Drugs and Cosmetics

Overview of Drugs and Cosmetics licence

In India, the Drugs and Cosmetics Act, 1940, regulates the manufacturing, and sale of drugs and cosmetics. A Drugs and Cosmetics licence is a mandatory requirement for individuals or entities involved in these activities. The licence ensures that drugs and cosmetics are safe, effective, and of standard quality. There are different types of licences depending on the nature of the business, such as manufacturing licence, sale licence, wholesale licence, and import licence. The licensing process involves submitting an application to the State Drugs Control Authority or the Central Drugs Standard Control Organization, depending on the jurisdiction, along with the required documents and fees. It is essential to comply with the regulations and guidelines set by the authorities to obtain and maintain a valid Drugs and Cosmetics licence in India.

Procedure to apply for

Tamil Nadu Drug licence

Write a covering letter stating the purpose of the application to the Assistant Director of Drugs Control in Tamil Nadu.

Attach a court fees stamp of Rs. 2/-.

Submit a licence copy.

Visit the Directorate of Drug Control in Tamil Nadu.

Submit the applicable document from the list provided by the authority.

Pay the fee for the licence in the format accepted by the authority.

Consult with the respective drug licence authority for your area to prepare fees requirements.

Wait for the SMS alert from the authority.

Finally, a drug licence online download is possible at e-Seva Centre after receiving the SMS alert.

Documents required for drug licence in Tamil Nadu
  • Covering letter stating the purpose of the application to the Assistant Director of Drugs Control in Tamil Nadu.
  • Court fees stamp of Rs. 2/-.
  • licence copy.
  • A challan of ₹ 3,000.
  • Owner's affidavit on 20-stamp paper.
  • Education certificates must be self-attested.
  • Property tax receipt/sale deed copy of the building - Xerox copy duly attested.
  • Affidavit in original by a pharmacist/competent person on Rs. 20/- stamp paper, signed by a Notary Public.
  • A blueprint of the premises' plan, signed by a licenced engineer and the applicant.

Frequently Asked Question

How can I get a drug licence in Chennai?

To obtain a drug licence in Chennai, you need to apply to the State Drugs Control Administration and meet their requirements. The process involves submitting an application form, paying the necessary fees, and undergoing inspections of your premises and records. 

How do I get a drug licence in Tamil Nadu?

It is a common question among those who wish to start a pharmaceutical business. It is important to note that the State Drugs Control Administration has strict regulations in place to ensure the safety and efficacy of drugs sold in the state. Therefore, it is essential to comply with all the requirements and maintain high standards of quality control. 

How much does a drug licence cost in India?

The cost of a drug licence in India varies depending on the type of licence and the state in which it is being obtained. It is important to consult with the State Drugs Control Administration or a legal professional to determine the exact cost and requirements for obtaining a drug licence. 

What are the licences required under the Drugs and Cosmetics Act?

To operate a pharmacy, you need a retail drug licence, and anyone dealing in the wholesale of pharmaceuticals and other drugs needs a wholesale drug licence. A cosmetic licence is required for anyone who manufactures or imports cosmetics.

Who is eligible for a drug licence in India?

To be eligible for a drug licence in India, the applicant must have a degree in pharmacy or pharmaceutical sciences and must comply with the regulations set forth by the Drugs and Cosmetics