Draft guidelines finalized on post-approval changes in drugs

It is also important as it has a bearing on the drug quality more so as these guidelines are voluntarily followed by all regulators towards compliance and quality

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Draft guidelines finalized on post-approval changes in drugs

The Dr Venkateswarlu headed sub-committee, constituted by the Drugs Controller General of India (DCGI) to draft guidelines on post-approval changes to drugs i.e. pharmaceutical products, has finally drafted the report after incorporating industry recommendations.

The sub-committee is planning to submit the final draft guidelines soon to the union health ministry, according to an official associated with the development.

“These guidelines are very important from the standpoint of global regulatory harmonisation as all the developed markets are following it.

It is also important as it has a bearing on the drug quality more so as these guidelines are voluntarily followed by all regulators towards compliance and quality,” informed one of the members Dr H G Koshia, Gujarat Food and Drug Control Administration (FDCA) Commissioner.

Though Drugs and Cosmetic (D&C) Rules have been amended to raise compliance levels since 1940 but these guidelines were not mandated.

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India is the pharmacy hub

Now that, India is the pharmacy hub to the world, these guidelines need to be adopted and implemented.

“These guidelines will be instrumental in streamlining the process of drug manufacturing to make it viable for the domestic industry to adopt it and hence ensure compliance and quality at par with global counterparts,” Dr Koshia concluded.

This also marks a major step by the Indian drug regulator to align with the global regulatory framework as per global regulatory harmonisation.

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.

Also read: Sub-committee on post approval changes to pharmaceutical products: DCGI

What is covered in graft guidelines ?

The draft 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.

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 this year to bring in similar guidelines for Indian pharmaceutical industry as per global regulations.

These draft guidelines will be further reviewed by the DCC and Drug Technical Advisory Board (DTAB) to make it more effective and industry friendly.

Members of the committee

Based on the DCC recommendations, DCGI had constitutes a sub-committee under the chairmanship of Dr Venkateswarlu, joint director, Drugs Control Administration (DCA), Telangana with members as D K Tiwari, assistant commissioner (Drug), Uttar Pradesh Food Safety and Drug Administration Department (FSDA UP), Arvind Kukrety, Deputy Drug controller, Central Drugs Standard Control Organisation (CDSCO), West Zone, Ahmedabad, Dr H G Koshia, commissioner, Gujarat Food and Drug Control Administration (FDCA).

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USFDA guidelines

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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The discussion of the change being reported should be accompanied by a Risk Assessment (RA) for FDA review and recommended documentation.

Change control is generally understood to be the responsibility of the Quality Control (QC) unit. Effective change control activities are key components of the Pharmaceutical Quality System (PQS).

Although the draft guidance does not repeat the concepts and principles explained in the Good Manufacturing Practice (GMP) and ICH guidance, FDA encourages the use of modern pharmaceutical development concepts, Quality Risk Management (QRM) and an effective PQS at all stages of the manufacturing process life cycle.

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