How to ensure quality of products in third/contract manufacturing?


We were planing to start pharmaceutical marketing company, read your posts. we found it very helpful. Still we have one confusion; if drug product manufactured by third party shows some adverse reactions then in that case DCGI take action against whom marketing or manufacturing company? and what will be the penalty for accused?


Manufacturer will manufacture only DCGI approved molecules. These molecules and combinations are already tested toward adverse reactions. In some cases if products show any adverse reactions or drug department found product of substandard quality then manufacturer will be responsible for it. Marketing company has to show proof of sale and purchase in that case and satisfy the drug department regarding marketing company don’t have any knowledge about substandard quality of product.

But its also responsibility of marketing company to take quality report along with product or test each batch at independent laboratory for quality and efficacy of product.

DCGI can make accused manufacturing company or in some cases it make accuse all distribution channel along with marketing company. Penalty could be only fine or imprisonment or both depend at severity of matter.


I’d like to ask you one more question. Though manufacturing company has already got the approval for drug product from DCGI. But, what if they produce drug products which are not having API strength specified or they provide products with 100% assay value but product not remain stable during shelf life and undergo degradation, hence reduction in assay value. As a marketing company we are planning for contract manufacturing, so in that case how can we ensure quality of products?
Can you please reply on this? I would be really grateful if you could answer.


In case of product that are not produced with quality standard by manufacturer or not having API strength as specified. You have two option:

First ask COA ( Certificate of Analysis) along with Batch you received from manufacturer.
Second send few sample for independent laboratories for testing. Many laboratories provide facility for testing products and will give you assay report of batch you received from manufacturer.

Above two steps you can follow to ensure material you are receiving is of standard quality.

In case products degrade during shelf life. Except few sensitive API’s, most of API’s will be stable during shelf life or between its manufacturing & expiry date. If you receive product of 100% assay, there is very rare chances, its assay strength will reduce to dangerous level or below allowable level. Mainly vitamins, minerals, clavulanic acid degrades during shelf life, so companies add some over ages to prevent loss during shelf life.

Main degradation problems you can face is moisture or air bubles in tablet/capsule blister/alu-alu packaging, breaking of tablets, crystallization in syrups etc. If you found any sort of problem or manufacturing defect in product, you can send back whole batch to manufacturer. This will be written in your agreement, you will signed with manufacturer before getting manufactured your product.

Read whole procedure of third party manufacturing here

You may also be interested in: What is the difference between pharmaceutical loan licensing, third party manufacturing and pcd/franchise

Hope above information was useful to you…

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  1. If I start pharma company as proprietorship in Solapur with DLNo. & GSTNo. Can I mention address of Mumbai on product as marketed by?

    1. For showing marketed by address of Mumbai, you need to show Marketing or sales office there. You don’t need drug license in Mumbai but at least you need to have any place there from which you can show office there…

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