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Biologicals

Planning to Market biologicals in India?  Start by getting market authorization

Biopharmaceuticals have really been making inroads into India, with the biotech industry estimated to grow to $100 billion by 2025. Biosimilars, which are newer versions of innovator biopharmaceutical products and are marketed after the expiration of patents, are especially important in the Indian market..

Biosimilars

Biosimilars are versions of innovator biologics that are marketed after patents get expired. In India, biosimilars are becoming increasingly important- they include everything from therapeutic protein to DNA vaccines to monoclonal antibodies.

Biosimilars have unique guidelines for market authorizations— based on  “Guidelines of similar biologic: Regulatory requirements for Marketing Authorization in India” (updated in 2016).

  • There is a multi-step process for market authorization. This involves several government agencies — CDSCO, Review Committee on Genetic Manipulation (RCGM), Drug Controller General of India (DCGI), Institutional Biosafety Committee (IBSC), the Genetic Engineering Appraisal Committee (GEAC), the Food & Drugs Control Administration (FDCA) and the Institutional Animal Ethics Committee (IAEC).
  • If the reference biologic is not registered in India, then it should have been marketed and distributed in a well-regulated market for at least a period of 4 years. Only in case of rare, emergency drugs, this period may be reduced.
  • There are a number of quality-based considerations that are taken into account including—analytical methods, product characterization, specification, pre-clinical studies, clinical information, and stability.
  • A quality comparatability study between the reference biologic and similar biologic is also required.
  • Pre-clinical trial approval is granted in the second step and the clinical trial in the third step. After this the company can apply for market authorization of the biosimilar to the DCGI.
  • The company also has to submit post-marketing surveillance data.

 The regulatory framework can be intimidating but it can be navigated by following a systematic process

  1. Market Authorization for Manufacturers;

As a manufacturer/sponsor, you have to submit an application using Form CT-21 to get Market Authorization.

A good application that will actually go through requires a range of documentation including:

  • Clinical and non-clinical Information
  • Manufacturing process
  • Pre-clinical studies
  • Administrative and Legal information
  • Chemical, Biological, and Pharmaceutical Quality Information
  • Product characteristics

When it comes to biosimilars, the guidelines are especially stringent. Market authorization is needed from a whole set of agencies such as:

  • Central Drugs Standard Control Organization (CDSCO)
  • Review Committee on Genetic Manipulation (RCGM)
  • Drug Controller General of India (DCGI)
  • Institutional Biosafety Committee (IBSC)
  • Genetic Engineering Appraisal Committee (GEAC)
  • Food & Drugs Control Administration (FDCA) and
  • Institutional Animal Ethics Committee (IAEC)

Not only do you need a whole range of permissions, but the reference innovator also needs to be registered in India. If it’s not registered in India, you should be able to prove that it’s already been marketed for 4 years in a well-regulated market.

What’s more, authorization isn’t granted in one step. First, you get pre-clinical trial approval, after which you receive clinical trial approval. Only after this can you apply for market authorization.

The challenges in the application process can often seem insurmountable — from the extensive details needed to the number of departments and steps that you need to follow. The good news is that things can get a lot simpler if you leave this process in the hands of an expert.

At CliniExperts, we provide end-to-end regulatory support for Biologicals — from multiple approvals to manufacturing license to post-approval checks. If you’re looking to kickstart your business without getting caught in a regulatory whirlpool, just reach out to us today.

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Call :  +91-767 20 05 050

  1. Marketing Authorisation For Importers

In order to understand the dynamics of market authorization for importers, we need to first understand the biopharmaceutical industry as a whole. The industry has been advancing rapidly in India in the past few years. It consists of two main aspects :

  • Innovator biologics
  • Similar biologics or biosimilars

Innovator biologics

For an innovator biologic, the rules are similar to any new drug:

  • The CDSCO (Central Drug Standard Control Organization, CDSCO) prescribes the information to be submitted for market authorization.
  • Form CT-18 is an application for permission to import or manufacture a new drug and it applies to innovator biologics.
  • The requirements for Chemical and Pharmaceutical information are as per the International Submission requirements of the Common Technical Document which has 5 modules — Administrative/Legal Information, Summaries, Quality Information (Chemical, Biological and Pharmaceutical), Non-Clinical Information and Clinical Information.

Given the levels of approvals and the documents required, getting market authorization for biologics can become a very long and cumbersome practice. A good way of avoiding wasting time in the regulatory complexity is to hire experts to sort the process out for you.

At Cliniexperts, we have years of expertise on the regulatory framework for Biologicals — including multiple approvals for marketing authorization, manufacturing licence, import and registration and assist in post approval changes. Our services are also subject to stringent quality checks, ensuring that the process is completely smooth and seamless for you.   

  1. Test license for manufacturers

Looking for a testing license to manufacture biologicals? Everything You Should Know

Perhaps you want to manufacture biologicals simply for the purpose of testing and analysis — you still need to get all the right permissions.

You can use Form 30 to apply for a test license. A test licence application is made to the Licensing Authority appointed by the State Government.  The validity of a test license is three years.

However, there are some conditions you need to keep in mind for such a license:

  • You can only use the drugs manufactured under this license for testing, analysis, and examination
  • Any inspector appointed under the Act can enter your premises without notice to confirm that only testing, examination, and analysis is being conducted
  • You need to keep a record of the quantity of the drugs being manufactured and to whom they’ve been supplied

What’s more, the application process itself can be quite arduous, taking up a lot of your time and attention that would be better spent in the more technical aspects of your work. It’s a good idea to simplify the entire application and post-license process by leaving it to experts. If you need help with getting a testing license, you can reach out to us at any time.

Book a consultation

Call : +91-767 20 05 050

 

  1. Import and Registration

Import of Biologicals: Everything You Need to Know

How to Get a Biologicals Import License 

Here’s what you need to know to get a biologicals import license in India:

  • The import, manufacturing, sale and distribution of biologicals is regulated under the Drugs and Cosmetics Act and Rules.
  • You need to fill Form 8 to obtain the license, which you will receive either in Form 10 or Form 10-A
  • An import license is valid for a period of 3 years from the date of issue unless it gets cancelled before that
  • You need to have a number of documents listed by the CDSCO (Central Drug Standard Control Organisation).

How to get a Registration Certificate for Biologicals

Apart from an import license, you also need a Registration Certificate to start importing the biologicals.

This Registration Certificate is issued by the licensing authority under Rule 27A, via Form 41. Not only do you need to register the biological that’s being imported, but also the manufacturing site that will be used. Like an import license, a Registration Certificate is also valid for 3 years from the date of issue.

You need to apply to the CDSCO (Directorate General of Health Services, Office of Drugs Controller General of India, Biological Division) for the Certificate in Form 40 with the following:

  • A treasury challan with the prescribed fees
  • All the relevant data and documents that the authority requires. This keeps changing from time to time.

Getting the Import License and Registration Certificate for biologicals can be a very long and cumbersome process. It becomes especially arduous when your application gets rejected and you’re not sure why. It’s a really good idea to take the help of experts and make this process as simple and hassle-free as you can. If you need expert assistance, you can reach out to us at any time and we’ll be happy to help.

Book a consultation

Call : +91-767 20 05 050

References

https://www.cdscoonline.gov.in/CDSCO/oldhomepage

https://morulaa.com/cdsco/regulation-of-biologics-in-india-2/

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