Drug License
Finlegal Forte offers comprehensive assistance in obtaining Drug Licenses for manufacturing, sale, and distribution of pharmaceuticals. Our experts ensure compliance with regulatory requirements, enabling businesses to operate legally and efficiently.
Drug License - An Overview
Securing a drug license is essential for any business involved in the manufacturing, distribution, or sale of drugs and cosmetics in India. Regulated under the Drugs and Cosmetics Act, 1940, this license ensures compliance with safety and quality standards. A separate license is needed for each state and location of operation. The term “drug” includes all types of medicines and medical devices—Allopathic, Ayurvedic, Homeopathic, Unani, Siddha, and more. These are regulated either by the Drug Controller under the Ministry of Health or the AYUSH department. The license helps prevent misuse of drugs and is mandatory for pharmacists, manufacturers, wholesalers, retailers, importers, and traditional medicine providers. Along with a drug licensed, businesses must also obtain a trade license and register under the Shop and Establishment Act. Finlegal Forte simplifies the complex registration process by offering expert support to ensure full legal compliance.
The following groups are typically required to secure a drug license to operate legally within the pharmaceutical and healthcare sectors:
- Pharmacists: Professionals authorized to prepare, dispense, and advise on pharmaceutical drugs, ensuring their safe and effective use by having pharma license.
- Wholesale Distributors: Businesses involved in bulk purchasing and distributing drugs to various retail outlets or other organizations.
- Retailers: Businesses that sell drugs directly to consumers, providing the final link in the supply chain between the manufacturer and the end-user. These entities must obtain drug license along with medical store license.
- Manufacturers: Companies or individuals producing pharmaceuticals and cosmetics, including formulation, compounding, packaging, and labelling.
- Drug Sellers and Dealers: Individuals or entities engaged in the commercial trading of pharmaceuticals and cosmetic products. They must have both drug and pharmacy license to carry out the operations legally.
- Importers: Companies or individuals who import drugs, cosmetics, and traditional medicines from abroad, ensuring these imported items comply with the local regulatory requirements.
- Ayurvedic, Siddha, and Unani Drug Providers: Entities dealing in traditional Indian medicinal products, also regulated under the Drugs and Cosmetics Act need to have pharma license.
cLASSIFICATION OR tYPES - DRUG LICENSE
The following groups are typically required to secure a drug license to operate legally within the pharmaceutical and healthcare sectors:
- Manufacturing License: Needed for companies that make pharmaceutical products, whether allopathic or homeopathic. It’s mandatory for anyone producing drugs.
Sale License: Required to sell drugs and comes in two types:
Wholesale Drug License: For businesses that sell medicines in bulk to other businesses, not directly to customers.
Retail Drug License: For shops and pharmacies that sell medicines directly to consumers, hospitals, or dispensaries. Selling without this license is illegal.
Loan License: For companies that don’t have their own manufacturing unit but use another licensed manufacturer’s facility to make their products.
Import License: Needed for importing medicines into India, either for resale or further processing. It ensures imported drugs meet Indian quality standards.
Multi-Drug License: For businesses running pharmacy chains in multiple states under the same name. It helps streamline the licensing process across all locations.
Documents Required for Drug lICENSE
The documents required for a drug license vary depending on the type of business and the regulatory authority
However, some of the most common documents include:
- incorporation certificate of the company
- KYC documents of each director, partner, or proprietor
- Proof of premises, such as a rent agreement, electricity bill, or property tax receipt
- Site plan
- List of drugs with product sheets in a specified format, including the composition formula
- Ownership details of the brand of cosmetic, whether it is registered or under a trademark
- Manufacturing process description with flow diagrams
- Method of analysis of products
- Copies of BIS (Bureau of Indian Standards) certificates, where applicable
Frequently Asked Questions
The form used to apply for a license to manufacture new drugs is Form 44. The form must be submitted to the Drugs Controller General of India (DCGI).
The form used to grant a license to manufacture new drugs is Form 46. The form is issued by the DCGI.
The purpose of a license to manufacture new drugs is to ensure that the drugs are manufactured in a safe and controlled environment. The license also ensures that the drugs meet the required standards of quality and efficacy.
The other forms used to apply for licenses related to drugs are as follows:
- Form 40: Registration Certificate for registration of the premises and the drugs manufactured by the manufacturer meant for import into and use in India
- Form 8: License to import drugs excluding those specified in Schedule X
- Form 8A: License to import drugs specified in Schedule X
- Form 12A: License to import small quantities of drugs for personal use
- Form 12AA: License to import small quantities of new drugs by a Government Hospital or Autonomous Medical Institution for the treatment of patients
- Form 12AA: License to import drugs by a Government Hospital or Autonomous Medical Institution for the treatment of patients
- Form 29: License to import or to manufacture drugs for the purpose of examination, test or analysis
- Form 19AA: License to sell, stock or exhibit or offer for sale by wholesale or distribute drugs from a motor vehicle
- Form 19-B: License to sell, stock exhibit or offer for sale or distribute Homoeopathic medicines by retail or wholesale
- Form-19 or Form 19A: Restricted licenses to dealers or persons in respect of drugs whose sale does not require the supervision of a qualified person
- Form 19-C: A License to sell, stock, exhibit or offer for sale or distribute drugs specified in Schedule X by retail or wholesale
- Form 24: License to manufacture for sale or for distribution of drugs other than those specified in Schedules C and C (1) and X
- Form 24A: Loan License to manufacture for sale or for distribution of drugs other than those specified in Schedules C and C (I) and X
- Form 24B: License to repack for sale or distribution of drugs, being drugs other than those specified in Schedules C and C (1), excluding those specified in Schedule X
- Form 24C: License to manufacture for sale or for distribution of Homoeopathic medicines or a License to manufacture poetised preparations from back potencies by licensees holding License in Form 20C
- Form COS- 1: Registration certificate for import of cosmetics into India
- Form COS- 4: Import Registration Number for Import of already registered cosmetics
- Form COS- 5: License to manufacture cosmetics for sale or for distribution
- Form COS- 6: Loan license to manufacture cosmetics for sale or for distribution