Requirements for Setting Up Third Party Manufacturing Pharma Unit in India

June 15, 2018 by admin0

With this article, we will be outlining the step by step process of setting up a third party manufacturing pharma unit in India. Pharmaceuticals, especially the 3rd party manufacturing pharma industry is one of the fastest growing Indian industries. Third party manufacturing pharma means outsourcing pharma production to third parties that have the expertise and adequate facilities to support bulk medicine production. The process is ideal if you want your batch produced and delivered on time.

India is a favourite hub for 3rd party manufacturing because the country offers less regulatory constraints and the labour costs are comparatively lower than other countries such as U.S. However, one must do proper research before embarking on the journey of starting a third party manufacturing company in India.

third party manufacturing pharma

The do’s of setting up a 3rd party manufacturing pharma unit are:

  • Investment: Draft a comprehensive and well thought out business proposal for your lenders. The capital investment may vary from company to company depending upon the inventory.
  • Company name: By choosing a unique name for your pharma production company you can attract instant attention and set you apart from competitors. Establish the type of business you will do. Decide if you want to start as a third party manufacturer or a 3rd party manufacturing company that does its own marketing.
  • Company Location: Many pharmaceutical companies apply for a permit to operate in Special Economic Zone (SEZ) such as Baddi in Himachal Pradesh. SEZ supports excise free production and gives special provisions and allowances to manufacturing companies.
  • Registration, License & Permits: The very first step after deciding the company name and type is to get it registered under Companies Act 1965 and MSMED Act if applicable. One requires following permits to operate as a legal 3rd party manufacturing pharma unit in India:
  • Manufacturing Permit from FDA
  • Drug License number
  • TIN
  • CST number
  • Permit for Test lab
  • GST registration
  • NOC pollution certificate
  • The IEC code to operate as an export-import company
  • International Approvals & Accreditations: Add credibility to your business by getting certifications from international regulatory bodies such as WHO, GMP, GLP, ISO, etc.
  • Equipment: The next step in the process would be to buy and install plant & machinery. If it suits your budget, you could go for automated laboratories that are recommended for quality purpose.
  • DCGI approval for pharma products: Once the company is established and fully operational, make sure to get your pharma products tested by DCGI. DCGI approved medicines are more likely to be in demand due to their safe composition and high efficacy.

By covering these aspects, you are least likely to make a mistake with your third party manufacturing pharma company.

For more information on 3rd Party manufacturing of pharma products, call us +91 9888885364 or drop a mail at uniquesurinder@gmail.com.


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