Licensing is mandatory to do business in Drugs & Cosmetics in India. The provision for this has been made in Drugs & Cosmetics Act, 1940 which extends to whole of India. It is an Act to consolidate the laws relating to drugs & cosmetics, which establishes the Drugs Control Department. It is a regulatory authority to regulate manufacture of drugs & cosmetics and storage, distribution, sales of drugs. In 1964, the Act was amended to include Ayurvedic & Unani drugs. However based on the business transactions a particular business may require different types of drug licence, you may contact us for consultancy on it.

Basic features of Drug Licence in India

  • It is mandatory for drugs & cosmetics business
  • Licences for the sale of drugs can be granted in the commercial premises or other premises independent of residence.
  • Every drugs & cosmetic business needs to comply with the conditions of licence
  • Licence shall be displayed at the prominent place of premises

Drug Licence is mandatory for drugs & cosmetic business. There are different types of drugs licence depending upon type of activities. Before making an application to Drugs controller, the applicant should ensure that they submit the correct application forms along with the necessary documents as per the checklist or guidelines of Drugs & cosmetics Rule. Applicant should contact the duty officer before depositing application for the drug licence at the mail receipt counter of Drug Control Department for any guidance or any necessary information.

Classification of Drug Licence

Drug licence is classified under different categories. These are Manufacturing Licence, Sale Licence and Loan licence. Licence to manufacture allopathic/ Homeopathic medicines/ and cosmetics and also to repack Drugs can be granted only in the recognised Industrial areas of Delhi. Sale licence is further classified as wholesale Licence, Retail Licence and Restricted (Gen.Store) licence depending on the manner in which sales is done. Whereas loan licence is the licence issued to the applicant who intends to avail the manufacturing facilities owned by another licensee.

In case a business is operating in more than two states, it has to obtain drug licence in every state in which business is being carried on. Drug licence is location specific. If drugs are sold or stocked for sale at more than one place, separate application shall be made, and separate license shall be issued, in respect of each such place except migrant vendors. However, based on the business transactions a particular business may require a particular type of drug licenses, you may please contact us for consultancy on that.

Once the licence is granted to the business, all such Licensee must ensure that all the condition in the drug licence are complied at all the time during the course of the business. All the records /registers /Forms must be maintained in the manner specified by the licensing authorities and authorities shall be kept informed for all the changes or modification in the business activities.

Import of Drugs in India

Drugs and Cosmetic Act aims at ensuring safety, effectiveness and conformity of the drugs and cosmetics sold in India to the state quality standards. Drugs & Cosmetics Act specifies the drugs in different schedules. Import of the drugs specified in schedule X and those drugs not specified in Schedule X require the import to seek the import licence.

A single licence may be issued, in respect of the import of more than one drug or class of drugs manufactured by the same manufacturer but if a single manufacturer has two or more factories situated in different places manufacturing the same or different drugs a separate licence shall be required in respect of the drugs manufactured by each such factory.