Drug License registration for manufacturers | Fees, Procedure and Documents Required

• Must have a qualified or competent person
• Proof of premises
• Detail of machines
• Invoice of all necessary types of equipment

These are the prerequisites that are required to start a drug manufacturing business in India.

Classification of products under drug and controller act

Drugs are classified under the following categories.

• Medicines
• Health Supplements
• Nutraceuticals

The professional fee for manufacturer drug license with us is INR 49,999/- only. Applicants are required to pay a government fee during the registration process as required respectively.

There are several benefits of a registering One Person Company in India, which are discussed below:

• Legal Compliance: One of the primary benefits of acquiring a drug license in India is that it ensures legal compliance. The Drugs and Cosmetics Act, 1940, mandates that anyone involved in the manufacturing, distribution, or sale of drugs and pharmaceutical products must hold a valid drug license. Failing to do so can result in legal consequences. By obtaining the necessary license, you demonstrate your commitment to operating within the bounds of the law.
• Quality Assurance: A drug license registration in India involves a rigorous evaluation of the products and the facilities where they are manufactured or stored. This scrutiny ensures that the drugs being produced meet specific quality standards. As a result, consumers can have confidence in the safety and efficacy of the pharmaceuticals they purchase, which is vital for any healthcare-related business.
• Consumer Trust: Consumers tend to have more trust in products that are legally approved and regulated. Having a drug license displays a commitment to quality and safety. It can significantly enhance your brand's reputation and help you build trust with your customers, which is especially important in the pharmaceutical industry.
• Market Access: Many government tenders, hospitals, and medical institutions require suppliers to have a valid drug license. Without it, you may miss out on lucrative business opportunities. By obtaining a drug license, you can expand your market reach and access a broader customer base, including government and institutional buyers.
• Export Opportunities: If you have aspirations to export pharmaceutical products, a drug license is often a prerequisite. International markets demand strict compliance with quality and safety standards. A drug license can facilitate your entry into global markets, making your business more competitive.
• Regulatory Support: Obtaining a drug license means you are part of a regulated industry. This can provide you with access to regulatory support and updates on industry best practices. Staying informed about changing regulations is crucial in the pharmaceutical sector, and a drug license keeps you in the loop.
• Business Credibility: In a highly competitive industry like pharmaceuticals, credibility is everything. Having a drug license adds a layer of credibility to your business. It assures partners, investors, and stakeholders that you are a legitimate player in the market.
• Risk Mitigation: Operating without a drug license carries the risk of product seizures, legal penalties, and damage to your business's reputation. By obtaining a license, you reduce these risks and ensure the smooth operation of your pharmaceutical business.