator, as it could have an impact on public health. The CLA has also banned several FDCs approved by the SLA in the past, after consulting with experts and identifying that these drug combinations are irrational. Many of such actions also were brought under the scrutiny of the High Courts and the Supreme Court of India in the past.
Under Section 33P of the Act, the Central government is conferred with powers to give directions to the state government for the purpose of carrying into execution, in the state, any of the provisions of the Act or any Rule or Order made thereunder.
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