Over 6,500 Sch M units to improve product quality through Guidelines on post-approval changes in drugs: Regulatory experts

According to regulatory experts, The much awaited guidelines on post-approval changes to pharmaceutical products, which is under the draft stage as of now, can help over 6,500 Schedule M units in the country to improve product quality.

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

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

A sub-committee had been constituted by Drugs Controller General of India (DCGI) 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 as members to draft guidelines on post-approval changes to pharmaceutical products.

The committee is in the process of finalising 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.

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.

As per the US FDA 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 US FDA (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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