There is need for clear definition of excipients and its GMP: IPEC

Currently, just like APIs, excipients are import dependent

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Last Updated on November 4, 2021 by The Health Master

Experts in the area of excipients are of the view that there is a need to relook at regulations whereby excipients should be separated from APIs. There is need for clear definition of excipients and its GMP.

Excipients play a critical role in the manufacture of drug formulations by helping to preserve the efficacy, safety, and stability of APIs (active pharmaceutical ingredients).

From an India standpoint excipients should be separated from APIs and there is need for clear definition of excipient and its GMP, said Kaushik Desai, secretary general, International Pharmaceutical Excipient Council of India (IPEC India).

IPEC India with its global reach can support in this direction. In fact, the Council has already forwarded its recommendations to the regulatory authorities with positive hope that it will be taken up by the committee formed by the health ministry to review existing drug laws, he said.

Optimal use of excipients provides pharmaceutical manufacturers with drug development cost savings, enhanced functionality capability and can also assist in drug formulation innovation, he added.

Currently, just like APIs, excipients are import dependent. However India is fairly good at manufacturing traditional excipients. But, with evolving of new drug delivery systems, India can also venture into novel and complex excipients manufacturing. A collaborative will be the key for the growth of the industry to make a global impact.

The lack of understanding of the function of an excipient in all likelihood could comprise quality and process control. This is a changing world where contaminated excipients from China & elsewhere enter the market leading to counterfeiting. It is also an age of bioterrorism.

Many a time, cost reduction objectives could result in wrong decisions. There is need to look for continuous quality improvement, increased supply chain controls and traceability as well as product consistency, Desai said at the All India Drugs Control Officer Confederation (AIDCOC) Training programme while speaking on the critical role of excipients in formulations.

Excipient design controls would include focus on Quality by Design, manufacturing process control and distribution needs that adhere to GMPs, auditing, QC testing and supply chain security. IPEC has developed several guidelines for the industry.

Further, there are also important physicochemical attributes affecting excipient functionality and performance. These include particle shape, size distribution, surface area, flow property, molecular weight, density, viscosity, purity and moisture content.

While the analytical properties of excipients are routinely tested and controlled, physical characteristics play an equally important role to enable a robust manufacturing process, he said.

Moreover, excipient selection & use considerably influence its safety & effectiveness of drugs. Quality of the excipients used by different product manufacturers or at different manufacturing sites of the same product may be different, particularly if the companies are engaged in multi-sourcing.

Variation could range from minor to significant depending upon the function of the excipient used in the product, its interaction with the actives, and product characteristics, including its route of administration.

Therefore, manufacturers should understand the functional contributions of the excipients. Without this knowledge, it is difficult to demonstrate pharmaceutical equivalence among products synthesized or perhaps formulated differently at different manufacturing sites, concluded Desai.

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