The pharmaceutical sector in New Delhi is experiencing rapid growth and innovation. For those entrepreneurs and Marketing agencies that would like to enter this market; setting up their own manufacturing plant that has attained a WHO-GMP certification can be quite expensive thus making it difficult to enter the industry. Generating your product through the use of a Loan License will allow you to leverage another company’s infrastructure (as an example: Supermax Laboratories) to manufacture and sell your products without having any brick and mortar overhead cost. In addition, this article will explore how loan licenses are legally administered for drug manufacturers in New Delhi and how partnering with Supermax Laboratories may be advantageous for any new company that wants to enter the market.
What is a Loan License?
A Loan License is a type of regulatory provision under the Drug & Cosmetic Act of 1940 and the associated rules (1945). A Loan License will allow a company (the loan licensee) that does not have its own manufacturing facility to manufacture drugs using the spare capacity of a host company and its machinery, equipment, and personnel. The Department of Drugs in the Government of the National Capital Territory of Delhi administers the Loan License process in New Delhi. For companies that are focused on building and expanding their brands, marketing, and distributing their products the Loan License option is advantageous because the Loan License shifts the burden of technical and infrastructural compliance to the Host Manufacturer.
Securing a loan license can be difficult and time-consuming.
It often requires extensive documentation and a formal agreement with an entity that is legally licensed to manufacture (i.e. has obtained and possesses a manufacturing licence from FDA/Delhi). This may involve the following steps:
Identify a Host Manufacturer: The first step in obtaining a loan licence is to identify a host manufacturer that has a valid manufacturing (Form 25 or 28) and has met the requirements of Schedule M (Good Manufacturing Practices (GMP)). Supermax Laboratories with manufacturing facilities in Delhi and Uttarakhand is a good choice for this type of host manufacturer.
Document Your Application:
Generally speaking, when applying for a loan licence you will use either Form 24-A (Non-biological drugs) or Form 27-A (Biologicals/Schedule C drugs).
A few examples of the required documentation include:
Consent Letter: A letter from the host manufacturer (Supermax Laboratories) indicating their ability to manufacture your product.
Site Plan and Blueprints:
A copy of the approved site plan and blueprints of the manufacturing facility
Technical Personnel:
List of individuals performing production and quality control functions during the manufacturing process
Constitution of the Firm:
Memorandum and Articles of Association, Partnership Deed, or GST Registration of the applicant.
Product List:
A list of all of the various types of formulations (e.g. tablets, capsules, syrup) that will be manufactured.
Evaluation and Approvals
Upon submission of your application to the Delhi Drugs Control Department, it is then evaluated by a Drug Inspector who conducts an on-site inspection of your host facility, to confirm that both the equipment and testing instruments will be sufficient for the new increased production capacity. Once satisfied with the results, a Loan License may be issued (ie. Form 25-A or Form 28-A); typically valid for 5 years.
What Makes a Good Partner
The choice of host is critical, as the quality of your brand hinges on the compliance standards of your host. Supermax Laboratories is an established leader in the contract and loan licensing manufacturing space for the following reasons:
Compliance and Accreditations
Supermax Laboratories operates with WHO-GMP, ISO 9001:2015, and FSSAI certified facilities; therefore their strict compliance with all global standards means any drugs produced under their roof will meet the safety & efficacy benchmarks set forth by the multiple international authorities who govern those measures.
Extensive Range of Manufacturing Capabilities
Whether you are seeking to launch a line of basic medicines or specialty treatments, Supermax has a large range of different options available to meet your needs, such as:
Oral Solids: Including coated/uncoated tablets, orally dissolved, and chews.
Capsules: Including hard gelatin and custom versions.
Liquid Orals: including Syrups and dry syrups.
International Reach: As a major exporting manufacturer, will also provide you with the necessary documentation (Dossiers and COPP) so you can easily export your products.
SuperMax laboratory tests incoming and outgoing raw materials and finished goods with the best analytical instruments. There are also chemists and pharmacists involved to guarantee that each “SuperMax” product is made to a requirement of the original color, shape and formula from starting material through finished product.
Advantages of the Loan License Route
| Feature | Benefits |
| Cost Efficiency | No need for massive investment in land, building, or high-end machinery. |
| Speed to Market | Use an existing, approved facility to start production in weeks rather than years. |
| Focus on Growth | Delegate the “headache” of manufacturing and lab maintenance to experts while you focus on marketing. |
| Regulatory Support | Partners like Supermax assist with the technical documentation required for license filing. |
The Future of Pharma in Delhi
Advances will be made through better communication between the government and industry, which is why the Delhi government has established the OSLA system (online license for Applications). Once implemented, obtaining and renewing a license will be much easier than before, and for entrepreneurs wanting to get started, this creates a great business climate, supported by the high quality manufacturing capabilities of Supermax Laboratories*.
Conclusion
SuperMax License is not simply a regulatory piece of paperwork – it is a strategic link between your business idea and your actual product; by teaming up with an experienced and well-respected manufacturer such as Supermax Laboratories, you are ensuring your product is based on quality, integrity and state-of-the-art technology.
Should you wish to pursue your pharmaceutical company in Delhi, continue following the direction of excellence while complying with all applicable laws, and allow Supermax Laboratories the opportunity to put together your company according to science while you create your business according to art.
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