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DCC asks govt to amend Rules to make mandatory for cos to provide details of critical post-approval changes
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Gireesh Babu, New Delhi
September 11 , 2023
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The Drugs Consultative Committee (DCC) of the Union Health Ministry has recommended to the government to amend the Rules and conditions related to licensing of drugs to make it mandatory that the manufacturers provide the details of the critical or major post-approval changes to the licensing authority.
It has also recommended to the government to issue an advisory for mentioning details of excipients on drug formulation by various means or modality on voluntary basis, as there are no provisions at present to make it mandatory for the manufacturers to provide package inserts along with the drugs manufactured or marketed in the country.
The DCC, in its last meeting held in June, 2023, observed that the post approval changes or change control, is one of the most important key elements of regulation of pharmaceutical products.
It was apprised that any change to a licensed product may impact on the quality, safety and efficacy of the product and any change to the information associated with the product may impact on the safe and effective use of the product. However, these changes may be made for the purpose of maintaining routine production, improving the quality attributes or improving the efficiency of manufacture or updating product labelling information.
"Therefore, the regulation of such post approval changes or change control, is one of the most important key elements of regulation of pharmaceutical products by the regulatory authorities in ensuring quality, safety and efficacy," it observed.
The Committee deliberated the issue in detail and recommended the preparation of a guidance document for execution of existing provisions of the rules, comparison of base dossier with the major/critical post approval changes, verification about the post approval changes during the audit and make it mandatory as a part of the inspection checklist.
The Committee also recommended that the rules should be amended to incorporate appropriate provisions under the conditions of license to make it mandatory that the manufacturers provide the details of the critical/major post –approval changes to the licensing authority.
DCC was also apprised about the grievance received on the usage of parabens in pharmaceutical products as preservatives, which is one of the product used as excipients and that there is no clear cut indication of composition of excipient on strips of medicines available on retails medical shops which causes inconvenience to the patients who are allergic to such excipients.
The Committee was also informed that through the representation it has been requested to rectify this problem to stop suffering of such patients/consumers and suggested to add details of excipient or INS codes of excipient on every strip of medicines.
"The Committee deliberated that the details of the excipients should be in the package inserts of the medicines. However, presently there is no provision which make it mandatory for the manufacturers to provide package inserts along with the drugs manufactured/marketed in the country. The criteria to mandate mentioning of the details of excipients on drug formulations have to be evaluated at length for its implementation," said the Committee.
"Considering overall perspective, the committee after detailed deliberation recommended to issue an advisory for mentioning details of excipients on drug formulation by various means/modality on voluntary basis," added the Committee according to the minutes of the meeting released by the Central Drugs Standard Control Organisation (CDSCO) recently.
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