A contract manufacturing organization (CMO) is an organization that serves the pharmaceutical industry and provides clients with comprehensive services, from drug development to manufacturing. Outsourcing to a CMO allows the pharmaceutical clients to expand their technical resources, without increased overheads.

Generally, third-party manufacturing is a process of manufacturing medicines and products from other parties. In this process, signing an agreement is done between the company and the manufacturing company, and the manufacturing company manufactures the products as per the contract.

In third party manufacturing, there is no time compulsion to deliver the goods whereas contract manufacturing has delivery time compulsion. Mostly small companies work at the basis of third party manufacturing whereas medium size and big companies work at contract manufacturing basis

What is packing material for pharmaceutical/Ayurvedic products?

Packing material is outer covering in which dosage form is packed. It may in form of paper or plastic or rubber or tin or in other form. Packing material includes Outer cartoon, mono cartoon (if applicable), foil, label, lami tube etc. Generally vial, ampoule, protein powder tin, pet bottle don’t be considered in packing material but these are also the part of packing material. It is considered to be part of product. Manufacturer will give you rate including bottle, vial etc even if you will ask for rates without packing material. In pharmaceutical industry, there is norm that must be printed at packing material.

Types of Packing Material:

• Box
• Foil
• Label
• Lami Tube
• Inner/mono ( if applicable)

Costing of Packing Material:

What are these norms? Is it necessary to follow these norms?

Timely, Government and health department change the norms. In drug and cosmetic act, there are mentioned different schedules. Packing material of pharmaceutical products should compile with rule under these schedules. For products that can be sold under only doctor’s prescription, should mention warning and Rx should also be placed above salt name. Warning, caution, dosage etc should be mentioned according to these schedules. For example, newly implement Schedule H1 is must for antibiotics that come under this schedule. For Ayurvedic Products norms are different from pharma products.

Who is responsible for correction of these norms? Marketing company or Manufacturer!

Correction and implementation, checking of matter is full responsibility of manufacturer. If product fails to comply with these norms, drug department may issue notice to manufacturer and marketed by both. But manufacturer is considered to be the main party for violating the rule.

What is the role of marketing companies in packing material procurement process?

There is two way to procure packing material in third party manufacturing. One you can directly involve in printing of packing material or you can let it to manufacturer to procure it for yourself. Likewise manufacturer will give you rates at third party basis with packing material or without packing material. Cost will be nearly same in both cases.

What is the procedure for the printing of packing material for pharmaceutical/Ayurvedic products?

Before starting manufacturing process one need to print the packing material for the same. Packing and design of the products make first impression at mind of customers. In past when these modern equipment were not available, companies used to write at plain paper to describe the product. We will recommend you to procure packing material yourself but if you don’t have time and staff to look after printing process, you should let it to the manufacturer.

Procedure of Packing Material printing:

• Select printing material supplier and manufacturer.
• Prepare design for the packing material. Finalize best design.
• Select paper for packing material for cartoons and labels.
• Send it for correction and approval to the manufacturer for technical corrections.
• After correction and approval, send it for printing.

If anyone doesn’t want to involve in printing of packing material then what is to do?

Manufacturers provide both options, with packing material or without packing material. You can ask manufacturer to procure packing material. You just have to finalize design sent by manufacturer or manufacturer’s printer. You have to check for brand name, composition, marketed by address or other particulars, you want to change.

If anyone want to pack his products in special packing i.e. in special pet bottles, tin, vial, ampoules or in special dye!

Manufacturer will make your product with respect to your specifications. But that depends upon availability of these materials. If manufacturer is not able to procure these materials, you can also send these materials to manufacturer by yourself.

Query:

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?

Response:

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.

Query:

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.

Response:

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 to independent laboratories for testing. Many laboratories provide facility for testing products and will give you assay report of batch you received from manufacturer.

It Depends Upon Company As Well As Product Section , Its Varies Company To Company , Party Can Negotiate With Manufacturing Company .

Query:

Requesting your help regarding drug brand name registration I run a proprietorship company in Bangalore pcd business already but want to enter contract manufacturing. Companies are demanding brand Name Affidavits. I just want to clarify that

Response:

Companies demand brand name Affidavit for avoiding any future problem. In Pharma daily new molecule launch and companies has to search for a unique Trade Name/Brand Name for it. One most common way to search unique brand name to search at IP INDIA website and know whether your brand name is resembling to any other or not. But there is lot of brands available which are not applied for brand name registration. That can’t be searched by it. So, there is maximum chances, any new chosen trade name could clash with any already existing trade name.

Manufacturing companies will ask for brand name affidavit because they want to confirm that you are not using any other company brand name. You Brand Name/Trade Name is unique and don’t resemble to any other Brand Name/trade Name available in Market. If in Future your Brand Name will clash with any other Company’s Brand Name, you will have total responsibility for it. Manufacturing company will not bear any responsibility and expenditure with regard to this brand name.

If one company is marketing by Name of Sovamax, you can’t choose any Trade Name/Brand Name Similar or resembling to it like Aovamax. It will be offense under Intellectual Property Act. You have to choose different Name like Kdakmax etc. For entering into contract manufacturing, you should set-up your new marketing company and have to choose brand names for it.