Guidelines on post-approval changes in drugs: Sub-committee DCGI

The guidelines will cover changes like facility, scale and equipment changes associated with all steps of drug substance manufacturing

Meeting Committee FDA
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Last Updated on March 6, 2021 by The Health Master

The sub-committee, constituted by the Drugs Controller General of India (DCGI), has submitted the guidelines on post-approval changes in drugs to the Union Health Ministry which are today very important from the standpoint of global regulatory harmonisation.

This, according to a senior official, will do away with unauthorized and upright changes in the product. These guidelines which are adopted in the regulated markets will streamline the protocols to make post approval changes in the drug as it is closely related with the product life cycle approach.

DCGI had constituted a sub-committee to frame guidelines on post approval changes to pharmaceutical products in line with the global regulatory framework in November 2019.


The sub-committee was constituted under the chairmanship of Telangana drug controller Dr Venkateswarlu with Dr H G Koshia, Gujarat Food and Drug Control Administration (FDCA) Commissioner, D K Tiwari, assistant commissioner (Drug), Uttar Pradesh Food Safety and Drug Administration Department (FSDA UP) and Arvind Kukrety, Deputy Drug Controller (DDC) as members to draft guidelines on post-approval changes to pharmaceutical products.

The guidelines will cover changes like facility, scale and equipment changes associated with all steps of drug substance manufacturing, specification changes to starting materials, raw materials, intermediates and the unfinished and final drug substance.

These guidelines which are also being followed in all the developed markets marks a major step by the Indian drug regulator to align with the global regulatory framework as per global regulatory harmonisation.

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Though Drugs and Cosmetic (D&C) Rules have been amended to raise compliance levels since 1940 but these guidelines were not mandated. Since India is the pharmacy hub to the world, these guidelines need to be adopted and implemented to ensure compliance and quality at par with global counterparts.

This also includes synthetic manufacturing process changes, changes in the source of drug substance and changes to the container closure system of the drug substance.

The matter was deliberated during the Drug Consultative Committee (DCC) meeting held in Delhi in September 2019 to bring in similar guidelines for Indian pharmaceutical industry as per global regulations.

This will help over 6,500 Schedule M units in the country to improve product quality, according to regulatory experts.

There are around 8,000 Schedule M units in the country and around 1,300 WHO GMP compliant units follow these guidelines.

Picture: Pixabay

As per the USFDA guidelines, manufacturers of active pharmaceutical ingredients (APIs) who want to make changes to the drug substance (DS) manufacturing process during an application’s post-approval period should consult USFDA (Food and Drug Administration) new draft guidance released on September 10, 2018.

The guidelines provide recommendations to holders of approved new drug applications (NDAs), generics (abbreviated new drug applications, (ANDAs), new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs) and holders of drug master files (DMFs) and veterinary master files (VMFs) who may want to make a change to the drug substance manufacturing process during the drug product application´s post-approval period.

The guidelines note that late-stage changes in the drug substance manufacturing process are generally viewed as “more likely to have an adverse impact on the quality of the drug substance and, consequently, on the drug product.”


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